employee benefits. so the court has just come off of a case that emphasizes the importance in terms of judging of laws that affect tax policy in the u.s. versus spending clause. >> i would also add that's precisely the logic by which justice roberts upheld the first challenge to the law. because it was a tax. so that gives him a nice little added to say. >> anymore questions? >> my question was for lynn. you talked about the sort of in 1965 sort of delay of states of implementation, that the data sort of won out. there's a part of me that's a

little skeptical wondering whether or not the tone of the country back in '65 to '70 was different than five years from today. can you reassure me that the data -- or can you sort of elaborate on what you think the tone will be in five years or what makes you believe that the data will win out? >> well, the good news is in five years i will be retired. no, look, i can't tell you what it's going to be like in five years in our country. what i can say is don't forget in 1965 why we had to pass voting rights and all that stuff. remember the part of the country that opposed all this stuff. that's precisely the part of the country that delayed implementation of medicaid. let me tell you about my high school. i grew up in rural arkansas. brown vs. board of education was 1954.

we finally got total integration in 1970-'71, my senior year. how long is that? so that part of the country totally opposed all of that stuff. and yet in five years, every southern state had had created a medicaid program. the state that lastest the longest against it was arizona. i noticed they still don't have daylight savings time. so, look, you cannot have a worse environment than the south was in 1965. so i think, in fact, what's different now is that the hospitals lived through that or more precisely they know about the hospitals that went through that. and they know what the implications are for not getting this uninsured hemorrhage solved. and they have chapter and verse.

every chamber of commerce, virginia, texas, any place they are not doing it, the chambers of commerce support this. because they can do the math. the chambers of commerce didn't support. so you have a very different kind of ground swell of logic and support. then i would finally say, look, this tea party stuff, it's going to happen. it's always been kind of there just bubbles up from time to time. it's got to pass or we can't run a government. and i think you'll look at how boehner has tried to figure out how to make it happen. i'm much more optimistic about down the road than i am for tomorrow because a lot of smart people -- adults are figuring out we got to have these conversations. math really helps. and the overwhelming logic of allowing that much money to flow into your economy whether you like the people getting the coverage or not allowing that money to flow into your economy is just overwhelming.

not doing it in a time when we're still trying to recover, in some ways, is malpractice at the political level if you don't do this. so i'm mor optimistic we'll get it going. once it's taken hold on a number of states, and we're starting to see results already from for profit hospital systems. hca is doing better in states that have expanded medicaid than in states that have not. while it's a fine company, does not leave the world. so if they are doing better enough to make a substantial difference on their bottom line, just think at the nonprofit hospitals. i think there's overwhelming support in the health care establishment and the chambers of commerce are in a a different place than they were 30, 40, 50 years ago, so i have hope.

got to have hope. >> i think if that was the last question, we'll thank or speakers very much for giving a great session. hopefully you found this useful and we'll be trying to have more health policy seminars in the future. thank you very much for coming. the o 2015 student video competition is underway. open to students to great a 5 to 7 minute documentary on the kw the three branches and you." shows how the branchs have affected you or your community. there's 200 cash prizes totaling

$100,000. for the list of rules and how to get started, go to studentcam.org. next a discussion of what immigration should look like. specialists gathered at the heritage foundation to look at some of the proposals to improve border security and immigrant children. >> good morning, everyone. the news organization here inside the heritage foundation. on behalf of president jim demint and my heritage colleagues along with our friends at national e review, we welcome you to this event. there's a lot to talk about. there's a lot going on in the world. it's certainly something that's caught the attention of many americans is the whole issue of our border. is it secure? how that's affecting our country? how that will impact immigration reform as we move ahead. that's what we want to talk about this morning. we have a terrific panel to kick off our session and we'll be hearing from the governor.

we will be taking questions at the end of our panel. we'll have microphones for you. anyone who wants to ask a e question, raise your hand, we'll send a microphone to you. you present your name and affiliation and go from there. let me introduce the panel. they will each make their remarks. first speaking this morning is jim carefano, vice president of foreign and defense policy studies. he oversees four centers here, the allison center, asian study center, center for international trade and economics and margaret thatcher center for freedom. jim is an accomplished historian and teacher as well as a prolific writer. he's the author of several books including "winning the long war", and his most recent "conflict in a socially networked world." he's testified many times before congress and is a regular guest analyst on television programs.

he's also a 25-year army veteran rising to the rank of colonel. he holds a doctorate as well as a masters of strategy. he will be kicking us off talking about where we are on the border today and what the situation is there. following jim will be rich lowrie. he serves as the editor of national review, which is a position he's held since 1997. he began his journalism career in college at the university of virginia where he edited a monthly magazine. he later went on to work as a research assistant for charles krauten hiemer before joining national review in 1992. prior to his position as editor, he covered congress and served as an articles editor. you have seen his byline in "the new york times," l.a. times and others. he's also the author of a "new

york times" best seller "legacy: paying the price for the clinton years." he will be talking about the debate over administrative amnesty and where the gop should be going in terms of how it thinks on immigration policy. following rich is the professor ting, professor of law at temable university in philadelphia. he joined that faculty in 1977 and teaches in the areas of citizenship and immigration law and tax law. his articles and media interviews related to those suggests have been publish ed. professor ting has regularly testified before congress including before the 9/11 commission and the judiciary committees of the u.s. house and senate. professor ting was assistant commissioner of the immigration and naturalization service in the early '90s and ran as a republican candidate for the u.s. senate in 2006.

professor ting serves on the board of directors for immigration studies. he's a graduate of harvard law school. professor ting will be speaking to us about the rule of law and how that specifically applies to immigration policies across the board. finally, she's not here yet, but joining us shortly will be kelli ann conway. she's one of the most sought after pollsters in the country. many of you have seen her on tv. one reason she's sought after is she's often right. her team is one of the few on the republican side of the aisle to use correct modelling and predict the outcomes of many of the major races in 2012. she's a co-author of "what women really want." throughout her two decades in market research, she's provided research for clients in 46 of

the 50 states. she's not just involved in the political rem. her clients go from policy organizations like heritage and freedom works to leading brands of industries including major league baseball, american express and lifetime television. her company just put out a study on immigration and how the american public is increasingly viewing this it issue. it just came out this week. a lot of interesting findings and she's going to share those with us. we have a great panel. i'm going to hand it over to jim. >> thank you. first of all, thank you for coming today. don't care where you stand on the issues, but it's an important issue and people are concerned about and want to have a dialogue. that means a lot and that's important. the contribution i want to make today is to talk about on the border how we got here from there. this is something that's not in academics. it's something i have been personally involved in from the military to over a decade at heritage where i visited the border several times with local law enforcement with federal

agencies and also trips to mexico. so you can really start the history in 1986 with the reform bill. if you go back and read it, it would have resinated with people who talk about comprehensive refor reforms. it said we're going to clean the slate. and then we're going to fix the problem going forward because we're going to deal with the components. we're going to add border security. we're going to implement better programs to get the workers that employers need to grow jobs. and grow the economy. we're going to force internal immigration and workplace enforcement laws. we actually did enhance border security. that's very interesting. a terrific researcher here at heritage did a fascinating study several years ago where he

looked at the available social science research on the border and what he concluded is there's a lot of consensus about what happened. that is we continually put more money and resources on the border through the '80s and '90s. government did what it promised. as a result of that, the unlawful population of the united states actually grew. it was about 3 million and grew to 16 million. so how did that happen? well in part it happened because since it was more difficult to get in, people that came in instead of manager more migratory in their employment, they would do seasonal employment and go back to mexico. it was difficult to get back in, they would just stay. since they were having to coincide with the rise of the economy, there was a lot of construction, you could have full-time year round employment by going from seasonal job to seasonal job. so people stayed more so that bumped up the population.

the economy was growing. so people tried harder to get in because the transactional costs were low. if you got. thrown back, you tried to come back. the economic incentive of get ing in was far higher than the cost it was of getting caught and getting sent back. and then the third is that only about the estimates vary a great deal, but somewhere between 40 and 50% we think of the population that's unlawfully present came in through illegal point of entry. the tougher the border skrurt gets, the more growth you get in the unlawful population from people that overstay. so that problem continued to grow. and the next really big chain happens on 9/11. and one of the things that 9/11 did was prompt the homeland security. it added some efficiency at the border because until that point

we treated goods and people as two different things. one guy was in charge of goods, one in charge of internal enforcement and this h no incentive or requirement to cooperate with each other or other agencies. one of the things that the homeland security did accomplish is they call it face at the border and we did gain greater efficiency from how we address border security issues. not just because of being concerned about security at the border, but also recognizing that the border both in northern and southern borders are engines for america and enormous amount of productivity occurs because of the process of crossing the northern and southern borders. so the job of security is not just to keep bad things out, but to keep the people's goods and services that are growing the economy in the western hemisphere moving. there was a lot of effort put in that. so in 2007 when we talked about the last time we talked about comprehensive immigration reform, the model proposed to

move us forward was pretty much repeat of 1986. so as that was being discussed, not shockingly, the numbers of illegal crossings are starting to bump up. so just the promise of amnesty caused the the numbers to increase. then the baill failed and the administration at the time said, okay, we get it. you don't want to do this, but we're going to continue to work on internal enforcement and border security. and the numbers starting in 2008 started to go down. we can e equate some of that to the fact we were in a recession so that's probably true, but some of it due to increased security and those numbers continue to decline through 2012. in 2012 what happens? the con influence of a couple things going on there. one is you have the impact of military sequester. and a lot of the border crossing activity, which is the movement

of people, guns, money and drugs was as a result of the cartels. and the amount o we did against the cartels significantly began to drop. i was down in key west talking back in the earlier part of the decade. they said if we had twice as many assets, we still wouldn't have enough to interdict everything we would find. that's at the time we were growing the mission. the mission significantly acts as the pressure. so that put more pressure on the border. the second thing was the success. . we did a great job in colombia. a lot of the cartels were pushed out and what they did is wept to other places and started to set up business. that combined with poor interaction that we had with countries working on public safety and security missions in central america in the last couple years. the money was going to the wrong programs. we weren't working with those governments very well. and all that really led to a

strengthening of the cartels. the other thing we had in 2012 was removing children and that was whether the administration intended it or not, we can debate that forever, that was put up as a billboard saying now is a good time to come to the united states. we saw those numbers start to climb in 2012 and mushroom recently. so that's kind of what's gotten us where we are. and there are lessons to be learned from this history. and i think they are pretty clear. americans all want border security. i haven't found anybody that thinks that's a bad idea. having said that, we'd never quite wrapped our hands around what it really takes to do that. you can't secure a border by standing on the border. the border is just one step in activity that runs from latin

america way into canada, but legal and illegal. wuf to address the system as a whole. so good border security is part of that. so is the enforcement of your internal laws. so is having worker programs that gets the workers you need to grow. the economy and grow more jobs. and part of it is dealing with the countries in latin america to create the conditions to grow the economy as opposed to just moving people. we have never put a solution on the table that does that. all we have ever done is let's have another amnesty to overwhelm everything else we're trying to do to fix the problem. until we address the problem rather than debate amnesty, we're going to wind up right back where we were in 1986. thanks. >> thank you, jim. rich? >> thanks very much. and thanks to all you for being here and thanks to the heritage foundation for hosting us. the heritage foundation has a special place in my heart because way back in the day i

was an intern at the heritage foundation. i was a part-time intern. i like to think this wasn't because heritage wanted to deny to me the full benefits and protections that are due full-time interns at the heritage foundation. sometimes i wonder about that. i grew up around here and started reading national review in high school. i would smug issues into the classroom and hide them in my textbook and read them during class. so what playboy magazine was to most teens, national review was to me. i would record episodes of their tv program boasted by bill buckly and obsessingively focus on every detail of the argument and make sure i was following everything. so obviously, i wasn't a very popular teenager. enough about my personal problems. i just want to underline what jim said at the end of his very

able remarks, which is at the border crisis is not really just about the border. it's about a broader breakdown in the enforcement of our immigration laws in the interior. these folks who are coming across the border and increasing numbers in recent months are not trying to evade border patrol agents. they are deliberately going out of their way to surrender to border patrol agents because they know that they will be processed somewhere into the country. if they are kids, they will be enrolled in school and very quickly they will back part of that broad category of people ú

to be con ttemplating a vast expansion of that deferred action program possibly to include the parents of the people who brought these people.

they got but we're going to give them to the parents who were responsible for coming. is it any wonder that the u.s. is now experiencing this flood of aliens crossing our border illegally including record number of miners all expecting to benefit from the administrati administration's policies. if you listen to the smokesman, they say technically we need to explain they are not going to qualify for benefits. technically you need to explain that, but the people on the ground coming in across our border know better what's happening at our borders than the bureaucrats sitting here in washington, d.c. . and they know they are getting through and as jim says, they are getting benefits. the kids are enrolled in schools. they are being transported at taxpayer expense to their parents or relatives who are already in the country illegally and so they know the reality that they are here to stay. they are never going home as long as this administration's

poli policies remain in place. and they are calling home to spread the word. this works, it absolutely works. find a reliable smuggler in the united states and take your best shot. so that is the reality the administration says, well, unaccompanied minors, our hands are tied. there's an anti-trafficking law. but the center for immigration studies has published a document showing that at least three reasons this is just another administration excuse. the vast majority of these young people don't fit the definition of unaccompanied minors under the statute. they are not victims of trafficking. they are being smuggled. families are spending large sums of money to join relatives already here and finally there's an exception in that statute for exceptional circumstances, which members of-8yky֖ congress havey cited. last point i will make is this. what if a future president wants to cut income taxes to a flat

10% but can't get congress to go along with it. could the president exercise discretion to announce that taxpayers refusing to pay taxers will not be a priority for enforcement as long as they pay 10%. it seems to me that's where the president is leading us right now. if we want an imperial presidency, that's the way to go. thank you. >> thank you very much. kelli ann, i told folks you had a great study coming out. i'll hand it over to you. >> thank you very much. thank you to the heritage foundation. i like to thank all of you for your interest in giving us some time ahead of that. we do have a big poll that came out this week on immigration. it's a very deep dive that goes

beyond some of these very simplistic useless questions about immigration reform. you can ask americans fill in the blank reform and get a high response. we support q tip reform unless we know what it's going to cost us and what the relative benefits and liabilities are to each of us and to us as a nation. so we took a deeper dive and a look at the immigration reform issue and the immigration issue overall. the entire ten-page memo is provided through a link and you also have hard copies of it. so it's there for you to see. let me go over some of the key results that also show some of the underlying evidence to some of the remarks made earlier today. in 27 years of polling, i have never seen immigration at the level where it is in terms of the american consciousness. what has happened at the border has brought into sharp relief some public opinion. out of sight, out of mind is over. people know what they see and seeing for the public is the

first step towards believing. what is it they see and believe? 18% of americans are saying that immigration is a top issue that they believe congress and the president should address. that's not going to happen if you ask a traditional way, what's the top issue that the president should address. there it will be 4 or 5% on a high day. but when asking is immigration your top issue, top 3, and then not even if your top 10 which is the way people think. 18% say it's a top issue. additional 39% say it's not the top, but it's in the top three. and so you do have a spiking of paying attention and just getting attention. the lens through which many americans are looking at immigration generally most americans say it is not humane and compassionate to have the children there. i have hardly seen these

shelters or safe havens set up in nancy pelosi's district. everybody has a pie in the sky of idea, but very little action on the issue. the media seemed to be in ferguson, missouri, as well as the chief law enforcement officer, not down at the border. what americans say about immigration and the president's role and congress's role is very simple. they don't see either party having a national advantage. i'd like to make that very clear. it is true that president obama's disapproval rating on immigration is over 60%. it's 4 points higher than his disapproval rating generally. but right now sitting here they have a natural advantage. part of it is a lack of a coherent plan frankly or lack of coherent message. if voters can tell me what the plan is from either party, i'm listening. but we did test the recently

house passed plan by the republican party but did not associate it with them. 58% support and 32% oppose the plan, which basically has three main parts. extra funding for immigration enforcement, making it easier to return young illegal immigrants to home countries and e restricting the president's ability to act on his own. that goes for any president, not just this president. to restrict a a president's ability to act on his own with respect to immigration. . in a separate question, 74% of americans say they would like the president to work with congress not on his own when it comes to immigration. let me read you key cross tabs in your pact. 74% overall would prefer the president to work with congress. 21% say it's okay to go it alone. it's a majority of independents, 81% of independents, 56% of democrats, 75% of moderates. really the only subgroup that

wants -- that's on page 5. that wants the president to act like the lone ranger are liberals. there's a divergence of opinion between democrats and liberals. i would imagine many running r for u.s. senate this year as well. so what do people want? the immigration issue is a big issue, but it is also seen as part of o the overall economic e equation. if they think they are going to run on jobs and economy, they are going to get the result that mitt romney got. if you only talk about jobs and the economy, it means too many different things to too many different people. when you talk about jobs, we have been speaking ant the difference about talking it to the job creators.

most don't want to be entrepreneurs. that's about 7% of the country. another 7% are the job seekers. they are the folks unemployed or maybe higher number of unemployed and stopped looking. it you're only talking to job creators and job seekers, you're up to 15% of the country. they are the ones paying very sharp attention to what's happening at the border and with immigration policy overall. they are the ones saying why do we have two, three jobs in our household. we're not worried about losing a job or replacing a job, but why is the job no longer enough? and it was enough when your grandfather had job and my grandfather had a job. they do worry about job security and about affordability and long-term economic security. they look at immigration of one piece of the equation. it shouldn't be looked upon at some issues package. it's seen as part of the larger

picture. and all throughout the survey, it's clear that americans don't believe that we have a surplus of jobs. . they believe we have a surplus of job seekers. they are competing for these jobs. americans overwhelmingly believe that americans who want to do jobs, who are k look for work should have a fair opportunity, if not a preference to do that work. it turns on its head the cynical meem that illegal immigrants or immigrant. s do the jobs that americans won't do. that's not true when you put that question to people who are looking for the job. they are willing to do those jobs. they are not willing to do it for $4 under the tanl, but they are willing to work. and they are looking for these jobs. they do not think we have a surplus of jobs, just a a surplus of job seekers. so 50% believe it's unfair that we bring in 1 million immigrants that can look for jobs while americans are having trouble finding work.

45% the unemployment situation will get worse in the next few years. they are not looking at the monthly jobs report or listening to economists. they know what they believe in terms of their own financial wherewithal. 77% believe that u.s.-born workers and legal immigrants here should have preference for jobs they are seeking. 89% they should have the preference over illegal immigrants. 58%, because i have never seen this question asked, but 58% agree there are plenty of americans to do the jobs in the construction, manufacturing, service industries. 80% believe businesses should be required to recruit and train more american workers. here business cannot just sign up for e-verify and say we're doing our part. they want businesses to help recruit, retain and train a workforce that does include many americans looking for work.

the data also shows that politicians and leaders may be ignoring these issues and ignoring what's happening at the border, but the american people are not. it's not as simple as just talking about the same issues over and over again. it really is recognizing when people see something for awhile and seeing is first step toward believing, they expect solutions. they expect action. there's a strong consensus for some simple economic populous. one is to strengthen immigration laws. it's like them saying equal pay for equal work. who is not? my first boss said to me 27 years ago, if you see an 80/20 issue you wasted the poll question because everybody agrees with enforcement. but ladies and gentlemen, americans see that as the floor.

really far away from the ceiling. so yes, they do agree with strengthening enforcement of current laws. they also believe in encouraging, this is an important word. so many people talk about denying and restricting. they believe in encouraging immigrants who are here to return to home countries. particularly the children at the border. they also believe in limiting chain migration to the nuclear family. this is incredibly important to them. finally, i will say if you look at the final page, you see a tremendous amount of, i would say, tripartisan, all ideology agreement that, yes, rule of law, national security is incredibly important. jobs is the primary motivator for awakening action on immigration. you see that hispanics, even liberals pipe up there, independents, those making less

than $40,000. and 85% of blue collar workers. they believe protecting american jobs is an important point of this immigration equation to them. thank you. [ applause ] >> thank you very much. thank all our panelists. a lot of good information and observations. we want to get your questions on that. so i ask you to please raise your hand. if you have a question, we'll have a microphone come to you. if you'll state your name and affiliation, we'll go from there. first question here in the front. >> ken meyer, world docks. do we owe anything to the to lure the best and brightest through increasing the heritage suggests or as a former mississippi governor suggests

happeneding out green cards at graduation ceremonies? >> i think it's great. the one thing i'm really excited about this panel and i think the great thing has been the strength of the immigration debate is when you get people on the panel that don't agree on totally everything, that's how you actually have dialogue. i think it's important that everybody not agree on everything. jobs is a really good example. i think with the immigration debate, from a policy perspective, what actually solves problems. if the notion is the immigration debate is the key to unlocking the human capital potential of americans, i don't think that's exactly right. i would look at things, which we have written a lot about before, is if you take the chains that government has imposed on the economy that limit the opportunity for economic growth and freedom, if you focus on education reforms that give people the skills they need to

be successful rather than just throw money at it, if you have welfare programs that encourage people to get into the workplace and work rather than make them dependent. and if you have enkurmg couraged families that create people that want to be productive citizens, those are equally important things to focus on to really have human capital. human capital is the most valuable thing america has. the ability to draw that from around the world is a huge competitive advantage. the one thing we agree on is immigration is part of that because you can never get a system that really works if you're just pretending that you have immigration laws and e pretending you have border security. then you're not exercising sovereignty over your own country and ability to choose from a future. >> thank you. >> thank you, ma'am. john gissy, chief political

responsib correspondent with news mags. following up, mexico after 12 years went. back to the preparty that had been in power. and some people were nervous about the president and yet he a appears to be moving in the direction of more market-based solutions as well as giving people who have business degrees an opportunity to pursue private sector employment. the same could be said about the president of guatemala. my question is r very simple. do you see other countries moving in the right direction? and if so, how many years can we see it where people will not be inclined to come here? >> yeah, so, we do a great thing

where we grade every country in the world on their level of economic freedom and opportunity. and i do think if we want a western hemisphere market that actually works, and where you're not having a sense of distortion, at the end of the day, it's a huge part of that. i do think for example, that talking about all the countries in central america, which we have seen spike in the same thing is not fair or correct. there are different problems stemming for different reasons. mexico, you're right, has done better. the problem i have with mexico today is the past. mexico has facilitated the latest ground of migration from the central american countries to the united states. and i think that's wrong. and we have seen that problem before. we had an influx from brazil a few years back. they were going to mexico and getting visas because it was easier to get a visa to mexico. then we said, look, you have to deal with this.

they cracked down on brazilian visas to mexico and worked out well. we need a similar relationship. it's not just the mexican economy that i think is important to normalizing the markets, but also they have to have amarkets, but also they have to have a responsible policy in dealing with these latin american countries. >> thank you. lee and ra bernsteen. there's been a lot of discussion about the rule of law here and it's pretty much been identified that the united states isn't exactly following our own immigration laws, but when it comes to international requirements to honor refugee statuses or refugee status, a lot of -- i've spoken to a lot of people on i'd say the other side of the immigration debate who see the u.s. turning away

especially the young immigrants from central america as a violation of our responsibility to honor incoming refugees, which is also connected to our u.s. commitment to fighting the drug war in central america, latin america. so what is -- what is our responsibility to international law as far as refugee status with these immigrants? >> ipg international law places a more restrictive burden on the united states and on other countries than we think it does. the definition of a refugee is someone who's got a well founded fear of persecution on the basis of race, religion, social group or political opinion. that's it. if you're fleeing generalized poverty, if you're fleeing generalized violence, even

fleeing civil war, you don't actually fit the definition of refugee. that's just a fact under the international law. in reality, the vast majority of people coming through should be turned around and the united states has laws on its books providing for expedited removal at the border where we make a quick determination, do you even have a credible theory under which you're a refugee on account of race, religion, nationality, political opinion and if not we can turn you around at the border. but the president says i have this 2008 unaccompanied minors being trafficked law that ties my hands. as i've said in his cis.org has said there are good reasons why we shouldn't be applying that law. we're using that law as an excuse. but our actual international obligations are being respected

under current law. indeed one could argue the united states has consistently gone beyond our international obligations. we've gone outside to bring in overseas refugees from refugee camps around the world to whom under international law we have no obligation, and yet we regularly bring refugees to the united states bec need of refuge and we want to do our fair share in the united states. so i think we have a record of dealing with refugees in the united states which exceeds our international obligations and is one of which, frankly, we can all be proud. >> in the very back row. >> thank you. i'm an attorney. i have one question for the professor and miss conway. could congress legislatively outlaw all of his amnesties legislatively, undo the deferred prosecution policy and so forth,

or is congress, because of separation of powers, barred from doing that? and for miss conway, you've got all this polling date tha that s that taking a tougher line on immigration reform is politically popular. why is it so difficult to get the leadership of the republican party to pay attention to these numbers or are they just so emotionally or financially tied to the u.s. chamber of commerce that no matter what data you showed them, they just won't budge? >> i'll take the second first. well, the leadership in the waning days of congress, they passed this bill and we tested it. it supported 58-42 opposed, just the tenets of it. i don't think baiting the chamber is advisable so much as something that rich lowrie said earlier, i think there's a huge

misperception, a cynical if not an elitest one held by many that if the way to win hispanic voters is through immigration and i think that's incredibly cynical because it treats hispanics first of all in this country as a monolith. it's really the way the left believes that all women care about is everything from the waist down. let's just talk about abortion which now they call, quote, unquote, women's health. soon they'll just call it women's issues or we'll just touch our temple and we'll know ha they mean. so on immigration, it's similarly cynical. it also is just completely disproven. hispanics like any other ko hort in america they care about many issues. immigration is one of them. i believe phyllis laughly put out a report where she dissects -- and everything can access it -- she dissects just how untrue that is. it's got a lot to do with

electoral politics. whether speaking on behalf of public opinion or myself, i don't think that any politician should ever act on immigration being craven for votes one way or the other. you have to do what's right and you have to do what's right for everybody concerned. fairness is a core governing value in this country. so far the debate, potential now with the border crisis currently is always about what's fair to the immigrants, but americans are saying what also is fair to the workers, the blue collar worker, to the college students who are told, we'll just help you forgive your loans or pay them later or increase the minimum wage? what's fair to everyone? is be business being fair to everyone? are policies being fair to everyone? so anybody who is doing anything on immigration with votes in their eyes really should take a look in the mirror or find another line of wrk or actually compete for jobs. >> on the congress of what congress can do, congress can do anything they want to do and are

able to do. i mean, the reality is in order to enact legislation under our constitution, you usually are to get the president on board or you have to override a presidential veto and in the current situation that's very difficult to do. we should not lose sight of the fact that congress has enacted laws already. we have very complicated immigration laws in place that were enacted by both houses of congress and signed into law by the president of the united states those laws set up a complicated formula who can come into the united states and who can't. we have the most generous legal immigration system in the world bar none. we give out more green cards for legal permanent residents with a clear path to full citizenship every year than all the rest of the nations of the world combined. so let's not lose sight of that. congress has spoken on this question. they've enacted the laws. it's up to the president to

fulfill his constitutional obligation to faithfully execute the laws properly under the laws of our congress. >> let me associate myself with that sentiment because the problem is, right, if you already have laws on the books that the president of the united states is ignoring, what good is passing a new law saying he should honor the laws that are on the books going to do? and the administration defense is this is an exercise of prosecutorial discretion. there's wiggle room like that that traditionally been used but just for minuscule cases. chinese students subject to deportation at the time of the t teen man square takedown. nothing this sweeping. you don't have enough resources to prosecute everyone, so a few people you let go because you don't have the energy and the time and the resources. this is entirely different. this is taking energy and resources and personnel from

enforcing the laws and using them to administer an entirely new dispensation under the las s because whatever this new dhaka is, if it works like the old dhaka, people will apply, they have applications, they have to get i.d. cards an this whole apparatus created out of nothing in defiance of the laws that are already on the books. >> we'll have to leave it there. join me in thanking our panelists. and i'm going to ask rich lowrie to come up and introduce our special guest in addition to the other special guests that we've already had out here. rich, come on out. >> every guest is special.

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on twitter. the house energy and commerce subsubcommittee on hea host host host hosted. sill veer ya burwell, francis collins and fda commissioner dr. margaret hamburg talked about ongoing efforts in the medical new treatments and cures. >> we'll get started. good morning, everybody. today, this morning, we're going to continue our really very strong bipartisan efforts on the 21st century cures initiative with this roundtable. to discuss ideas that the committee had received over the last couple of months and look to more specifics about the

steps that we can take to accelerate the cycle of cures, embrace technology advances and the rise of personalized medicine and keep america, in fact, the innovation capital of the world. over august and early this morning our committee members held round tables across the country to hear about how american innovation is providing hope, saving lives, and, yes, creating jobs. the initiative affects every american, every one as they, their families, their friends have been affected by disease. there are committee members during august hard work remains to find and deliver cures and treatments for the approximately 95% of diseases without cures. we have seen an outpouring of support inside and outside washington to work together and achieve this common goal. today to continue that work towards more cures and treatments, we brought together

truly another all-star roundtable. joining us, we have sylvia burwell, hhs. secretary of hhs. dr. francis collins, director of the nih, dr. margaret hamburg, commissioner of the fda. michael milken, chairman of the milken institute. dean kamen, founder of deka research and development. mr. bill parfet from michigan. and dr. dan theodorescu director of the colorado cancer center. we need to hear from participants as much as possible. that's why we have this roundtable today. we're going to listen. i know my colleagues agree that the participants are the experts and this roundtable is an opportunity to learn. to that end while we may want to ask the experts some questions to guide the conversation,

we want to keep our talking to a minimum. i would also ask the participants to try to keep their answers brief so that we can keep the conversation moving, knowing that we have really a hard stop at noon. in closing, i want the thank these folks who have offered their input on the 21st century cures initiative. i can't tell you how much we appreciate the thoughtful contributions especially those of everyday americans. we intend to release a cures legislative discussion draft in early january, 2015. we'll look to swiftly move the legislation early in the next congress. so if you want your idea considered, you can send it to cu cures@mail.house.gov really as quickly as possible. the more specific the idea, the better that it will be. so now i want to turn to my colleague diana degette from the great state of colorado. >> thank you very much, mr. chairman. thank you for convening this

last roundtable. i want to welcome everybody here today. i see the chairman today, in whose shadow we toil. i'm glad he's here. i want to thank secretary burwell for coming. i know she has a very busy day and, of course, my homie, dr. theodorescu, from the university of colorado, i want to thank you for coming all the way out here. as fred said, we've been working together to hold a big series of roundtables and hearings on the 21st century cures initiative and have taken many white papers. we've had a lot of suggestions, but i think we will both agree that we have a lot of commonality in the themes that we're hearing and we're eager to sit down and actually start drafting legislation. the roundtable we had in denver over the break, we talked about personalized medicine. and we had active engagement and interest from the audience. we heard from the nih, the fda. we've heard from local

universities and health centers and private investors, industry and researchers. and we're really beginning to honey in on some areas that we can think about how we streamline the process so that we can get from the lab to the clinic. and that's very important to all of us. one of the things we talked about, for example, was the potential time and cost savings of a central irb process, which is something i have been working on for a long time. we also talked about the importance of sharing data and information among clinical registries. and these are just some of the topics that fall under this. today, what we're doing is we're looking for feedback from participants on what we've learned so far and where we could go. and i'm really happy to see so many members here. some of the common topics that we've seen are modernizing clinical trials, facilitating data collection and data sharing, incentivizing drug

research for unmet need, incorporating the patient perspective into the research and regulatory process and developing young, emerging scientists as well as making sure we have adequate and stable funding for biomedical research in this country. and so i'm looking forward to hear from our experts and our colleagues today about how we can make a positive difference. i just want to echo your thanks for all of the members, all of the participants who have worked so diligently on this. it just really shows that there's a need. i want to leave you with one thought. i went around my district in august and some of you might know, just as happens every two years, in election year, colorado's a purple state. so we have shock and awe of campaigning going on there right now. and every time i talk to somebody, democrat, republican or unaffiliated about 21st century cures, their eyes lit up.

they were so excited about the prospect of bipartisan n?h q legislation, where we would actually be working together in congress to do something, but even more to do something big about how we can get those cures to the patients. and that's why i think we've got the germ of something here. i told a group last night, the big risk is it falls of its own weight. we can't let that happen. we have to work together to make it happen. and so i just really appreciate this effort. thank you, mr. chairman. >> we'll start with secretary burwell. >> thank you, chairman upton and representative degette for convening this roundtable and having me here today. i'm looking forward to working with all of you. that's why i'm here today. while i'm sorry i won't be able to stay, dr. collins and dr. hamburg, two of our best at hhs will ably represent us. but i wanted to come because of what you both said. the importance -- i'm here today

because we want to be your partner in making something go forward. i'm a big believer that if we're going to deliver impact, we have to start by building the strong relationships. that means listening to the experts we have and listening together and being responsive as we work together for meaningful solutions. i want to just first thank you for what you all did in terms of bringing everyone together, but this committee has also done important work previously in this space with fda and our user fee legislation. these roundtables are an excellent way to continue making some of the progress that we've already made. when we watch a loved one who is taken by alzheimer's or als, we all want the same things, the most effective treatments, the groundbreaking cures and the best medical care possible. and so we take at hhs that very seriously and we're committed to keeping us on that cutting edge of innovation, science and technology. and nih has supported most every significant advance of

biomedical research in the last 50 years. we've led from the human genome project and attempting right now to unlock those secrets of the most complex mysterious things like the brain. and dr. collins and his team walk the line, i think, some days between science and science fiction in terms of whether it's robotic, exoskeletons, nanotechnology developments or the revolutionary possibilities of personalized medicine and what that can mean. this work isn't just improving our health care system. it's hopefully going to transform it. these advancements allow us to shift from keeping up with illnesses to getting ahead of illnesses and they empower patients to engage in their own health care like never before. and new biomedical science and technologies create high-paying jobs and strengthen our economy, another important part of what this work is about. in fact, we have estimates that say for every dollar of nih funding, it generates over a

dollar in local economic growth. so, at a time when the world is vigorously forging ahead in medical innovation, we must protect our competitive edge and make sure that we're a global leader and not falling behind. with that said, we have a crucial equilibrium to maintain and hhs tries to balance that in terms of the speed of discovery with the oversight that keeps us safe as a nation. and that's why dr. hamburg will be speaking to those issues. fda is committed to reducing the length and cost of medical development. we've shortened the high-risk device to review times by a third since 2009 and also working to strengthen and improve the medical proprocess. we've expanding accelerated development pathways. last year nearly half the new drugs approved took advantage of expedited development and review approaches with review times as short as 4 1/2 months. over the last years we've made great progress with support and

we appreciate that. we also know there's a lot more to be done in that space and we want to focus on that as part of this conversation. we're committed to partnering with you while continuing to maintain a safe and accurate product data and information for people. with that, we look forward to working with you all. this kind of session where a conversation can occur, i think, is an important part to moving forward. and the committee process, which we want to engage and support. so thank you for having me. >> i just want to say that you and i talked about this, literally, the first week you became secretary of hhs. and you indicated then you would be very supportive. we're delighted for your participation today and all the way down the line. so we really appreciate you being here knowing that you still have to leave a little bit early, but thank you. >> thank you. >> peggy, do you want to say something? >> sure. well, thank you so much for

including me in this discussion and importantly for the leadership that chairman upton and congresswoman degette have brought to this 21st century cures and all of you on the committee. and it is true, as secretary burwell said, this committee has done great work to support science and the advance of biomedical product innovation and most recently with the passage of fadazi, i think we really accomplished something that's important in a very bipartisan way. this goes to the heart of what matters to us at the fda. our mission is to deliver on the promise of science for the public, to do our part not just in assuring the most streamlined review times, but also in helping to support the most effective and efficient research and development pathways for promising new products, and to be able to provide information and oversight throughout the

whole life span of a product not just in the development and review stij but also when it's in the marketplace being used by people when we have the opportunity to learn more about what works and for whom and why. and, you know, we think that the discussion so far has been enormously productive. in the identification of some of the critical area that is congresswoman degette noted are ones that very much align with our priorities and perceived needs. we want to work with all of you, to continue to reduce the length and cost of medical product development, to improve medical product review. of course, improving business processes and systems but also to bring new tools and perspectives to bear. more advance science and technology, patient perspectives and, of course, increasing the predictability and transparency and partnership in what we do. we think that there are a lot of

lessons to be learned from the work that's been going on with accelerated development, including the breakthrough designation that congress enabled us to move forward with with the passage of fadazia. the more the fda engages with stakeholders and importantly with companies as they develop products to make sure that the right studies are done, we can reduce the time for research and development. we can certainly dramatically decrease the time for review. and, most importantly, we can give the american people the products that they want and need, recognizing that the ability to really advance biomedical product innovation is essential for the health of individuals and families, but it's also vital to the health of our health care system and the health of our economy and the continuing preeminence of our great country in this important sector.

so, i'm really delighted to be part of this and look forward to moving to the next stage of really translating all these good ideas into action. >> great. bill? >> thank you, fred. and i'm very pleased to be here. i'll take a few minutes to give my background. not too impressed. i'm humbled by how little i know but to share with you where i'm coming from as we have these discussions today. so i'm 67 years old. and for the last -- i'm proud of it. and for the last 50 years, i have been developing drugs. i worked at the upjohn company for 20 years. then i started my own ceo with the contract research organization. we do business for small biotechs, many of who just have three months of cash flow and six employees. as we know today, they've been very effective and productive in bringing new products to the market. and i also served as chairman of stryker corporation, a device company located in our district.

i'm pleased with my background, humbled by what i don't know, but excited about what we can do here today and in subsequent periods before your legislation moves forward. i've listed -- i'm not going to go through them now but i hope during the two hours that we have here today, what i consider to be the critical success factors for our success going forward. talking about such things as the collaborative role we need between the private sector and industry and government. including regulations that are required and can be a real companion to what we're doing, including looking at the changing role of the patient. we have to have a changing role for the patient, including the consequences of risk, which are sometimes becoming so onnerous that risk takers don't want to step up to the plate with really innovative ideas. and looking also at the role of government in terms of helping out some of these smaller biotechs that have great ideas but don't have the funding sources. then finally, making sure we can energize our young people

to be rigorous scientists. we clearly are the best -- we have the best health care system in the world. we have the best ability to innovate in this world, and we want to unleash, unshackle some of the impediments that, over time, have allowed us to be the best we can possibly be. i'm pleased to be here and thank you for the opportunity. >> i'm dean kamen. i'm not 67, but i spent a lifetime designing and building medical equipment over the last few decades, as everybody in this room is aware. i'm concerned that the pace at which technology is developing is increasing. we're in the 21st century and accelerat accelerating. the pace at which the systems around us are moving makes us

feel like we're trapped in a 19th century model trying to deal with 21st century opportunities. again over the next few hours i'd like to maybe talk about a few of them, but a list of things that i think should be noncontroversial that could help things go better since, as michael milken has said more than once, the whole issue is time and money. we've got to shorten the time and reduce the cost. if cms, fda and all the other agencies that are part of the chain of events could work together so that we could, for instance, in parallel do all the work we need to do as industry to deal with cms and reimbursement at the same time as we go through the fda process, things would get faster and simpler and cheaper. another issue, which i hope is noncontroversial, no business i know could run if it lost 25% of its people every year. we have had multiple projects come through the fda and the

reviewer changes. one of our most recent projects, the reviewer changed four times. each time you sought to do a restart. it's expensive, it's frustrating, it takes time and it costs money. we have to find a better way to keep continuity on the government side of this process. the third, and i'm glad that the congresswoman brought it up, is irbs. you develop a product. you want to get it tested around the country, you go through a pretty detailed expensive process of getting an internal review board to approve it. that's a necessary thing. it protects the public and the company. you have to do it in three or four medical centers and have to go through each and every one separately. that's a little crazy. we should find a way to make it more universal. international competition. it's not just that they compete sort of in the marketplace. these days, most of my major partners, the biggest companies

in the world that want to take our products out, look at the situation and because of the lack of certainty in how long it will take to get a product approved or the lack of certainty of what the reimbursement will be for it, almost -- almost universally now, we transition to a world where our biggest clients would prefer to go and launch a product in europe or japan than in the united states. and that hurts on many levels. it makes the product less accessible in the united states. it has a lot of bad implications. we should recognize as a country we should be competing to be the most favorable place to attract innovation. finally -- and maybe it's just a small one to some of you -- the device tax which does nothing but make things more expensive, but it's really kind of a slap in the face to this industry. you could say it's only a few percent. but a few percent is a pretty big number to people that are

trying to make a new product. and particularly because it's uniquely a medical device tax. as a matter of public policy, we learn that you tax tobacco, alcohol, have luxury taxes. there's certain taxes that the government puts out because they're trying to encourage or discourage certain kinds of behavior. i don't know why people trying to make life-saving equipment should be taxed the way you tax industries that you're trying to say it's a luxury or it's a sin tax. i don't like to be lumped with that crowd. and i think it's bad policy. >> thank you. dr. theodorescu? >> yeah. close. and the green light on. >> it's a privilege to be here.

and a little bit about myself. i'm director of the university of colorado comprehensive cancer center. in that role, i am charged to really set the vision and the synergies of cancer research at the university of colorado which is a consortium cancer center which means we encompass three universities as part of our consortium. i also have a very vibrant laboratory that's funded by the federal government with multiple nih grants. and our area of interest is -.6d really doing personalized medicine, establishing genomic tests to assign therapeutics as well as doing drug discover pep in addition, because of my role as cancer center director, i'm involved directly or indirectly with clinic trials and i also get a lot of positive and complaints from our membership regarding the access and process of global trials. so, i think i bring a perspective of both the user and also somebody that's recipient

of feedback from my colleagues. you know, i think this is a -- this enterprise by medicine is basically bringing upon it a defining moment for this country because this is something that is going to be the future. personalized and precision medicine. how we do it is really our moment in time. the united states, thanks to dr. collins' initiative and vision has really built an incredible genomic engine and infrastructure and has resulted in a lot of technology to really push forward a molecular and biotechnology in medicine. it would be a shame not to capitalize on that and maintain our international and national leadership in that area. we have a great opportunity. this initiative is fundamentally important, i think both from a health perspective and doing right and doing good by our citizens, but our international

leadership and also for the economy. and we have discussed the numbers of things about the irbs, et cetera. there are tangible things that we can do. one of them, for example, is aligning the reimbursement process with the regulatory processpf f biomarkers. biomarkers are really the part an parcel companions to targeted agents. you can't have a targeted agent without a biomarker. they go hand in hand. we need to establish the guidelines for biomarket development. because the biomarker sphere is really an area that's a lot less reimbursed than drug development, yet it's really fundamental to precision medicine. so we really could thing how we have parallel tracks so companies, small biotechs, small businesses, can really develop biomarkers and have a possibility an expectation of a return on investment to grow this economy.

the other sort of vignette that i like to bring out is in trying to protect our patients, patients are basically the heart and soul of translational medicine. we rely on them. we're eternally grateful for their participation. but we need to encourage them to participate which means removing barriers. when we have consent forms for drug trials 40 pages long, even though they're written at the eighth grade level, perhaps my children when they're in eighth grade were not as smart, but i can tell you they were really not prepared to read 40 pages. i think we need to visit this because in trying to protect people we are actually dissuading them from participating and we're hurting them. we really need to rethink that. that's a vignette of a practical thing we could do in addition to the central irbs and supporting our young investigators. that support can be in the form

of facilitating the transitional research operation. people who want to do translational research have to have a clear career path and basically be able to spend their time really with forward motion. getting trials done, getting patients on trial. if the barriers to approving patients for clinical trials are so high we'll get progressively fewer young investigators wanting to embark on those careers. it's not a money thing. it's basically trying to overcome obstacles. after a while, you just get tired and you just go and do other things. we need to remove those barriers and that will promote our young investigators and also the entire translational infrastructure of clinical trials. thank you. >> thank you, mr. chairman. i commend the work that both you and representative degette had done in this efforts. i am here today not as the chairman of the milken

institute. i'm here today not as the chairman founder of faster cures. i'm here today not as the chairman and founder of the prostate cancer foundation. i'm here today not as one of the founders of melanoma research alliance or adviser to the focused ultrasound foundation. i'm here today as an american who lost ten relatives to cancer and representative of the men and women in america, one in two men, and one in three women, that will be diagnosed with cancer. and i am the happiest person to be with you today, mr. chairman, months to live when i was diagnosed with cancer 21 years ago. and i'm here to remind the committee that 50% of all economic growth in the last 200 years has come from bioscience and public health. that the greatest achievement in

the history of the world has been the increase in worldwide life expectancy from 31 years of age in 1900 to over 70 today. it took millions of years for average life expectancy to go from 20 to 31. and a little more than a century we've risen average life expectancy from 31 to 70. i'm here today to remind all of us that it was 20 years ago that a woman had more than a 90% chance of passing hiv or aids on to her children. and today with modern science, the probability of passing it on has gone from over 90 to 2. it's easy to understand economic growth when in sub-sahara africa, life expectancy has increased by 50% in a generation

with two-thirds of everyone living with hiv or aids. living in sub-sahara africa today and it is no surprise as a result that today six or seven of the fastest growing economies in the world in this century are in sub-sahara africa due to the great benefits of u.s. medical science possibly the greatest contribution of the united states to the world has been the benefits of this medical science that is available to so many people today. those countries that lead in the biosciences will lead the world in this century. we're not just talking about health. we're talking about agriculture, environment, energy, air, water, et cetera. and so we're of the dawn of the golden age, this enormous investment that the american public has made with the

leadership both in the administration and the senate and the house, approving in '98 an increase in funding, which now exceeds over 200 billion. we're about to reap those benefits. whether those benefits will accrue to the united states of america or to some other country will be determined by the leadership and the commitment of this committee and others today. there are five easy lessons we could talk about today that we've seen over the last 30 or 40 years. one, putting the patients at the center of discovery, development and delivery process. more efficient clinical trials. meaningful working relationships between patients. and disease-specific organizations. one of the great advancements of the past two decades has been the strengthening and

improvement of the disease recognition research group. two, incentivize collaboration across sectors in the r&d process. public/private partnership. look at history books and see those partnerships between ford and kaiser and the government that allowed us to have victory in world war ii as we moved our for-profit industrial companies quickly to produce ships and other products we needed during world war ii. three, encourage novel financial solutions that address the riskiest r a& d endeavors. change this risk/return ratio. as an example, mr. chairman, all we have to do is look at acid rain. a major issue in the latter part of the 1980s in america. movies, public hearings, et cetera, the loss of life to acid rain. the creation of a financial

market for sulfur index that allowed people to reduce their emissions, get credits or for those to buy credits that in seven years eliminated 95% of all the aid cid rain in america. strengthening the basic translational research infrastructure depended heavily on the next generation of young scientists. today stem education is the rage for both men and women, boys and girls in america. after 15 years of studying, ph.d.s, m.d.s, internships, residency, we have little to promise them in the future. and today, america is losing our best and brightest students to the rest of the world, and we run the risk of losing generations of young scientists either to

other countries in the world or to other fields today. fifth ensure sustainable and predictable funding for our science agencies. nih, fda, f it's impossible to build an organization or recruit the talent you need when on a year-to-year basis you don't know whether you can fund them. the probability of a young scientist today being funded is the lowest it's been in more than four decades. this golden age is in front of us. we think about the cost and to do no harm. but in many ways by lengthening time we are losing lives. by not providing access to the state of the art treatments today, by not incorporating science. in many ways, science today is running in the 21st century.

but as dean has pointed out, it's running on tracks from the 19th and 20th century. we wonder why today in america that the average train, symbolic of science, travels at the exact same speed it traveled at 100 years ago. it has nothing to do with science or the ability of the train to move. it is running on tracks that cannot afford to have trains run at those speeds. we look at china and other countries around the world whose trains run two to three times faster than ours. it's not that they have different technology. it's that they've allowed different infrastructure, 21st century infrastructure to allow those. one of the things i'm quite confident is that work on this committee will help us to build that 21st century infrastructure. >> i'm francis collins, director of the national institutes of

health, and mike milken, i think, has wonderfully articulated the promise and the challenge of living up to that promise. and representative degette for convening this whole series of discussions and many members of participated by convening similar hearings and roundtables in various parts of the country. i was here for the first roundtable may 6th in this room. i was two weeks ago in lancaster, pennsylvania, when representative pitts convened a very interesting group of us around that table. it is enormously inspiring and encouraging to all of us involved in biomedical research to have this kind of focused attention on the opportunities that now lie in front of us for developing these 21st century cures. i live a paradoxical life because as director of the nih, i have the opportunity on a daily basis to see amazing science that is possible.

things that i would not have dreamed would happen in my own lifetime. at the same time i also preside over an effort, which, as mike has laid out, is under the greatest stress that it has seen in four decades. with young scientists who find it increasingly difficult to see a path forward to live out their visions. so it is welcomed indeed that this group has come together to try to see what could be done to cat ta liz greater progress and those cures that are still being waited for on those roughly 7,000 diseases, only 500 of which currently have a therapy that's available. the genome project helped us a lot in stepping into a new space here. now we now have technologies that allow us to look into the intricate details of how a cell does what it does and how things go wrong in the presence of disease. and yet we're not capitalizing

on that opportunity at the level that we might. my own area of genomics, i can't help but point out that while we, the united states, led the human genome project and from that derived the return on that investment is 178-1 in terms of economic growth that derived from our leadership of that effort. yet if you ask me now where is the largest investment in genomics in the world, it is not in the united states. it is in xenjiang, dhin. they read our playbook. saw an opportunity and took advantage of that. meanwhile we, over the 11 years since the genome project was completed in 2003 have seen a steady decrease in our ability to support research with a 23% cut in our purchasing power for biomedical research since 2003. and the results of that is the

subsequent loss of the leadership that was basically clearly ours at that point. don't get me wrong. i celebrate what other countries are doing to contribute to biomedical research, but why would we, the united states, with all the talent and creativity and vision here decide to exit the stage just as it was getting interesting? we clearly have a critical role to play here. i really appreciate the way in which this 21st century cures nx effort is asking very specific questions of what could be done by the congress in legislative terms that would assist us in terms of our ability to go faster. and we will be supplying -- i already mentioned in some of the other sessions, specific examples of that sort. it's getting to be quite a long list. some are big ideas and some of them seem kind of small, but they would help us a lot. they fall into three categories. one is how to enhance participant protection and increase transparency, to encourage participation by

people in clinical trials and biomedical research but also make it clear we are transparent about how we do this. such things as providing privacy protections for individuals participating in research so that their private data doesn't find its way into unauthorized places, simply prohibiting, for instance unauthorized reidentification of individuals based on dna sequence would be an important step forward. second area is to facilitate collaborations and innovation. we've already heard some of those issues as relates to central irbs, something that we also feel quite strongly about and the common rule which is the way in which we have overseen human subjects research for 20 years is desperately in need of an upgrade. a lot of work has been done on that, but it has not come across the finish line. a simple area that, in one way, is getting in our path, our new national center for advancing translational sciences. for reasons that i think reflect

anxieties about whether this would be competitive with the private sector is legislatively prohibited from pursuing clinical trials beyond phase 2a. something which now at the present time really makes very little sense. i think almost nobody would support the rationale for that given that we have worked very hard to be sure that we are in no way competing with private sector efforts. and the third category, reduce administrative burden and increase efficiency. the famous paperwork reduction act has been for nih the source of the greatest amount of when it comes to individuals who are trying to run simple studies where they wish to actually do a survey. this happens many times for trainees in our intramural program. you may not know that you can't run a survey to ask people about their opinions about precision medicine, for instance, if you're going to ask more than nine people, unless you go to the omb and get approval for that. that takes about nine months, at

which point the trainee's about ready to leave. so clearly there are some helps we can use here. and all those reports, if you start adding up the reports that are congressionally required and which, as far as i can tell, nobody reads but which requires many hours of busy people's time, it would be great to sort of go down the list and throw out a lot of those that really have, if they once served a purpose, no longer do so. but again i just want to say how critical it is that we look at this issue from a holistic perspective of all the ways that our enterprise could be more vigorous and healthy. particularly as mike milken has said and others, diana degette mentioned it as well, the need for a stable sort of support system. there's a great sense now of instability of insecurity, of a trajectory that nobody can be quite sure of. that's the worst thing you could do if you're trying to encourage innovation. to find that path forward would make a huge difference. it will make a difference in very concrete ways of saving

lives. tell you one other story which is very much on my mind, and then i'll yield up. here we are, all of us, deeply troubled by what we see happening. the number of deaths from the ebola outbreak now over 2,000 and with no end in sight because of the way in which this terrible disorder is spreading rampantly like wildfire in liberia, sierra leone and begin pep the nih began working on a vaccine for ebola in 2001. we have steadily pursued that effort over these last 13 years. hoping that by the time a big outbreak occurred we would be ready for it. that vaccine has now been in animal trials shown to be highly effective but as of this summer the outbreak really began to catch fire, had not quite reached the point of a phase one clinical trial. we worked in record time with

enormous assistance from our colleagues at fda to speed up the process. and last week, the first volunteers at the nih7yfñf clin center were injected with this vaccine in a phase one trial to determine whether in fact it is going to be safe. and in another two or three months we'll know that and be in a position to do a phase 3 trial which it's most needed in africa. but i have to tell you if we had not undergone this ten-year decline in medical research support, we'd be a year or two ahead now. think about the difference that would make. had we been in 2014 been in position to distribute rapidly tens of thousands of doses with our colleagues of this vaccine, how much different would this be and how many lives would have been saved? so the consequences of what's happened in the last ten years are not just that it's been tough on in scientific researchers, although it really has been. not just that it's damaged our

ability to take advantage of economic growth that otherwise would have happened, it's also that lives are not being saved that could have been. the importance of this conversation could hardly be greater. i thank you for the chance to be part of it. >> thank you all. great experts in your fields. and i didn't mention at the beginning that, you know, not only is this committee united in working on this together, but we also have the commitment of lordesh leadership on both sides. steny hoyer was there and testified and kevin mccarthy our new majority leader is on board as well. let's open this up for discussion. frank, first. >> thank you. again, i want to say to both you and diana how valuable i think that these roundtables have been. and we had one i guess it was --

was it only a week ago? it seems like two weeks ago with chairman pitts in his hometown in lancaster, pennsylvania, i thought was very good. i wanted to follow up on something that commissioner hamburg mentioned that day. you had talked about engaging patients, and i think you were responding to some extent to the woman who was from my district from medicine who was with the hydrocephalus foundation. and i just wanted you to talk a little bit more about that and how we can engage patients. and i was particularly referencing i know in the user fee bill we had a provision that allows patients to be part of the advisory panels. so that would be maybe one example of how we engage patients and maybe you can talk about that specifically, but i didn't want you to just limit it to that. it's just the idea of engaging patients.

because a lot of times, as you know, the initiatives in terps of legislation that we pass on the floor and, you know, some of the bills that we did last night on the floor actually come from these patient groups, if you will, who are so grass roots and involved and spent a lot of their life, you know, on some of these -- as part of these foundations like that. if you could elaborate more and mention more about the advisory panels and participation. >> thank you, such an important question. this is a critical time as we're really rethinking not just within the fda more broadly about how to really put patients at the center of what we're doing and really include the patient perspective and reflect the patient needs in the work that we're doing. it goes far beyond engagement on an advisory panel if we do have patient representatives on advisory panels, but it really is to sit down with patients and

patient groups in a systematic way to better understand their experience and their perspectives on the products that they're using, whether drugs or medical devices to better understand what they need and that they're experiencing their disease and what are the critical symptoms of their disease that they want addressed. and then how we can -- and what, of course, are the unmet needs. and then how can we actually incorporate that into both product development and product revie review? for example, biomarkers were mentioned. but we want to use patient reported outcomes like biomarkers to ensure that we are both assessing the right measures of whether a product is

having an impact and use those measures in a more fundamental way to define success. so i think that's really critically important. the other thing i would mention and, of course, mike milken in his various fillen tlop es and organizations have been leaders in this area but the role of patient specific philanthropies and organizations. we increasingly work with them wls with the research community and product sponsors to really identify critical needs and opportunities and then together think about how to shape the in particular the clinical trials that need to be done, but other aspects of data collection so that the research and development and review process can be as accelerated as possible. one good example is the work that was done with the scientific community and the cystic fibrosis foundation to

develop a new drug kaleidako which is for some people who have cystic fibrosis that have a particular fibrosis foundation. a new drug which was for a subsection of patients that was cystic fibrosis that have a particular genetic marker. it was the first drug that treats the underlying cause and not just the symptoms with the devastating and this has been transform of a and provides the patients and the cystic fibrosis foundation made this work building on research on which francis collins did a while back. this has been transformative and the cystic fibrosis foundation really made this work possible because they helped to create the patient community necessary to rapidly move into clinical trials to get the tissue as well as the patients that could create a foundation for understanding the opportunity and moving forward quickly on it.

and put up some critical resources, not just patients but also dollar resources to help move the project forward so there's a lot of important activity in this area and i think we need to look at what's being done and its incredible success and importance and then build on it. and i do think this effort can put a major focus on this and help us advance this work. >> thank you. mike burgess. >> thank you, chairman and thanks to all of our panelists for being here. dr. collins, the offer still stands. i will be one of our test subjects for the safety of the ebola vaccine. you rejected me on age criteria before. i thought that was discriminatory on your part. >> i had to reject myself on the same grounds. >> i still stand ready to offer

my services. we had a good -- with manhattan institute, we had a good roundtable and faster cures was part of that up in boston and the concept of adaptive licensing came up. currently, of course, through clinical trials, something is either approved or not approved. it's a binary function and once approved to be safe and effective until proven otherwise. but the adaptive licensing pathway that some are using did to appeal because we live in the information act. the rapidity in which something can come to partial approval with the feedback and rapid learning possible with the information systems that we have, it seems like this would be a reasonable direction in which to proceed. i hope it's something we will consider when we write our legislation but i'd also ask the administrator of the fda, is this something you all are

looking into or would be receptive to in the realm of adaptive licensing. >> it's very much a topic of discussion. and we have been involved deeply with counterpart regulatory authorities in other countries looking at this as well as the scientific community to look at what are the opportunities to get robust scientific answers from a range of innovative approaches in terms of clinical trial design that can underlie licensure and also innovative regulatory pathways. at the present time, you know, the fda actually has quite an array of tools and regulatory flexibility thanks to our work with congress including the breakthrough degree significant nation and, in fact, our approaches are not binary in the sense that accelerated approval, for example, using again going back to bio markers using bio

markers as surrogate end points enables us to move a product with promise into the marketplace but then collect data in a continuing way to actually then assure the final approv approval if the product really works and provides an overall benefit for patients but, you know, this is an area that i think is ripe with opportunity to explore how can we streamline modernize and best adapt our regulatory pathways to make a difference. i think that secretary burwell mentioned that half of the recently approved drugs used various methods for expedite add proval and that is making a huge difference, breakthrough designation is proving to be a real benefit and i would have to tell you that i think one of the

most important things to emerge in the recent years in terms of all of this work is that what makes the most difference, the most difference in actually reducing times from discovery to the bedside is really the ability for the researchers and the companies and fda to all work together early and in a continuing way to shape the development process to identify what is the data that's needed to move us as swiftly as possible over the finish line and i think, you know, that is really where the most important work needs to be done to make the most difference for patients. >> well, just, you know, i have to add then the comment was made this morning about the 25% turnover, someone is working with someone at the fda. they're gett?]pyuz a point where perhaps the next steps are ready to be taken and you got to go

back to square one. i hear this all the time. it's not new. >> that's a huge concern, you know, for us and, you know, it reflect reflects unfortunately that people are stretched too thin, work too hard, burn out, the conditions are challenging, and they're competitive in other sectors so i think we need to address those issue, the user fee legislation has enabled us to begin a process of hiring on more people and being able to riley create the training and management systems that we are intending to help us do a better job at recruiting and retaining people, but that is an essential issue and it can undermine all of the best efforts adaptive licensure will not fix that problem. we need to address the issue of recruitment and retainment, i

think, in a very targeted and forceful way because it is essential and it has so many critical ramifications. >> then cross twaining within the institutions was not up to one individual. thank you, mr. chairman. >> henry. >> thank you very much, mr. chairman. i want to commend the conferences roundtable discussions. they've been very valuable and what has come home to me and the number of meetings we've this is the promise of a lot of new innovations in the health care area and it's an exciting time in medicine. i also have been struck by how dependent this whole future is on the government in the sense of nih and fda having the ability to do their work in a new fashion. we gave fda a lot of authority to be more nimble and

be more flexible and work more collaboratively with those who are developing pharmaceuticals and medical devices. and i've heard a lot of praise for that and with the nih, there's just so clear how dependent the future is going to be on a stable and appropriate funding for biomedical research. if we've had a ten-year decrease downhill in funding for nihi. it's not just the people that work at or for n. h. it's the whole health care system that pays a very heavy price. so if we're determined to do anything and i think reflecting the will of the american people overwhelmingly, let's adequately fund nih research and the food and drug administration. i'm embarrassed although i accept it already that we have to fund the work of fda through user fees. this is a government function.

and those who are trying to develop new breakthroughs have to figure out how to pay the user fees. it's just -- look, i authored the law to set up the user fees but we have to do what we have to do. and we shouldn't see the constant decreasing or flattening out of the funds which erode over the years. i also am proud to have my constituent and friend here mike milken and i thank you for his presentation and the work of this whole panel very much relied on the work that your organization has done particularly the 2011 discussions about barriers that prevent progress. and i was struck by the fact that you talked about the cap and trade program for the acid rain, to get rid of acid rain which i authored. and it seems to me

we need to do that to unleash the market forces. which is to unleash market forces. don't think the government can do it. we need to give the right incentives and step aside and let market forces dictate the creation of the infrastructure to accomplish the goals we want. we need to do it more in the environmental area and especially have to do it in the health area. part of that infrastructure must be the maintaining and stable funding of the government areas. now, to whomever on the panel that wants to address this, legislation can a blunt instrument. we heard about the paperwork reduction act which has caused more paperwork, the reports and all the other things that will make things easier and instead they make had