prepared to -- for minimum wage. >> there are 40 or 50 republicans i would sign immediately. can you report. [inaudible] they will get a chance and they will get a chance in the relatively near future. we believe minimum-wage whether talking about the economy or talking about the economy working for everyone we believe the minimum wage and i just want to make a comment frankly. from 1968 on they got a cola adjustment with the far up of $15 i think. i will be corrected on that. it was $10.57 in 1968 and $2013. it's now $7.25 and $2013 so

eroded from 1968. they will get that chance. we believe the minimum wage is absolutely critical to lift people so that they can be full participants in this economy. we have heard economist after economists tell us this is a demand-driven economy. if it is a demand-driven economy you have to have demand. raising the minimum wage will increase demand. raise the growth level in our country, create jobs and be good for everyone which is the central theme of this conference but they will get their chance. ? how will republicans do you expect to get? >> i don't think we are every c confidant we will get 18 republicans to sign the discharge petition but we have

some over here so perhaps thinks are changing. if they want to make sure people have an incentive to work they will pay them a wage to not leave them in poverty. i think the overwhelming majority of democrats will sign this. we presume it will be close to everybody. >> well, we have been listening to some of the republican colleagues who have been asked this question, the same one you are proposing with respect to the minimum wage, some said no, and many have said they areo opn to it. so we will give them an opportunity to put their signature where their statements are. or tell their followers if they are for or against it. 50 members on the republican side who have talked about

supporting the immigration reform bill -- talk is one thing. actually doing something is another. i am sure they will have a chance between now and november to let their followers know if they are serious about immigration. many have said they are open to the minimum wage proposal so let's find out how open they are >> what issue do you see as the biggest brick wall taking back the house of representatives for democrats in 2014? >> i don't accept there are brick walls. we punch through thoses. you should have the republican members who have decided to retire, who have now understood

that if you are a moderate republican, there is no place for you in this majority. so there has been an exit of moderate republicans. let's talk about pathways. middle class economic security is a defining issue today. how you create broad and rising prosperity is a designing issue. people want solutions and priorities. if there is a republican who will not sign the discharge position because they argue the economy can't afford the increase in minimum wage. people will want to know why that person is voting for subsidies of oil companies of $40 million. and why they support subsidies to corporations to outsource jobs. or a minimum tax credit for businesses to buy corporate

jets. this is about contrast and priorities. the minimum wage is an illuminating contrast we have and wil be a defining issue over the next six months. >> there is no issue that causes you to lose sleep? >> he tells us the rest of us he loses sleep over the undisclosed special interest money that is poured into the system. and this isn't just about unease we have about winning the election. this is about undermining the democracy. and that is why we had a meeting with john bane who is taking the lead on the reform package. amend the constitution to overturn citizens united. this big money does more to

suppress the vote by suffocating the airwaves with endless special interest, undisclosed money that causes confusion and then people throw up their hands and say i don't get it, and that is a victory for the special interest in our country. and so we are very proud of the response we have gotten from the grassroot people and proud of the recruitment of the very good candidate under the leadership of steve israel. we feel we are into good place. not just us, but our democracy, has a lot of sleep to lose over what the special interest money is doing to undermine what our founders fought for and sacrificed for their own words:

a government for the many, not for the money. >> i think the worry about brick walls is on the other side of the aisle. i say that because we talk about ladders of opportunity. that is a latter to the majority as well because 70%, 65%, and 60% of the american people agree with us on everyone of the issues we have been discussing. i was kidding to steve israel that two chairman decided to retire and i am guessing they don't think they will keep the majority. >> the administration announced another delay on the employer mandate on the affordable care act. do you think that opens up

wiggle room for democrats to delay the employee mandate that employees are required to buy? if not, why not? >> no. because that is a completely different think. in other words, the president has, as we do with all legislation, the implimentation and how we can use this to improve the american people's lives. the mandate is central to what the law is. and the law is sound policy. to go back to the founders who sacrificed it all for life, liberty and the pursuit of ha

happiness. this bill is central to that. >> i thought my shirt said it all here. >> it does. [laughter] >> he's getting ready for st. patrick's day. >> i was making a point going back to the question about the path as mr. israel said. there has been more republicans retiring and we have a bigger chance of taking the seats from them. >> 13-3 in competitive districts. >> so in that -- >> oh, 11-3. sorry. >> i think we stand well in

terms of anticipation of the election. but that is months and months away and a lot can happen >> after we raise the minimum wage and immigration reform. >> i am going to make you a single weapon. >> thank you very much. >> i have one more thing to say: my colleagues set this up as we have the frame of building an economy that works for all-americans. the theme of the conference under the leadership has been strengthening ladders of opportunity. we see as a first long in the ladder, raising the minimum wane. and we see another wrong in the ladder of passing immigration reform. and we want to do so appropriately in the presence of so many stakeholders in that issue so that will be coming soon. but today we are announcing the first wrong: minimum wage.

part of the full agenda and very central to who womenpresident r

portrpo portrpo portrait gallery. >> now we have a hearing on the subcommittee and health about

drug shortages. this is an hour and 15 minutes. >> the submcommittee will come o order. the chair recognizes them seset. in years, we have seen an increase in the number of drug shortages in the united states, particularly with generic sterile, injectible drugs. while the number of new

shortages dipped, the total number of on-going shortages have increased. this is unacceptable. what is the agency doing to help address these situations? news reports are highlighting coverage of items that are missing such as common saline solutions. delays in treatment, rationing of care and higher cost are some of the problems this is causing. there are medical errors are providers are forced to seek alternative treatments. there is no simple solution to this challenge problem. ...

to present and mitigate drug shortages and submit annual report to congress including relating actions taken by the agency. it also require gao to exam the cause of drug shortages and formulate recommendations how to prevent it.

last october fda issued the strategic plan for preventing and mitigating drug shortages. it only covers the first three quarters, 2013. they release the final report. while drug shortages continue to plague our health care system. they indicate some progress on some front. i'm pleased to see the legislation has had a positive impact. i would like to welcome our witnesses. marsha cross, health care cricketer at gao and douglas, deputy director of regulatory program at the fda. i would particularly like to thank gao for their comprehensive report. and the time they have spent with my staff on the issue. i'll yield the remain of my time

to vice chair dr. burg ease. >> thank you, mr. chairman. when doctors don't have the essential tool they're restricted in what they can do for their patient. members in this committee have taken the lead and made major strides by passing the food and drug administration safety and invasion act of 2012. in addition, i have worked closely with chairman upton and chairman pits on several of the provisions contained therefore in and things have gotten better. as recently as last week the food and drug administration listed sodium chloride as a drug shortage. it's not a particularly exotic molecule. for having that much trouble with salt, it only makes you wonder what other more difficult molecules may the shortages may encounter there. food and drug administration has a role in addressing drug shortages. it is a complex issue.

in 2010, over 240 drugs were in short supply or unavailable and more than 400 dper gear in rick were -- they operate on a margin so tight productions becomes corrupt companies cannot afford to continue the manufacturing. this leads to one of the more more than 3,000 backlog of applications. physicians are faced with having to tell patients they can't receive the care they need not because there is no treatment because a product is simply not available. i thank the chairman for holding the hearing. so we can learn more on the drug shortage problem. i'm pleased general accountability office report is being released and look forward to hearing from them on the findings. the law is aimed to ensure providers have the tool in this case need alleviate suffering of every patient and certainly anxious to hear testimony today yield back to the chairman.

>> thank you, chairman. i'm glad we're having the hearing today on the critical issue of drug shortages. over the past several years, we've saw an alarming trend of increases in drug shortages. we know the devastating effect this can have on patients prolonging disease or closing permanent disability or death. this is an issue i and many of my colleagues on the committee long concerned about. congress took action to provide the food and drug administration with tools to help address the problem through provisions in the food and drug administration safety and invasion act. which passed on the strong bipartisan basis in 2012. we asked the government accountability office to reveal several factors related to drug shortages. i want to highlight the other

aspects that addressed drug shortage problem. in the 2011 report the ago recommended and we heard from other stakeholders too and early information to requirement for potential shortages so fda can work with manufacturers sooner to take steps to prevent or mitigate shortages. we included sufficient a requirement in it and encouraging that the number of new drug shortages declined in 2012 compared to the previous two years. and that partial data from 2013 in the case of the trend is continuing. the fda has cited this and other drug shortage provisions as contributing to their ability to prevent by their calculation 140 drug shortages in the first three quarters of 2013. we also heard from stakeholders the need for fed to review time for gear in rick drug applications and reduce the significant backlog of pending application.

as we heard a few months ago the agency has been a aggressively hiring for the generic drug program. which is of course the complex problem. as i'm sure we will hear today from the witnesses drug shortages remain high and remain a problem. many of the shortages are still a sterile injectable drug. i'm aware the drugs face unique changes because they are technically difficult to manufacture. and each drug is also manufactured by one or a small number of companies making it difficult for other companies to be able to fill the need if any one company developed manufacturing problems. so it is clear while we have made progress in some areas, our work is not over, i thank our

witnesses from fda and gao for being here to continue the topic on drug shortages. i look forward to learning with a we can do to prevent prevent them. i yield back. >> the time recognize the vice chair of the committee, gent the lay -- gentle lady from tennessee. >> i want to welcome our witnesses. thank you for being here. i thank the chairman and the vice chairman of the committee for their attention to this issue. as you know, 2012, 2011 we healed hearings. we have looked a the the process and what the factors are. that are causing the drug shortages we know they increased recent a years. let's get to the root cause and the problem. so we are solving this. i continue to talk with those

health professionals in the community and tennessee and get their input on this. we take a bipartisan action. the chairman and the ranking member mentioned. and that was to address it the shortages and they did provide fda with the authority to say needed. it put new requirements on the manufacturers to help prevent and mitigate the shortages or supposedly on paper that is what they're to do. so this is a wonderful opportunity for us to look at the gao report. to question do you hear from you and continue to try to look at the systemically holistically and get to the root cause of solving this problem. and mr. chairman, i yield back to you for further yielding. >> chair thank the gentle lady. it concludes the panel's -- or members' opening statement.

on the panel today, we have two witnesses dr. marsha crosse. health care us accountability office and dr. doug deputy director for regulatory programs. senator for drug evaluation research. thank you for coming. your written testimony will be made part of the record. you have five minutes to summarize your opening statement. at this time the chair recognizes dr. croses for five minutes for summary. >> mr. chairman, ranking member, members of the subcommittee, i'm pleased to be here today. to discuss our work on drug shortages. as you know, prescription drugs are a critical part of political care. over the last decade there's an increase in the number of drugs that are in shortage. it included drugs that stablize dray tray ma victims, control pain during surgery, to treat heart disease, and cancer and

provide nutritional support to premature infacts. a study you mandated. i'm happy to discuss our key findings. we found the number of short shortages remains high and providers experience challenges responding to -- without affecting patient care. beginning in 2007, the number of new drug shortages increased each year until 2012. when the number of new shortages declined. and that downward trend appears to have continued through 2013 based on the partial d.a. we analyzed. however, while the number of new drug shortages has begun to decline, the total number of shortages active during a given year including both new shortages and ongoing shortages that began in a prior year, has continued to increase because many shortages are prolonged with some spanning multiple

years. the majority of shortages are sterile injectable drugs particularly generics. shortages of mltly necessary drugs can have a range of negative effects. a drug shortage may require providers to delay or ration care, create difficulties finding alternative drugs, increase the risk of medication errors, thread higher cost, reduce time for patient care, and result in the stockpiling or hording of drugs in shortage. for example, providers may have to ration care by prioritizing the patients who have a greater need for the drugs. the immediate cause of a drug shortage can generally be traced to a manufacturer halting or slowing production to address quality problems. triggering a supply disruption. other manufacturers have a limited ability to respond to supply disruptions due to con constrained manufacturing capacity. we also identified potential

underlying causes specific to the economics of the generic sterile injectable drug market. such as the low profit margin have limited infrastructure investments or lead some manufacturers to exit the market. although there are few studies of underlying causes, among issues that have been examed are purchasers focus primarily on price rather than quality, reducing incentives for manufacturers to invest in maintenance or quality improvement. the group -- on the behalf of hospitals and other providers. lowering profit margins for manufacturers that win contracts and leaving losing manufactures to exit the market. and 2005 change in medicare part b. drug reimbursement policy for outpatient providers decreesed both demand and prices for generic drugs. the stakeholders we met with,

which included manufacturers and group purchasing organizations has ,000,000ed view on the potential underlying causes with no general agreement on the role such factors may play. in examining fda activities, we found that the agency has prevented more potential child support age -- shortages and improved it. the new requirement that manufacturers must notify f f a in advance of a special short age allowed them to take steps to prevent and mitigate short ages sooner. for example, it has expedited application reviews and inspections. exercise enforcement discretion, and helped manufacturers respond to quality problems. these steps are important to respond to some of the immediate causes of shortages. however, some of the underlying causes we identified are beyond the agency's authority. as fda does not have control

over private companies' business decision. for example, the agency is unable to require manufacturers to start producing or continued producing drug or build redundant manufacturing capacity regardless of the severity of a shortage. of the information it has to address drug shortages. we identified shortcomings in the management and use of the agency's drug shortage data. and our report we made recommendations to fda to improve it data base and to conduct routine able cease of the agency agreed with the recommendations. in summary, all fda has made progress in preventing potential drug shortages, and responding to actual shortages, the number of shortages remains high and many persist for months and even years. the large number of potential shortages reported to the agency

suggests a market is still at risk of supply disruptions. as a result, patients and providers will continue to struggle as a essential and life saving medications remain short supply. mr. chairman, this completes my prepared statement. i would be happy to respond to any questions you or other members of the subcommittee may have. >> thank you. >> the chair recognizes five minutes to summarize his opening statement. >> mr. chairman, and member of the subcommittee. i'm douglas deputy director of fda center for drug evaluation and research. thank you for the opportunity to speak you about it about the work they are doing to address drug shortages. i would like to begin by discussing their causes. drug shortages as others have said are usually proceeded bay disruption in manufacturing of a product. some product disruptions are manufactured or controlled such as decisions to permanent discontinue reduction of a drug no longer profitable. other factors are outside the manufacturers control such a natural disasters or the

unavailability of materials needed for manufacturing. a particular problem the materials are only available from one supplier. most often; however, shortages are the as a result of quality failures within manufacturing facilities. preventing the supply disruptions acquires the manufacturer to commit to quality manufacturing. turning to drug shortages in the u.s. today work remains progress has been made in the prevention and resolution of the drug shortages in the united. the agency is well positioned to work with manufacturers to find ways to prevent or reduce a shortage impact on patients provided we are aware there is the potential for a shortage. early in timely information to by manufacturers has aided

importingly by the executive order of the president as well as by passage of the it and enabled fda and manufacturers to prevent 170 shortages in 2013. we are also seeing fewer new shortages. nut number of new drug shortages in the united states rose steadily from 60 in 2005 to all-time high in 2011 of 251 new shortages. after a seer of interventions the number of new drug shortages has fallen to a low of 44 in 2013. there continue to be shortages that persist for longer periods. here while progress is being made exediting fda inspection

and review the submissions for manufacturers currently producing as well as manufacturers who are interested in starting new production of a drug and shortage. and finally, exploring risk mitigation measures for products initially not meeting established stoonders allow them to remain available safe will -- safely. it do not change it balances our standards with the needs of patients for particular products. considered before taking enforcement actions or are issuing warnings letters. inappropriate cases temperature prayer exercise of regulatory flexibility is important tool in ensuring access to needed drugs. as a part of the work on drug shortages in 2013, the fda released the strategic plan as calmed for. the goal of the plan are to improve the agency's response to drug shortages anded a van

locker term approaches for addressing the underlying causes of shortage. first, to improve how we address imminent or existing shortages ftd a's potential shortages focusing in three areas. first, improving communications communications with within it the fda to ensure that our decisions are official and appropriate. second, we are improving our data bases related to drug shortages creating a dedicated drug shortage data system to improve how we track drug shortages and allow us to better assess progress on prevention and mitigation of the shortages. including the work we do to produce the annual report to congress required under it. recognizing the commonly begin with the supply disruption related to product quality fda long range effort include a focus on preventing supply disruption and shortages by encouraging and sustaining improvement in manufacturing quality.

for over a decade, fda has been working with academics and industry experts to stimulate the development of novel manufacturing technologies which can help prevent drug shortages linked to manufacturing quality. in conclusion, progress has been made in efforts to prevent and mitigate important drug shortages aided by early communications with sponsors about the potential. shortages don't occur fda will continue to work to address them. importantingly, fda don't work with others to support the pharmaceutical industry in the long-term effort to modernize drug manufacturing to prevent shortages. by working together, we can prevent drug shortages from occurring, address them when they occur, and provide patients with access to medicines when they are in critical need. i'm happy to answer any questions so you. >> thank you. it concludes the opening statements of the panel. we'll now begin questioning, and i will recognize myself for that purpose for five minutes.

doctor, while it required that the report be submitted by no matter than december 31st, 2013, fda's first annual shortages report was submitted to the committee on february 5th. and with d.a. from only the first three quarters of 2013, you notice 170 shortages were prevented in 2013. this is up from 140 in the report fda submitted. i assume it means fda claims to prevent 30 shortages in the fourth quarter of the year, is that correct? >> we do have our full year data available now. we would be thiep that share with you, mr. chairman. >> all right. let's use that smaller sample size for sake of discussion. it would be help to feel have more detailed information about how fda prevented these

shortages. what specific actions did the agency take? which drug products would currently be in shortage if not for the agency's actions? >> i can get you some specific information. i can give you a general sense of some of the activities that we took in this last year. if that would be helpful. >> all right. one issue regards something called regulatory flexibility. these are places where we either expedited additional actions that otherwise would taken bit longer or taken a review and underhanded additional work on it. we had 76 instances of regulatory exercise effecting a total of 86 product. there's another way of thinking about actions we have taken recently to speed the qoment of products or assure that product that go in to shortage remain available. several of the offices receive applications from sponsors for

new factories or new -- lines within a factory. last year my office of generic drugs exexpedited 118 applications involving a total of 62 accelerated new drug applications. an important number of products where we worked hard to make certain they were more quickly reviewed than normal. our office of new drug quality, which is another office looking at supplemental applications to approved drugs that improved innovator drugs. looked at 52 supplemental applications and expedited form last year. and finally my office of bilogical products which look at new products very important issue in term of therapeutic qoment. they expedited seven reviews last year. i think in total those things reflect the commitment that my center has to looking at them. expediting whenever we're able to do it. >> you mentioned the office of

generic drug expedited 118 applications included 62 abbreviated new drug applications. in order to prevent or mitigate a shortage how many of those application. actually approved? >> i need get back with you about that information. obviously we're applying our usual standards but 118 applications speak to the level of effort we have undertook. >> on average how long did it take fda to approve the review status? >> it's a good question. ly get back with you. with that information. >> okay. i would like know more about expedited review means in this situation. referencing a product in shortage go to the top of the cue is there a special team within the office of generic drugs responsible for moving them through the review process faster? this will be a longer conversation as i'm sure you're

aware. we have number numerous forces under the act. as part of the resources we reorganized the office generic drugs. we are elevate it in term of the importance within the center for drugs. it's a part of that action we're looking to be as efficient as we possibly can. to an your question, i'm going need to get back and look at the kinds of changes that office has made without the review staff. did you have any discussions about what it mean farce shortage product to receive expedited review status within it? >> we did talk with fda about this. we are continuing or work where we plan on taking more in-depth review of the number of drug shortages expedited and how that relates to the number of applications that are sitting in the cue for drugs that are?

shortage. one issue, of course, is that even when you expedite app an application if it is approved that doesn't mean that the manufacturer is ready to begin production that day and there is some concern that approving one may displays another drug within that manufacturers' facility if you're trying to move very quickly to move something to the top of the line without the sort of normal planning time. so that is something we heard about. but we are looking further to try to get some statistics for you on how frequently fda is moving on the applications. and what proportion of the applications are getting moved on. >> yeah. and i would also be interested in how fda works with the manufacturer to address their targets to assess production capacity and output addressed the shortage. my time is expired. the chair recognizes the ranking

member for five minutes for question. >> thank you, mr. chairman. i want to start with the doctor doctor. i would like to know how helpful you're finding the drug shortage provision in it. i would like to hear more about the strategic plan for preventing and mitt gag drug shortages. i was pleased to see it released last october in one of the obligations. essentially three questions. when you update how it stand today with with regard to the drug shortages in the agency's plan to address them. and now the fda has some experience with it, are there parts of the law don't work as intended or, you know, as well as as they should? and third are there other areas we should be thinking about to help address the shortages? >> thank you. let me say the provision of it that expanded the information to

that manufacturers have been providing for us has been enormously helpful. it's hard for me to overstate that. we are learning about shortages earlier than we had previously. it is giving us the opportunity to talk with manufacturers in ways we hadn't had an opportunity to before. and we have been able to prevent short ables as a result. so unquestionably that aspect of it has been useful from the fda's perspective. we continue to make use of it. as you know, are continuing to write rule making and things related to it. but it is fundamentally a valuable aspect of the work we're doing that is useful. the other aspect i think have been useful for us as well. the requirement to produce an annual report i think is valuable because it does give us an opportunity on annual basis to look back and assess whether there are things we need to continue to work on where progress has been made. that's a piece we were able to provide to you recently for

three quarters of the year's data. we obviously need to update you with the full year data. we think that gives a fuller picture of the activities that the fda has conducted. and so fundamentally it has been valuable to us from a shortage prevention strategy. you asked whether addition signal things were identified in the strategic plan that needed to be done and the short answer is yes. there are many things we can do internally. there are things we need to do from a process sphoaft make sure that the fda continues to improve our responses to the drug shortages issue. those relate many of them to process. i share the task force that has been steering our response to drug shortages since the passage. that task force is made up of individuals from across the agency so not just simply my center but also the center for buy logics, the inspection

branch of the fda all of us are coming together to talk about the things we need to do. the things we need to communicate about better. to be able to basically do the job more feshtly and more appropriately. we also recognize we need to improve our communications to communications we place on the website are looked at hundred of thousand of times by individuals looking for information about shortages. we heard loud and clear when we talked to the stakeholders that needed to be improved so the information was easier to find so that topical information was easier to identify the normal shortage, for instance, was at the top of the cue. you opened up the web page you get the information quickly. we have heard the kinds of comment. we're doing what we can to improve the communications. separately; however, there are things that as doctor said outside of our scope and outside the thing the fda is able to undertake. there are things that the

manufacturers, we believe, have a role to explore. there are other thicks that other stakeholders could explore that have great potential, i believe, in addressing underlying causes of shortage i'm happy to talk with you about those if you're interested. >> let me get to one more question. one of the gao's investigation they conduct routine able sis to identify trends. that seems like a reasonable suggestion. request you tell us a little bit more what you shop the improvement will accomplish and fda believe that performing analysis such as gao recommendation help it come up with the recommendations for avoiding shortages. >> 15 seconds.

>> thank you, mr. chairman. and again, i thank each of you for being here with us. i want to -- i've got just a couple of questions. i know, that the fda report said, you know, the number of reporting shortages has declined in 2012. and for the first three quarters of 2013. but then gao says the total number of active shortages continues to be high. so do you each agree with that? dr. croses? >> yes, we agree.

the number of new shortage has decreesed. and we think that the early information to has been very help informal that regard. but a number of shortages have persisted across time -- okay. >> i think we present that information in your report. >> yes, you do. do you continue -- do you agree with that the shortages continue to be too high? >> absolutely. >> okay. just want to be sure. everybody is in complete agreement on that. because what i am hearing from the providers in tennessee they agree with the gao report. and they look at yours. it's kind of a head scratcher. because they're not seeing the amount of the improvement your report would lead people to believe is there. injectable drug. the i've fluid. the medications for anesthesia,

some of the cancer therapy. these are problems. you might be making some progress. it is not coming fast enough. let talk about fda implementing the system preventing getting to the point if they can prevent new shortages in decrease the bag lock of the current shortages. give me a couple of things we need to be holding them responsible for doing. i think we need to look a little more closely at the generic drug applications. the tex tend they have been able to expedite the applications,

which could be something that would help. >> okay. >> there are stale number. if i engage you. you said you expedited 118 this year. >> generic applications. >> okay. with a would be a better number? if you were setting a goal for him. how many should they be expedited this year? >> i don't know. i don't know. i think there is a concern if you expedite too many then you're creating a clog at the top. and -- even within the priority. and approved but then they can't put straight in to manufacturing. >> right. there needs to be conversations within the manufacturers about how quickly they come online. they need to be engaging them on the front end rather than the back end. at this point, approval. would predictability in the process with the review system.

as i talked to some that are working generic space biotherapyic space, the un pre predictn't seem to be a problem. it's not something they pointed to here because the unpredibilitiability when a shortage might occur. okay. i want to draw a distinction between the number of ongoing short acts that those that last extend period of time which are important. it's one group of shortages. i think we need know less about than we need to.

having said that; however. ic we have to acknowledge there has been work that has been important that has been able to prevent new shortages from adding on to that pile, if you were. we were able to prevent shortages that matter. our new important task. a task we need undertake is understand those longer. >> my time is expired. i thank you for that additional explanation. mr. chairman, as i yield back, i want to take a moment and wish happy birthday to congressman gut i. i yield back.

happy birthday. the chair recognizes the ranking member of the full committee. five minutes for questions. >> mr. chairman, i thank for your courtesy and holding this important hearing. properly address the business of the properly address the business of the entity. while we made some progress in this area the last time the committee held a hearing on drug

shortages the situation was dire. is it correct that the number of new drug shortages quadrupled from 2005 to 2011? yes or no? >> yes. >> yes. >> from, is it correct that fda successfully prevented 170 through shortages in 2013? >> working with manufacturers, yes. >> doctor, at that time used slightly different metric. did the agency also find a decrease in new drug shortages in 2012? >> yes. did the new authority provide to the agency in fda sia help fda

to reduce the number of drug shortages. yes or no? >> yes. >> would you submit to the record additional changes that need to be made to further reduce the delays and the shortages when they occur. >> yes. >> i also would like to know would piers them and more money assist fda in terms of addressing these questions? would you commit a monoimraf. do they need additional authorities to help combat both existing and future drug ages. yes or no? >> existing authority are providing important tools. would you please detail response to the record including the resources needed by the agency? >> yes.

>> doctor cross, gao's report on drug shortages face two rights to fda specifically you recommended the agency uses drug shortage data base in more proactive manner to identify friends and veterans to help prevent shortages before they occur. is that correct? >> yes. >> doctor, does fda agree with this recommendation? >> yes. >> would you please both submit a detailed response for the record regarding how fda could use this data base more proactively and whether you need more resources to implement the recommendations? >> yes. >> now i am pleased with the progress made. and preventing drug shortages since the passage of fire fda's sia. we need to take step back and look at the big picture.

drugs are in shortage because we simply aren't making enough of them. as you know, many current short js are generic sterile injectable drugs. does fda believe there is sufficient -- this market today? or more needed? important question i can't answer it without fuller discussion with more stake -- >> yes. >> now, i think it is time to start thinking outside the box about how question continue to make progress on preventing these drugs. and combating existing shortages. when you do a new innovative idea to help solve the problem as well as cooperation for all stakeholders. i look forward to working with my colleagues on the committee, the fda, and all stakeholders on

this critical issue of moving forward. mr. chairman, i thank you. i yield back the balance of my time. >> the chair thank the gentleman. yield five minutes to dr. burr guess for questions. >> thank you, mr. chairman. doctor, we have the executive order from october of 2011 and then food and drug reauthorization in july of 2012. but for the casual observer to this problem of drug shortages, can you kind of give us a thumbnail what is being done to deal with the existing drug shortages? >> we have a number of things. first off, existing drug shortages especially those that lasted for a prolonged period of time are hard to resolve.

>> hold on for a second. let me ask you the manufacturers have been responsive? >> they understand the issue. we have been in close discussion with many of the manufacturing organizations police department a and other groups. they identified this group. these groups of longer term shortages as things we need to continue to talk about absolutely. >> is dr. cross talked about enforcement discretion and you talk abouted exercise of regulatory flexibility propofol

is there anywhere where regulatory for examplability may help in the particular sort age? they were in limited ability because they are having a hard time producing enough sufficient materials. fda expedited any and every review. expedited all of our activities to make certain whatever the manufacturers was able to provide we were able to make certain available to serve the infant the newborn as quickly as possible. we had other camps where they

have been found. camps of drugs and shortage. articulates have on surface required sensation manufacturing. have it has been scoafm. we'll talk about propofol. i get a lot of questions. lack of anesthetic drug is a big deal. >> absolutely. and propofol is a slightly different situation because they're the issue is a large fraction of the prop follow comes from there are concerns

about importation because of use of propofol in unapproved uses. the fda's interest focus we've had is make it available for patients who are using it on label. as indicated. as you said in outspaisht settings for an though -- an though is a. received when it was indicated for them. abbreviated to the other compound peevely available. absolutely we know in the past there was a propofol shortage move from propofol to other products they were less familiar with, you know, mistakes occurred. they were not as familiar with the dosage and how to monitor

patients and things like that. making certain the product is available is important for the u.s. >> just very briefly. and the cost for tam flu expore initially increased. did you speak to that. >> i haven't heard that the cost of tam flu has spiked. there are other increases in pricing that we have been hearing about. it's not something that the fda normally has the statutory authority over. and while there were some spots shortages with tam flu we think we're able to produce the needed -- necessary amount of it necessary. >> thank you. i have some additional questions i'll submit in writing. i thank you for the courtesy. recognize the lady from virgin islands. >> thank you, mr. chairman i want to thank you and the ranking member for the hearing

today. while i'm happy to hear that the drug shortages are reducing as everyone has said they remain too high. and we know that rural areas communities of color, territories like my district will be some of those where we will feel it. the most where there is a drug shortage. i will -- a i have a question that digs a little deeper in to my colleague from tennessee. the vice chair's question. they were forcing manufacturers to come up with a state-of-the-art manufacturing practices even though the old tried and true were completely adequate to ensure safety and effectiveness. the argument is meet the new

status some companies had to shut down. the facilities resulting in shortages. and eventually those warnings unfortunately came through. can you comment on these two different perspectives? you mentioned in your testimony that fda is trying to encourage industry to duck new technology for at the same time that fda is not raising the bar. not raising the bar in standards for existing appropriate technologies. it seems very nuanced point. can you e lash rate for me? >> absolutely. there are a set of standards that are in place right for manufacturing for certain quality manufacturing that we would expect the firm making propofol, the firm making a tablet form whatever. the set of standards they have in place that would guide, you

know, the manufacturer of product so the sufficiently safe and 66 indication and quality manufacturing. those things are working. and we're not changing those standards to help guide drug manufacturing. and then make recommendations in the form of guidance and ways that manufacturers can look at to do better than the current. we're not looking to change the current assessable processes. we're looking to increant vise a move toward a more efficient and continuous kinds of manufacturing we think offers a lot of potential for preventing shortages by improving the

overall quality of manufacturing. >> thank you. dr. doctor would you like to add anything it. >> well, too, heard from industry. the same concern and fda. the same response. fda has moved increasingly and now under it explicitly is moving to a risk-based nmtion decision making process about which manufacturers they should be inspecting which frequency. the drugs that are in shortage of the sterile injectables are inherently risky in the manufacturer. and so you would expect there to be a higher level of inspection of those facilities. just because of the risk of the product. we -- as part of the ongoing work i mentioned before. we are looking at the pattern of inspections that have fda has had across number of of years of the facilities to see if we're seeing any change because it was

a concern raised to us by manufacturers. it doesn't focus on shortages of millionly important jokes. can you tell us how trends provided in the report are likely to track with the millionly important drugs. is that something you can focus on in the future? >> they've had a data base for longer. we were able to look at trends across time. fda didn't develop it until 2011. we wanted data going back to 2007. the majority of the data that

utah millionly necessary drug. there's a close alikement. there's a difference in the way fda and utah count the drugs. so the numbers may look different even though you are talking about the same drug shortage. this really important for me to always remember the whole project pie.

the military and the like. in the budget debate as people say we hear the discretionary part of the budget, we are illed a violated not to always talk about the problems of mandatory spending. i would say fda is one of the few agencies that got a few through the budgetary fights than a lot of other agencies. which iman in prior years. now i guess the first question i have is on --

so in the 2000 you have 40. that's true. not cumulative of all. some are resolved and so they drop out. we have some extended for five years. a small number. most are resolved within one year or two years. but there are a few small number

of shortages that have continued across multiple years. thank you. the lighter plu portion is success has been made in the new shortages. what most people talked about. i guess a couple of years ago when we've been having this debate, i always wondered why the market itself doesn't

respond to alleviate the shortages based upon a price. dr. burgess mentioned mentioned which you may have dismissed there was a tam flu signal sent. i don't know that you said you didn't know that. why -- i have a minute left. is there something structurally about how we either the government in its coding or its spend through medicare and medicaid or the assurance applications of purchasing drugs. is there something that distorts the market signals for shortages ? >> i'm not sure, you know, we didn't really look at that. >> maybe that's something mr. chairman followup with. on another question in the future.

what do you think. i think others commented economics have to be playing a role in the decisions that the manufacturers are making here. i think we know less about that speaking for myself. those are important. a lot of these shortages are low margin generic drugs too. if they're low margin they make penny on whatever the application is. others remember better. someone said the profit on a dose in the tens of cents. >> great. excellent. thank you very much, mr. chairman i yield back. >> gent nice the gentleman from kentucky. >> i appreciate what the gentleman from jill is asking. i had a high school reunion with friends. a friend of mine is an

physician. he was telling me about the shortage of drugs. it wasn't the expensive stuff. he couldn't do the service. there are price control but not ability to move the price for some reason. to investigate then you would say it is going to be shortage in quality. it's two things you mentioned shortage of the ability and quality and seems there's not a price signal that gentleman from illinois allow other people to enter. we're not talking about hundreds of dollars or thousand of dollars. we're talking about cents and dollars. and people are getting over that. in the -- you moment noted the requirement they november the fda in advance help the situation they are able to take from steps. while fda is planning to establish a new information system to track data there are significant concerns specifically conducting routine

analysis of existing data drug shortage in the data base to respond practically. can you elaborate on it? >> yes. we had concerns about we call internal control. they ensure the accurate sei in data base. and extend to which they are doing broader able cease to look at things like the ongoing shortages as opposed to use it as a tool it help them track the status of an individual shortage. what we're not seeing is the kinds of larger able cease looking at trends and as time goes on. they have more fully developed data. we believe it is important to engage. they agreed with us it is something they plan to start doing now they have a little bit more data for a little longer period of time. that is something they can do. we talk about your earlier point the economic that is part what

we're trying to continue to look at. there have been issues raised to us but no agreement on whether or not there's any one source of what holding down the prices. .. ..

i don't know if i came in speak if it is consistent i can give details on what actions they take. >> i yield back. >> i now recognize the gentleman from virginia. >> i appreciate that. think. . . be here today. i employed the rebus to know the drug shortages of sterile ejecta wills our leave the health care providers feeling dependent on the compound to drugs that led to the phone goldman died this outbreak in 2012 that killed 64 americans including two in my area. because they were difficult to obtain illegal manufacturers that called themselves compound in pharmacies enter the market

to fill the be but thankfully conagra's put fta on notice to deal with the drug shortage quite congress did with large-scale, got bigger and illegal manufacturing. fda officials have signaled they can better predict quality issues that the factory facilities. can you comment on these improvements? >> mostly to say the importance to get that right. with what those metrics are a and then having a discussion how those would be used is very important so with our efforts to speak with manufacturing experts of what a plant uses to follow their own quality and

how a purchaser could recuse with that information. >> i appreciate that. one of my concerns was with that meningitis outbreak of lawyers were not using all the powers available to oversee and while we don't want to much oversight for those to do the right things , i am hopeful they are more aggressive if it is out of line 31 to a good supply and also a safe supply. are lawyers being a little more aggressive post the problem? >> absolutely we need to do whatever we can do to ensure a safe supply. >> gao recommended improves its database for a more predictive analysis. how did the agency respond and how far off are they putting into practice? >> they agree and they are

doing it immediately. >> the gao says it lacks the procedures and policies related to british renewed use of the drug shortage database. what does this have of the agency to prevent or mitigate shortages? >> they do need these kinds of standard procedures in place to insure the accuracy and the understanding of how data should be entered a and to analyze. the also agreed they would move forward with those tax. >> do think that could play a teacher with drug shortages? >> they need to have good information because they need to look at this more broadly, with an class's and time to measure whether or not they put the right steps in place to have the impact to improve the situation rather than treating each

individual situations that have to uniquely be solved through mecca yield back. >> the gentlelady from north carolina. >> thank you. thank you to the panel. this is a very specific situation then i hear from all the hospitals in particular the 870 bad health care system with multiple facilities around rob the north carolina. they basically do with the three primary vendors in all three have experienced quality issues as well as holiday production shutdowns the contribute to the shortage is spent an additional $80,000 in january to stock up of the drug in anticipation.

i appreciate the efforts of the fda to address the shortage but they only address the symptoms. i am also concerned about medicare reimbursement especially the explosion of the discounts reducing margins for generic manufacturers pushing them to stop producing low-cost generic injectable spa just like those community cancer clinics and it appears the manufacturers simply don't have the margins to invest in the manufacturing plants which is why we see many quality problems. but how are we addressing these issues right now? i want to focus my question on the fda work to make sure everyone works together to find a solution. dr. throckmorton, there remains virtually no transparency in the process

for the drugs to make it onto the shortage list ultimately get off. how does the agency decide it is no longer in shortages and is there a consistent and standardized formula forum a shortage list? >> the short answer is yes we do have a consistent process to decide when the drugs come on and when the shortage is no longer existing and they can come off. our focus is to determine whether or not patients in the u.s. can get the treatments they need. not product by product shortage, there may be a shortage were one manufacturer may no longer be manufacturing but maybe for other kinds that are available. from our perspective because the other products will bring about. to talk with those other

review factures we can assess using prescription and other data we can determine whether those other review factures can fill in for that many facture who made a decision to not be a fracture or needed to stop to improve a product line. that is slightly different than the kinds of data university of utah accounts the data that is referred to. we look at the totality and the availability of a gifted if there be not in individual product. our numbers are slightly different that university of utah house. hours reflect the availability before the product but we have a process in place to determine and then to work with manufacturers and can

meet demand to come off the shortage list. >> very specifically dr. throckmorton the fda inspection of api candy a barrier how has the agency tried to improve the record of this issue to ensure that the anda can market the drug and address the shortage? >> the first part is the expedited reduced the fda can do but there is a second longer term with the generic drug user free act provides additional opportunities did resources to balance the

playing field so we can devote their resources to the generics market which 85 percent of the drug market is you generics. and how to make certain with the compliance history in the review that they need is the important admission. >> my time is expired. >> that concludes the questions we have additional ones we will send in writing if you will respond promptly remind members they have 10 business days to submit for the record and members should submit by close of business tuesday, a february 25. thank you very much. the testimony we look forward to continue to work with you. without objection we are

adjourned. [inaudible

>> we do expect to have a series of votes later this morning so we want to make sure we have ample time to hear the testimony from our panel of witnesses. i am very pleased the chairman has been able to

put together this joint hearing with the senate small business committee and we have just been joined of the chairman of that committee who is chairman for a few more hours before she changes committees in senator cantwell becomes the chairman of the small business and are cheaper viewership committee. i've also very pleased to welcome my colleague from south carolina who has been a terrific member of the senate special committee on aging. thank you for being here with us today. been that senator nelson will be joining us shortly. with the land of opportunity owes much to the hard work energy and optimism to take

the risk to start up businesses of their own. through their success they helped to create a better life for themselves and to create jobs for others. the role played by american small business to create jobs to opportunity is well known but the role played by america's seniors may come in between the ages of 55 in 64 will do business odors even at the height of the dot com boom. by those over age 50 and under 25.

most seniors don't want to spend retirement on leisure and many simply need to earn extra money to help make ends meet. seniors often haven't vintages that make them excellent to watch prisoners such as life experience in real world education and the networks to maintain throughout their careers. looking at my home state of made to illustrate. bruce spread -- spent his career in the catalog business been advertising richer for the of bank. as a hobby he also created high quality custom-made knives after he retired with the help of score a terrific

program run by the sba that taps into the skills of retired business odors he could turn his hobby into a full-time job now sells his knives to customers around the world. david thomas spent 28 years and international paper when he retired him and three colleagues started a small consulting firm to help other large producers get their businesses off the ground. he said the great thing about writing your own business and retirement you can work as mature as little as you want and still make a difference in the world propelled by a choice it is now a pro bono. and when he was 64 years old he picked -- she picked

yourself back up by starting her own public-relations business using an earlier in the career now she works out of her own home on her own schedule marketing for copied do is the world's largest weekly restaurant publication of. to become less successful block larger print your spottily through their hard work but the assistance of experts that score with programs run through the sba i was telling the representatives today being a united states senator my favorite job was when i was sick administrator of the sba and did -- in due reid went on dash new england so i am particularly pleased they are represented here today.

i am absolutely delighted to see elizabeth at the witness table knowledgeable a and tireless advocate for senior on to print your shepard id hails from the great state of maine state you for calling this important hearing i appreciate the chairman's staff island for a to hearing from our witnesses on how sba and other programs can be better tailored to help seniors start up businesses to create good jobs for themselves and others. thank you, mr. chairman civic you may be surprised that senator collins did i

run this committee together. madam chairman congratulations on being madam chairman of the energy committee. >> as the ranking member said for the next few hours i still maintain a my gavel to get through this hearing and later this afternoon i will take the gavel of energy. that is how important this was to me and our team. thank you for being willing to join us in this effort. it is such a promising subject to be explored a and supportive. i love the term encore want to print your with older people in citizens

entrepreneur weiser, the colbert in their older years to fake in a dream and build great businesses. our country with our structure here in washington and local communities really be to recognize this welfare and treasurer to best help them. i will submit to my statement to the record i want to underscore what senator collins said. the foundation and that is a reliable source of could information about entrepreneurship not partisan says 2006 through 2010 and 26% of entrepreneur activity in this economy which is the backbone was reduced from ages 28 at age 34. that was expected to almost

40 percent were produced by people 55 through 64. this difference is expected to widen as more americans age a and we have to be better positioned here in washington in the state capitals to be good partners with these entrepreneur. louisiana has led her to 60,000 residents over the age of 55 ready to go. the sba just the sheer logic a strategic partnership with aarp to provide counseling a and training to entrepreneur who would want to start a business by 2013 the collaboration had met and exceeded the goals to reach 120,000 seniors and this is just the beginning.

through the court partnerships with saboorian to their here represented a series of other partnerships with the private sector this is so promising to not only provide an opportunity for seniors but to create a golf for themselves, their families, communities, the united states. i have to conduct another hearing i will submit the rest of my statement for the record but it is a privilege to work with you on this we have introduced a bill to empower the encore entrepreneurs fact perhaps the testaverde can enhance our efforts with that piece of legislation and we can enjoy together with a republican colleagues to do

something for bird in the near future. >> i will submit for the record a statement. first we will hear from ms. montgomery who serves as the associate administrator of the office of entrepreneurs development in the sba isn't from mr. yancey ceo of score. then the co miami senior living solutions. aid we are in a delighted to hear from the co-founder of the senior entrepreneurship aide works accompanied by dr. o'neill the director of

the national academy of beijing. -- a.g. in society. we will start with ms. mcgarry your written testaverde is uncertain as part of the record if you will share with us for five minutes we will go down the of wind and open for questions. >> chairman nelson ranking member and senator scott thank you for the opportunity to testify on the sba work to serve the encore entrepreneurs new and aspiring small-business owners of the age of 50 we commend you for highlighting this important topic and grateful for your ongoing leadership and support we know the facts small businesses employ half of the work force to create two out of three net private sector jobs. what people don't realize is

americans between the ages of 55 and 64 comprise the fastest growing group of entrepreneurs in the country. according to the kauffman foundation encore entrepreneurs start at a higher rate to it in the other age group. more over 7.for a billion -- 7.4 billion a self-employed. one out of four americans between 44 and 70 are interested to start a business or nonprofit. we're committed to ensure that encore entrepreneurs has the tools they need to turn great ideas into successful companies. through our 68 district offices which include 11,000 score mentors, 900 small business development centers in were the 100 women business centers we counsel

and a trade more than 1 billion current and aspiring entrepreneurs in italy. -- generally argue initiative enables us to more effectively target our services to encore entrepreneurs in 2012 as strategic alliance was formed to provide encore entrepreneurs with the two will send information they be to launch new companies the objective was threefold to increase our reach to the growing segment of prospective entrepreneurs. second to connect individuals with the programs in resource partners and certain present entrepreneurship as the next up for americans that allows them to translate their ideas and professional experience into a successful business ventures. between april 2012 and

may 2013 we had hauled hundreds of workshops to and mentoring sessions from writing a business plan, a franchise opportunities, accessing new markets, addressing the technology needs of encore entrepreneurs. also offering of resources such as what deniers -- webinars if david individual was ready. to connect more encore entrepreneurs with mentors sba and aarp establish the first national encore entrepreneurs mentor month. struck the month our partners teamed up with state aarp offices to host more than 100 events around the country. included speed mentoring to allow mentors to share

information with five minute sessions and lunches for entrepreneurs to learn best practices from established orders. as a result a a r.p. engaged almost 120,000 individuals. due to the initiatives and ongoing popularity we have seen a rise of the number of older americans taking advantage of the sba programs. reno these aspiring business owners are poised to join the ranks of other encore entrepreneurs folks like one of a beverage for 21 year career in banking in her husband's experiences in construction and to launch a business in reno nevada. securing government contracts calling the company revenue 3 million up

that $15 billion per year. together with resource partners wheel afford to continue this important segment of this population in helping more encore entrepreneurs grow and prosper. think you again for the opportunity to testify and happy to answer any questions you may have. >> mr. yancey. >> thank you. chairman nelson, senator collins, senator scott, dave is mr. yancey nine this kilo score thank you for the opportunity to offer testimony with the challenges of senior entrepreneurship and scores experience to serve this segment of the population probably to think senator lee untrue to sponsor in introduce said bill 2008 score for small business act of 2014 to strengthen the

resources by approving the program the additional funds provided by the bill will allow us to continue to improve the services by volunteers do deficiency a you don't reach a and the underserved communities to include encore entrepreneurs or resource partner to celebrate our 50th year aaron today score has over 320 chapters more than in volunteers and also seniors. they get back to their communities to have significant economic impact in fiscal year 2013 they assisting clients 38,600 new businesses were started 67,000 new jobs growing

revenues 40,000 enterprises gore is one of the most efficient and effective job creation in june's personally in the sba arsenal of resources. study sponsored by nightlife in many areas the results are consistent with the liberation we gather from. 25 million americans are interested to start a business venture in the next 10 years. slightly less than half interested to social to benefit the community in addition to making a living. these aspiring entrepreneurs have a significant network to bring to the table an average of 31 years of work experience. many have managed experiencing and most of perry realistic expectations for their own small business

experience. this is consistent for what we gathered. fiscal year 201330 percent of our clients were between the ages of 44 and 55. an additional 31% or 55 randall burt. of these roughly 29 percent were considering starting a business, 30 percent were in the process, 29 percent excuse me 33 percent were already in business. that is a lot of numbers but our senior clients often have the tools needed to start but may not have the ability to apply the resources in a small business setting in do not have complex capital requirements in most don't aspire to a business size that require it ye shall venture or private equity financing. many plan to sell fund with

personal savings with only a small amount of outside capital less than 50,000 committee have vendor relationships and other personal relationships to aid in the startup and management process. while a senior entrepreneurs we have decades of experience often it is not a direct translation into the role the small business. score mentoring, coaching and assistance provided support to use appropriate their existing knowledge to resources. also helps to focus on tasks temporary use in the tools to be a successful small business owner. we appreciate the support of the two committees here today of the issues around senior entrepreneurship in score. we believe encore entrepreneurs will continue to be an important segment

in the small business marketplace. these individuals have significant knowledge and experience and resources to use with their own business initiatives. the benefit from education and mentoring to start and run a small business. score clients over 55 make up the largest client demographic. you recognize what an important contributor they are to the economy if you will help us to continue to meet the growing need. i'll be pleased to answer any questions to provide documentation. think you for the opportunity to testify. >> i am so happy to be here. into the members of this committee i am delighted to share my thoughts on what it takes to be a l