chair of the caucus, the former house democratic in the majority, an assistant leader. >> thank you very much. let me offer my thanks and congratulations to the chair. thank you all so much. yesterday as i listen to the vice president and witness, as we all did, the reaction of our colleague i looked over and i mouth something to the leader and she can hear me. i was thinking, mime mom and father both were cancer victims.

my my mother was 54. i thought about my last conversation with her. when she implored that she spent all of her savings if she had no chance to live. of course she had no chance to live where told that she would not live beyond eight months. and we spend all of her savings. they thought about what that does to families. the question is why? most of us come to congress bring with us our experiences we try to answer through service that question why.

every session i sat through there's a common theme of unity of really open up opportunities to all and i think it was embodied that chance between art colleague in the last president. as i go away from this conference a much better person than i was when i came. i hope that as we democrats back to the hill on monday that we will really stay united creating opportunities for all and going to the american people in this election year. to presenting a united front

dedicated for opportunities for all. >> thank you jim. first i want to thank all of the leadership for a wonderful conference. i would like to thank the chair. even my colleagues asked me what role does the vice chairman play is a democratic -- i tell them i carry the chairman spake. literally i carry his bags, that's what he makes me do. but it's a pleasure to do that. things i have this weekend, you don't want to know. i think one of the roles of the vice chair is a sounding board. i can tell you my colleagues expressed a tremendous gratitude for this particular conference.

the issues we discussed and what appears today as well are second to no other conference we had before. so congratulations on the successful retreat. i also was going to talk about, what a great name -- he did make the points about why we are here. i think we democrats understand why we are here and we are united on my car colleagues and the other party we see that on display right now in terms of the presidential primaries. we know where we want to go in how we get there. i think that's important to help create a safer america and a safer world as well. so we'll be hearing from tom

today about the challenges but is not just a challenge for the united states before our world. we have to be the leaders in terms of environmental reform in this country. the president and we will hear from the vice president as he said so many wonderful speakers, to hear the president speak last night and will be his last visit to us as president. he said, we have to look back on what we have accomplished and appreciate what we have done. to have the strength and to help build the strength to meet the challenges before us. i strongly believe that challenge creates opportunity. we know why were here, we know where we want to go, and we know how we need to get there. this caucus stands ready to do that. this retreat has helped to unite us even more so than what we

were a few days ago. with that i asked my good friend the chair of the -- to take the podium. >> first off the morning. thank you for making it appear for the weekend and getting the chance to chat with all of you. congratulations on what has been a strong few days are ready with an amazing afternoon still to come. work talk about ideas and how to work together. look, i thought we were pretty strong and united coming into the retreat. the leader has been doing an amazing job in making sure we continue to work together. we are leaving this weekend stronger and more united than we were coming inches the exchange exchange of ideas, optimism, the speakers that presented to us were extraordinary. you are in the room with the president vice

president spoke. you. you could feel that energy, the enthusiasm. people talking to you visiting with you as well. everyone spoke about the why. there's a reason for that. when vice president biden was introduced, i think you also saw that humility when he was being introduced. the bow of the head, the emotion that feels us when we remember those that we lost. vice president biden is committing himself so that no other family has to go through what he and his wife had to. if all of us can do something to make lives a little bit better for whoever it may be out there, stranger or friend, it is worth it. that is the why. there's a lot of people out there that need our help. i can tell you what, i am am happier that unemployment is done five thing closer to ten. i'm happy that there's been

consecutive months of job creation and we have a foundation to build from. i will close with this, i am excited. i'm looking for to the next ten months and there's a lot of enthusiasm coming our way. with a 55 districts that have candidates in it more to calm, stay close and help us make sure we tell the stories of people across the country. >> welcome home. on the presidential race, i talked to supporters and senator sanders on the republican side, mr. trump. all of them say they're supporting the candidate they chose is the establishment isn't

meeting their needs. it is not addressing their concerns. first what you say to that? and secondly, does your caucus, does the republican caucus share the blame for creating that attitude? >> thank you for your welcome back to baltimore. isn't it a great city? do you feel very comfortable here. i think it was wonderful choice i cannot wait to spend a little more time outside the hotel in baltimore. the fact is that there is a disillusionment with government in general. as i have said to some yesterday since 2000, we have had 911 and the reaction to it is to go to afghanistan and then to iraq. all of the serious mistake that was for our country to do that. we had katrina, we are in the campaign where there is , and

comes katrina what their roommate is the head of fema fema who has no confidence to do their job. then we had a natural disaster and that a man-made disaster after that. among other things we had the meltdown of the financial services industry. that was because of the policy of the bush administration. will bring in free markets, we don't believe in no supervision, no regulation, no self policing in the industry. that left a very severe scar and the mentality of the american people. for many people they want their homes, their job, their their living off their savings and pensions are at risk. can they they send their children to school.

what do we do? we had to to correct the situation with the and the vision that they have is that we bailed out the banks. but the fact is we did bail out our entire economy. they they see all of this and what good is happening for me? if i think we had a shortcoming in all of this it is that we did not message correctly. we are not -- we do not have a national trait to out there and say you should see how really bad it is. and that they are up to doing this again. i think it's really important in this campaign that the public understand that republicans are very much on the course of reversing dodd frank, of wanting more tax cuts of special interests and will take us to a place where our economy would be weekend. having said the, the leadership

of barack obama and the measurements we took, practically every time with no republican vote, we had with mrt have the deficit, 70 deficit, 70% reduced 1,400,000,000,000 to 500 some billion. we still want to go lower. but we went drastically in the right direction. an auto industry that was on its heels and now it is was on its heels and now it is leading the world were hoping to have double-digit sales of autos in 2009 and 2010, we now have 17 million cars this year, record-breaking. the list goes on and on. it's a very long one. i will just allude to those points. we are are the strongest economy in the world. those countries that exercise austerity are not coming back the way we came back from oh

eight. >> .. >> >> i think the press has

made this equivalent they had a decision to have day trickle-down rather than middle-class. this is essential to use the success of the economy unless it has purchasing power or consumer confidence or is willing and confident to consume 70 percent consumer economy we will not turn around. and not to point more clearly what they were about to inspire fear and instill confidence but if they want

to take it there. because nothing less is at stake of the community is america is this bottom-line capitalism where decisions are made for those shareholders and ceo but the employees in the community at large. >> we have to break quickly select their reminding me had a cup of coffee this morning. [laughter] >> one of the important parts is how we come back to

our responsibilities. then it is the oath of office. with the remarks of our members to participate which was such a success if we did not come early we may not be able to get in on it. >> you perceived a potential softness with birdies on -- sanders is the nominee? is because there is some of in line with bernie sanders. >> elections are about contrast as well. if the premise is he will be the nominee who is he running against?

that is the concern as well but in the end how they can bring together the electorate around the democratic nominee -- republican nominee. we have the debates about an exchange of ideas and i had to watch two different television sets to get the full debate last night. that is a sideshow and it is evident. >> we are so proud of the demeanor and the focus on issues and values of secretary clinton and senator sanders a governor o'malley i am pleased out bernie sanders has expanded the universe of young people interested in the political process. i also think his suggestions

are excellent but let's point out reducing the role of money in politics. whether our economy or fairness or opportunity to save the planet the list goes on and on and are affected by big dark money in politics. , and we are gathered here as well for his leadership role to take on the big money issue. to amend the constitution to overturn citizens united, and to empower to stop block people at the vote. we want to rock the boat

they want to block the vote. tsa i think it is important if we diminished participation. of governments of the many. but that is one of the draws to his campaign. >> senator clinton is already recognized to energize people and they think at the end i don't believe so but that isn't to

people of new hampshire to make that determination. >> the candidacy had a wholesome effect on our political process and we're proud of that. [inaudible conversations]

it is much more efficient and effective. >> like 3d printing? >> we approved a 3d printed product, the first one this year. that is one of the aspects that enabled doing things like that,

yes. that is an aspect we really should explore to provide agility into the system. >> thank you. i apologize. >> no, thank you and thank you dr. woodcock for that. senator collins and senator mack asko have done a lot of work on this subject. you don't have legislative authority so we welcome the work product from your committee as we work on our legislation. senator casey, senator franken. >> thank you. i appreciate the questions, part of your answer seems to suggest the data that you have on the market is not totally complete.

>> that is correct. >> is there anything you can do, is it an aspiration of yours to make the data more complete? >> it is very difficult to figure these things out because -- >> who would do that do you think? >> senator collins's hearing talked about the contracts and rebates and all the different things in the u.s. distribution chain that nobody knows the answer to. insurers would really like to know how these drugs are moving and what is being paid for them at different steps that they don't know. that is what i took from the testimony and we confined out why looking at what has been dispensed at the end of the day and putting the picture together but it is difficult to say.

>> trying to figure that out would inform what you are approving, what you are taking up to approval because you want to make the market more efficient. i want to ask you about an article in the wall street journal this week. i am sure even worth it. it was bought as a ceo of the drug company and suggested that basically he pointed to a drug that his company did and we took up compounding in this committee and a number of us including the chairman and senator roberts but he was basically saying, he did successfully compound a drug that had been one of these drugs

they exploded the price son and he got the market by compounding this. we saw the risks associated with compounding but also gave the fda authority to regulate compounding. you read this piece, these things there are risks to this? is the upside -- what is the upside and was a risk? >> i believe there are great risks. congress established outsourcing facilities as part of the reestablishment several years ago but those are for sterile injectables. the tablets would be compounded by any compounding facility

under what was being proposed and the in the last two months we have dealt with two outbreaks, one was vitamins with a compound did did it vitamins, putting too a tablet, people were hospitalized with kidney failure. the second one. >> those are vitamins considered supplements? >> we regulated those plans we intervened, able to track people down. the second one was a hormone, it was 1,000 times more potent than it was supposed to be, people ended up in the hospital very sick. these were small outbreaks so the pharmacy and us together were able to track these people down, people who were still not in hospital, make sure the drug was recalled but mass production

of drugs such as to substitute for generic or an innovator drugs that is out there under don control conditions, everyone talks about regulatory burden. what we ask and to do is do the right thing each time and this is what happened. they put in too much, they used the wrong source, use the concentrated source and put people in the hospital and if they make thousands of these tablets, they put thousands of people in the hospital. that is what we face. if alternative sources that don't have good manufacturing practices going to mass production. >> i am out of time. i am out of time. >> that is that very helpful question about two important pieces of legislation before this committee, very interesting

discussion. senator cassidy. >> i echoed dr. collins's compliments of your work and appreciate your straightforwardness. a couple things. someone asked regarding backlog applications, 85% of those who were freed this legislation had some action. that means 15% do not. if you are one of the 15% you are like oh my gosh! secondly 85% of the action might have been to take them back. any comments on why did 15% is purgatory and 85 presented cetera? >> when we negotiated this agreement with industry they were realistic that we could not reduce thousand applications in three years and higher at thousand people and rebuild our drug system and reorganize, all of which we have done so the goal was to clear out 90% of the

bat on applications by the end the program, five years. that was the agreed upon bowl with industry. with no other intermediate goals. what we have done, we have already gone back to them or worked on 82% of them. >> don't let me interrupt. i have so many questions. i am told by industry, have them saying what i am told, not what i know. when you complete low-quality applications they are low-quality because in the interval between they are submitted and reviewed standards have changed so it is low-quality not because it was low quality in terms of mission but of review. are those applicants notified when standards change and the implications of the change is on the quality of the initial application? >> absolutely we try to do that.

we're issuing more guidance, often product specific guidance, like a couple or recipe. >> follow-up question, they tell me is not the case that has been made public, the guidance of what is a good quality application. >> we try. we have gotten applications where they cut and paste portions from another application, totally the wrong application but it is hard to think of every single thing that isn't right but we try to give policy offices, we aspire to putting more guidance on what in training is acceptable. i have a slide. >> i will accept your application. following up on what senator collins said, and the energy and

commerce committee, one of the reasons for drug shortages is concentration of drug manufacturers. the problem with one concentrated facility and it rippled through. what i am told is there was a facility, and if you have one facility, and the contract manufacturing division, somehow you lower the facility's, and a concentration of manufacturing units the is that a fair assessment. >> don't know if that has driven concentration or not but there are many factors that could have been one. we are certainly considering that in discussions for the next program. >> we should consider that because it requires substitution of a product fee as opposed to a facility fee. >> there are many ways that make

the structure as fair as possible. the burden is shared appropriately among people who benefit from the program. >> do you have a list for how many manufacturing units were active before, and the manufacturers and facilities that you are supposed to do? >> one of the innovations was self identification and we have one in 2012, they peter hanson we are making a generic drug or an active ingredient. we have it for three years but not before. >> how many -- do you have that number? >> i don't have that. >> could you require drug manufacturers to publish or could you up choir, we are making these drugs and we are contract in now for this.

we are concentrating manufacturers, you told us that is a major cause of drug shortages and some imac at actors. a lot of problems are not. if it were made public we would know how many they were a gift they are good or bad actors. is it possible to make that public or available to us? >> if we gave you all for all numbers we could try that making the actual people public would require regulation machines or something. there is registration and lifting that is done now but we have different problems we can get back to. >> thank you, senator capacity. senator warren. >> everyone is looking to bring down the cost of drugs, brand name engineering drugs, but

can't do that if we don't correctly identify why the prices are so high. some people want to blame the fda saying if the agency would approve generic drugs faster then drug pricing problem would go away. i want to dig into that claims. let's begin with generics competing with a brand name drugs. according to an analysis it takes an average of 12.5 years for brand-name drug to face competition by generics. no doubt if those brand name drugs compete with generic drugs they would be cheaper but the law is clear the fda can't bring a generic drug to market while the brand-name drug is still protected by exclusivity. so than franken generic there be allowed on market.

how long does it take the fda to approve a new application for a generic drug. >> that is in flux. but this year it will take us 15 months on average to get back to the firm if they send in a complete application. that is where new applications. >> the ones that are submitted this year. >> what commitment i you looking at going forward in september, october of this year, submitted inert drug application you can expect to get an answer back in ten months going from 15 months to ten months. >> you feel like you are on target. >> i want to measure that against the claim of the average time for fda approval has increased. we talk about the backlog and

the difficulty dealing -- the average time, is it going up or going down. >> new applications, the time to get approved, they came in that year and it was a 15 month year. and we approve a number of them that was shorter than the goal. >> committing to a shorter time period. >> we are committed to meeting goals for each cohort. let me ask one other question. when a company suddenly raises the price of a generic drug, obviously approval of a competing generic drug bring the price back down. does the fda expedite applications in situations like that? >> no. we don't really know.

we have to be fair, and generic drugs and so forth. and it costs $0.30. or it costs $875. and we don't have the expertise to determine, we are not economists or financed people. and leaders and scientists. >> and care that you did not do that. and expedite on that particular drug. >> there may be ambiguity, it would prioritize. and answer that specifically, and if there was a bulletproof

-- >> there has to the way to look at. and proposals on the table today. and the fda has the funding and personnel in need. and the generic drug approval process is the new user fee program is fully implemented. there are limited situations, they might expedite review of generic drugs. and and that should help. and the market for prescription drugs that little transparency, broken elasticity that has long legal monopolies, and small changes, approved generics but real change will require us to face the fact that the market for prescription drugs is not

working and rethink the overall structure of drug pricing. >> thank you, senator warren. senator roberts, senator casey, senator bird and senator murphy. >> senator robert. >> thank you. thanks to the ranking member for holding this hearing. everyone knows about the cost of prescription drugs making headlines and i truly appreciate dr. woodcock, you are an excellent witness and thank you for your clarity and your comments. in addition to new user fees in 2012, the fda has proposed

regulation in 2013, regarding a generic labeling but according to one estimate could increase spending and generic drugs by billions of dollars. in 2015 a proposed metrics program to draft guidance, at draft guidance that would require manufacturers to collect new information and collect and report information from c m os, the generics drug manufacturers have raised significant concerns to everybody regarding reporting complexity, confidentiality of data, increased information technology that would increase the burdens on manufacturers and require significant efforts to resolve and it is necessary to ensure high-quality drugs, generic drugs should this be done to rulemaking?

this is the first time in my house or senate career i have proposed a ruling but rulemaking rather than guidance to look at the impact of small business and those who were involved can't respond to comments which to me seems very important. >> the regulation you mention first that the draft guidance we issued some time ago for quality metrics, request for comments, draft guidance is not actionable request for comments, we received a great deal of comments on these but this is the time of digesting these comments and we will take appropriate steps after we got feedback, we got a great deal of feedback on quality metrics draft proposal. those from the innovator

industry and it is one of the few times they appear to be united in their opinions. we will certainly take that into consideration in what we do next. >> i appreciate that. most of the questions i have here asked by members, the definition question that was raised by senator mary -- murray, in your testimony you highlight the ongoing challenge of submission quality. the question is that he made public guidance for good quality submissions. when was that released or windy we release that? >> different guidances for example. we issue products, specific guidance that tells you if you

copy this innovator product, you do your bio equivalence. we have ramped up the issuance of those because they are helpful to industry. >> how many folks you have doing this? >> guidance the vellum and? >> we are talking about -- interested in 2015 and everybody left behind and those in the future. how many people, 1,000 people doing this? >> may be a thousand people in the office of generic drugs, 900 people working on this and our inspectors, we added 17 new inspectors to do these foreign inspections and stuff so the program is perhaps 3,000 people over all. >> i have 30 seconds left.

i will yield to senator franken who needed more time. >> it will take me 25 seconds. i yield my time. >> thank you for this bipartisanship. >> thank you very much. thank you for your testimony, your service. i want to focus on an area i know you spoke to but i am not sure the specific question was asked. we have to be careful. the risk evaluation, and the other acronym, elements to ensure safe use and the basic question i had was when you

testified about some of the challenges you have implementing shared risk evaluation system can you outline for as the challenges you face if any, and i am assuming there are, what you propose as solutions? >> when congress put in place the written, when they had to contemplate the days a risk evaluation mitigation system that is supposed to be risky drugs to mitigate some of the risk and we approve drugs if they are particularly risky. when they go generic, the generics also need to have this respect system around them and congress to decrease the burden on health care if at all possible, they have single ones against the innovator and

competitorss. this is proven to get competitors to work together to get market share from that innovator has proven challenging for the fda to get that done and that is access. in addition the program may restrict who gets the drug and that has used as an excuse to not give the drug to generics the they can compare it to their drug. all of these have cause barriers and delays in getting generics on the market. more broadly the company's on their own behalf have restricted program the we don't understand, but they are not related. we have over 100 inquiries from generic companies to can't get a hold innovator drugs to compare their drug to. we have done everything we can. we have written a letter saying it does not require this.

you can given out for this purpose and we also refer these to ftc, we still continue to get complaints from generic companies that they can't get a hold of the drugs to get a comparison they need to do. >> i want to make sure i understand the problem. why has it not -- >> the innovator companies feel is their duty to their stockholders to delay competition as long as possible. the citizen petitions we get an all sorts of things it can to delay generic competition and this is another opportunity. >> what would you hope we would do if anything? >> the part of a provision that requires a single shared system is a practical matter, we have to try and try and finally we

declare defeat and let the generics have their own system that is separate but equal. if that provision were removed from statute then potentially we could just go to that and they would not have that delay involved but that won't fix the instance where the innovator company is not providing outside of it, they just have a way of not providing the drug to the generic company and that would require discussion. >> thanks very much. >> orrin hatch this next that nobody will mind me saying it is not often alienated state senator has a chance to introduce a significant piece of legislation in 30 years later see it be successful. taking the number of generic drugs prescribed from zero to 80% of prescription drugs though welcome to hearing on your bill.

>> thank you, mr. chairman. that need to do that. there was a real battle in my office between the generic industry and pharmaceutical industry. the pharma companies, at one point they both jumped up all three of them. and they got stuck in the door. they started to laugh and they came back but at one point, i said i will kill both of you. para three they two were particularly bad and really irritated, i have a bad tooth at the time and aggravated as well. to make a long story short we are very pleased with the efficacy, deserve a lot of credit at that time for cooperating on this. in the inception of the generic

program in october of 2012 there were approximately 2800 generic applications and the average approval time for application if i got it right was 30 months. going into its fourth year, 1 play $2 billion later, the backlog increased to 4,000 plus applications and the average approval time for an application risen from 30 months in fiscal year 2011 to 43 months in fiscal year 2014 to 48 months in fiscal year 2015. this is eight times longer than the statutory six month review time, one of the bills i feel pleased about. further, since 2013 the number of approvals showed declining trend in overall approvals that are tentative and final. fda approves 619 generics in

2012, 535 in 2013, 500 in 2014, 346 in 2015. the critical subset of approvals are first generics which offers the first opportunity for consumers to benefit from savings provided by generic drugs over brand drugs but only if they are approved on a first earliest day. i understand it is staggering to think of savings that were lost in the u.s. health care system in 2015 alone due to first generic approval delays so having said all that i want to personally thank you for the workload you do. you do a terrific job and recognize it. would you agree this backlog keeps low-cost generic drugs off the market and reduces competition? just yes or no. >> yes. >> i thought you would.

let me go a little farther. will the backlog be eliminated before they start? >> absolutely. we have already acted on 82 percentage, communicated with 82% of those. >> how many applications of generic product as the agency received? >> that i don't know. >> would you provide that to us? >> we can get back to you. it is 15% of the workload and we expedite all those. >> appreciate it brad lidge how many first generic applications on the earliest possible date at if you have that knowledge? >> i have to get back to you on that. it is the small number. >> submit for the record type action dates for the first generics pending before the agency without naming the applicant and the associated

reference products. >> we can do that. >> how does fda track prioritization of generic applications like those associated with public health needs, drug shortages, what is that average approval time for these critical applications? >> we track them through the new high tea system and have project management over all these applications so we have a project manager aware of each one of them making sure it moves properly through the system and we can get you the numbers. >> my time is up. may i make a statement at the end? >> yes. >> the reason it was so essentials is only 16% to 18% of the generics on the marketplace back when we did that. today it is approaching 90%, today it is a very good thing

but some people play the market and distorted it with regard to generics, we want to get to the bottom of this and i thank the chairman and ranking member of the committee for getting into this and i intend to hold from every step of the way and one of the first people at fda, it is a hard job. you get all kinds of pressure, all kinds of the irritation and comments, and we don't give you enough health to do it now. we also -- the fda getting a future facility, 30 plus offices allover this. all i can say is generics bar

absolutely critical to the federal budget and absolutely critical to the successful review to asian of the fda. hopefully if you see any changes in the bills, that you are subject to that you think would help, we would like to hear from you. >> thank you, mr. chairman. before we go, senator murphy, i may have made a misstatement to woodcock. there were no generic drugs 40 years ago, there were some but they had to go through the whole process. what would be that accurate way to describe the percentage of generic drugs? >> they word not of taken because they had quality problems as well. the program that was put into place improved quality and acceptability of them as well but there were some generic drugs out there at that time.

>> okay. senator murphy. >> thank you very much, mystery chairman. welcome, dr. woodcock for your service. a comment, just an extension on the point senator warren was making. and spiraling drug costs, and really waste too great of a share on the regulatory process and efficiencies, and it is worth restating what is exceptional about the united states is the way in which we structure our market for drugs, the way in which prices are set, we are virtually the only country in the world that doesn't have a process for

controlling drug costs. the results of that is american consumers and the u.s. government the lion's share of costs for the entire industry globally and the rest of the world consumers are free riders and second and more difficult to talk about is the fact that if you take a look at the 16 publicly traded companies that still the best selling drugs in this country, half of them are taking in a greater profit at the end of the year than they are spending on research and development. that is 2014 numbers. we certainly have discovered and dispensed life changing drugs because of the profit motive built into the system but those are stunning numbers. my question is a specific one. you ended your testimony with a set of challenges and barriers

and one that you outlined was this problem in which we don't have convincing bio equivalence test method available and that is worth exploring a little bit. you got money to develop those halfways and you caution was that it takes time so can you tell us a little more about the timing of that research, how to judge its beef effectiveness and to the extent we have been successful in getting $2 billion, what is the degree of cooperation, what can they be doing to solve this problem? >> and i age does not typically do this type of research. this is applied research and what we are talking about is drugs are not systemically and swords and go through the blood. are hard to determine whether they are by a we equivalent to

the innovator drugs though that would be all the creams and lotions and different topical agents as well as insulation drugs. and we have a complicated drug out there that offer has problems characterizing them and making sure they are the same as the innovator. the research we are doing you can judge if you will bear fruit because we issued draft guidance and the draft guidance would have a new bioequivalence testing it and we might do workshops before that and other things to make sure the scientific community is on board, lycee instead of having to do clinical trial and all that entails, comparative clinical trial, you can use this biweekly months test, put the cream on these people and the other cream and measure

something or whatever you do, whatever we say and that would cover the results. that would improve the uptake in the junior competition in these areas they are chemically absorbed drugs. >> forgive my ignorance but the guidance would be for classes of drugs, types of treatments or for specific drugs or treatments? >> it would be drug classes, a specific drugs other times. >> do you have enough funding where we should be 5 or 10 years from now internal of the amount of guidance necessary to keep up with the pace of technological change. >> we need to get back to you on that. we invested a substantial amount, we invested $24 million. we are having a lot of research

done but it takes time as i said in my testimony to get the research finish to understand the implications translated into policy and guidance and education the world on how to do these studies but this is the key to some of that silver gap there of drugs that don't have generic competition at all. it is too expensive for almost impossible or in feasible to figure out how to show they are the same. >> thank you. dr. woodcock. >> senator whitehouse. >> thank you for being here. i will continue on the same fema. i am not an advocate for price controlss but it does seem to me there are circumstances in which very clever people had observed or created a monopoly for themselves and use that monopoly

power to exhort prices that the market would not support if it were operating correctly. it seems to me there are some pretty obvious signals of wind that might be taking place. to me it is not a determinative factor but a red flag factor if the people involved are not in the business of creating pharmaceuticals coming in business of speculation, that ought to put up a red flag to me. if the price hike is beyond a certain amount, and send a poor red flag. to which is in sets of customers or patients can readily turned that would be part of the monopoly posture. i am wondering if your organization, to define where

the market failure is taking place and saying these are red flags or you see that as somebody else's job. >> the report issued yesterday on some pricing issues around pharmaceuticals gets to some of those issues. for the economic ones they are better suited than the fda. >> not looking at that. >> it is a red flag for it there could be shortage because there's always one manufacturer and if something goes wrong that is a big problem. >> a shortage point of view as opposed to price manipulation point of view. >> that is right. you could chose the bar chart. >> we look at those that have few competitors. some of the oneness in that chart there where a they only have one generic might be the

only drug on the market, the innovator may be off or there are two, those are areas where there isn't a lot of competition and there could be a shortage or loss of product. >> if we can correct the define the characteristics of the bad behavior everyone on the committee sees and acknowledges exists then going the long way around to figure out how your drug approval process can resolve that problem is an efficient way to do it. and create massive price increases and diffuse that won't allowed that any longer than people go away and find more productive things to do with their time. let me ask a different question entirely. we had conversations about the device regulating side of fda

and the drug regulating side of the fda and the need for a new track for drug device combination and this committee is looking at that. what can you tell me about where the fda is in terms of making a recommendation to us on what the drug device combination would look like? what is your recommendation for that? >> i believe the fda is ready to work with the committee on this and we are very interested in looking at some solutions to this problem. >> what do you propose? >> we have not propose specific legislation and don't know where the administration is on that but i would say from my own technical point of view that it is the problem. we need more clarity, we need different paths. >> in charge of the drug's side and device side both said the

same thing to me which is you can't do drug device combinations using our process. there has to be a new process that emerges. you think it would be y s 4 you on the device side to sit down and spend time making a recommendation as to how you think those drug device combinations might be best regulated? >> we had numerous conversationss with combination products and going through multiple scenarios. we would be very eager to discuss in committee. >> proposal from the agency that would be obliged to implement it would be helpful to the committee. thank you, chairman. >> thank you, senator murray, the you have any further comments? >> i want to thank dr. woodcock for her important expertise and answer to your questions. a lot of work ahead of us and

look forward to bipartisan fashion to move forward. >> let me add my thanks to you, you have been there 30 years in one position or another but hard to imagine there will be a more exciting time given the rate of innovation. we have the logical tension that exists between price, safety, effectiveness and incentivizing and encouraging a supply of new treatments and curess and devices that will save lives. we are talking the next generation of cancer treatments, innovative therapies for alzheimer's, infectious diseases, we have seen what happens with hepatitis c, we

have seen what happened with cystic fibrosis, you had a role in all of that. we know we are told in alzheimer's that we simply delay onset five years that could save the health care system $367 billion by 2015, the grief and pain which is incalculable. there have been 123 unsuccessful attempts to develop alzheimer's drugs while four are successful. my hope is why we are working on safe and effective, keeping the market competitive so prices are as low as possible that we don't do anything to discourage development of these new lifesaving treatments. the hearing record will remain open, members may submit additional information if they would like. the next session will be

executive session, the step-by-step process to produce legislation. several bills will be considered with amendments. these are bipartisan bills in the sense that they have been sponsored by members of the committee on both sides of the aisle and perhaps they can grow into companion legislation to the work the 21st century package house has already passed. the president is interested in what we are doing with precision medicine and also now with his cancer initiatives. we welcome the administration's been put on that. we look forward to february 9th and we thank you for coming today. the committee will stand adjourned. [inaudible conversations]

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>> we have more or less three strategies of preventing the abuse, the alternative payments, saving lives and trying to encourage better treatments on the market and underat utilized and effectively from people. that strategy is taking a lot of action. >> talk about the hearing today. do you believe you have all the resources you need to maximize generic competition? do you think there are other steps? >> congress has not invested the authority to oversee anything to

do with drug pricing. we have no authority in that area but we are charged with making sure products that could get on the market i developed and reviewed sufficiently as possible. we have a huge strategy, we have sufficient resources on the review side and hopefully on the inspections i. we are working on inventory. someone -- senator roberts was asking me about that. but the research side, we will get back to is them. it could be hard to research because we not only have non chemically products, different equivalent methods and the different one for each one but we also have more and more of

those. we approve a generic capacity, tremendous amount of effort. and the anticipated workload of research and effort we are going to have moving forward to continued to approve these. >> we talk about cleaning up the backlog by this, use an absolutely, this will be cleared out. why so certain? >> we have to take first action. >> 90%. >> 86% down. we have two more years. we never have 100%, there will be strain here and there and there could be a policy reason or another and no reason we

can't take action, we are blocked by a patent dispute and can't help that but we know because of our performance -- >> 86 right now, i thought you meant 82. >> it depends, 84 if you count original applications if you include the free approval supplements but is all in the testimony if you look at actual numbers that those numbers change it everyday. i understand the senator's frustration because of performance of the program the last several years, but we redid everything about the program. a modern review process and we are going to crank the next two years no doubt. >> do you think the fda should,

at their is something about price. as price becomes a bigger and bigger issue nationwide to he is think the fda needs to expand its review here? >> no regulator involved, they have separate entities, national health care system and so forth, regulators, if they give us direction to prioritize based on certain criteria someone else, we could do that but stick to the science, safety and effectiveness and that is a level playing fields, we are embroiled in the review process

we don't talk about very much in putting statistics. and other legal maneuvers to keep us from approving generics and that is a massive workload en if you ever read the responses, this goes through them and that is a great deal of work too so any further elements that are introduced where prior ties another opportunity to be making this life salinas or say we are not being fair. there is the balance, better for the fda not to get involved in pricing issues but doesn't mean you couldn't respond to some other body. [inaudible] >> most generics are decreasing

in price. a small area of course, for the medicaid, prices for generics wind down 64%. >> this older slice you are talking about. >> the innovator drugs that don't have any generic competition. nobody waiting, complex drugs, they might be equivalence tests. the market space may be too small if you have other entrances into that space than they won't make money. >> should you be thinking what to do about that? >> we wanted to present the reality to the committee about where the vulnerability is our.

people we think -- presenting this as a jury problem, i go to the drug store. it was $0.23. it is my co-pay. my insurance company did not pay very much. inert general the drugs are affordable. there is a full segment which we want to prevent where they don't have a lot of competition. there's only one generic we should. they may or may not -- there might be only one in that state and the silver part there is no competition whatsoever even though there could be. why is that? those are the areas when they have a lot of freedom to change things around. >> do you have any thoughts, why is that? >> it is generally driven by the

opportunity. people don't see business opportunities in small markets or if there is a barrier, you have to do clinical trials. that is the barrier. millions of dollars on research in the industry gave us the money because they see if they could get a bio equivalence test and then there would be generic -- >> we need to wrap it up. >> the small markets for endorphins and others, aziz told small volume, they are hard to make. have to be sterile. everybody has learned that. they have to be sterile and nobody takes them -- they stock the emergency room carts with them. it is not a big market. held many players?

where is the business opportunity? that is where we are working on advanced manufacturing. so we can make manufacturing more agile and flexible and so forth than we think would help people enter or lower barriers entry. ..