hard effort that you make. >> thank you. >> appreciate your work. thanks so much, mr. chairman. >> thank you, senator. thank you, commissioner, too. just curious, you know, you started out under one administration, you said during your confirmation period you wanted to serve your full six-year term, be independent, just do your work. your thoughts now as you're near the end of your term? >> well, thank you, mr. chairman. um, it's been a very interesting experience to straddle administrations really, i think, for the first time as kind of a constitutional experiment. i want to give credit to the administration, i think, for trying to approach what i'm sure was not what they wished would happen in a good spirit, and i've tried to respond in kind. so i think it's actually worked pretty well. since you've asked, i'll be honest, i'm not sure in the

construct of washington today that we can count on it to work well going forward. so even though it's worked well this time, i think it's something you ought to keep in mind and think about for the future. um, it's been an extraordinary, i'm in my sixth year now. it's been extraordinarily rewarding, extraordinarily draining. i'm very grateful to president bush for having given me this opportunity. i'm very grateful to this committee for having given me this opportunity. um, it's an incredible group of people the try to lead. the dedication to mission is remarkable. almost everybody comes right out of high school or college and spends their career with the agency. it's the kind of thing, it's

remarkable, i worked for a commissioner in the mid '80s and, of course, you know, everyone thinks about what they would actually do if they could have the boss' job, and i certainly did in the '80s, but i never thought i would have the chance to do it. so it's been a great blessing, um, to have that opportunity. and again, thank all of you because i was thinking about this on the way up, this is probably my last appearance actuarially -- >> six more years? >> no, i don't think so, senator. i think it's time for me to go home to massachusetts. but, um, i started working with this committee as a very young person in 1985 and really did get to know, um, senator moynihan, senator dole quite well in that period, some first-class staff people, the

committee treated me extraordinarily well when i was confirmed in 1989. and it has been in the same spirit since. and the two of you have been spectacular. senator grassley was spectacularly helpful too when he was ranking. the staffs worked much more collegially than is common in the congress these days. so i guess i feel blessed, um, all the way around. >> well, we're sure blessed to have you working for us, and especially the american people are blessed to have you working for the american people. you set a very good tone of collegiality and cooperation and work together. you're a good role model, and it's something that we're -- i'm going to keep in mind throughout the years, remembering you and all the good work you've done. >> thank you. >> thank you. hearings' adjourned.

[inaudible conversations] >> the u.s. senate meets this afternoon at 2 ian. senators -- eastern. senators will continue a bill to continue a bill to pay for fda's review of prescription drugs and medical devices. also today an appeals court judicial nomination, and we'll have live coverage of today's debate here on c-span2. and president obama is in chicago for the final day of meetings with nato leaders. he'll be holding a news conference, a closing news conference in chicago at 4:30, and you can watch live coverage of that over on our companion network, c-span. secretary of state hillary clinton now on global food security and a $3 billion initiative aimed at alleviating hunger and poverty in africa. secretary clinton's half hour

presentation was part of an event hosted by the chicago council on global affairs here in washington d.c. [applause] >> good afternoon. i'm from the federal government and and here to help you. [laughter] yeah, good. got the right crowd. i don't know what to say when no one laughs. [laughter] no, i'm really, i was telling director shaw, i think i've spent maybe one friday a year in washington, and this is a or worthy cause -- this is a worthy cause. the lady i'm about to introduce, a little pressure on me here because i don't want to ruin a promising political career. [laughter] i hear she -- 2016 will be here before you know it. [laughter]

she's going like this, yeah. [laughter] anyway, at the risk of ruining a career, i'm going to say nice things about her, and people out there listening, don't hold that against me either. [laughter] on our side. the reason i'm here is africa will bite you if you go, do you agree? once you go and you see things up close and personal and from a role model perspective as a republican, i do appreciate the kind introduction from the former secretary of agriculture. but george w. bush is a good role model for any republican who wants to be involved in africa. and president bush's legacy when it comes to africa is a good one, is something i think republicans and democrats should try to follow. and i just want to publicly recognize that president bush started some great programs, president clinton and president obama.

we've tried to make this bipartisan, but there are a lot of young children alive today because of the work of the bush administration, the obama administration and the clinton administration. but when you go to africa, it just jumps out at you that we abandoned the continent at our own economic and national security peril. when you go to africa, you see that a little bit of money well spent goes a long way. in washington a lot of money doesn't go anywhere. [laughter] except could down a hole, it ses like. but director shaw is, i think, a good example of a public servant who has taken a business approach to a very difficult job trying to incorporate the private sector, and the purpose of this exercise today is that for the people like me in the government, secretary clinton and director shaw, is to let you know the private sector, the faith-based community, the gates foundation, one foundation, the

private sector, entrepreneurial businesses in america that we cannot do this without you. that the public dollars being spent, i think, are being well spent. director shaw has really been very good at reorganizing usaid. secretary clinton, if we paid her by the mile, we would -- well, we're bankrupt. we'd just be more bankrupt. [laughter] i've never known someone so passionate about her job, but she along with director shaw have looked at all the programs, particularly the food security programs, to make sure the american taxpayer is getting their value when it comes to helping africa. and to my republican colleagues who have been supportive of the foreign operations account, i know when you're this deep in debt, republican and democratic members of the congress have a hard time going back home and explaining to their constituents the money we're investing in africa when we're so broke here at home.

well, the foreign assistance account is less than 1% of our budget, and i embrace the idea that america is one of the leading voices if not the leading voice in the world for good. i accept that is our destiny. when it comes to africa, there are three goals that i have for our nation. one, to create jobs in america. 85% of the continent has no power. one day they will. let it be american power companies and american entrepreneurs. the ability to feed africa is very much at a tipping point. to our european allies, please, be more open-minded about modern food and agricultural practices. [applause] please. [applause] and, secretary clinton has been a champion of trying to open the door to africa so that we can increase our food yields by, you know, embracing farming practices that are in the 20th century, forget about the 21st. and africa is ready to move

forward, a lot of energetic people. we're turning the corner on malaria, we're turning the corner on aids and the ability to feed and sustain the nations in africa is going to be a good business opportunity for this country. our european allies and friends, please, open your mind and hearts to better farming practices. the other issue is i don't want to give the whole con innocent over -- continent over to the communist chinese. [laughter] i want to be able to compete for the hearts and minds in africa and create jobs for americans, but our chinese friends are all over africa taking more out than they give back. and quite frankly, i would like to have a policy where we can engage the continent and have a alternative to some of the chinese business practices that are being offered to the african, the continent of africa. and the last thing that i would

remind people in my business is if you abandon places in africa, other people will fill in the vacuum. radical islam is raring its ugly head throughout africa. and if we can engage different -- the continent and countries within the continent in a more businesslike fashion, in a win/win fashion where you allow young girls to go to school and people can feed themselves, sustain themselves, create an economy, the worst nightmare for these radical islamic movements is a good education and a good job. that's worth 100 brigades. we've been involve inside two very long wars in iraq and afghanistan, the money that we've set aside in our national budget for africa we're getting a good return on investment. and if you believe as i do that

there's got to be more answers to fighting radical islam than using military force, i would argue the account that we're talking about here, the food security program, feed the future, will do more to combat radical islamic terrorists than any military engagement strategy we could come up with. [applause] so we can't afford not to be involved in africa. it would be a very short-sighted policy for the united states not to be involved with the private sector. now, as to the private sector, the amount of money we have at the federal level for africa is about $8 billion. the amount of money to be made helping the african people is hundreds of billions of dollars. the number of jobs to be created in america helping the african continent is millions of jobs.

and we need you. we need you more than ever. so this partnership that we're talking about today is the future. no more money to dictators. money goes to people, and through the private sector it's going to get its best rate of return. now, my job was to and is to introduce secretary clinton. all i can say is that if you had to pick a person to tell the american story in africa or anywhere else -- and god knows we have our political differences, i have to say that. [laughter] for her own sake and mine. [laughter] but here's where we have a lot of commonality. she's dedicated to her job, she loves her country, and she understands the issues, and there are a lot of them in her

job to understand. but more importantly, i think she is a good role model for young people, not just women -- [applause] who look to america for leadership and hope. so on behalf of all of us in the united states, it is my great pleasure to introduce one of the most effective secretary of states, greatest ambassadors for the american people that i've known in my lifetime, secretary hillary clinton. [applause] >> oh, thank you all. thank you. thank you.

well, that was really a wonderful introduction from someone who i've had the great pleasure of working with on a number of important issues and am delighted to be working so closely with senator lindsey graham again as he is the ranking member on the foreign operations subcommittee of the senate appropriations committee, and i'm so appreciative of his strong support of america's development and diplomatic efforts around the world. we prommed him that we would -- we promised him that we would seize and erase all tapes of what he has just said. [laughter] so don't take it personally, any of you in the press, but this is to protect him going forward. [laughter] well, this has been an amazing day, and, um, i'm all that stands between you and getting out into this absolutely

beautiful afternoon and enjoying some of the sights that washington has to offer. but i wanted to come to close out the formal part of the program to express great appreciation, first and foremost, to the chicago council, in particular catherine bertini and dan glickman for bringing us all together today, to our very special guests, the heads of state and government. from tanzania, ethiopia and ghana. and to tell you how exciting it is that we have this partnership at the highest levels with the countries that you represent here at this conference and for the months and years ahead. i also want to thank raj shah and his great colleagues at

usaid. raj has led a tireless effort on behalf of advancing food security worldwide along with the wonderful help of people not only here in washington, but in our posts and missions across the globe. thanks to our g8 partners. i see representatives from the secret countries here -- g8 countries here. thank you for your commitment to food security, for the great work that started in la quila and has continued forward to here in washington. and thanks to all of you in the private sector, the not-for-profit sector, in the academic world, in the faith community, in the agricultural/productivity and research world. thank you all. and this has been a real diverse conference. not only heads of state and

government and foreign ministers and aid workers and health experts and businessmen and women, but we had at least one rock star. i have it on very good authority. [laughter] and although we hail from different regions and hold different points of view as senator graham said about his and my perspectives, on this we all agree: the need to drastically decrease hunger and poverty worldwide and strengthening global agriculture is a powerful way to do that. now, it wasn't long ago that a symposium on food security would have drawn a very different crowd, because for years passionate and persistent advocates made the case that this issue needed to be on the development agenda of every nation. well, the united states listened, the g8 countries listened, and now it's a

signature issue. billions of dollars have been pledged by the world's largest economies, and those pledges are being met. the g20 has embraced this mission, so has the world bank and the african union. and 30 african nations are creating national agricultural investment plans and revising their budgets to making ature a leading priority -- agriculture a leading priority. now, in the united states we've created our own global food security initiative, and as you were able to hear directly from president obama earlier today, feed the future is at the forefront of our global development agenda. now, we took on food security right out of the box in this administration because the facts were so compelling. yes, it's a complex, far-reaching issue. but it comes down to a couple of very key facts. nearly a billion people worldwide suffering from chronic

hunger. by the year 2050, the global population will climb to nine billion, and the world will need to produce 70% more food than we do today. just to feed everyone. 75% of the world's poor live in rural settings and depend on agriculture for their livelihoods. now, there are many other facts, i -- but i think these three are sufficient not only to make the case, but to add up to a tremendous opportunity. because if we can help the rural poor produce more food and sell it in thriving local and regional markets as well as on the global market, we can decrease chronic hunger today, we can build an ample food supply for tomorrow, we can drive economic growth in places where poverty is persistent, and we can have better futures for men, women and children.

now, i think what we are seeking to do through our investments in global agriculture is not just to solve the problem of hunger. we also want to solve the problem of extreme poverty. and agriculture, in our opinion, may be the best intervention point to do that. development dollars spent on agriculture have the greatest impact on poverty reduction. more than money spent in any other sector. so if we want to make big gains in the fight against poverty, agriculture is the best way to do that. and there is no place that that is more true than in africa where there is such great potential for gains in agricultural productivity. so together african governments, donors, international organizations, the private sector and civil society can close the productivity gap and feed many more people.

now, having said that, agriculture development can deliver strong results. i have to admit the goals we have set for ourselves are very ambitious. they need to be. the countries that we are supporting are trying to transform how people farm, what people eat, how crops are stored and sold. and that is not easy. some of the changes they seek will take years, perhaps even generations to lock into place. so we need to have the foresight and to stay committed to this mission. many worthy ideas have been shared here today about what should come next in the global fight for food security. and i want to emphasize three issues that i believe deserve our particular attention. all three are areas in which progress is both urgently needed and well within our reach.

and and all are priorities of the new alliance for food security and nutrition that president obama announced this morning. the first is a centerpiece of this symposium. partnering with the private sector. as president obama said earlier, the new alliance includes a major push to mobilize more private sector investment and involvement. now, part of the reason for that is simple math. consider the 30 african countries that have created or are now creating comprehensive national agriculture investment plans. when we looked at a their own spending even in those countries that have met the goal of allocating 10% of their national budget to agriculture, and then when we add to that the pledged support from development partners like the members of the g8, a significant gap still

remains. because governments alone cannot supply all the investment needed to transform agriculture. we need the private sector. now, that's not only true of agriculture, private investment has become invaluable to development across the board. in the 1960s official development assistance from governments and multilateral organizations accounted for 70% of capital flows going into developing countries. but today that number has fallen to just 13%. and that's not because public assistance has gone down, it's because private investment has skyrocketed. thousand we need to drive more of that investment toward agricultural growth. and beyond investment the private sector has a great deal

to offer in terms of skills and expertise. whether it's improving the supply chain to insure crops aren't spoiled on their way to market as premium foods is doing in ghana, or training growers in certified seed production like is being done in tanzania, or expanding the production and processing of highly nutritional foods like chick peas and soybeans as is being done in ethiopia. businesses often know how to do important things better and more or cost effectively than anyone else. african countries are taking the lead on cultivating private sector involvement. they are reforming their policies to make their economies and agricultural sectors more attractive for both domestic and international investment and private sector activity. their partners can support this by launching our own innovative

collaborations with businesses, both local and international. now, i do realize that not everyone welcomes wholeheartedly the notion of more private sector involvement. and let me be clear that while global corporations play an irreplaceable role, we want them to prosper alongside local business, not at their expense. private sector activity must start with the small holder farmers whose future prosperity is the focal point of all our efforts and then expand outward from there. furthermore, i know that some worry that by asking the private be sector to step up, governments are hoping that gives us the excuse to scale back. well, i want to say as clearly as i can that the united states

is in this for the long run, and we ask others to hold us accountable as we will do the same in turn. and we believe accountability must apply to our private sector partners as well. but private sector activity is the only lasting basis for self-sustaining economic growth. and ultimately, after all, isn't that our goal? the second topic i want to emphasize is nutrition. in recent years we have learned that improving access to food does not automatically lead to improved nutrition. neither does raising incomes, nor creating new markets. what leads to improve nutrition is focusing on nutrition itself and integrating it into all our food security initiatives. nutrition is just too important

to be treated as an afterthought. children's entire lives are shaped by whether they receive enough of the right nutrients during those crucial 1,000 days from pregnancy to second birthdays. and this in turn heavily influences whether a country will have a healthy and educated work force. so when we overlook nutrition, we set ourselves up for a less healthy, less productive, less prosperous future. two years ago during the annual meeting of the u.n. general assembly i joined international leaders including secretary general ban ki-moon, the foreign minister of ireland and others in if announcing announcing the' partnership in support of the scaling-up nutrition movement known as s.u.n.. that was the first time foreign ministers had gathered to focus squarely on nutrition as a

critical development priority. and can since then a growing number of countries have committed to improving nutrition. twenty-seven countries have committed to taking action through the s.u.n. movement, and i urge more countries to join because we have proven solutions to the problem of under and malnutrition. and let me also say that undernutrition is not just a problem facing only developing countries, we're struggling with it in the united states. and we have plenty of food. but many people, including far too many children, are not eating nutritious foods. they're eating, but they're not eating in a way that improves and sustains their health. and they are increasingly facing serious health problems. in chicago on monday while the nato summit is underway, there will be a 1,000 days summit to

focus on the problem of child underknew tradition. not only abroad, but here at home in cities like chicago. mayor rahm emanuel is taking on the so-called food deserts as a public health priority. because this problem of undernutrition cuts across all borders and all incomes. the united states has set an ambitious nutrition target within feed the future. we aim to reach seven million children within five years to prevent stunting and to increase child survival. i think we have the capacity to reach even more, and the if we all work together -- if we all work together, we can set a global target. the third issue i want to emphasize is gender equality. i'm sure it's no surprise to anyone that i am convinced women are critical to our success in every field of endeavor, and this is not a matter of

sentiment or personal interest on my part. this is also, actually, a fact- based, evidence-based statement. [applause] it has been said that -- [applause] .. part of a deliberate,

determined strategy that takes gender equality into account across everything we are doing. and the results speak for themselves. the fao estimates that if women farmers had the same access to productive resources as men, seeds, credit, insurance, land title and so on, they could increase yields on their farms by 20 to 30% and that in turn could raise total agricultural output so much it could reduce the number of hungry people worldwide by up to 150 million. now the obstacles that stand in the way of women's equal access to resources in agricultural or anything else are unfortunately formidable. they include laws, deeply-held traditions, lack of information, plain old

inertia. and we have to overcome each and everyone of them. we can't just hope that women get the support they need as a side-effect of our works. we have to push for it and it's not optional. it is not marginal. it is not a luxury. it is not expendable. it happens to be essential or we will never reach our goals. the united states has integrated gender equality throughout the future and we will do the same with the new alliance for food security and nutrition. we created new tools like the women's empowerment and agricultural index to mesh is sure our impact and we look to our partners to help us through this broader effort. when we liberate the economic potential of women we elevate the economic performance of communities, nations, and the world. so the work we're talking about today will require all of us to change how we do

business. now that's not always easy. i've seen that first-hand at the state department and us aide. give you -- usaid. i strucked our ambassadors in the many parts of the world to take on agricultural issues, not something that our typical ambassadors know a great deal about but they have educated themselves about land reform and export bans and fertilizer subsidies. they have gone out and worked closely with our partners to help them achieve their goals. no institution is easy to change. some of you know that all too well. but the state department and usaid have changed for this issue because we are so convinced of its overall importance. and we will all have to change and change again to keep moving forward. but if we continue to align our investments and resources, find

opportunities for partnership, share news of our progress and share the lessons from our mistakes, and hold each other accountable, i absolutely belief we will succeed in significantly decreasing hunger and poverty worldwide. if the past 3 1/2 years i have been privileged to serve as secretary of state i have traveled to nearly 100 countries and many i met with farmers and agricultural scientists, policy makers, nutrition, percent and of all i have seen and all the people that i have met, my hope and commitment has only been deepened. there is a sense of anticipation that we can move ahead. not since the green revolution has there been this level of focus, by the world, on this problem. and we also are heartened by the real progress that we see already underway.

when i was in taens sane yaw last year i visited a women's farm cooperative with the prime minister. the farm receives funding from usaid. the women there are raising vegetables, pepper and leafy greens mostly, but show didn't have a market near by where they sell their excess crops so they started one. and then they built cooling huts and even though their vegetables are high value the women don't sell all of them. they save them for themselves and their children because they have been made aware of how rich they are in nutrients, especially for growing children. they were so eager to show me their crops, their drip irrigation system, their green house, they know they are contributing to something of great importance, not only better

lives for their own children, but a better future for their country. so to anyone who wonders whether progress is possible, go visit women like the ones i met in tanzania. go visit the scientists in india carrying on the tradition of the green revolution by developing drought-tolerant rant and disease-resistant seeds. go visit their counterparts in kenya who are working in their labs and greenhouses to create a green revolution in the africa. look at the school lunch program in brazil which provides nutritious food every day to every brazilian child all grown by small holder farmers. look at the policymakers in indonesia who had the foresight to make a substantial investment in nutrition as at strategy for economic growth. look at the farmers, the entrepreneurs, activists,

the political leaders, the teachers, the parents who are devoting themselves to making their communities healthier, more just and more prosperous. these are the people who are on the front lines of progress. our places standing right behind them giving them the support they need to succeed. i am very proud to be part of this movement because indeed that's what it is. and to work with each and everyone of you and countless others like you who sign onto this movement's mission. i am absolutely convinced we can not only keep the progress going, we can show results that will just surprise people everywhere. and give hope to those who will never know our names, will never understand what we were doing here in washington but who's lives

will be so much better because we made this commitment together. thank you all very much. [applause] >> the u.s. senate meets this afternoon at 2:00 eastern. senators will consider a bill to continue a food and drug administration user fee. it pays for fda's review of prescription drugs and medical devices. also today an appeals court judicial nomination. we'll have live coverage of today's debate here on c-span2. next a look at the national flood insurance program. the house voted last week on a temporary extension of the

program while negotiations continue on a long-term solution to the program's debt. due to recent flood disasters. this is about 40 minutes. >> host: on mondays we have your money segment. what program is about and who participates and who benefits. we're talking about the national flood insurance program and our guest is carolyn cows ski, a -- kousky. fellow at resources for the future. >> guest: thanks for having me. >> host: national flood insurance program. tell us why this is a federal program. we think of insurance, private insurance, things like fire or theft but how are floods different? >> guest: yeah, so the idea for a national flood insurance program dates back to the 1950s t was actually created in 1968 in response to a widespread belief that private flood insurance was in the readily available for american homeowners, and if

it was it was extremely expensive. the so congress created the national flood insurance program and designed it to be a partnership between local governments and federal government. local communities decide to join the program. when they do they must adopt some minimal flood plain regulation and in exchange the federal government makes insurance available for all the residents of that community. currently homeowners can insure the structure, their building up to $250,000. they can insure the contents of their home up to $100,000 and insurance is also available through the program for businesses which can insure their structure and contents each up to $500,000. right now there's over 22,000 communities participating in the program nationwide. it covers much of the area of country subject to flood risk. there is over 5 1/2 million policies in fours nationwide. so it is a big program. those policies represent over $1.2 trillion in coverage. >> host: let's look at numbers in more detail. policy information, who has

policies and how does it work. 5.5 million active policies as of february earlier this year. total worth is $1.2 trillion. the average claim payment, $15,000. $15,000 doesn't sound like an enormous amount of money if you had flood damage. how far does it go in terms of helping people who have floods? >> guest: average flood came is not that high. there is lot of small-scale flood damage, localized flooding that causes some damage to property or contents but not, doesn't destroy the whole structure. if you look, for example, the average claim payment in 2005 after hurricane katrina the average claim payment was $95,000. when we get very severe events that can cause more devastating damage we correspondingly see increase in claims. >> host: congress is working on the national flood insurance program and in its latest extension. house extended for 30 days. but unless the senate also does the same the program

runs out of money on may 31st. >> guest: the program is set to expire may 31st. the program has been operating under series of short-term extensions since 2008. actually several times the program has actually completely lapsed. and what's going on right now there is an effort to try to pass some more comprehensive reform legislation for the nfip and extend it for much longer, for five years. that comprehensive seven legislation has already passed the house. it was passed with overwhelming bipartisan support i should say but the senate has passed that bill, a similar bill out of the committee but has not yet acted on the floor on that bill. the house, as you said, recently passed a short-term extension to give the senate more time to act. so what people are looking to see this week is whether the senate will pass a short-term extension and delay the reform efforts or take up more comprehensive reform and longer term extension to the program. >> host: what happens to people who have floods if they fall into that window when the program is expired?

>> guest: yes, if the program expires no new policies can be written that can be a problem for people trying to transact on properties in the flood plain. trying to buy or sell property. if your policy was already in force when it expires and you, a flood happens during the time it lapsed you can still submit a claim payment. as long as there are funds available claims will be processed. people with policies in force won't be in too much jeopardy but it stalls writing of new policies. >> host: carolyn kousky, research fellow, focus on national resource management and individual and sew sighsal responsibilities to national disaster risk. let's go to the phones and hear from our first call. kenny, a republican in huntington, new york. good morning. kenny, are you with us? >> caller: yes. okay. >> host: go ahead. >> caller:, well, anyway, yeah, well, you know, i lived in an area known as,

off just slightly off huntington bay, an area known as hillside region and every time it rains the streets, you know, get flooded. but it is only during hurricane irene that i had to finally put everything up in my apartment and leave because the area really flooded out badly and you know, wind up coming into my apartment. so i would like to know, seeing i didn't have any, you know, insurance at the time, no homeowners insurance or, renters insurance at the time, i would like to know if i could put, even if i put in a policy, you know, how long would it be that i could still make a claim any

damages might have been there? >> host: so of the fact, when a flood hits, a hurricane comes through is there anything you can do if you didn't have insurance? >> guest: unfortunately after the fact is too late. you need to be holding the insurance policy at the time the flood occurs. there is also a 30-day waiting period between when you can sign up for flood insurance policy and when it takes detect. -- effect. i also say in response to the caller's questions, for most homeowners insurance, flood insurance is not included in homeowners policies that is important thing for homeowners to keep in mind, if they want additional flood coverage they need to purchase through the nfip extra policies. might be also worth saying an important aspect of the program for homeowners located in 100-year flood plains and part of the nfip fema flood map risk for participating communities and designates 100-year

flood pains, homeowners with 100 year flood plains from a federally backed or approved lender. they are required for that. there are a subclass of people required for purchasing flood insurance. >> host: we're looking at new york borroughs for 100 year flood zone and areas that could be potential 100 year flood zone and areas potentially in the future. art, democrat, from fort pierce, florida. good morning. >> caller: good morning, how are you? >> host: good. >> caller: appreciate you taking my call. i live in a florida plain in florida here and i have to buy flood insurance because i have a mortgage and yet i know there are certain people in this same allotment that don't, are exempt from having flood insurance even though they still have a mortgage. so i'm confused as to why certain people, it's

mandatory and yet others it's not mandatory? maybe you can help me out on that. thank you. >> guest: yeah, sure. the flood insurance purchase is mandatory if you're in the 100 year flood plain and your loan is from federally back or regulated lender. so there are some lenders you could get a mortgage from where this would not apply. certainly if you don't have a mortgage or loan on your property you also are not required to purchase flood insurance. that said, there has been ongoing debate about how well this requirement is actually enforced and practiced and unfortunately we don't have good data nationwide on the number of properties in 100 year flood plains. the numbers of those with qualifying mortgages. so it is hard to say the extent to which the extent of compliance with the manadatory purchase requirement. some research that myself and colleagues at wharton have done suggest that after a few years, lots of people let their policy lapse. it is unclear whether lenders are around to continue people you know, to have people holding onto the policy for the life of the loan.

certainly an issue raised from gao reports and so forth. >> host: our guest mentioned wharton. visiting scholar and risk management and processing center at wharton school at university of pennsylvania in philadelphia. our guest carolyn kousky mention what happens in congress related to the flood insurance program. a story from nola.com, "the times-picayune", debate over how the flood insurance program should go forward. tell us about the reforms that republicans in the house in particular want to make to the program before allowing it to get reauthorized. >> guest: sure. i think the first thing is talk a little bit about how prices are set because that is really one of the key issues of the reform. so right now prices in the nfip are set, they're sort of two differences in rates that are important. one is that rates vary according to the flood zone, fema maps. so the important distinction there, in the 100-year flood

plain or out of it and have higher rates if you're out of the 100 year flood plain. and properties subject to wave action. they also have a different rate structure. then on top of that, difference in rates by flood zone fema also has two classes of policies. those they refer to as acutarial policies. these are policies where the premium is set based essentially on modeling of the expected damages and historical damages in the area. so they're more or less based on the risk that you face. there is a small group of policies, about 20 to 25% of all the policies nationwide that receive discounted premiums. sometimes referred to as subsidized policies. these homeowners are paying only 40 to 45% of the full premium. and a lot of concern has been over the nature of these discounts. they were initially put in by congress as a way to help encourage communities to participate in the program and to encourage homeowners to purchase insurance

because there was essentially thought that it wasn't fair that people who might have built or located in the 100-year flood plain before they were aware of that flood risk should be penalized with high prices and insurance requirements that might also lower the value of their homes. it was thought that those discounts would phase out relatively quickly over time because as structures were modified the idea was that the discount would phase out but they have been persistent and one of the problems is that those policies that are paying discounted rates are also some of the riskiest properties in the program. so they face the highest claims and highest damages and they're not paying enough really to cover that. so that's been part of the problem. what happened in the early 1980s is that fema decided that the combined revenue from those discounted policies and actuarily policies should be enough to the '80s and 1986 that wasthrouh

achieved. fema was taking in enough premium revenue to cover average losses. go back to 2005 that was not average loss year. the amount of claims the nfip paid out in the 2005 was more than the sum of claims they paid out through the entire life of the program. that plunged the program deeply into debt. the nfip was designed so that in years where there was excessive claims payments the nfip could borrow from the federal treasury and pay that with interest. which worked fine when there were a few losses and in good years they could repay that. in 2005 they had to borrow billions of dollars. the debt peaked in 2008 after hurricane ike at around 19 billion. currently at 17.75 billion. this has been the focus of a lot of the reform effort with the current premium structure the n fismt p will be unable to repay this debt essentially. so bringing us all back now to the reform, one of the key things in both the house bill and senate bill phase

out discounts on subclass of property owners. would phase out discounts for commercial properties, for second homes and vacation homes, for what are refered to as severe repetitive loss properties, these are essentially the riskiest of the riskiest properties. some of the bills, they deliver slightly, one of the bills would phase out the every time the property turps over. in a new person purchasing home or homeowner lets the policy lapse when they renew, phase out the discurrent. discount. >> host: there is push back of the program overall in of itself. listen to kenneth miller, republican from michigan. this is debate from last week on the national flood insurance program. >> this program is not actuarily sound t charges some of the highest risk areas subsidized rates and charges other areas of no risk astronomical rates to pay for those subsidies. you can use my home state of

michigan as a great example where our residents have been forced into this program, charged thousands of dollars, every years even though we have almost no risk of flooding. in michigan we look down at the water, not up at the water. we've paid multiple times more in premiums than we ever received back in benefits. in short, mr. speaker, the people the gait state of michigan are getting fleeced by this program. >> host: congresswoman miller of michigan. let's get your reaction, carolyn kousky. is this widely-held opinion in the house and also in the senate? is it really based on your geography? >> guest: yeah, certainly it is widely understood that the program is not pricing to be able to cover catastrophic years like 2005. it wasn't designed to do that. it now put us in the terrible financial position we're in now. the question then what to do about it? there seems to be broad, bipartisan support for reforming the way we handle the discounts in the program which would help increase

revenue and bring rates closer to what would be risk-based rates and that is in the reform bills and seems to be something that would move forward. more radical reforms to the program, there is less consensus on. i know for instance, she is one of the individuals who believes we should simply abolish the nfip and privatize it and that is subject getting more attention by different stakeholder groups. also one of the potential reform options considered by fema in an recent effort to evaluate different policies to improve the nfip. there is a little bit less consensus on that. my personal view is that while i certainly understand the questioning of why the federal government is involved in a program that seems to be underpricing risk and has a huge deficit that might become a burden to the general taxpayer, there is lot we still need to investigate and understand before we were to launch completely into privatization or completely eliminate the program. and this gets to one of the concerns about flooding in

particular. it is a catastrophic risk by which i mean, there are lots of years when there are very few damages or more small damages. then you could have a very severe loss year like 2005 where damages are just incredible and so that is very different from some other lines of insurance like say automobile insurance where the claims year to year are more or less stable and it is easier to match premiums to those claim payments and pay for them. for a private company to insure a catastrophic risk like flooding they need to have access to a large amount of capital in any year so that when an event like 2005 occurs it doesn't bankrupt them. private insurance companies can do that in number of ways. they can build up reserve funds and set money aside. they also can purchase private reinsurance. this is insurance for the insurance companies. these are more broadly diversified, generally more global companies that can help primary insurance companies manage their risk. but both of those strategies

are expensive. and those costs are passed on to homeowners. so private insurance for these types of disasters can often be expensive. one concern if the nfip were to try to privatize all its policies that a lot of homeowners might see huge increases in premiums that they face. that might not entirely be the case about the question then is what happens? do homeowners who can't afford these policies simply drop coverage or, you know, do homeowners choose not to insure and we need to ask what the implications of that are. >> host: sharon from california, democrats line. good morning. >> caller: good morning. >> host: go ahead, sharon, you're on with care lynn kousky. >> caller: i have a question. my question is i live in visalia, al important, which is in the central valley we're mandated to pay for flood insurance because they

say we're in a 100 year flood zone and we're paying very same rates they're paying in new orleans which is a high-risk flood zone and they're using 1986 and 87 maps, and people like my neighbor, for instance, who is on social security, whose house is 1 1/2 foot into her yard is in the flood zone, is mandated by bank of america to pay and they take her social security check and leave her no money to live on, and this is ridiculous. and we even have a dam that they raised 23 feet so we wouldn't be in the 100 year flood zone and, and they're still going by the 1986 and '87 maps. >> host: get a response from carolyn kousky. >> guest: thank you for that call. you raised important issues as we're thinking about trying to improve this

program. the first i want to mention is the outdated maps. that has been a problem. fema was criticized for years because a lot of the maps around the country had not been updated in years or even decades and were based on outdated data and outdated methods of the in response to that fema has launched, you know, over the last five, 10 years, some programs to update the maps, to digitize them. bring in better data, more information and those have been rolling out across the country. everywhere has not yet received new maps. so i assume that you're one of the communities that is late to receive them. and so hopefully when those come they will more accurately reflect the risk and incorporate new flood control structures such as the dam that you mentioned. but the second point that you raise is a little more difficult to deal with and that is that the rates are set on these very broad classes. so exactly as the caller said, if you are mapped in the 100 year flood plain where she is in california you're paying same rate and same home and same character

tishgs of that home, put that home in new orleans or anywhere else in the country in the 100 year flood plain you face the same rate. there are lots of people who, say that that will create cross subsydation in the program and people pay too high rates or too low rates. >> host: can you challenge it? go to surveyor office or who she talks about her neighbor is partially in the zone or area? >> guest: you can challenge the designation of being in the 100 year flood plain. there is a way for communities to do that especially when the new maps come out. there is way for individual property owners to do that. if you think the 100 year flood plain map for your community doesn't reflect particular local conditions of your property, maybe you're up on a hill something that is not reflected you can appeal that to fema and get marked out of the 100 year flood plain and get exempted. but you can't change the rate if you're map understood the 100 year flood plain. >> host: james writes on twitter.

they just redid the flood maps in my town. i haven't gone to look at them because i'm sure there is no good news. in his opinion. our guest is carolyn kousky, resources for the future. james a republican, good morning. . . >> guest: there are two things to mention. one is that there are, it's important with any insurance policy to read the fine print, and there are some classes of things that are covered and not

covered, and i'm afraid i don't know the particular details when it comes to structural damage what's included and what's not. i know this has also been an issue with basement damage. so it's important to know that. another thing is that you choose the -- and this is not exactly the question raised by the caller, but i think worth mentioning -- you choose the coverage level so you can insure your home for $10,000 or $100,000, and if you sustain damage above that level, you'll are have to pay that and also the deductible which for standard policies are $1,000. >> host: someone tweets in, how and where do i buy flood insurance? >> guest: flood insurance is not sold by fema, for the most part. policies are purchased through what are referred to as write-your-own companies, companies that market and sell and process claims on behalf of fema. they get a fee in exchange, but the risk is all written by the

nfip. so go talk to your homeowner insurance company, and they might be able to help you out. >> host: chris, a democrat in portland, oregon, welcome. >> caller: hello. you kind of just answered my question. but first i wanted to point out that my lender requires me to carry flood insurance because i do not own 30% of my house myself. so when that gentleman calls to say, you know, some people do and some people don't, well, the people that don't probably own more of their house. um, but my question to you is fema considers me to live in a 100-year floodplain, but the city of portland does not. when the city of portland releases their map, my street is the sandbag route. my house is out of the flood area. how specifically do i ask fema to reconfigure this issue? my house on their plan, my house

is in it, in the city's plan my house is not. what can i do? thank you. >> guest: that's a difficult question, and there are many ways of designating the 100-year floodplain depending on how much data you use and what methods. i recently saw dangerouses in the way -- differences in the way fema and the corps of engineers does it. i will say for the regulatory requirements of the program, it's the fema map that matters, and so in terms of whether you're going to be subject to that requirement and the rates you're going to face, that has to do with the fema map. again, if you think the fema map is in error, there's a process for submitting a letter of appeal, and if you just go to the fema web site, you can google and find the information on that. >> host: susan writes in on twitter and asks: when was the last time that new york city flooded? she mentioned the image we showed on the screen a few moments ago, we'll show it again. is this something that that happens every 100 years?

>> guest: that terminology seems to suggest that once a 100-year flood occurs, we're safe for 100 years. it actually means there's a 1 in 100 or a 1% chance of that magnitude flood occurring in a year. you could have two in a row, you could go 100 years without seeing the 100-year flood. a1% chance is difficult for people to wrap their head around. i'd also note that the 100-year floodplain for the requirements of the nfip is often a sort of bright line thing, are you in it, are you out of it. that changes your rate, the mandatory purchase requirement. but actually, of course, the risk varies continuously through the 100-year floodplain and beyond it, so there are places that will be flooding much more frequently and have much higher damages and others that will be seeing much less, you know, less

frequent flooding and less damage. >> host: an independent caller in pennsylvania, good morning. brent, are you with us? all right. let's move on to sand point, idaho. james, a republican caller. hi, james. >> caller: hello. >> host: good morning. >> caller: i'd like to explain a problem that we have where fema is taking control of our property. in 2008 we purchased a property for nearly $900,000. we did not select insurance. in december that year, the county accepted fema guidelines. now we went from a 100-year floodplain to a floodway. so fema has mandated that the county seize our property and throw us off. they've been even, they've each said that they will put us in the jail or fine us on a daily basis. we seem to have no option but to

move off of our property, and because the house has been here for 20 years, they've went back 20 years and said that the house was improperly permitted. so we're in thes process of losing our property or either going to jail or fined, and this is just a power grabby fema. i would like to hear your comment, please. >> host: have you heard about this kind of thing before, carolyn cows sky? >> guest: no, a troubling thing, i'm sorry for the caller. the guidelines are much stricter, so if property had been mapped into that zone, i believe they're facing much tougher requirements. what has been a bigger concern nationally or perhaps just more common is when these new maps come out, homes will be mapped from outside the 100-year floodplain to within in the

100-year floodplain. and fema already had in place a couple of policies to help homeowners deal with that adjustment. if you had a policy at the the time that the 100-year floodplain is expanded, as long as you maintain your policy, you can keep your old, less expensive rate as long as you maintain your policy. for policy bees, there's actually a group of policies for homeowners that has very low loss histories, and those are called preferred risk policies. you've got a really much lower rate for those policies. if you have one of those policies and you get mapped into a 100-year floodplain with a map, you can keep your premium risk category for two years and then you can move into this grandfathered rate as if you were outside the floodplain. both pieces of language in the house and the senate would phase in rates for newly-mapped 100-year floodplain homeowners over several years.

>> host: on twitter, maverick writes: mortgage companies demand you get flood insurance even if you're not at risk. is that true? >> guest: that will vary by lender. if a lender thinks there is significant risk of flooding, they could mandate that as condition of the loan -- >> host: so separate from the map. >> guest: yeah. similarly how lenders will require homeowners' insurance. >> host: new jersey, jack, independent caller. welcome. >> caller: yes, good morning. >> host: hi. >> caller: i have comments about myself, and i have a sister. my sister lives in ft. lauderdale, florida. she's about five miles in from the beach and, again, the flood maps were redrawn. she now pays over $6,000 a year in flood insurance. she's 67 years old, works as a nurse. she'd like to retire, but one of the reasons she can't retire is the $6,000 yearly flood insurance bill. here in new jersey i live about ten miles in from atlantic city. i'm not affected by any floodplain, flood danger maps

yet, but there there have been numerous articles in new jersey they keep adjusting the floodplain inland. and what it comes down to, again, i'm an independent. i think both the tea party movement and the occupy movement be would agree on this, it's a case of the wealthy transferring their expenses onto the backs of average people. i'll give you an example. this community just south of atlantic city called longport. you cannot buy the smallest cottage in longport for under a million dollars. most of the houses are multimillion dollar houses. they are subsidized for their flood insurance. when the beach needs replenishment, everybody -- state and federal government, meaning everybody, has to replenish their beaches. but if you want to go on their beaches, you have to get a beach tag, and then they don't provide any facilities. you can't find a place to park, there's no public restrooms. it is just another case, that's

why i'm so frustrated. this has become a rip-off nation. everything is transferred onto the middle class. the wealthy get subsidized, the poor get sub is sitized, and people like my sister who's a nurse and i'm retired police officer, we pay the bills. thank you. >> guest: yeah. the caller raises two important points. the first more minor point i just want to make is that as we've talked about already, the types of flood risk can vary substantially around the country. and so properties that are at risk from storm surge and hurricane-related flooding can often if they're mapped into that special class of properties pay much higher rates. and so i believe that if caller's sister's in one of those zones and is purchasing the full $250,000 of coverage, she could easily be paying the rate the caller said, and that is a lot of money for people to be paying especially when that's only the flood insurance. and in hurricane-prone states like florida, you also need your

homeowner's nups to cover the wind damage because the nifp only coffers the flood damage. so insurance bills in hurricane areas can be steep because insuring those risks is expensive. but i think a broader and important point that the caller raises is this question of who should really be paying for disaster damages. and it's something that people disagree about and that i think we need more conversation about as a country. should the people who choose to locate in hazardous areas pay most of the costs of disasters? because a disaster is only disaster when there are people and structures there, of course, to be damaged. or do we think that very extreme events, you know, particularly extreme events like we saw in 2005, should be borne generally by all the taxpayers as a whole, and that it's part of our duty as a citizen to help all those victims. and i think we haven't come to agreement yet on how those costs should be apportioned across segments of society. i will say it's my personal opinion with regard to the nifp

that the way the current program is structured is in need of serious reform, and the reason for having those discounts because people didn't know about the risk, i think, are in most places no longer valid. these maps have been around for quite a long time, and we should replace those with based on need or income. homeowners can get some rebate for that reason, and homeowners who can readily afford the high premiums can pay them. a fellow at resources for the future, previously at the wharton school at the university of pennsylvania and in philadelphia as a visiting scholar? risk management and decision processes center. she has a ph.d. from harvard and did undergraduate work at stanford university. here's a story from npr, tropical storm alberto weakens, this is the first tropical storm of the season. the piece says it hovered off south carolina's and georgia's coasts sunday producing showers and serving as a reminder that the 2012 atlantic hurricane

season is just around the corner. it starts june 1st. >> guest: it does start june 1st, and that's why it's imperative that congress figure out what they're going to do with the program and don't let it lapse. it also brings up a point that i think is worth mentioning. the nifp is a national country, over 20% are in texas and louisiana, so it's a very important part of how we protect ourselves against flooding from hurricanes. >> host: larry, republican in beaverton, michigan. go right ahead. >> caller: hi. thanks for taking my call. one of the comments your guest made saying how we can figure out how to share the burden, i guess, of disaster relief. i live on a small lake in michigan, and fema just went through this past year and did a flyover photograph assessment of where we are. the bottom of my home is at least 12 feet off the top of the river that is now a lake caused

by a dam. actually two dams creates a small lake. if our water raised two feet, it would be spilling over the spillway, over the dam. so we would have of a catastrophic flood that would flood out the entire state before my home would be touched by high water. but i'm going to be forced into buying flood insurance. my thing is your comment with the previous caller about sharing this, right on the verge of socialism. i'm paying flood insurance which i'm never going to have to use for people that are not real smart, and they built a city that is x number of feet below sea level. we have to every couple of years go down and rebuild the dikes and the berms and so on. that is ridiculous. if i built my home under the water level here and it flooded, shame on me for being that stupid. >> host: i think the caller raises a good point. >> guest: the costs right now are not based on the risks that

people face, and there are homeowners that have much lower racing that are paying the same race as those with much higher risk. if the caller thinks there's been some error, they should, you know, take that up with fema. i'd also say within the 100-year floodplain, the rate varies based on where the waters come. so if be you're up out of it, you will have lower rates to compensate you for reducing that risk. but it's certainly a question about i think to date there's been an implicit assumption that doing finer-based risk pricing so we tease apart some of these broad categories of risk would not be worth the benefits to the cost of fema doing that, but i think it's in more need of investigation and research. >> host: hover reasons sow in san antonio, texas. good morning. >> caller: good morning. i think we're going to go to self-insurance sooner or later.

i'm an agent, but i'm not going to renew my license. the banks are selling all the insurances for home buying, whenever you buy a home, life insurance, auto insurance. they're in the business, they are throwing all the agents out. you have what they call a rep. i don't know what a rep is. they're still liable. but anyway, oklahoma is city, i lived there for four years, and we got hit twiet with tornado -- twice with tornadoes, and they wouldn't even cover. fema came around, and they had good sandwiches. we ate their sandwiches, but as far as insurance, you don't get any help from fema. they gave you a $2,000 shelter. so everybody now has a shelter, but you don't need one for the whole neighborhood. you can have one or two or three or four. but anyway, yeah, we're being driven out of the insurance business, and that's thanks to our governor. thank you mump. much. >> guest: yeah, thanks for the call. a couple responses. first, the nfip does only cover

flood damage, so fema does not offer insurance for other hazard-like tornadoes. that you'd have to talk to, you know, the insurance for your homeowners coverage to see whether that was included. also it's worth mentioning that disaster aid and the relief efforts are also often managed by fema, but they're a separate program. and there's some interesting interactions between the two that we've recently looked at in a program, but they are separate programs. and we could see a little bit about disaster aid. that's governed by the 1988 stafford act, and when a disaster occurs that is judge today exceed the capacity of a local government or state government to respond, they must request a presidential disaster declaration from the president. fema advises the president on that. and if such a declaration is issued, then lots of aid become available through fema and perhaps through other agencies. say more about that if caller is interested, but those are separate programs.

>> host: california-based tweet. i want to get a government subsidy for auto insurance and earthquake insurance. this gets at one of our other callers talked about why should i have to help carry the load of people who are in higher-risk areas, but why not get the government involved in other kinds of insurance as well? >> guest: yeah, it's a good question. right now the government is involved in other lines of insurance in some minimal ways. pricing and some requirements around different lines of insurance are governed by state insurance commissioners. there's also some state involvement in other lines of insurance policy. california, for instance, offers earthquake policies, the state has a program offering earthquake insurance policy. and lots of gulf coast states have state wind pools which are, essentially, state-run insurance programs for people who cannot find a policy in the private market. so there are other ways in which the governments are involved in insurance. >> host: carolyn kousky, fellow at resources if for the future looking at the national flood insurance program. thank you so much for coming on

and talking about this. >> guest: thanks so much for having me. >> host: and the national flood insurance program $17 billion in debt, and as carolyn kousky mentioned, it's up for reauthorization in the senate. we'll be watching that to see how that will unfold. >> and the u.s. senate meets in the about 40 minutes to consider a bill to continue a food and drug administration user fee. it pays for the fda's review of prescription drugs and medical devices. also today an appeals court judicial nomination, and we'll have live coverage of today's debate here on c-span2. and president obama is in chicago for the final day of meetings with nato leaders. he'll be holding a closing news conference in chicago at 4:30 eastern. and you can watch live coverage on our companion network, c-span. >> fda deputy food commissioner michael taylor says the agency is out to give the public the best bang for the buck. he spoke at the consumer federation of america food

policy conference in washington for about 40 minutes. >> good morning. my name is -- [inaudible] and consumer federation of america. i'd like to welcome you all back to the second day of of the national food policy conference. again, i'd like to thank both our sponsors who are listed on the back of your program as well as our advisory committee for their help in putting together this great agenda. we had a great day yesterday, looking forward to another good day of terrific speakers and great panelists. for those of you who use twitter, follow us @cfa food policy. katie bryan is going to be live tweeting the panel sessions. we have a hashing that's food policy conf, so you can use that if you want to tweet. again, we've got a terrific

program today, and in just a few minutes we're going to hear from mike taylor, deputy commissioner of foods at the food and drug administration. later this morning we're going to hear from undersecretary for food nutrition and consumer services, kevin concannon and bill dietz who is director of nutrition, physical education and obesity at the cdc. giving a sort of an update of a number of the key administrative initiatives that have been going forward in the past several years. so we're going to see where things are, where they stand and where they're headed. so we're very pleased to have mike taylor here this morning to speak to us. before he begins, i'm like to introduce carol tucker-foreman, our distinguished fellow at cfa for food policy. she has a long record as an influential consumer advocate for cfa, so i'd like to turn it over to carol. carol? >> thanks, chris.

good morning. good morning, folks. it's a terrific pleasure to be able to introduce mike taylor, the deputy commissioner of foods for the food and drug administration. this morning. consumer advocates who have worked with mike know that there's no other federal official that has ever brought the same level of intelligence, energy, creativity and integrity to the effort to make our food supply safer. as the administrator of the food safety and inspection service in the 1990s, he led the effort to install the system modernizing meat and poultry inspection, and he declared e. coli to be an adulterant, beginning the long effort to overcome that terrible packaging.

he, with a lot of assistance along the way from caroline smith dewalt, worked for years to develop the concepts and almost to modernize fda's food safety programs. and when he sold it first to the obama administration and then to congress. we all celebrated the passage of the food safety and modernization act in late 2010. it is landmark legislation that completely reorients fda's approach to food safety. and provides important new tools to reduce the 48 million illnesses and 3,000 deaths attributable to food foodborne illness in the united states each year. consumer advocates and industry believed then and now that passage and implementation of the new law would spare

thousands from the pain and suffering of foodborne illness. we worked alongside the victims of foodborne illness who set aside their sorrow long enough to come to congress and tell their stories and plead for the passage of new legislation. and we worked alongside leaders in the food industry -- some of whom are here today -- who share their belief that new law was necessary. we were successful in this -- in our effort in large part because in march of 2009 the new hi-inaugurated president -- newly-inaugurated president of the united states endorsed the need for new law to modernize fda's archaic food safety provisions. the president endorsed the legislation at each step along the way and signed it into law on january the 4th, 2011. even before bill was signed,

mike taylor had organized the staff at fda to produce within the very short time limits set by congress the massive body of proposed regulations necessary to make the law real. you pass a law, but it doesn't mean anything until there are regulations to carry it out. and they have worked efficiently and massively to get ready to put this law into effect. while we've not seen the proposed regulations, most of us in the broad coalition that supported the bill feel confident that the agency has worked in good faith and that we will agree with a large part of what they propose. i'm pretty sure as well that we're going to disagree with parts of it because there has never been a time that we didn't

want an agency to go further and do more. i, for example, am absolutely sure that the fda will not invest the resources necessary to provide adequate inspection of food processing plants and will tilt way too far if favor of industry self-regulation. remember i said it here. [laughter] if and when that happens, cfa and the other consumer and public health groups will do our best to persuade the agency during the comment period to see the light and revise if regulations. -- the regulations. we might even get congress to change the laws that's necessary. that's part of the give and take that makes our system work. you have a debate over the law, you have a debate over the regulations, and by the end you've got a product that's usually pretty well honed to do

what it's intended to do. when planning this conference, we were really confident that this morning would provide an opportunity for all the interests who worked on the legislation to get together and debate how well fda had done in its efforts to administer the new law in the most effective manner. we figured we would have had plenty of time to wade through the thousands of pages of proposed regulations and be ready to congratulate the agency and argue for improvements in the final product. it's funny how life springs these little surprises on you. here we are over three years after the president endorsed the legislation, 16 months after he signed the bill into law, five months after fda was to have implemented four major portions of the law, and we're still waiting for omb to publish the

proposed rules. not the final rules, but the proposed rules. a small staff of white house bureaucrats and their boss, the president of the united states, have brought the effort to bring new weapons to the fight against foodborne illness to a complete halt. the administration that proposed transparency has dropped a shroud of secrecy over the fda's proposals. they've shut down what was to have been an open process. effectively said, hell no, we won't go. they won't go toward on a bill that the -- forward on a bill that the president endorsed and signed and congress passed. it offered no reason for this for a simple reason: they don't have to. they can pretty much sit back and ignore our frustration. now, mike is going to tell us that fda continues to move ahead

educating the public and the industry and preparing for implementation. fda will, indeed, soldier on. that's what they have always done. the reason that we sought passage of this law was that fda had soldiered on for 70 years with legislative language that didn't address the problems of a modern food safety system. and they are going to continue working on it, i'm sure. we're entering that season of the year when foodborne illness cases tend to rise. in 2008 as the president campaigned across the country, we became aware of an outbreak of sal no o knell la attributable to to contaminated peanut products. it continued all the way through the campaign and into 2009. in the end, nine people died,

over 600 people were made sick. thousands -- hundreds of food products that no one knew had peanuts in them had to be recalled. the cost to the industry was billions of dollars. and endorsing the need for the new law, the president mentioned that food safety is something we cannot do for ourselves. it requires government action. and he added a personal note about his daughter's food -- the staple of his daughter's diet, peanut butter sandwiches. it would be an unspeakable tragedy if in the midst of his re-election campaign this year another series of foodborne illness outbreaks were to hit the country, and the president had to explain why the bill was still sitting in the white house. why the rules were still sitting in the white house. now, it's true that even fully

implemented fisma will not end foodborne illness, but it's also true that until we get a chance to debate the proposed rules and fda gets a chance to begin implementing final rules, the efforts to reduce foodborne illness related to fda-regulated foods will be severely ip -- crippled and the american people exposed to unnecessary risk. as i said, mike's going to tell us all the things that fda is doing to try to overcome this additional burden that has been laid on them. and we wish them well, but there are some things that even mike taylor can't accomplish by himself. so i'm going to say to y'all, write to the president, write to your members of congress, tell 'em to get these things off the

desk over in the white house and start moving this thing forward. mike, thank you. [applause] >> now, that's an introduction. [laughter] it really is, actually, great honor to be introduced by carol tucker-foreman. i was a young staff lawyer at the food and drug administration in the late '70s when carol was the assistant secretary for agriculture overseeing food safety and a bunch of other things, and she was a big presence in my professional life then on a number of issues like nitrate and bacons that affected the intersection between those who programs. and i saw carol in action then, and she was an unbelievable, dynamic force, and she has been one for many years since, and i don't think there's anybody who's had more of an unerring

view on what toas the right thing to do and holding folks accountable for doing the right thing. we all benefit from it enormously. i also just want to thank chris and cfa for inviting me to be here, and i'm really glad to have this opportunity. this conference really is an important annual event, you know, with the food safety and nutrition community coming together. i think it's a great opportunity for sharing information about issues, but having, you know, building opportunities and relationships for real collaboration and partnership to accomplish things. and it takes that to get things done in washington these days, to say the least. i am going to talk about the food safety modernization exact what we're doing to implement it. i want to give you a process check, and i also want to put what we're doing on regulations in a larger context and on ways fda is looking to manage its work differently so we can work to make this law a success over the long term. but let me just first answer the

when question, that's the question that i get. here's the way i would answer it, and i actually, seriously, want to be very reassuring, and i wouldn't just puff, you know, blow smoke at carol tucker-foreman and attempt to be reassuring because it would always come back to me. [laughter] but i just want to assure folks that not only at fda, but throughout the administration people are working hard to get this done. it will get done, and it will get done soon. we're close. and i think the time it has taken is a reflection of the scale and complexity of the regulations. we've got more than one, we've got several major regulations that are interconnected, they have to work together. you know, we have had to do a lot of work within fda to figure out how those pieces fit together. the review process that we've been going through, the norm oira interagency process has been one in which very legitimate questions have been raised that help us think through issues, and we feel very

good about substantively the way that process has gone. we anticipate, you know, publishing soon. so just watch this space, keep your reading glasses close at hand. there's going to be a lot of work for folks in this room to be doing in the coming weeks and months on this matter. so, again, i appreciate the sentiment and the spirit that underlies your remarks, carol, about the importance of getting this process going. and everybody shares that. and that's why, again, folk bees are working hard all up and down the administration to get that done. so don't, don't despair and don't, again, keep an eye on us, and we'll be with shifting some burdens to you pretty soon. one thing that i want to talk about is just in the way of -- a sense of how we're seeing implementation is to talk a little bit about how we have approached developing these rules at sort of a high level. and one mr. president of it --

element of it is the outreach that we've done. and, in fact, we have invested enormous effort over the last year plus since enactment in engaging the community that cares about this. it was an industry/consumer coalition that brought this law into being. we have been benefiting enormously from a lot of engagements throughout the last year and any number of meetings and dialogue sessions, listening sessions, farm tours with folks across the food system and industry and from the consumer community. and i want to assure you that that input has very much informed our proposals. carol is absolutely right, when you get -- when you read these proposals, you're going to find issues. we're going to have a robust comment process. we think we have done a pretty good job of laying out a framework for implementing this law as envisioned by those who came together and got it passed. but we, we want to really continue this dialogue in a serious way. it's got to be a robust comment period. we'll find ways to engage

directly in person. we need your robust engagement to get the rules right. we are very much conscious of implementing this law, as i say, in a way that carries forward the themes that were central to its enactment and the motivations that brought people together. obviously, it's all about prevention, it's all about achieving the public health goal of reducing foodborne illness through systematic farm-to-table prevention that's risk based targeted on interventions that can make a practical difference for improving food safety. a central theme of this law is recognizing industry's primary responsibility and capacity for producing safe food, but with clear standards for implementation of modern preventive controls throughout the system and much-enhanced accountability for meeting those standards on a continuous basis. and the law, again, as you know, not only includes a mandate to set the kind of standards it will be setting through the regulations, but also new tools, new inspection mandates to

insure that we get high rates of compliance with those standards. we take that dimension of the law extremely seriously. a third theme of the law, of course, is to address globalization. so, you know, the import tool kit is really transformative. shifting a system that historically has rested on the port of entry exam by fda inspectioners to catch problems, shifting to a system in which the importers have a defined responsibility to manage supply chains and provide assurance that problems have been prevented with, again, much greater tools for us to see that private sector supply chain responsibility ising being met. there's a lot of work to do to implement that, but that's a theme that we embrace, it's a serious part of the law, and you'll see it, our approach to implementing that, as we go forward with the rulemaking process. is the fourth thing that we are very attached to and i think it's very a strong theme of the law is partnership be, is recognizing that fda, you know, can't do this by itself.

there's some 50 specific mandates just as an example in the law to connect with other federal agencies to coordinate and to collaborate in various aspects of implementing the law. there's the mandate to partner with state governments, to create a national integrated food safety system, to partner and collaborate with foreign governments and build capacity there. but also to collaborate, again w the private sector to figure out a way that we make the public role of setting standards and creating accountability work with the industry responsibility. how do we get the right guidance out there over time, for example, to insure that the expectations are clearly defined about what preventive controls mean in particular circumstances? and, of course, collaboration and partnership with the consumer community. i mean, this is all about meeting the public's high expectation. consumers' high expectations for the safety of the food ply and, again -- supply, and, again, we look forward to both the rulemaking process and beyond and benefiting from really active engagement with the consumer activity. so that's broad brush how we're

approaching implementation. again, you'll judge for yourself how well we're doing. we'll look forward to comments and work together from there. the thing that is, i want to sort of etch size in the few minutes -- emphasize in the few minutes more that i'll take of your time this morning is as much as our focus has been over the last 16 months on the regulations which, again, are critical. they're the legal regulatory framework for the new food safety system we're creating. this system is about a lot more than the regulations. it's really about creating a whole new system that involves effort by fda, it's going to involve effort by the private sector, and it's going to require change in how fda manages its work. so just, again, to emphasize and remind of the kind of work that are go on, you know, beyond the rulemaking, i mentioned the guidance and technical assistance to industry point be. we know that we can't just put these regulations on the books and think that that answers all

the questions and meets the needs of those who are out there seeking to comply. think of the small growers who are going to be responding for the first time to national mandatory food safety standards. we've got to work with them and provide the technical assistance b and guidance for how that's going to work. same with small processers. but across the system we take seriously the burden to go beyond the rules to work with the commitment to articulate in greater detail how firms can comply with the new preventive control mandates. we've got to retrain our own work force to have the knowledge and the skills to inspect preventive controls framework and to use the new administrative enforcement tools that we've got. that's something i think our work force will embrace enthusiastically because it's all about equipping them to work in a more public health-oriented way. it's empowering them to have a greater impact on public health, but it's a whole new skill set, it's a whole new orientation. we've got to invest in that training activity.

building the federal/state partnership, again, this is a feature of the law. we're mandate today create a national integrated food safety system, one that can insure harmonized oversight across the country as states are conducting inspections under their own authority, but also in partnership with us. we want joint work planning with the states. we ought to be efficient in using all the food safety resources that government can bring to bear to provide the most efficient, effective oversight. we want to share data with the states and really harness, among other thing, the vast amount of testing data, of inspection results that the states have that can be, if we do it right, can be integrated, shared and be used to improve the effectiveness of the whole system. and we have to invest in the import system that congress has mandated. the regulations that establish the foreign supply verification program are central, they're foundational, they're the ones that importers have a new accountability, but they're just part of a larger system.

the regulation itself, of course, just spells out the rules of the game for importers. how do we reorient our work at the ports of entry in our relationship with the importers to be able to be sure we're able to audit those programs effectively, to be sure they're really working well? that's a whole shift in how we deploy our front line field force. the voluntary qualified importer program, one that's intended to give incentives to companies who are going the extra mile, able to more thoroughly document food safety performance and give them a little bit of advantage coming at the port of entry, that's, i think, that has potential to really help us focus our efforts more effectively and insure that it incentivizes firms to go the extra mile. but that's a whole new program. we don't just issue a rule on that and think it's operationalized. the accredited third party certification program.

again, one of the important rules we'll be moving forward on soon is a program that's all about taking an existing body of work that's done by private auditors and turning that into something that could be meaningful in the public assurance system for food safety. so how do we not only establish rules that guarantee the quality, the objectivity and the transparency of those awd kits -- audits, but actually operationalize that, have an adequate spry of qualified auditors, have ways to oversee the accrediting bodies themselves and to assure the system has integrity. if done right, that can be a valuable part of the system. if we don't build the infrastructure to do that right, it won't add and, i think, will create its own issues. again, i could go on. foreign -- we're mandated to have a foreign presence that's way beyond what we've got now. we've invested in a good bit of that in establishing foreign offices. we significantly increased foreign inspections. that's an important part of the law, and it's all part of this

new system of import oversight that, again, goes well beyond the statute, the regulation itself. so i go through all of this just to emphasize that there's a big agenda there that goes well beyond just these regulations. it's an agenda that i will say is putting enormous pressure on fda's staff, on fda's management. i think i really appreciate what carol said about the effort that folks have made. it's been extraordinary effort by the people working at fda to develop these proposals while also engage anything the outreach we've done, while also operating the program we've got in place today every day. they've been incredibly resilient, incredibly thoughtful, and i just can't say enough about the effort that they've made. just to flush out the picture a little bit more about why we're looking to manage differently, i don't have to remind folks in this room that the job at fda

isn't just limited to implementing the food modernization act. we have a set of issues that we have to address. we, of course, regulate dietary supplements and continuing challenges there in that part of the food system. food labeling, including nutrition labeling and claims, we're looking to update the nutrition facts panel. we're implementing the menu labeling law, and, again, looking to improve information that consumers have. we're investing effort in looking how we can reduce sodium in the food supply. so there's this enormous body of work and opportunity, actually, to improve public health. how do we address it all? i haven't even mentioned our animal drug work and antimicrobial resistance. again, major areas of work where we're investing effort and taking advantage of opportunities to protect public health.

so it's in this context of this enormous set of mandates and limited resources in the world in which we're currently working that has really focused, you know, our attention on how do o we prioritize, how do we target our efforts optimally to protect public health? we went through a process over the last 18 months or so to try to hone in on our priorities, and that was, it resulted in a strategic plan for the foods and veterinary medicine program we released in february. it's on our web site. i know strategic plans aren't the kind of most engaging documents typically, and we tried to make it as concise as possible. but if you want to know what we're focused on internally at fda, not only on the substantive work that we're doing -- of course it's food safety, but it's also addressing priorities and everything else i mentioned -- read this document. it'll give you a sense of what we're focused on and how we're going ab it. one thing you'll see in this document is it's not limited to

the substantive work, the policy, the regulatory work that we do. it is addressing, also, how we manage. and i just want to touch on this aspect of what we're doing so you can get a sense of how we're grappling with the agenda that we've got or the magnitude of the work that we're doing. you'll see in the strategic plan that a central theme of how we're going to manage internally is to, is to develop the capacity for true data-driven, resource allocation. that's become kind of a buzz word. we also express it in more colloquial terms, and we find ourselves looking for maximizing public health bang for the buck. that's what we think it's all about. we think this is just good policy in general, but it's really essential, we think, in today's budget climate. we've got to be able to assure ourselves and others that we're making best use of our resources. i want to assure everyone here

that what risk-based priority setting and resource allocation is not, it's not a way to somehow overlook or not address hazards and risks that don't show up on some top ten list of public health hazards. fisma really addresses that issue at a very foundational way because fisma says that every facility is responsible for addressing the arizona arizona that are reasonably likely to occur whether it's one on some top ten priority list or not. that's the foundational protection and prevention framework that fisma so wonderfully gives us and creates as the foundation for the system. what wiewr or wiewsh target is is -- what we're talking about is how we can optimally use our resources and allocate our efforts within that framework to get maximum public health advantage. how do we deploy our research efforts? how do we prioritize our

standards setting? our inspection activities? what initiatives should we prioritize to go after the top ten list, the major threats to public health? we think that a more systematic approach to risk-based priority setting and resource allocation will enable us to do that. this is something that fda's been working on for some time. fisma mandates it. if you haven't read section 110 of the food safety modernization act, you really should. it's titled sort of blindly, domestic capacity build being, but it mandates fda every other year to issue a report to congress touching on a lot of subjects including, essentially, what do we need in terms of capacity and authorities to do our public health job? but it corrects us to report every -- directs us to that those actions most likely reduce risks from food, and it includes a mandate. it's an odd way -- i didn't write this part, i just want to

show you this. this is not my language, but it specificically then in that report provision of the law has a mandate to us to promptly undertake those risk-based angsts that are identified as likely to contribute to the safety and security of the food supply. i emphasize in this language in the law because we're now mandated to take a public health prevention approach and to prioritize and take actions that will reduce the risk of foodborne illnesses. we know carol will insure that we implement that properly. but we take this seriously, and it's a major focus of effort at fda. i will mention one other document for further home work for those who are interested. you may have -- i'm sure many of you are aware of the institute of medicine report issued in 2010 titled enhancing food safety. if you want to get a sense of how we're approaching priority setting and resource allocation, i'd encourage you to read that document.

the last thing i'll say about this whole effort just to demonstrate our commitment to it is that we've actually created in my office a new position and eventually there will be an office of resource planning and strategic management. and this is going to be a focal point for the foods program and veterinary medicine program broadly. this is where we'll do the risk analytics, the data integration to do risk-based priority setting, this is where we'll do the strategic planning of resources, budget formulation, and we'll have strategic i.t. capacity to really institutionalize the capacity to work in this new way. so i go through all of this just to recognize that there's a big picture here that these rules are part of. it involves a lot of system building both within our agency and in the food system that we regulate. it's a long-term enterprise to put this system in place, and it's one that's going to take a sustained effort, again, by a lot of people both inside and outside fda. i'm not going to make this a resources pitch speech, but, um,

for all the work that i think we can do to make best use of the resources we've got, we, obviously, we need additional resources to do all of the system building. the president's budget lays out the areas in which we need resources to carry forward implementation of the food safety modernization act in an effective, timely way. it's important that we solve the resource problem. it's going to take a lot of collaborative effort by a lot of folks to do that. so i'm going to end on that note. i just want to emphasize how enthused we are about moving forward on this law, building it into the system and doing it in partnership with this community. we can't possibly succeed in isolation. i know we can succeed working with this group, and i'm excited about the prospect of the years ahead. thanks very much. [applause] >> all right, we'll take some questions. i think we have time for one or two questions. >> but i've answered the when

question, just so you know. [laughter] >> tony from food and water watch. first, i want to apologize to carol for being late to listen to her introduction -- >> it was an excellent introduction. [laughter] >> the red line had another hiccup this morning. but i have to confess, mike, that i did tell carol yesterday that i did not think that the rules were coming out of omb within the next few days because i saw you at nationals' park wednesday night in your cargo shorts. >> yea, he did. [laughter] yes, he did. >> the question i have is the congress ratified a number of free trade agreements recently. and this morning i see in the federal register already moving ahead to approve a permitting process for imported produce from colombia. celery, arugula and spinach. and i've always been fascinated by the lack of coordination

between afis and fda. afis will take care of the bug issues, and then you folks are saddle with the the food safety implications. can you elaborate in terms of what the coordination effort is between usda and fda on imports? and next question, are you going to be at nationals park tonight? [laughter] >> in spirit, i will be there tonight in spirit. i don't -- i'm still debating, actually, i may, i may go spontaneously. as you know, tony, of course, and folks here, i mean, afis has its own distinct responsibility to look out for plant health, essentially, protect american agriculture from pests that can come in the country through imported produce. and they have systems set up to do that. and we have the food safety responsibility. we do coordinate at the border, we coordinate at a headquarters level. again, the missions are distinct

enough so that it's not sort of a day-to-day operational interaction, but there's information sharing and coordination. i think, you know, i think there'll be issues around as we implement our new law how we make the pieces fit together even better. if you have ideas about how it should be done differently or better, please, fire away. but, again, we have a complex food system and congress having in its wisdom laid out a structure that that is what it is. but i would say just broadly, you know, carol could add her own perspective, as wonderfully as we worked together in the '70s, i don't think that ever has there been as much interaction and day-to-day collaboration between the fda and usda on multiple fronts fronts as there is today. not that there's not room for improvement, but we'd welcome

suggestions. >> one more question? >> avi from csdi. you mentioned that, you know, there's these new mandated reports for accountability coming out every two years which, in theory, obviously, sounds great. but i think not just within the fda, but many government organizations there's mandated reports and accountability that sits on desks and kind of falls through the cracks. so are there new systems in place? be i mean, how are you planning on insuring that this, these new levels of accountability and these mandated reports are actually going to be followed through and that it's not just going to kind of be the same old story? >> yeah, well, that's, that's my job. [laughter] it's a question of priorities. >> yeah. >> and we've articulated, i've articulated here a bit my priorities, and our strategic plan articulates priorities, and it's an external accountability

function. that's why i emphasize that. public agencies get pulled in a lot of directions, a lot of influences on what we do day-to-day. you need to hold us accountable for it. i can only express my commitment and expect to be held accountable. but, again, it's focusing on what's the most important thing, and i think building this system and being much more data-driven about pulling out resources optimally for public health is a central responsibility be. it's, essentially, why my job was created if you look back at that. so i'm all in. >> please join me in thanking mike taylor. thank you. [applause] >> the senate today resumes debate on moving forward with a bill to extend the food and drug administration user fees. this bill deals with fees on prescription drugs with the funds being used to oversee

safety of prescription drugs and medical devices. senators will also consider the nomination of california lawyer paul wattford to the u.s. court of appeals, a vote to move that nomination forward is scheduled for 5:30 eastern. the house is not in session today. members are taking the week off for its memorial day recess. live senate coverage now here on c-span2. the presiding officer: the

senate will come to order. the chaplain dr. barry black will lead the senate in prayer. the chaplain: let us pray. eternal lord god, our provider, give to our lawmakers provisions for their daily needs. give them grace to keep your commandments, to accept your guidance, to stay on your path, and to walk in your light. give them stamina to run until they reach their goal and to be true to you until the very end. make them this day wise with your wisdom

and strong with your strength. help them to believe in your power so that they may be certain that you are able to do for us -- for them more than they can ask or imagine. we pray in your merciful name. amen. the presiding officer: please join me in reciting the pledge of allegiance to the flag. i pledge allegiance to the flag of the united states of america, and to the republic for which it stands, one nation under god, indivisible, with liberty and justice for all. the presiding officer: the clerk will read a communication to the senate. the clerk: washington, d.c.,

may 21, 2012. to the senate: under the provisions of rule 1, paragraph 3, of the standing rules of the senate, i hereby appoint the honorable benjamin l. cardin, a senator from the state of maryland, to perform the duties of the chair. signed: daniel k. inouye, president pro tempore. mr. reid: mr. president? the presiding officer: the majority leader is recognized. mr. reid: i now move to proceed to calendar number 400, s. 3187. the presiding officer: the clerk will report the motion. the clerk: motion to proceed to consideration of calendar numbered 400, s. 3187, a bill to amend the federal food, drug and cosmetic act, and so forth and for other purposes. mr. reid: mr. president, we're now on the motion to proceed to the f.d.a. user fees bill. at 4:30, the senate will proceed to executive session to consider the nomination of paul watford to be a member of the ninth circuit. at 5:30, there will be a cloture vote on the watford nomination. if we're able to confirm his nomination, we should expect a

second vote, cloture vote, on the motion to proceed to f.d.a. user fees legislation. mr. president, this week, the senate must complete work on legislation that will enact crucial reforms that will prevent drug shortages and bring life-saving medicines to market more quickly. senators harkin and enzi, a democrat and republican, work very hard to bring this legislation to the floor. i'm cautiously optimistic that spirit of bipartisanship will continue because democrats can't pass this legislation without the cooperation of our republican colleagues. i certainly hope they will allow us to advance this bill this evening without additional delay caused by another filibuster. i would like senators from both parties to be free to offer relevant amendments to approve a worthy bill, but before we can get to work on this legislation, our republican colleagues must stop their filibuster. americans living with cancer and other life-threatening illnesses are watching closely to see

whether the senate is capable of quick action to ease these shortages of crucial medicines or whether we will once more be paralyzed by republican obstructionism. americans have seen that obstruction time and time again this congress. we are frustrated with the slow pace of the senate's inaction to reauthorize the violence against women act, on iran sanctions, on legislation to stop interest rates from doubling on federal student loans. earlier this month, republicans balked at an attempt to keep higher education affordable for seven million students, but democrats haven't given up. i hope our republican colleagues will come to their senses and allow us to prevent this crisis that affects seven million young men and women before it's too late. the republican obstruction and fighting also stalled new sanctions on iran. for two months the democrats have worked to resolve republican objections to this bipartisan measure which passed out of the banking committee unanimously. the stakes couldn't be higher.

sanctions are a key tool to stop iran from obtaining a nuclear weapon, threatening israel and jeopardizing the united states national security. we cannot afford more delays to put stronger sanctions in place. i'm hoping my republican colleagues will realize how important it is to advance these measures and prevent iran from obtaining a nuclear weapon. republicans have also needlessly blocked progress on reauthorization of the violence against women act. this helps law enforcement effectively combat and prosecute domestic crimes against women. although both chambers have passed a version of this legislation, house republicans have refused to go to conference with the senate. their excuse, the hype technical budget issue called a blue slip isn't much more than a fig leaf to blatant obstruction. the republicans are looking for any chance to stall or kill this legislation, but the american women haven't been fooled. if republicans really want to give police the tools they need

to prosecute domestic abusers, they will drop this facade. if republicans really care about protecting women and families, they will abandon this objection and join us in conference. mr. president, there are differences between the house and senate bills that could be worked out easily. american women and families are counting on action, but this congress has been -- it seems the republicans are interested more in inaction than action. they are more interested in blocking worthy legislation for partisan gain than in working together. their infighting and partisan games have stopped the reauthorization of the violence against women act, iran sanctions and the student loan fix, stopped them right in their tracks. these are a few ways of their stopping legislation, important measures they have stopped in the past few weeks. but the f.d.a. bill, stopping

and preventing shortages that make life-saving medicines available more quickly must not become victim of this partisanship. i hope republicans seize this opportunity to be cooperative rather than combative. mr. president, would you announce the business of the day? the presiding officer: under the previous order, the leadership time is reserved. under the previous order, -- the motion to proceed is now pending. mr. reid: i would note the absence of a quorum. the presiding officer: the clerk will call the roll. quorum call:

mr. reid: mr. president? the presiding officer: the majority leader. mr. reid: are we in a quorum call? the presiding officer: we are. mr. reid: i ask consent it be vitiated. the presiding officer: without objection, the majority leader is recognized. mr. reid: i ask unanimous consent that the cloture vote which is scheduled this afternoon on watford be vitiated. all of the provisions of that order remain in effect. the presiding officer: without objection, so ordered.

the presiding officer: the clerk will call the roll of the senate. quorum call:

quorum call:

a senator: mr. president? the presiding officer: the senator from maryland. ms. mikulski: gavin good afternoon, mr. president. i ask that the call of the quorum be vacated. the presiding officer: without objection. ms. mikulski: i come to the floor to ask my colleagues to vote for the motion to proceed to the f.d.a. administration safety and innovation act. mr. president, i come to this floor as someone who represents a state that is absolutely critical to the innovation economy. and like you in delaware, with its excellent private sector and public sector, have been in the

hallmark of innovation. if you're from maryland, you know that life science innovation is one of the important economic engines in our economy, both today and in the future. we're the home to government agencies like the national institutes of health and to f.d.a. iconic internationally branded universities that do research and move it into clinical practice at johns hopkins and the university of maryland. and also lots of thriving biotech companies and some medical devices. so for us, life science is part of the life blood of the maryland economy, and it's also part of the life blood of the american economy. my gosh, think of what we do. we come up with new biological products, new pharmaceuticals, new medical devices that save

lives, improve lives, and also enable them to help people in our own country. and because they are f.d.a. approved, the gold standard for safety and efficacy, they can sell these products around the world, often to countries that will never, ever be able to afford an f.d.a. now, where we are is we've worked very closely on a bipartisan basis to be able to create the legislative framework called the pharmaceutical drug user fee act, and there will be a lot of other ufaa, user fees, in this. and we have worked together on a bipartisan basis to bring this legislation to the floor. i note on the floor this moment is the ranking member of the full health and education and

labor committee, tax reform wyoming, senator enzi, who has been a leader in fashioning legislation where we can have -- continue the mission of what we want at f.d.a., safety and efficacy, moving drugs into clinical practice, regulations that are sensible, regulate but don't strangulate the innovation economy or the potential for saving or improving lives. the bill before us is integral to achieving this shared goal. this is not new legislation. pdufa was enacted in 1992. at that time, we were facing almost a crisis in our country. there was an unduly long wait for patients to have access to new medicines and technologies. for f.d.a., it often took two or three years to review a drug application. the submission of materials were hand -- were submitted manually

in a very rigid fashion. it cost manufacturers to the tune of almost $2 million a month. so we decided to come together in the era when bill clinton said big government was over, not to make government bigger but for government to be smaller, and we came up with a public-private partnership called pdufa, the pharmaceutical user fee legislation. it supports drug review and, in exchange, f.d.a.'s agreement -- so those who made the products paid a fee to be able to have their drugs reviewed and also they expected their government to reduce the time that it took in order to move it expeditiously and yet safely. now, let's be clear, this is a public-private partnership. for f.d.a., as it looks as its -- remember, f.d.a. has two

jobs, food safety and then the safety of drugs and medical devices. more than 60% in the drug and medical devices comes from industry fees, $712 million. the remainder comes from federal appropriations, $473 million. so private sector really carries a big part of this responsibility. the kind of staffing, expertise and modernization we have at f.d.a. could not have happened without this public-private partnership. it's been a success. now more than 1,500 medicines or technologies have been approved since 1992, and everything from the dreaded "c" words, like cancer and cardiovascular disease, to infectious disease, to the dreaded "a" words around alzheimer's, which we're working

on, and others. it's allowed f.d.a. to have more science -- more scientists and staff, and for that, giving value to the private sector to be able to decrease review times. we've reduced it from two years in 1992 to 1.1 years today. now, over the last six -- so we have excellent -- had excellent hearings. they were very civil, very content rich. but i also launched a listening tour in maryland where i went out to the major biotech counties and heard from over 25 different companies about what did they think we needed to do. i asked them where their government helped them, where their government hurt them, where should their government get out of the way, and also, where did they need a more muscular government, meaning really moving things ahead. they had great ideas. and it was just fantastic. what i heard was we have to

reauthorize pdufa quickly and we must make, though, improvements to the program. we needed to improve the drug review process. we need to increase communication there in order to speed the drug review process. we've made sure that we've increased the number of mandatory performance requirements between f.d.a. and the life science product sponsors. i say "life science" because it's bio it's pharma, it's medical devices and some things that are both. pdufa5, which this is -- it's the fifth time -- allows us to use bio markers to decrease development time by helping demonstrate thiewrp i -- therapeutic benefit more quickly. it requires f.d.a. to develop a dedicated program for drug development and training of staff. we faced turnover -- and there is a lot of reasons for that; i'll come back to that -- but we

make sure that those young people who are so smart in science need to know how to work to make the science evaluate in a timely and -- way. this is absolutely critical. we've also incentivized the development of drugs for rare diseases. we also heard that particularly for parents with children with very unique and poignant, heartbreaking diseases. it requires f.d.a. to develop guidance related to advancing and facilitating these, increase out-patients not only to the industry but to those who represent the patient advocacy groups, and, again, to develop training and certificate programs within f.d.a. on how to review drugs for rare diseases. i could go through the many benefits of pdufa. we've done also in here mdufa,

the medical device act. we do generic ufa. so there are several bills in this bill. but we have to act. there has to be a sense of urgency. see, this is a different bill than many others. if we don't reauthorize many other bills, you know, they just keep on going. but with the pdufa's and the other user fee legislation, they actually would be sunsetted if we do not pass them by october. now, you might say, "well, we'll wait till october. you know, we'll deal with it with the cliff." well, we can't do that because of the impact on both the people in the private sector and those in the public sector. failure to reauthorize this in a timely manner would have catastrophic effects on f.d.a.'s ability to carry out its

important role. if the user fee agreement expires, public -- patients, public health and industry will suffer. this isn't senator barb speaking. this is what our leading business and public health advocates are telling us. if we don't reauthorize this legislation -- the user -- this legislation, the user fee is sunsetting. so that means, u.s. pharmaceutical industries, which supports 4 million jobs, would be adversely affected. they couldn't -- there would be no f.d.a. to really work with. in 2010, maryland private life science companies supported over 25,000 jobs. these companies are true innovators. on the average, it takes a new medicine 10 to 15 years to develop. if we fail to reauthorize pdufa, which ensures efficient, consistent and predictable regulatory environment, our

private sector will lose out. we're going to lose out to europe and we're going to lose out to china, some of which is stealing our patents as we speak. it's going to have a terrible consequence to patients. tens of millions of americans rely upon drugs and by logics and -- biologics and medical devices. and we have we know we have legislation that works. we have a legislative framework that works. now we need to get to work. if we have -- don't pass this and reauthorize these major programs, what will happen is that we will need to send out riff notices. we won't do it. but dr. mary hamburg, the f.d.a. c.e.o., the commissioner, will have to, starting in july and august, send out riff notices to 4,000 federal employees at f.d.a. from the ph.d. and the m.d. to the important lab techs and so

on and others that keep f.d.a. going. this is no fooling around, folks. this isn't, "let's wait for the cliff." we will come to the brink if we do not authorize this. and just think about the world of f.d.a. if you think you're going to lose your job, that's what you're going to be preoccupied with. you're not going to be preoccupied moving the clinical clinical -- looking at these clinical trials and moving their advances forward. we've worked so hard on this legislation. the private sector has worked hard to find the sensible center. so has dr. mary hamburg and her team. our committee has worked so well we can do this. we have to have the will. and if we really want to stay ahead in the global economy, it's got to be by passing this legislation. you know, when everybody talks about stopping china, i don't know what china's going to do but i know we can stop ourselves if we don't pass legislation

that promotes innovation in our country and private-sector jobs in a partnership with its government. mr. president, i conclude by urging my people to vote on the motion to proceed, and i yield the floor. mr. enzi: mr. president? the presiding officer: the senator from wyoming. mr. enzi: i want to thank the senator from maryland, senator mikulski, for her passion and understanding and intense work on this particular bill. of course, she extends her passion and intense work on any bill that she's involved in. i'm so pleased that this bill has -- has gone to committee and had the time for the committee to work on it. and we have a very bipartisan approach on the bill and a very reasonable way to do it. so i do rise to support s. 3187, the food and drug administration safety and innovation act of 2012, and i appreciate senator mikulski doing the opening

statement on that. this bill will reauthorize f.d.a.'s drug and medical device user fee programs, authorize new user fee programs for generic drugs and bio similars and make a small number of targeted bipartisan policy reforms at the same time. this legislation represents over a full year of work by the help committee. fridays have been dedicated to coming up with solutions on this for over a year and it's paid off. it reflects the information we've learned from hundreds of meetings with patients, with advocates, with stakeholders, with outside experts and with the f.d.a. more importantly, it reflects both the ideas and the feedback that we've gotten from every member of the "help" committee and a lot of people outside of the "help" committee. the "help" committee approved this bill by a voice vote on april 25 and reported the bill out of committee on may 7. the bill will make important changes to how f.d.a. does

business. thanks to the efforts of senators burr and coburn, the bill now includes new requirements that will make the f.d.a. more accountable and transparent. a fundamental principle of effective management is that you have to be able to measure performance if you want to improve it. senators burr and coburn's ideas will help proiz provide those -- help provide those measurements, and as a result, americans are going to get better access to safe, innovative medical devices and medicines. the bill will also modernize how f.d.a. inspects foreign facilities to better account for the global nature of drug manufacturing. it will allow f.d.a. to prioritize and target riskier overseas facilities which will help prevent the recurrence of the problems with drugs like heperin. it will also improve how f.d.a. regulates medical devices. for the past several years, f.d.a. premarket review of medical devices has involve significant delay and unpredictability. this has threatened american

manufacturing jobs which have started to migrate overseas because of the unfavorable regulatory environment here in the united states. it's also threatened patient access to new therapies. i believe this bill will reverse those trends. the bill reflects the concerns that i heard in my meetings with committee members regarding the current shortages of vital and lifesaving drugs. senators blumenthal, roberts, casey, alexander, bennet and hatch should be thanked for all the work they put into the drug shortage proposal. the new notification and reporting requirements are important steps that will help prevent future drug shortages. the bill also enjoys broad support. we've received numerous letters of support from industry, from patient groups, from consumer groups and a whole raft of other stakeholders. we also worked to guarantee that any mandatory spending generated by the bill would be fully offset. over the past several weeks, we've developed offsets to pay for those provisions that produce mandatory spending.

in fact, according to the congressional budget office, this bill will reduce the federal deficit. chairman harkin and i have worked very hard to make this bill as bipartisan and noncontroversial as possible. we tried to avoid controversy because we understand that this bill needs to get done. if we don't reauthorize the drug and device user fee, programs before they expire this fall, the f.d.a. will be forced to lay 206,000 to 4,000 key -- 2,000 to 4,000 key employees. this will cause f.d.a.'s review of new drugs and devices to grind to a halt. this, in turn, will threaten the biomedical industry jobs, patient access to new therapy and america's global leadership in biomedical innovation. we're talking about 4 million jobs overall but 2,000 to 4,000 that will have to be chopped off because the money runs out when this bill expires, when the previous bill expires.ñ so it is critical that we get

that done. those are key technicians, scientists, informed people that have been working with this for a long time. faster device eus on the market. faster generic drugs out. faster. and all the other things that this bill covers. so in conclusion, i'd like to thank chairman harkin and all the other members of the "help" committee, the f.d.a. industry and many other groups for working with us on this important legislation. i particularly want to point out the cooperation that senator harkin has provided, the leadership that he's provided on the bill and the way that his staff members and mine have worked together for this, at least a year of regular meetings with all members of the committee. and so i think a lot of the controversy that could come up with a bill like this has been

taken care of. i'm hoping that it has so that we can get this done expeditiously. i thank mr. enzimr. kyl: mr. president? the presiding officer: the senator arizona. mr. kyl: i'd like to talk about this a afternoon is a bit about the president's economic record. i'm sure that americans have noticed that the president barely mentioned this economic record when he's out on the campaign trail. and can i well understand why it's not a very impressive record. especially if you are a taxpayer or a business owner. our national debt creeps closer

to $16 trillion each day. it's now more than $5 trillion more than it was when the president took office. it now adds to about $50,000 per person in the united states. and that is exclusive of interest payments. and by way of contrast, the median yearly household income -- in other words, all the people of the house -- is less than $50,000. it's $49,445. unemployment recently dropped, but it did so 230 for the simple reason that fewer people are searching for work and the president's signature legislative items -- his stimulus bill, obamacare, dodd-frank -- have not only been unhelpful but have left a trail of crushing debt. i wanted to make a few points today about each of those bills because i think they paint a fair picture of the president's

economic record. first, let me talk about the stimulus. we haven't forgotten about the stimulus, even though i suspect the president might like to. $1.2 trillion. it obviously failed to achieve the promised results. an associate press reporter wrote shortly before it was signed into law, "they call it stimulus legislation, but the economic measures racing through congress would devote tens of billions of dollars to causes that have little to do with jolting the country out of a recession." and of course that's exactly what happened. it seemed more designed to shower taxpayer dollars on certain favored constituencies and pet interests than to actually jump-start the economy. much of it was actually wasteful washington spending. many investors must have asked themselves why stheshed d they should put their money to work on new job-creating hav ventures when they have to compete with well-connected firms that can

wring taxpayer stimulus dollars out of congress or the obama administration. a "washington post" poll released showed that 48% of americans have an unfavorable view of the stimulus. and this was, after all, the president's signature effort to spur the economy. indeed, as jeffrey anderson notes in a recent issue of the "we cannily standard," the administration does steenl downplaying the law. not only has the stimulus failed to create growth, the costs have become more outrageous. "it has now been five months since the administration last put out a report card on the stimulus. a december report marked the sixth straight quarterly report showing that stimulus's cost per job is rising. it reports spanning january 2010 to december 2011. the stimulus's cost per job more

than doubled, rising from $146,000 in january 2010 to $317,000 in december 2011. with each passing quarter, the stimulus has become an even worse deal for taxpayers." end of quote. so this is the administration's own report card on the stimulus, concluding in the last report, $317,000 per job. think about that for a moment. to create each job, the taxpayers shell out $317,000. numbers like that remind me of a quip from christopher buckley." writing political sat tire can be difficult because it has to compete with reality." $317 for one job under the president's stimulus.

second, obamacare -- the $2.6 trillion bill is not aging very well. since its passage, the act has imposed an estimated $14.9 billion in private-sector burdens, aproarks $7 billion in costs to the states, and $58.6 million annual paperwork hours according to a weekly regulatory report. the april kaiser health tracking poll showed that more americans have an unfavorable view of the law that favorable. it is 43% to 42%. more than half of americans oppose its central provision, the so-called individual mandate. all tolled, the new taxes in obamacare would add up to $500,000,000,000 in ten years. many of these taxes will coincide with the biggest tax increase in history, the one scheduled for the end of this year. so at the very time that the income tax rates are scheduled

to go up, the new taxes from obamacare will hit, $500,000,000,000 of new taxes over the next ten years. finfinally, there is a dodd-frak financial regulatory reform bill. when it comes to financial regulatory reform, i think most americans believe there should be two goals -- preventing new crises from happening and making sure the taxpayers aren't on hook for wall street's mistakes. the dodd-frank bill did not achieve either goal. it is a complex web of regulations that institutionized too big to fail and has served to increase uncertainty, increase moral hazard and increase economic distortions. all the while adding $52.9 -- adding 52.9 million paperwork hours since its passage. so, as i said, president obama doesn't seem to be running for leaks on this record of the stimulus package, obamacare, or

the dodd-frank regulatory reform. instead, he's going to to be sending -- or maybe he's already sent to congress -- a to-do list, things h he'd like for congress to do, most of which are tax credits and other very short-term proposals that don't have much effect on jobs or growth because the business sector is not impressed with a one-time only short-term proposition. it wants to know that when it invests money, that investment is going to be for the long term. well, this happens to be small business week and one would think the president would turn to something that businesses would actually said they would like to do. that to prevent this tax tsunami coming at the end of the year, the biggest crasm ta tax increae history of the country, which would automatically take effect on january 1 of theks year unless congress does something

about it. the nfib, the national federation of independent businesses, recently released a list of the top five uncertainties in the tax code that they say would harm small businesses. let me mention three of these uncertainties. one is the pending increase in marginal tax rates, which will devastate the estimated 75% of small businesses that file as individuals. every one of the five tax rates in the i.r.s. code will be increased as of january 1, and since most of the businesses now patience especially small businesses, as individuals, so-called pass through entities, these rate increases directly will impact small businesses. second thing they're really concerned about is the death tax. that's going to ensnare 900 times more small business owners and 2,200 times more family farmers if the rate increases to 55% and the exemption falls to $1 million, as is scheduled to occur on january 1.

third is the alternative minimum tax which will hit 27 million more americans, including many small businesses, if it is not patched or repealed. well, small business cannot afford this -- what's been called tax ma get on and its -- taxmageddon and its devastating to-do list. a final thing i would say, and i will ask unanimous consent to include in the record at the end of my remarks a piece in ""national review"" by larry kudlow called "extend the bush tax cuts now." if i could ask unanimous consent for that. the presiding officer: without objection. mr. kyl: thank you. in this perks larry kudlow notes that with respect to this taxmageddon, the increase in everybody's taxes tend of the yeef, that it is the uncertainty

of it all that is preventing the investment by business which would create the jobs that we would all like to see. and i'd just like to quote three paragraphs and a couple of sentences and a fourth. he says, "the uncertainty over the bush tax cuts already has caused a number of business leaders to threaten a hiring freeze and a dampening of investment, until they can figure out the after-tax cost of capital and the rate of return on investment. hiring has slowed noticeably in recent months, and a number of wall street economists are move tmarking down the annie nick recovery even more suggesting that 39% growth at the end of the last year, which faltered to 2% gloaj in the first quarter, could be even less in the pood ahead." then he goes on to say, "a bunch of c.e.o.'s have even formed their own march on walking. 18 of them just wrote to the tim think geithner begging thoim oppose tax rate hikes on dividends and capital gains,

from 15% to near 30%. he says, equity capital is the lifeblood of investment and job creation for u.s. companies." that's what the -- that's what these c.e.o.'s wrote in the letter to treasury secretary geithner. and kudlow goes on to say, "they argue that the plans would do great marm to america's competitiveness and capital formation." then he quotes the ernst & young firm to say this, "the top u.s. integrated tax rate on corporate profits and dividends is on course to hit 68.6%, significantly higher than all other oecd countries." those are the developed conings of the world, "as well as brazil, india, russia, and china. capital gains would raise to 56 30eu7%." in other words, he's pointing out that not only would these high -- higher tax rates hurt the small businesses and the

families because of the individual tax rate -- marginal rate increases, but raising the dividends and capital gains taxes would be even more detain detrimental because we're asking companies in america to compete with firms all over the world and their rate would be much, much higher with this tax increase than the rate in all of the other developed countries as well as countries like brazil, russia, india, and china. how can american businesses compete in that situation? and then finally, kudlow notes the effect of all of this uncertainty on what matters most to most americans and that is the fact that they can't get work. he says, "bizarrely, some 25 million people have vanished from the labor force, from unemployment, underemployment, or simply dropping out altogether. and half of u.s. households are now on some form of federal

transfer payment assistance. so as we pay," he said, "many people nolt to work, we're sapping the vitality of the economy." mr. president, this is absolutely true. with half of the people in the country on some form of federal snangs, with 25 million people having just vanished from the labor force, not even looking for work anymore, businesses sitting on the sidelines because they cannot calculate what kind of return on investment they could get because of the potential for this huge tax increase that's going to occur on january 1, it's no wonder that we can't move forward with an economic recovery. and so i would just say to president obama that providing long-term tax rate certainty would go a long way toward establishing a sound economy in this country, on putting americans back to work, and ironically on establishing a better record on which the president could run.

a year and a half ago the president actually proposed, and congress was, i think, very happy to go along with a continuation of the existing tax rates because, as he said at the time, not to do so would be very damaging to the economy. and i would just submit that it's equally damaging for that to happen at the end of this year. so i would ask the president, help give the american people and american businesses the certainty that they need to invest, to create the jobs, to advance our economic growth and create prosperity for our future.

the presiding officer: the senator from louisiana. ms. landrieu: thank you. are we in a quorum call? the presiding officer: we are not. ms. landrieu: thank you, mr. president. i have one unanimous consent request for the committee to meet during today's session of the senate as the approval of the majority and minority leaders. i ask unanimous consent that this request be agreed to and that this request be printed in the record. the presiding officer: without objection. ms. landrieu: thank you. mr. president, i wasn't here to hear all of my colleague's remarks, and i know that there's a lot of concern about the end of the year and what might happen to try to balance our budget and give a solid platform on which this economy could

grow. one of the things that's holding us up is the republicans' refusal to put any new revenues on the table. they have been adamant and wrong and hardheaded and stubborn, and they have been very obstructionist in this way by not being willing to put a penny of new revenue on the table. and as a result, we have come to a standstill, because the income coming in to the federal treasury to support this government is the lowest level since president eisenhower was the president. so they can come to the floor all day long and criticize the president, criticize the democrats, but democrats just in the last two years have put over $2 trillion of cuts and reductions to some very important programs on the table.

some of us have even been willing to say yes, we know we have to reform social security and medicare and medicaid, and been willing to speak those words, which are not easy. but yet, not one single republican leader -- not one -- on either side of the house or the senate, not one has come to this floor in public, on this floor -- i've heard them say it in private. i've been in meetings when they've said it. but not one has come to this floor to say "we're willing to put revenues on the table so that we can match some cuts and move this country forward." so i'm a little tired of hearing them beat up on either president obama or the democrats when they are more to blame for the situation that we're in.

and the american people are getting tired of it too. because they can understand that it really is not 100% president obama's fault. in fact, when he took office, the titanic hat already hit the -- had already hit the iceberg because they had run right smack into it when the economic philosophies and policies that they had. the ship was already sinking. but all they want to do -- and it's either mitch mcconnell or jon kyl one day or the senator from arizona or the senator from kentucky, they every day come to the floor and just talk about how it's the president's fault that there's no way forward, there's no sure path forward, when they are the ones that have put boulders ni way every day. so i sure hope that the people can see through it. i came to the floor to talk about something else, but i'm getting a little tired of

hearing it myself, so i'm sure that everyone else is as well. again, democrats have put $2 trillion of cuts before this body, and we've implemented some of them already. but you can't run a government on 14% of the g.d.p. the average has been about 20% to 21%. so until they're willing to put some more revenues on the table, we're not going to get anywhere. and we're not going to be able to extend the tax cuts that cost people money. now i hope that we can do something so that we can extend some tax cuts to small business, which is what i came to talk about. and you, mr. chairman, know this well. instead of giving some of the biggest tax breaks to companies that are the biggest in the world and put all their jobs overseas, i wish the republicans would start talking about tax relief to businesses right here at home on main street. and that's what i want to talk about today. we have a resolution filed because it's small business

week, on behalf of myself and senator snowe, senator pryor, senator lieberman, senator enzi, senator kerry, senator brown, cantwell, ayotte, cardin and hagan; a very good representation of our small business committee and others, mr. president, that filed a resolution this week, again, and we've done so every year since 1953. we've done so every year since 1953, to recognize this week, or one week in the year as small business week. and so that's what our resolution which was filed earlier today does. and i hope that leaders mcconnell and reid will take this up and pass it, so that we can honor the 28 million small businesses that exist today in america. we've been doing everything we can, and i'm very proud as the

chairman of the small business committee that we've worked in a bipartisan fashion for the most part, trying to give our businesses, first of all, the recognition that nine out of ten new jobs created are being created by a small number of small businesses that are fast growing. they are the net new job creators. these are the businesses that are going to be putting this recession behind us. these are the businesses that are innovating and adapting and changing and being more strategic and smarter, looking for those opportunities in all areas and in all geographic parts of our nation. over the past few months my committee has held three very special round tables to explore strategies, tools and methods to strengthen what i like to call, mr. president, the ecosystem of

entrepreneurship. i mean, much like a rain forest or much like a desert, or much like the ocean itself, that's an environment where many, many creatures or organisms have to leave or interact, the same is true of the financial ecosystem, the political ecosystem, society itself as an ecosystem, where small businesses have to function. and in order for them to be healthy, there have to be the right nutrients, if you will. and so we've sort of explored in our committee what is it -- we know the united states does this well. we do it better than any country on earth, and that's one of the great strengths of america, is we really foster that entrepreneurship, free but fair markets, well-regulated, not too

lightly, not too heavily. sometimes we go a little overboard and need to pull back. sometimes we don't regulate enough and need to step up. that's what we've been exploring. in fact, we've broken our round tables down into dough mains. do our -- domains. do our small businesses have enough access to capital? do our small businesses truly have access to global markets? what did we learn this year? we learned less than 1% of all small businesses in america export. with the market growing overseas and only a small percentage of the world market being now in the united states, we were at one time the biggest market. when china was closed and communism was reigning in the soviet union and the arab world was in darkness, i mean, the market was here in the united states. but that's no longer the case as these countries and areas emerge and create markets of their own and opportunities. so one thing we learned is that

the ecosystem needs to be stronger, helping small businesses to export. they don't have the back office or the expertise or ten accountants, and you know, a chinese specialist and south american specialist. but we can, by being smart, help through the commerce committee, the small business committee -- i mean the small business administration, or maybe even through some of our research and development arms of some of our departments, really be the back office for small business. and we're excited about what's happening there. access to capital, access to global marriage, access to counseling, mentoring, technical assistance and education. i've had so many small businesses come before our committee, mr. president, and say, you know, senator, getting the loan from the bank was the first step. but if so and so hadn't shown up in my office from the score chapter, or if i couldn't have

reached out to my local university for my small business center there, i would never have been able to make it, because they told me what to do, saved me from making a fatal mistake and got me on my way, or helped me to rethink my market during the recession was how one lady put it before our committee and said helped her remarket her business to now it was growing faster than ever. i think also, mr. president, access to strategic partnerships. you know, we are not -- no man is an island. we don't accomplish anything by ourselves in this world. and that's true of individuals. it's true of small business. so we asked ourselves, who are the partners, strategic partners for small business? and cities are doing some creative things. you were county president. you know the things you did as county president, and your

reputation is well-known in that regard. states can be strategic partners to their small businesses. so we explored those opportunities. access to government contracting, the federal government and state government and local governments are some of the biggest spenders and biggest businesses, if they were businesses -- which we're not, and there are clear differences. but if we were a business, the federal government would be the largest business in the world. it buys more goods and services, and we don't have to do all of that just with the big businesses like i.b.m. or g.e. or exxon or exxonmobil. we can contract with small businesses. it takes a little more time, takes a little more energy, takes a little bit different approach. but we most certainly can buy some of the things we need from the small business right down the street. and so we are shaping policies to do that.

access to government contracting. and i might say that senator cardin from maryland has been particularly aggressive, particularly when it comes to contracting with minority and women-owned businesses, which make up a really significant and growing area and very exciting as more women enter not just the workforce, but decide they want their flexibility, they want to set their own hours, they want to be their own bosses, is they want to establish businesses that allow them to also raise children at home, to be there when their kids need them. so they find that small businesses operating out of their homes are sometimes the answer to that dilemma. we want to give them access to government contracting when, of course, they are capable and provide the right price. one of the big areas that we looked at, mr. president, is access to human capital. i think you've probably heard, and many of our businesses are

saying, why is it that we are bringing in some of the smartest people in the world, educating them at our universities to where they're getting master's degrees and ph.d.'s in engineering and math and science, and then we send them back to the country they came from, so they can create businesses to compete against us? why don't we extend visa privileges to these masters and ph.d. candidates? that's a good question, and we have bills to answer that. we also want to develop a skilled workforce in america, and access to human capital is what small businesses need to grow and to expand. and finally, access to flexible regulation and smart tax policy. we're never going to live in a world where we don't pay taxes. it's just the nature of what we have to do to keep our

government running and operating, which is a government that serves the people, for the people, by the people. but our taxes shouldn't be too heavy, too burdensome, and our regulatory regime shouldn't either be too light, you know, or too onerous. and it should be just right. and it's hard to get that just right approach, but we're working at it every day. senator snowe has been working on regulatory reform. senator warner has been working very hard on regulatory reform, and other members of the body. so the bottom line is this is small business week. we want to honor the small businesses that are really helping us put this recession in the rearview mirror. i want to ask the leadership to pass this resolution very straightforward, noncontroversial resolution by both democrats and republicans, recognizing this is small

business week, but i also wanted to bring to the attention of the body the conclusion basically of our three roundtables that we have held and thank the members who attended. we had very good attendance at these roundtables. we are bringing some excellent ideas about the brackets that i have outlined today and have been in the process of filing over the last week and throughout this week individual bills that reflect what we have learned in these roundtables. we have taken those ideas, turned it into legislation. i'm happy to say there is not going to be a big price tag to this legislation. it's not necessarily throwing money at the problem, although we do need additional resources in some areas, but it's just sharpening some of the things we already have on the books or reforming some of our strategies, some of our laws, rules and regulations on the books, encouraging by granting some competitive grants some of these strategic partnerships

with counties, cities and states. so i'm looking forward to seeing how the body responds to some of the new pieces of legislation that we have put out and look forward to working with my colleagues through this week, through this month, the month of may, through the summer and into the election to keep focused on the number-one issue on the minds of the american people, which is jobs, economic hope and economic opportunity for themselves and their families. you know, tom friedman has been saying all over the world when kids graduate from college, it's not a job they are looking for, they may not be able to find the job they are looking for. they need to create the job they want. they need to build the business, build a better mousetrap, think about a different way of delivering a product or a service, think about taking a business that's just selling to a domestic market and sending it

globally. with the technology, with the opportunities, many, many young people are doing just that. in conclusion, i had the wonderful opportunity on friday to be in boston and took the opportunity on saturday morning to stop in the cambridge innovation center, which is the granddaddy of all small business incubators. of course it's right across the street from m.i.t., right across the street from microsoft and google. there were some young and exciting college students in the building. you could either rent a little cubbyhole that looked like a little kindergarten cubbyhole when you were in kindergarten with just your name on it for a few hundred dollars to get in the building or you could rent a space kind of like a bullpen where you could be working and you could rent your own little cubical or private office. and thousands literally of young people were moving into that building. actually, not just young people. people of all ages. retired execs who said i have

always wanted to try out my idea, let me get my business started. i can tell you, even on a saturday, it was very quiet. i could feel that energy in that building although it was virtually empty as i walked through on a saturday morning with the director. i have walked through the incubators in new orleans. i hope you, mr. president, have walked through some of the incubators and helped to create them in delaware because that is what it is going to take, a strategic partnership between government and the private sector, letting the private sector do what they do best but letting government do what it does best, and that was a perfect example of what -- of what i saw in terms of taking research dollars that are spent at m.i.t., moving them out to the -- to the universities and then on to these ideas where they are literally being tested and commercialized to get out into the market to create wealth and opportunity for the united states and for the world. so i am really happy to be chair

of the small business committee, police economic growth, it's national small business week. i want to thank all the groups that are helping us to celebrate this week, and most importantly thank the entrepreneurs that literally risk everything to create their dreams and to bring economic prosperity not just to themselves and their families but to the nation that relies on them every day to do their very best work. we want to make that burden lighter. i want to help them in every way that we can in our committee here in washington, throughout our states, counties and cities to be the partner that they can rely on to get the job done. so, mr. president, i don't see anyone else on the floor. again, i urge my colleagues to adopt our resolution, and i thank all of those that will be speaking today and this week on small business week. and i yield the floor. i suggest the absence of a

quorum. the presiding officer: the clerk will call the roll. quorum call:

the presiding officer: the senator from oregon. mr. wyden: mr. president, i ask unanimous consent to vacate the quorum call and speak as if in morning business. the presiding officer: without objection. mr. wyden: mr. president, i believe the development of the internet, its networks and the digital economy is one of the great achievements of our age. the internet links humanity together, facilitating economic growth, bringing education and health resources to remote regions, reshaping societies and advancing human rights. while networks foster innovation , job creation and political and social progress, networks can also be used by actors with nefarious motives. it is in our national interests

to deter, detect and destroy real and viable cyber threats and to protect americans and preserve the benefits of the internet. americans must not be afraid to go online. mr. president, the internet works not just because it is open to all but because it is founded on the principle of trust. users truce -- trust that their browsers are visiting real web sites, not replicated ones. internet commerce succeeds because people trust that their transactions are private and their financial information won't be shared with others. people trust the internet because they believe their service providers work for them, not for their advertisers, not for scammers and not for the government. congress' effort to develop a comprehensive approach to cybersecurity must not erode

that trust. when americans go online to consume digital services and goods, they must believe and know with some certainty that their privacy is adequately protected. the content that americans consume must be at least as private as their library records, their video rentals and book purchases in the brick-and-mortar world. our law enforcement and intelligence agencies should not be free to monitor and catalog the speech of americans just because it's online. but the legislation passed by the other body, mr. president, known as cispa, would erode that trust. as an attempt to protect our networks from real cyber threats, cispa is an example of

what not to do. cispa repeals important provisions of existing electronic surveillance law that have been on the books for years without instituting corresponding privacy, confidentiality and civil liberties safeguards. it creates uncertainty in place of trust. it erodes statutory and constitutional civil rights protections, and it creates a surveillance regime in place of a targeted, nimble cybersecurity program that is needed to truly protect our nation. now, unfortunately, s. 2105, the bill before the senate, shares some of these defects. currently, internet services and service providers have agreements with their customers that allow them to police and protect their networks and users

rather than simply allowing these internet companies to share information on users who violate their contracts and pose a security threat, the house and senate proposals regrettably authorize a broad-based information-sharing regime that can operate with impunity. this would allow the personal data of individual americans to be shared across a multitude of bureaucratic military and law enforcement agencies, and this would take place regardless of the privacy agreements individual americans have with their internet service providers. in fact, both the house and senate bills subordinate all existing privacy rules and constitutional principles to the poorly defined interests of what's called cybersecurity.

these bills would allow law enforcement agencies to mine internet users' personal data for evidence of acts entirely unrelated to cybersecurity. more than that, they would allow law enforcement to look for evidence of future crimes, opening the door to a distowpathian world where -- where law enforcement evaluates your internet activity for the potential that you might commit a crime. in establishing this massive new regime, mr. president, these bills fail to create the necessary incentives for operators of critical networks to keep their networks secure. now, it's a fundamental principle of cybersecurity policy that any network whose failure could result in a loss of life or significant property should be physically isolated from the net. unfortunately, many of our

critical network operators have violated this principle in order to save money or streamline operations. this sort of gross negligence ought to be the first target in any cybersecurity program, not the privacy of individual americans. now, congress could target this behavior with yet one more rule book and one more bureaucracy, creating a cybersecurity contractor full employment program. i am not, however, convinced that this is a problem that requires that kind of solution. at the same time, congress should not allow our critical network operators to ignore best practices with impunity. it's vital that they understand that any liability for a preventible cyber attack is their responsible. there's not going to be a

governmental bailout after the fact in the cybersecurity area. shareholders and boards of directors must be vigilant and understand the risks to their investments. executives must understand that ignoring critical cyber threats in the interest of cost savings and convenience will leave them personally exposed. internet providers and backbone operators clearly have a role in this fight. when they defect -- detect abnormal network activity or have a user violating their contract in a way that constitutes a cyber threat, that they can and should inform our cyber defense officials. if it's necessary to grant them immunity to share this kind of information, the congress could grant it narrowly and with careful consideration. mr. president, there would be bipartisan support for the proposition that the federal government also has a

significant role that does not necessarily require billing taxpayers for legions of private cybersecurity contractors. the department of defense, the department of international intelligence, homeland security, and the justice department, four major parts of our government, all have cybersecurity specialists. the congress ought to be promoting the cyber capabilities of these agencies and providing the resources that are needed to protect these networks. these federal agencies should do a better job of consulting the private internet companies to better understand the attacks that are occurring every day across the net. some of these steps, mr. president, and colleagues, may require legislation, but many can be carried out by responsible actors in the public and private sector without waiting for the congress to act.

however, the legislation before the senate and the cybersecurity legislation that passed the other body leads our country away from the kind of commonsense approach to cybersecurity that i've outlined this afternoon. as they stand, these bills are an overreaction to a legitimate and understandable fear. the american people are going to respond by limiting their online activities. that would be a recipe to stifle speech, innovation, job creation, and social progress. i believe these bills will encourage the development of an industry that profits from fear and whose currency is americans' private data. these bills create a cyber industrial complex that has an

interest in preserving the problem to which it is the solution. now, in terms of the process, the senate ought to proceed in a way that's open and collaborative as the internet that the congress seeks to promote and protect. on substance, any cybersecurity bill must contain specific and clear descriptions of what types of data and when such data can be captured, who it can be shared with, and under what circumstances. anything not specifically covered ought to remain private. privacy in the cybersecurity arena should be the default, not the exception. legal immunity to corporations that share information should be the exception, not the rule, and void privacy protections or contracts are disregarded. the congress and the public must have the ability to know how any

cybersecurity program that's established is to be implemented. that means routine public and unclassified reports and hearings to examine whether there are any unintended privacy or civil liberty impacts caused by the program. no secret law, mr. president. bad internet policy is increasingly premised on false choices. now, earlier this year during the consideration of the protect i.p. act and the stop online priersy act, the congress was told again it had a false choice. the congress was told it either could protect intellectual property or it could protect the integrity of the internet. this was a false choice, i and others said so at the time, because achieving one should not and does not require sacrificing the other. now, mr. president, the

congress is being asked once again to make a false choice, a choice between cybersecurity and privacy. and i don't think these two are mutually ex cluesive -- exclusive. i think you can have both. our job is to write a bill that protects cybersecurity and the fundamental right to privacy of our people. there is no sound policy reason to sacrifice the privacy rights of law-abiding american citizen in the name of cybersecurity. mr. president, it's my intent to fight any legislation that would force members of the united states senate to make that choice. mr. president, with that i would yield the floor. a senator: mr. president? the presiding officer: the senator from indiana. mr. coats: mr. president, i rise today to talk about the

food and drug administration safety and administration act and innovation act. i believe we're going to be having a cloture vote, procedural vote on that this evening, and i'm pleased, all early indications are that will pass and we'll move forward on this bill. this has been a considerable time in the making. it is one of those pieces of legislation that has gained bipartisan support, both in house committees and senate committees, and it's moving through what i would call a regular process. we haven't seen too much of that in the last year and a half or so. this is a regular process, and for those who say congress can't get anything done, hopefully with passage of this bill we will have taken a very significant step forward in terms of being able to provide and bring to patients, doctors, administrators, and others across the nation new drugs, new treatments, new medical devices that can ensure better health, prevent

potential terminal situations, and better drug availability and device, availability to american citizens. i think it's important that we go forward and i'm pleased we've gotten to this point on a bipartisan basis. i think senator harkin and senator enzi deserve commendation for their work here in the senate, and of course those in the house in bringing the bill along on a parallel track. the whole idea here is to continue to provide the safest, most effective, and most efficient drugs and devices for american citizen and -- american citizens and disens around the world, two important industries where the united states have been the leading edge of providers, and we don't want to lose that. it's meant a lot to our economy. it's meant a lot of jobs for a

lot of americans. and this will -- passage of this bill will continue, i think, what has been a remarkable nearly three decades' worth of innovation that has taken place both in the biopharmaceutical industry as well as the medical device industry. now, part of this bill deal with the situation of drug shortages. i've talked to a number of doctors, my staff has been traveling the state talking to medical providers, and there's been an alarming number of drug shortages in critical drugs, particularly those designed perhaps to deal with -- with more rare instances of health problems, yet, obviously, important to those people who are suffering from those incidents of disease or health threlt. -- threat. it's been reported to me that

f.d.a. last year received a record number of drug shortage reports, more than 250, including critical drugs used in surgery, emergency care, and oncology. and the problem continues today. but there is legislation in this bill that addresses that, and hopefully will move us forward significantly in terms of dealing with this current problem. in fort wayne, indiana, my hometown in indiana, parkview's director said nearly 80% of hospitals consistently face shortages in drugs needed for emergencies, including cardiac and diabetic prescriptions, and this bill incorporates significant reporting requirements to the f.d.a. that i hope will help mitigate this critical problem. i think this is going to be ongoing and we're going to need to figure out ways to further address this, but this could be an important first step. now, whole concept here has been somewhat unique in the

federal government. that is, the makers of the products essentially pay a fee to the regulatory agency for the regulatory agency to conduct the work necessary to gain the approval for them to sell their drugs on the market. we've got a -- we've had a situation here which is sort of the cornucopia of new innovations in drugs and medical devices, yet that have been delayed by bureaucracy or the inability of f.d.a. to move in an efficient and effective way to -- to run this through the process and put its stamp of approval on it. and so the biopharmaceutical industry has basically said look, we're willing to put up between $3.5 billion and $4 billion in new user fees, i believe it's over a five-year period of time. fees that will account for nearly 60% of the funding designated by the center for

drug evaluation and research. in exchange for putting up those fees, f.d.a. has agreed to new performance goals and process improvements that will reduce the time for drugs to reach the market. so the key here is to provide the funds necessary to hire the right people and put the right procedures in place to expedite the study of and approval of safe, effective, efficient drugs that have been sent to f.d.a. for approval. so we can get them into the market and, of course, the goal here is get them not only into the market but using them to provide health and safety benefits for people. the medical device user act is also part of this. in indiana we not only have a large -- very large biopharmaceutical company and a number of affiliated companies, we also have a vibrant and

dynamic medical device industry. that is -- this industry employs over 20,000 hoosiers directly and many, many more indirectly with good-paying jobs and many of these companies are right on the leading edge of new innovation and new development. included in the legislation that will be voted on is the five-year agreement known as the medical device user fee act that improves the regulatory path deviceway. this is the medical device equivalent of the pharmaceutical user fee. the industry has worked with the f.d.a. again in an dwreement greement which -- agreement in which both sides contributes. they will contribute user fees to go to the f.d.a. that can be used to streamline, not compromising safety in anyway, but to streamline the regulatory process so the approvals can made. why is this important? well, not only getting these

products into the markets so that they can be used to improve the health in a safe way of our american citizens but this is a dynamic export industry and america has been the leading exporter of medical devices. i have heard from so many medical device manufacturers throughout indiana that they're faced with a dilemma of having to potentially think about moving overseas simply because of the delays and the bureaucracy and the time lapse that exists for approval, where if they -- they can manufacture these overseas and sell them overseas on a worldwide basis much more quickly. they don't want to do that. the united states is their home of origin. they want to produce here. but they have to compete with their competitors across the waters, and they are subjected to a lot less delay in

implementing their approvals. and so to counter that, we simply want to use these medical device user fees in a way that will help the f.d.a. review process and eliminate these unnecessary delays, and inconsistency of past practices. i do want to thank the f.d.a. for paying significant attention to our device users by coming to indiana, listening to them, a forum that i convened. there's been interaction back and forth, whether it's f.d.a. traveling to indiana or device manufacturers traveling here to washington. and i'm pleased that within this bill is the result of all those negotiations and all those exchanges between the two. let me just mention one last thing before closing here, and that is the medical device tax. that is not part of this bill, but it's part of the so-called

affordable health care bill that was passed, a 2.3% tax to pay for some of that bill was imposed which will begin in 2013. that tax essentially was imposed on an industry that is paying its full share of taxes, contributing to the user fee, and yet was slapped on as a way i believe the -- i believe as a way to pay for the health care bill. that has enormous impact over a period of time on these device manufacturers. and jeopardizes manufacturers' ability to remain based here in the united states rather than looking overseas. there's a number of states in addition to indiana, my colleague from minnesota is waiting to speak, i don't know if it's on this, but her state also is a major manufacturer and

innovator of medical devices but california, florida, illinois, massachusetts, new jersey, new york, ohio, pennsylvania, texas, wisconsin will all suffer potential job losses if this medical device tax is imposed. we're not taking it up in this bill. it would obviously potentially derail the bill, the agreement has been made that it would be set aside. i know senator hatch is looking for -- on our side is looking for an opportunity to bring that up at another vehicle, and i want to support that and i encourage my colleagues to take a look at the impact of that fee on our ability as a nation to be the leader in innovation and export of medical devices. with that, mr. president, i again want to thank senators harkin and enzi for shepherding the food and drug administration safety and innovation act through the committee. i think this legislation will

help improve patients' access to new medical technology. it will protect american jobs and improve the f.d.a. so america can remain a global leader in biomedical innovation. and i encourage my colleagues in the senate to support this important legislation and yield the floor. the presiding officer: the senator from minnesota. ms. klobuchar: i thank the senator from indiana for his words. we both are from states that have a lot of jobs involved in medical device, and, in fact, this bill is something that we worked on very hard. i'm the head of the medical -- cochair of the medical device caucus in the united states senate, this has been our top priority to try to move those f.d.a. rules along, and this bill does that. it's an agreement, a rare agreement between government and industry which is something that both parties want. we would like to move those approvals along for the patient, long-suffering patient

who should have access to medical devices and also for the industry where we've seen way too much venture capital money go to places like europe, simply because that process moves faster. and so this is a very good bill and i'm so pleased we have bipartisan support. i see the senator from wyoming, senator enzi, has come into the chamber and both he and senator harkin deserve a lot of praise. now, i wanted to focus today, mr. president, on one piece of this bill, something i've worked very hard on, and it really came out of things i heard in my state, things i heard from pharmacists literally two years ago, things i heard from patients and i got together with our staff, i see rose bowman and andrew hugh are here today, and we went and talked to all kinds of people involved in this, pharmaceutical companies, we talked to -- to try to figure out what was going wrong with drug shortages, we talked to the people who were

suffering the most, the patients, we talked to the pharmacists and said what would work here? and the f.d.a. told us that, in fact, when they did get early notification from pharmaceutical companies that there was going to be some kind of shortage, it helped. they were able to avert those shortages, in fact, they've done it successfully over a hundred times and they have done it many, many times with some key drugs. and the earlier notice that they have, the better it is for everyone, because they can, in fact, then avert the drug shortage and that's what this is about. i will tell you that for me, this whole bill and this whole provision really comes down to a little boy named axel, with a big smile and because of leukemia, this bill loy-by-when i saw him had no hair on his head. he and his family were dloan throne into a panic -- thrown into a panic when they learned an essential drug was in short supply and might not be

available for their son, diagnosed with leukemia was supposed to start treatment and the doctor said he should start immediately but we don't have this critical cancer drug, this lou teamia drug. they took axel to canada where the drug was readily available and just when they were ready to go there, they found out some of the drug had len boacted and axel could come in for his treatments. that should never happen, not in the united states of america, not for a family of a 4-year-old boy, both parents working hard to make sure their child could have health care and then this happens, it makes no sense. or the story of mary mchugh morrison who joined a forum i held in medina, minnesota. mary's cancer had, unfortunately, returned after a shortage of a chemotherapy drug that hept her ovarian cancer at bay and, in fact, this shortage

interrupted or regime. mary struggled to independent find remaining vials and struggled with the ethical dilemmas are using the drug she found when others would not be able to find it. she talked about how she had used connection, tried to find those vials and realized when she got those drugs, other people didn't get the drug. this shouldn't be happening in the united states of america. she shared her experience with us, and because of a few delays in treatment, mary's doctor told her that her tumor had, unfortunately, returned and she was no longer responding to that drug. this past february, c.t. scans, unfortunately, showed that mary's tumor size had doubled. she was immediately accepted into a clinical trial at the mayo clinic and began treatment. fortunately she is is far responding well and her health is improving. but these shortages, mr. president, are happening all over this country.

every single senator in this chamber has heard about one of them. you heard senator coats from indiana just talking about what he'd heard. and so the fact that we heard this first in minnesota i don't think is any surprise. we have an active state. we have people that believe that you can still make a difference. we have pharmacist as that are on the frontline every day and they came to us to get this bill introduced. we heard from emergency medical responders who have told me that shortages have made it difficult to stock lifesaving drugs in their ambulance. i've listened to stories from parents whose children rely on drugs to help maintain their focus at school. i've seen firsthand how doctors and pharmacists have had to struggle to keep their patients alive as they look for these drugs. these shortages have had significant impacts on these patients' quality of life, oftentimes forcing them to pay hundreds more for expensive alternatives. or risking their professional careers to adjust for their diseases and spending hours and days just trying to find a way to fill a prescription.

you know, when we are dealing with so many costs and resource issues with health care, the last thing we want is for our doctors and nurses and pharmacists to be wasting away hours trying to find drugs and then ultimately in most cases finding them. but this is no way to run a railroad. across the country, hospitals, physicians, and pharmacists are confronting unprecedented shortage of these drugs. so those are the stories but here are the numbers. the number of drug shortages has more than tripled over the last six years, jumping from 61 drug products -- remember, there's thousands and thousands of shortages but this is 61 different drug products in 2005 to more than 200 drug product shortages in 2011. a survey by the american hospital association found that virtually every hospital in the united states has experienced shortages of critical drugs in the past six months. more than 80% reported delays in patient treatment due to shortages.

for some of these drugs, no substitute drugs are available. or if they are, they're less effective and may involve greater risk of adverse side effects. the chance of medical errors also rises as providers are forced to use second or third-tier drugs that they're less familiar with using. a survey conducted by the american hospital association showed that nearly 100% of their hospitals experienced a shortage. 100%. another survey conducted by premier health system showed that 89% of its hospitals and pharmacists experienced shortages that may have caused a medication safety issue or an error in patient care. it is clear that there are a large number of overlapping factors that have resulted in these unprecedented shortages. experts cite a number of factors. market consolidation, poor business incentives, manufacturing problems, production delays, unexpected increases in demand for the drug, inability to procure raw

materials, and even the influence of a gray market. literally, people are trying to make money off of this now. they hear there's a shortage, they buy up the supply and then sell it at a higher price. financial decisions in the pharmaceutical industry are also a major factor. many of these medications are in short supply because the companies have simply stopped production. they decided it didn't work for their profits to keep producing them. mergers in the drug industry have fair narrowed the focus of product lines. as a result, some products are discontinued or production is moved to different sites, leading to delays. when drugs are made by only a few companies, mr. president, a decision by any one drug company can have a large impact that. would make sense. to help correct a poor market environment or to prevent gray market drugs from contaminating our medication supply chain, we must address the drug shortage problem at its root. last year i introduced the

preserving access to lifesaving medications act with senator bob casey. we also had the support of senator collins and others. this was a bipartisan bill that would require drug manufacturers to provide early notification to the f.d.a. whenever there is a factor that may lead to a shortage. we also had support from you, mr. president, as well as from senator blumenthal of connecticut and many other people from across the senate. this bill will help the f.d.a. take the lead in working with pharmacy groups, drug manufacturers, and health care providers to better prepare for impending shortages, more effectively manage shortages when they occur, and minimize their impact on patient care. and that is why i'm pleased that the early notification provision from my bill is included in the food and drug administration safety and innovation act, the one that senator coats and i were just discussing, and that we are debating today. i want to thank senator harkin

and senator enzi for their leadership on the "help" committee in bringing this legislation forward and including my provision. in a bipartisan manner, the "help" committee brought together several working groups to address a wide range of issues, from medical device innovation to drug shortages. in the drug shortage working group, we spoke with experts from patient groups, providers, drug manufacturers and the f.d.a. to try and find an appropriate solution. ultimately, the legislation now includes many policies that i believe will help direct shortages. in addition to the early notification requirement -- again, the f.d.a. is going to be able to look in our own country and if they can't find something in our own country, they can look at safe locations overseas. you simply can't keep these patients waiting for their treatment. so in addition to that, the bill directs the f.d.a. to improve communications inside and outside its walls, requires more robust record keeping and reporting, and asks for studies on how pricing factors impact drug shortages.

i believe that this bill represents a step forward in our ability to prevent these shortages. a strong step forward. with manufacturers provider early notification, the f.d.a.'s drus shortage team can -- drug shortage team can then appropriately use their tools to prevent shortages from happening. as i mentioned, in the last two years, the f.d.a., with this more information, has successfully prevented nearly 200 drug shortages. imagine the hundreds of thousands and millions of patients that that has helped. so we need to extend it. that's what this bill does. one such example is a recent shortage of methatrexate. this is a very common drug used in chemotherapy to treat cancers like leukemia. for me, the most devastating part about the shortage is that i heard about it from the zerbys family, the family of this little four-year-old boy that had to suffer through the shortage of cyterabine earlier. only this time, the f.d.a. took quick action once it learned of

this potential shortage and worked with other manufacturers to boost production and help stop the bleeding before this became a major crisis. that is an example of what can happen with early notification. they're allowed to then go to other manufacturers and find the people that can make the drug, to get it to the hospitals, to get it to the patients. and today, with strong cooperation between the f.d.a., pharmaceutical manufacturers, methatrexate is patient for patients who rely on them, just like that little four-year-old boy, axle zerbys. together with senator casey, we were able to work with the "help" committee and in a bipartisan manner come up with a solution that would give the f.d.a. more tools to prevent drug shortages and ensure patients like axle and mary have the drugs that they need when they need them. recent announcement by the f.d.a. have proven that cooperation with manufacturers have helped reduce the number of drug short ranls by over a half. there have been 42 newly scarce

drugs so if a this year compared to 90 in the same period last year. that's progress. while i applaud the f.d.a. and their efforts to address this crisis, 42 drugs in shortage is still 42 too many for me. that is why it is so important to pass this provision and give f.d.a. the tools that it needs to get the number down to zero. i understand that early noteificationoteification requiy be a short-term solution solution to a long-term problem. that's why i will continue towork with my senate colleagues to come up with a broad, permanent solution, one that includes methods to address the root causes of drug shortages. it has been a long road, mr. president, to get to this point. nearly two years ago i began hearing about this drug shortage issue and when i first talked about it, some of the other doctors said, really, i haven't heard about it? now think of all heard about t that's why we introduced the preserving access to lifesaving

medications afnlgt that's why we came together to get agreement. that's why the president issued an executive oord that pushed for more voluntary noteifications for manufacturers and the f.d.a. released an interim final rule that broaden thed scope of the current notification requirement. that why, mr. president, it is so important that we pass this legislation. patients such as axle or mary shouldn't have to be burdened with the added stress or worry about whether or not they will have enough medication to get through their next treatment. they have enough on their minds. so let's get this done. it is a great example of people working across the aisle when they heard something from their constituents, they were willing to listen and put a bill together. me, i'd like to have gotten it done two years ago. but later is better than never. we can get it done this week. thank you very much, mr. president i yield the floor. i note the absence of a quorum. the presiding officer: the clerk will call the roll.

mr. harkin: mr. president? the presiding officer: the senator from eye woovment. mr. harkin: i ask that further proceedings under the quorum call be dispensed with. the presiding officer: without objection. mr. harkin: i ask is that william mcconi had be granted

floor privileges for the duration of the f.d.a. act. the presiding officer: without objection. mr. harkin: after many months of bipartisan senate negotiation, the senate will move to a motion to proceed-on-on consideration of the food and drug administration innovation act of 2012. i hope that it will receive an overwhelming vote ^+soe that we can move ahead with it and dispense with the bill on the floor this week. this bill is the product of excellent bipartisan collaboration on the "help" committee which i chair. all senators on the committee have been involved, going back almost a year we set up working groups, different senators had different interests in different parts of the bill. they and their staffs were invited on both sides -- republican and democrat -- to be involved in those working groups, to put this bill

together. and so we have, i believe -- and the bill passed overwhelmingly out of our committee actually by voice vote, with only two reserving their "no" votes. and so it had overwhelming support on both sides in our committee. this bill reauthorizes important f.d.a. user fee agreements. it modernizes the f.d.a. post medical product authority to help boost american innovation and ensure that patients have abg stoets therapies they need -- access to the therapies they need. the backbone is the agreement f.d.a. negotiated with industry. we must remember a sizable part of f.d.a.'s budget comes from user fees the industry agrees to pay. it allows the f.d.a. to hire the personnel, get the equipment they need, to more quickly review product applications. we need to reauthorize this bill

to implement those agreements if we want to keep the f.d.a. running at full steam, which is critical to preserving jobs at both the agency and in industry and to ensuring that f.d.a. has the resources to get safe medical products to patients quickly. now, again, these agreements affect all of us by helping to maintain and create jobs in our home states. for example, in my own state of iowa, these agreements will support or bioscience sector which is growing, and it's increasing employment in our state. kphroepltation of these -- implementation of these agreements will help foster job growth throughout our country. the bill before us authorize the prescription drug user fee agreement, which is known in the nomenclature as pdufa. the medical device user fee agreement, known as mdufa.

and again, these will again continue and improve the agency's ability to speed market access to both drugs and medical devices while ensuring patient safety. and now we have a new part of the bill, the generic drug user fee agreement which is expected to slash review times to a third of its current level, from 30 ph-pbgts -- months to 10 months which will improve the speed at which generic products are made available to patients. this will generate significant savings in our health care system. in the last decade alone, from 2001 to 2010, the use of generic drugs saved the u.s. health care system more than $931 billion. so this agreement will ensure that we continue to see those savings, that patients will have access to cheaper drugs when they need them. and it also means that obviously taxpayers will be saving money because many of these drugs come

through both medicaid and medicare. and by having generic drugs available and more rapidly than they have been in the past means that taxpayers will also save significant amounts of money in the future. this bill also authorizes another new section, the biosimilars user fee agreement which will further spur innovation by shepherding the budding generic biologic industry as it matures. this secures the industry to do its job, to allow the medical products industry to survive very challenging economic times. but most importantly, to the patients who are the primary beneficiaries of this long-standing and valuable collaboration between f.d.a. and industry. and, as i said after months of negotiations with our staffs, with f.d.a., with the industry,

with consumer groups, the f.d.a. and industry and the other groups have crafted, i think, win-win agreements that they stand behind. so industry is behind this bill. f.d.a. is behind this bill. and hundreds of groups throughout this country have been supporting it. they've done their job. now it's time for us to do ours. it's absolutely imperative that we authorize these user fee agreements before they expire. again, if we don't, f.d.a. will lose about 60% of its drug center budget and 20% of its device center budget. it will have to lay off nearly 2,000 employees which will grind the drug and device approval process to an unacceptably slow pace. again, with devastating consequences for patients and for jobs and for industry and further innovations, both in drugs and devices. so we can't let that happen.

and that's why for more than a year we have worked very closely in our committee. i see my ranking member, senator enzi, is here who -- and we have worked very closely. our staffs have worked together. as i said, we set up these working groups on our -- in our committee. they weren't divided along any kind of partisan lines. they were set up along interest groups so that we had both democratic and republican senators and their staffs working together. senator enzi, i'm sure i can speak for him when i say this, our aim has been all along to ensure that in addition to the user fee agreements and all the other things, that this is the product of a consensus bipartisan policymaking process that we have had for the last year. it was open, transparent process. we had input from our members. other senators were also involved as they had interest in this bill. the stakeholder community at

large throughout negotiations on this bill were involved. and so, again, i can assure you this legislation has benefited greatly from all the diverse input from senators on both sides, industry stakeholders, consumer groups. it is an effort to define our common interests and i believe this will benefit patients and the u.s. biomedical industry. i just again very briefly say that the following things, as a broad stroke, this bill authorizes key user fee agreements. as i mentioned before, for both drugs and medical devices. it streamlines the device approval process while again enhancing patient protections. we do one other thing. we modernize f.d.a.'s global supply authority so that we have a better handle on and better

information and knowledge of where our products are coming from. 80% of all of the drugs manufactured in this country -- let me put it this way. of the drugs manufactured in this country, 80% of the ingredients come from abroad. and yet, we have not had in the past really, i think, really tight handle on where they were coming from, what kind of manufacturing processes were involved. this bill closes that up. it gives the f.d.a. a much better authority over that and much better input from where the drugs come from to make sure that they follow good manufacturing practices. it spurs innovation and incentivizes drug development for lifethreatening conditions. we reauthorize the pediatric trial program and improved it, so that we have specific trial

programs for pediatric drugs. again, to be reminded once again that children are not just small adults. what may work for an adult in terms of a drug, you don't just cut the drug in half and give it to a child. sometimes it takes specialized specific kinds of drugs for children that aren't just something that an adult gets. so this reauthorizes and improves those trials for children. we also -- we also, both senator enzi and i and others on our committee wanted to do something about preventing and mitigating drug shortages, so we have provisions in this bill that will do that, will help prevent them and mitigate these drug shortages by making sure that f.d.a. gets information and timely information from manufacturers if there is going to be any inter rupgs at all in the supply -- interruption at all in the supply chain.

i believe this bill increases f.d.a.'s accountability and transparency. that's just sort of a broad-brush stroke of what's in this bill. i will be in the next day perhaps getting into some more of the specifics of this. but i would just say that it's imperative that we keep pace with and adapt to techno lodgic and scientific advances. things move very rapidly in this area, and we want to make sure that we get the drugs and devices approved as quickly as possible, but always, always with keeping patient safety foremost. that's the single-most important thing, is to make sure that patient protections remain key. so keeping pace with the biomedical landscape that changes so rapidly as the aim of this bill to ensure that, again as i said, that the drugs coming from abroad are safe to, take

appropriate measures to protect our patients. so, again, mr. president, i believe we have a good compromise. i would say that neither democrats or republicans got everything they wanted in this bill. as i've said before, i didn't get all what i wanted in this bill. i'm sure others didn't either. but that's the process of consensus. and where we could not achieve consensus, we didn't allow those differences to distract us from the important goal of producing a bill that everyone could support. so again, it's a true bipartisan bill. it's broadly supported by the patient groups and industry. i have letters from over 100 groups outlining their support. just a few: the pew charitable trust, consumers union, the pharmaceutical manufacturers association, the generic pharmaceutical association, biotech industry organization,

bio, the american academy of pediatrics, advanced medical technology association, american foundation for the blind, and many, many more. those are just a sampling of over 100 groups. and, mr. president, i would ask that at least a list of those groups be made a part of the record at the end of my remarks. the presiding officer: without objection. mr. harkin: so again, mr. president, i am going to yield the floor. i would just say this, though. i'm expecting, we are expecting that there will probably be some amendments to this bill. fine, that's the way the senate should operate. but we would expect that all amendments to this bill would be relevant to the bill. relevant amendments to the bill. and i would hope that senators on both sides who want to see this bill passed expeditiously would keep that in mind. if there is a relevant amendment

and senators feel that they want to bring that up, that's fine. that's the way the senate should operate. but i would hope that nonrelevant amendments that have nothing to do with the bill would not be promoted on the floor. that would only slow the bill down and put us into some untenable positions on the floor in terms of getting this bill expeditiously done. we just can't allow unrelated partisan disagreements or presidential election-year politics to interfere with this bill and to keep us from completing our job. so i hope that amendments offered that must be relevant to the bill. and we must pass it now. the clock is ticking. everything ends by the end of this summer. we're out of here in august. we have the 4th of july break, memorial day break coming up. in order for us to get to

conference, for us to go to conference with the house, work out whatever differences we may have and get this back here so that we can finish it by late june or early july. i would hope maybe we could even finish this by late june so that there wouldn't be any disruptions at all in f.d.a. and their planning for the future or in the industry itself, that there wouldn't be any disruption. so i urge my colleagues to join in the bipartisan spirit of cooperation that we've witnessed in the "help" committee over the last year. let us come together to pass this legislation of such critical importance to the american people. mr. president, with that, i yield the floor. mr. enzi: mr. president? the presiding officer: the senator from wyoming. mr. enzi: i thank the chairman for his remarks and wish to be associated with them. this has been a very bipartisan process that has resulted in this bill coming to the floor, and i'm hoping that there will only be relevant amendments and that there will be few of those.

every amendment has a potential for disrupting the entire bill. this has been a very inclusive process that's led to this legislation. over a year ago staff began to meet with stakeholders of the policy issues that are addressed in this s. 3187, and starting in the spring of 2011, a group of staff from republican and democratic offices on the health, education, labor and pensions committee began a series of standing meetings. the group proceeded to meet every week for several months. they met with stakeholders and discussed policy solutions that each member thought would solve the problem. after much discussion of the benefits, costs and possible unintended consequences, members agreed to a list of policy concepts. it was not a consensus on a particular policy that it wasn't included. the chairman mentioned the importance of consensus, and that's what we worked on in

this. as this process progressed, my staff met with republican staff on the "help" committee for at least two hours every week to keep them informed of everything that was happening. i personally met with the members of the committee before the markup to make sure i understand their priorities. no one else -- office got entirely what they wanted. we did, however, find the 80% that we would all agree would help solve whatever policy the group was working on. what you see before you is the outcome of the hard work of these groups. the bill passed the committee by a voice vote. the bill reflects the work of every member of the health, education, labor and pensions committee. all of them have at least one provision included in this legislation, and many members of the committee worked with us to find consensus measures that address their priorities as well. this legislation is a model for how the process can and should work, no matter what the political environment. this went to committee, it was worked in committee, it's now at

the floor, and i hope that my colleagues will join me in supporting this truly bipartisan provision that reduces the debt and ensures that the u.s. will maintain its leadership in the innovation of safe and effective biomedical products. i thank the chair and yield the floor. the presiding officer: under the previous order, the senate will proceed to executive session to consider the following nomination, which the clerk will report. the clerk: nomination, paul j. watford of california to be united states circuit judge for the ninth circuit. the presiding officer: under the previous order, there will be an hour of debate equally divided and controlled in the usual form. mr. leahy: mr. president? the presiding officer: the senator from vermont. mr. leahy: mr. president, i'm glad we are finally able to debate and vote on the

nomination of paul watford of california to fill a judicial emergency vacancy on the ninth circuit. the distinguished presiding officer knows that several months ago we voted mr. watford out of -- out of the committee. actually, three and a half months ago, and we haven't been able to get agreement to debate or vote on this nomination since it was approved, so for the 27th time, the 27th time, the majority leader was forced to file cloture and get an up-or-down vote on one of president obama's judicial nominations. now, thankfully, enough senate republicans came forward. they said they are not going to vote to continue a filibuster, and so they ought to just have an up-or-down vote, instead of what we always used to do. don't vote maybe like a filibuster, vote up or down.

i thank those republicans who came forward and said enough of the cloture votes, let's vote, because this is the nominee, mr. president, paul watford. he is a highly qualified -- in fact, he has the highest qualifications for the ninth circuit. he shouldn't be filibustered. he shouldn't require cloture. he is a nominee with impeccable legal credentials and qualifications. he served as a federal prosecutor. he is now a highly regarded appellate litigator in private practice. the a.b.a. standing committee on the federal judiciary gave paul watford their highest rating, the highest possible rating they could give, and they gave it to him unanimously. he also has the strong support of his home state senators, senator feinstein and senator boxer. he has widespread support across

the spectrum. i think of a couple noted conservatives, including two former presidents of the los angeles chapter of the federalist society, and also judge alex cozinski, a conservative reagan appointee who is now chief judge of the ninth circuit. so by any traditional measure, paul watford is the kind of judicial nominee who should be confirmed easily by an overwhelming vote, a vote of both republicans and democrats. this is the kind of person we want in our federal judiciary. this is the kind of person when we talk about the federal court, we can say there, that is a judge you can look up to and can inspire others to seek to be judges.

i think those senators, including some who called me this weekend to say that they would oppose a filibuster, i thank them for that because what they are doing is not only the best for the united states senate in allowing the vote, they are doing the best for the ninth circuit but even more importantly they are doing what is best for the independence of our federal judiciary, because if you're going to vote to try to block somebody as qualified as paul watford, you are basically saying we don't care who you are, we're going to block you, and that is not a message we should send if we want to say we're going to have an independent federal judiciary in this country. he has a mainstream record. he demonstrates legal excellence, experience at the top of his profession. as a federal prosecutor in the 1990's, mr. watford handled prosecutions involving

immigration and drug offenses, firearms trafficking and major fraud, so he should be on the ninth circuit, and i'm delighted as i make a preliminary nose count, mr. president, that he will be confirmed as a judge in the ninth circuit. so so it is no surprise because of his work as a tough but very fair prosecutor, no surprise that he had support from conservatives as well as liberals. but the shock i had was that for a while, his nomination was being held up and we couldn't get a vote. incidentally, mr. president, i ask unanimous consent that copies of letters of support be included in the record at the conclusion of my statement. the presiding officer: without objection.

mr. leahy: now, paul watford is far from an ideological partisan selection. it shouldn't engender any serious objection. he is just too good for that. he is the kind of nominee in my years here in the senate who would normally receive unanimous support, usually not even requiring a roll call vote, because he has the qualifications, the judgment, the ability. maybe some who were concerned about it thought he was too well qualified, too relatively young or maybe some fear he might someday be nominated to a still higher court so they want to avoid voting on his nomination as they did when elena kagan was nominated to the d.c. superior court by president clinton.

or the nomination to the second circuit by president clinton. it generated controversy or whatever. well, don't try to nit-pick this man's legal career. after his service as a federal prosecutor, he has worked at a highly respected los angeles law firm on a wide variety of matters. he has always represented his clients ed cally and to the best of his legal ability. now, the distinguished presiding officer was the attorney general of his state knows the lawyers are supposed to give their best counsel and their best effort to those whom they are representing. that's what lawyers are supposed to do. in my case, i prosecuted -- i defended in private practice

criminals. i then prosecuted criminals as a prosecutor. in both cases, i knew what my role in the legal system was. as i assume that's what lawyers are supposed to do. actually, that's what republicans used to defend when federalist society and corporate lawyers were being nominated by a republican president. we should just look at the fact they are representing their clients. as chief justice roberts noted during his confirmation hearing, lawyers represent clients. they do not stand in their clients' shoes, and they should not have their clients' legal positions used against them. so let's abandon the crude and inaccurate test being applied to president obama's nominees. let's stop the caricature. if not, no lawyer could ever be confirmed to the federal bench. you have a lawyer who has actually been active in his or

her practice. of course, they are going to represent some people you disagree with. of course they are going to represent some issues where you may as an individual bringing the appeal say you would rather be on the other side of the issue. but how quickly would our legal system break down if lawyers could only represent one side of an issue or when a matter comes to court we could only hear from one side, not from the other? mr. president, one of the most valued legal systems in the world would disintegrate. our legal system is an adversary system. it's predicated upon legal advocacy for both sides. no nominee should be disqualified for representing clients zealously. go back in history. john adams, one of the most revered founders and later president of this country.

he wrote that his representation of the british soldiers and the controversial case regarding the boston massacre was -- quote -- "one of the most gallant, generous, manly and disinterested actions in my whole life and one of the best pieces of service ever rendered my country. did he agree with the british in holding the colonies subservient? of course not. did he agree with the efforts of us in this country to be a free people, free from alliance with great britain? of course he did. that's what he did when he represented and when he served as one of the founders of this country and when he became president. but he also knew our whole system broke down. if somebody within a court did

not have adequate representation on both sides, and that's why he represented british soldiers in the case involving the boston massacre. not because he is supportive of what the british were doing. not because he wanted anything other than to have us as a free people, but that he wanted to make sure that in a free country, in a free united states of america, when someone goes before our courts, they are going to have representation on both sides, and that's the way it should be. that has always been our tradition. i hope it always will be our tradition, but i am concerned that some feel it should change. if you have a litmus test, it would disqualify nominees because as a lawyer that represented the side of the case in which we disagree, that's a dangerous and wrong kind of

litmus test. almost every nominee who has actually been a practicing attorney, who has had more than one client in their life is going to fail such a test. they are going to be disqualified. because if they are practicing law, if they are doing what they are supposed to be doing, if they are making sure that you are adequately represented in court, no matter how unpopular your case might be, then of course they are going to take on some cases we might not like. and the distinguished presiding officer who is the chief prosecuting officer of his state i was the chief prosecuting officer of my county. there were some people i prosecuted. i just wanted them to go to jail for as long as possible, but the last thing i wanted was them not

to have a good and adequate lawyer on the other side. i wanted them to have the best of counsel for the other side because that way society was protected. that way our court system was protected. that way it meant also that if any one of us came in and we were really innocent and being charged, we would know that there was an example of always having representation. so i urge senators to show that we can work together to reduce the vacancies burdening the federal judiciary. do what some of my friends on the republican side of the aisle have said to me that they are going to vote for this and let's move forward. but they should also help the millions of americans who rely on their federal court to seek justice. and you know what? we can show we intend to do that, we can start right here by voting to confirm this good man, paul watford.

he is a highly qualified nominee to the ninth circuit court of appeals and say to the american people we believe in justice for everybody here. mr. president, i'm going to -- in a moment i'm going to be suggesting the absence of a quorum. i first ask unanimous consent that following the vote of the watford nomination the motion to reconsider be considered made and laid on the table with no intervening action or debate, that no further motions be in order to the nomination, any statements related to the nomghts be printed in the record, that the president be immediately notified of the senate's action and that the senate resume legislative session. the presiding officer: is there objection? there appears to be no objection. without objection, so ordered. mr. leahy: mr. president, i would suggest the absence of a quorum but ask consent the time between now and the vote at 5:30

be evenly divided. the presiding officer: without objection. the clerk will call the roll. quorum call:

a senator: mr. president? the presiding officer: the

senator from delaware. mr. coons: mr. president, i rise today in strong support of bipartisan legislation to reauthorize the food and drug administration. the presiding officer: the senate is in a quorum call. mr. coons: thank you. mr. president, i ask unanimous consent the proceedings of the quorum call be vitiated. the presiding officer: without objection. mr. coons: thank you, mr. president. mr. president, i rise today in strong support of the bipartisan legislation to which the senate will move to reauthorize the food and drug administration user fees and critical programs to ensure americans have access to safe and effective medications. most of us don't think about the f.d.a. on a regular basis. in fact, we rarely think about where the medicines come from, the scientists who vinted them, the investments required to develop them and the innovative, cutting edge treatments that are essential to keeping americans healthy and safe or the regulators who make sure these pharmaceuticals, devices and treatments work as they're supposed to. but when the moment comes we face a health crisis and doctors

prescribe a medications we want the pharmaceuticals available right away and to work as promised. one of the constituents who contacted me about pdufa, virginia from newark, delaware sent a letter to my office. she volunteers with the brain tumor it to and is concerned without this legislation, safe and effective therapies will be slower to be developed and available to patients needed them. she wrote it's too long since new therpts extend survival. anyone can be diagnosed with a brain tumor and are the second leading cause of cancer cet death in children under 20. i'm sure you are regularly visited by folks around the country or your state who are deeply concerned about continuing medical progress, discovery and development of the life saving treatments americans have developed over the last two decades and it's my hope that the senate will continue to