tv Politics and Public Policy Today CSPAN February 12, 2016 2:45pm-4:46pm EST
oppressed, excluded or attacked because of their identity. the president makes sure that phrase never again is not a hollow declaration by giving it a powerful voice in his every day life. so it means a great deal to have the president of the united states take part in the first righteous among the nations ceremony to be held on u.s. soil at the embassy of israel, and it's my distinct privilege to introduce my good friend and president of the united states, barack obama. [ applause ] >> thank you. thank you. good evening.
the talmud teaches that if a person destroys one life, it is as if they have destroyed an entire world. and if a person saves one life, it is as if they've saved an entire world. what an extraordinary honor to be with us as we honor four righteous individuals whose courage is measured in the lives they saved. one child. o one refugee. one comrade at a time. and who, in so doing, helped save our world. i deliver a lot of speeches. very rarely am i so humbled by
the eloquence that has preceded me. not just in words, but in the acts that we commemorate today. to my dear friend, steven spielberg, thanks for your moving and generous words. you spoke of the importance of finding your voice and using it for good, and i know that your work, whether a masterpiece by "schindler's list" or the stories that you have so persistently preserved through the shoah foundation is deeply personal. steven once said is the sho. a -- shoah is a story he was born to tell, the stories you heard from your family. steven, the whole world is grateful that you found your voice and for the good that you've done with that voice. it will endure for generations.
so on behalf of all of us, we are grateful. to ambassador and mrs. dermer, to nina totenberg, our friends from the israeli embassy, thank you so much for hosting us today. let me just add tonight that our thoughts are also with former israel president shimon peres. i had the opportunity to speak with shimon earlier this week. i thanked him for his friendship which has always meant so much to me personally and i thanked him once again for the shining example of his leadership. with his extraordinary life as a founding father of the state of israel, a statesman who's never given up on peace, embodiment of the great alliance between our two nations, shimon inspires us all. this evening we speak for all of us, israelis, americans, people around the world in wishing him a full and speedy recovery.
i also want to just note the presence of two of our outstanding senators from the great state of tennessee. i know that it is rare where you have such an extraordinary native of the state being honored in this way, but i think it is also worth noting that this represents the bipartisan and steadfast support of members of congress for the security and prosperity of the state of israel and they act on that every single day. the survivors, families of the righteous, and those they saved, to all the distinguished guests, we gather to honor the newest of the righteous among the nations and make real the call to never forget. not just on this day of remembrance, but for all days
and for all time. at moments like this, as i listen to the extraordinary stories of the four that we honor, memories come rushing back of the times that i've encountered the history and the horror of the shoah. growing up hearing the stories of my great uncle who helped liberate ordruff part of buchenwald and returned home so shaken by the suffering that he had seen, my grandmother told me he did not speak to anyone for six months. just went up in his attic. couldn't fully absorb the horror that he had witnessed. then having the opportunity to go to buchenwald myself with my dear friend elie wiesel and seeing the ovens, the little camp where he was held as a boy.
standing with survivors in the old warsaw ghetto, and then the extraordinary honor of walking through yad vishem, seeing the faces and hearing the voices of the lost, a blessed memory. and then taking my own daughters to visit the holocaust museum. because our children must know this chapter of our history and that we must never repeat it. the four lives we honor tonight make a claim on our conscience as well as our moral imagination. we hear their stories, and we are forced to ask ourselves under the same circumstances how would we act. how would we answer god's question, where are you. would we show the love of
valerie and mirila? not bad, right? they're in warsaw. they could have been shot for opening their home to a 5-year-old girl, that they cared for like one of their own. gave her safety and shelter. and moments of warmth, of family and music, a shield from the madness outside until her mother could return. would we have the extraordinary compassion of lois gunden. she wrote that she simply hoped to add just another ray of love to the lives of these youngsters who had already endured so much. and by housing and feeding as many jewish children as she
could, her ray of love always shone through and still burns within the families of those she saved. would we have the courage of master sergeant rodney evans? i know your dad said he was just doing his job, but he went above and beyond the call of duty, and so did all who joined in that line. faced with giving up his fellow soldiers, he looked evil in the eye and dared a nazi to shoot. his moral compass never wavered. he was true to his faith. and he saved some 200 jewish american soldiers as a consequence. it's an instructive lesson, by the way, for those of us christians. i cannot imagine a greater
expression of christianity to say, i too am a jew. and i ask these questions because even as the holocaust is unique, a crime without parallel in history, the seeds of hate that gave rise to the shoah. the ignorance that conspires with arrogance, the indifference that betrays compassion, those seeds have always been with us. they have found root across cultures and across faiths and across generations. the ambassador mentioned the story of cain and abel. it's deep within us. and too often especially in times of change -- especially in
times of anxiety and uncertainty -- we are too willing to give in to a base desire to find someone else, someone different, to blame for our struggles. so here tonight we must confront the reality that around the world anti-semitism is on the rise. we cannot deny it. when we see some jews leaving european cities where their families have lived for generations because they no longer feel safe. when jewish centers are targeted from mumbai to overland park, kansas. when swastikas appear on college campuses. when we see all that and more, we must not be silent. an attack on any faith is an attack on all of our faiths. it is an attack on that golden
rule at the heart of so many faiths. that we ought to do unto others as we would have done to us. for americans in particular, we should understand that it's an attack on our diversity, on the very idea that people of different backgrounds can live together and thrive together. which is why your father was right. we are all jews. because anti-semitism is a distillation, an expression, of an evil that runs through so much of human history. and if we do not answer that, we do not answer any other form of evil.
when any jew anywhere is targeted just for being jewish, we all have to respond as roddy evans did. we are all jews. we know that we'll never be able to wipe out hatred from every single mind. we won't entirely erase the scourge of anti-semitism. but like the righteous, we must do everything we can. all of us have a responsibility. certainly government has a responsibility. as president i've made sure that the united states is leading the global fight against anti-semitism and it's why with israel and countries around the world we organized the first united nations assembly general meeting on anti-semitism, it's why we've asked other nations to dedicate a special envoy to this threat as we have. it's why a statute from an an -
anti-semiic leader was central to maintaining a good relationship with the united states. and we let them know. it's why when voices around the world veer from criticism of a particular israeli policy to an unjust denial of israel's right to exist, when israel faces terrorist s, we stand up forcefully and proudly in defense of our ally, in defense of our friend, in defense of the jewish state of israel. america's commitment to israel's security remains now and forever unshakeable, and i've said this before. it would be a fundamental moral failing if america broke that bond. all nations that prize diversity
and tolerance and pluralism must speak out whenever and wherever jews and other religious minorities are attacked. in recent years we've seen leaders in france, germany and great britain stand strongly against anti-semitism and israel has spoken eloquently about the need for tolerance and acceptance among all israelis, jewish and arab. meanwhile, governments have an obligation to care for the survivors of the shoah because no one that endured that horror should have to scrape by in their golden years. we are working to provide care for holocaust survivors in the united states and with the compensation fund we helped create claims are finally being paid even more jews deported from france during the holocaust including survivors here in america can benefit from.
but, the task before us does not fall on government alone. every faith community has a responsibility. just as all religions speak out against those who try to twist their faith to justify terrorism and violence, just as all faiths need to speak out when interpretations of their religion veer in an ugly direction, so, too, must they speak out against those who use their faith to justify bias against jews or people of any faith. we know that there were muslims from albanians to arabs who protected jews from nazis. in morocco leaders from muslim majority countries around the world just held a summit on protecting reledge jus minorities including jews and christians. his hol holiness pope francis has spoken against
anti-semitism. these are the voices we must heed. and anyone who claims to be a religious leader must project that vision. that truth. and finally all of us have a responsibility to speak out and to teach what's right to our children and to examine our own hearts. that's the lesson of the righteous we honor today. the lesson of the holocaust itself. where are you. who are you. that's the question that the holocaust poses to us. we have to consider even in moments of peril, even when we might fear for our own lives the fact that none of us are
powerless. we always have a choice. and today for most of us standing up against intolerance doesn't require the same risks that those we honor today took. it doesn't require imprisonment or that we face down the barrel of a gun. it does require us to speak out. it does require us to stand firm. we know that evil can flourish if we stand idly by, and so we're called to live in a way that shows that we've actually learned from our past. and that means rejecting indifference. it means cultivating a habit of empathy and recognizing ourselves in one another. to make common cause with the outsider. the minority. whether that minority is christian or jew, whether it is hindu or muslim or a
nonbeliever. whether that minority is native born or immigrant. whether they're israeli or palestinian. it means taking a stand against bigotry in all its forms and rejecting our darkest impulses and guarding against tribalism as the only value. in our communities and in our politics. it means heeding the lesson repeated so often in the torah, to welcome the stranger, for we were once strangers, too. that's how we never forget. that's simply by keeping the lessons of the shoah in our memories but by living them in our actions. there's a book of deuteronomy teaches us -- justice, justice, you shall pursue.
i want to close with what i'm told is a jewish legend. it said that within every generation there are 36 virtuous individuals. individuals so honorable, so filled with compassion that their good works sustain the very existence of the world. they are called lamed vanics and without them society crumbles according to the legend. we don't know who they are. they're entirely indistinguishable, ordinary people. like valerie and marili and lois and roddy. you wouldn't necessarily recognize them in a crowd. but i believe that their
generation, the generation of schindler and wallinberg, carski, demanded a lot more than 36. they called for more than 26,000 righteous among the nations. it called for the millions of heroes who did not go quietly and who stood up and fought back. and may we all strive to live up to their noble example. to be those of our generation. to do our part to sustain each other and to embrace the humanity that we share. and in so doing, save our world. may the memory of the lost be a blessing, and as nations and individuals may we always strive to be among the righteous. god bless you. god bless the united states of america. and god bless the state of
israel. >> ladies and gentlemen, please stay in your places for a few minutes. former secretary of state hillary clinton and vermont senator bernie sanders will be in minnesota tonight for a democratic fund-raiser. they're speaking at the democratic farmer labor party dinner in st. paul. it begins at 8:00 p.m. eastern and you'll find it live on c-span. saturday night c-span will have a discussion by silicon valley tech experts on how to improve government's online services. you'll hear from mikey dickerson the google executive who was hired to fix healthcare.gov.
he talks about the disarray he found when he arrived in washington, d.c.. here's a quick look -- >> if you just walk in as an engineer and walk in and look at a bunch of other engineers and see what they're doing and how they're doing it, and it was just total insanity, like, when you first looked. there were 55 different companies contracted to work on different parts of healthcare.gov, which is a fairly complicated operation, but it ain't y that complicated. and there were, i don't know, conservatively -- nobody -- this is another piece of insanity, literally nobody knows how many people were -- engineers, developers, whatever you want to call them, technical roles on the project. at least hundreds. they're in dozens of different buildings. and not only did they have no kind of habit or custom of working together, they were in most cases explicitly forbidden
from talking to each other because of the way contracts are managed by the government. and this was set up. and this was nobody -- the government reserved for itself the job of coordinating how this would all go and the problem is the government doesn't really have that skill set. i'll leave that where it is. i could elaborate on that. but it wasn't really equipped to do that job. so, what was going on just made zero sense. >> mikey dickerson and his team participated in an event at the computer history museum in mountain view, california. you can see the entire event saturday night at 8:00 eastern on c-span. every weekend on "american history tv" on c-span3 we feature programs that tell the american story. here's some of the highlights for this presidents' day weekend. saturday afternoon at 5:00 eastern author margaret oppenheimer talks about "the
remarkable rise of eliza jumel." her unusual life including a second marriage to aaron burr. >> what brought these two celebrities together? on burr's side of the altar, the undoubted attraction was jumel's money. a marriage to eliza jumel will give him a big pot of money to spend. jumel had her own motivations for the marriage. on the one hand, she would soon have to begin settling her first husband's estate. burr, with his knowledge of the law, could help her protect her assets. but the main attraction of the marriage for her was the opportunity to enter social circles that had been previously closed to her. >> at 6:00 on the civil war,
historian dennis frye on the reactions of both southerners and northerners to john brown's 1859 raid on the federal armory at harper's ferry. the subsequent execution and a nation's divided sentiments as americans headed toward the 1860 election. sunday afternoon at 2:00, historians explore the history of the death penalty in america. including the 1976 greg v georgia u.s. supreme court capes that affirmed the constitutionality of capital punishment and monday afternoon at 3:30 eastern author and historian james swanson compares the assassinations of abraham lincoln in 1865 and john f. kennedy in 1963, their personal similarities and differences in their terms in office, the backgrounds of the assassins and the state of the country at the time and he also talks about the experience and reactions of the two widows mary lincoln and jacqueline kennedy. >> but jackie was very con, of history. jfk was very interested in abraham lincoln, knowledgeable
about lincoln and so jackie did have very much in mind the lincoln precedent for the funeral. >> for the complete "american history tv" weekend schedule, go to cspan.org. the senate health education labor and pensions committee held a hearing recently on the accessibility of generic drugs. janet woodcock was the sole witness. this is an hour and a half. >> senate committee on health education labor and pensions will please come to order. senator murray and i will each have an opening statement. then we'll introduce our panel. and after witness testimony we'll each have five minutes of questions. in december, president obama signed into law that every student succeeds act which proves our committee can work on difficult issues successfully. but a law that isn't properly
implemented isn't worth the paper it's written on which is why we're going to have strong oversight on that law and why we're having this hearing today. because we're here for the similar purpose of conducting oversight on the 2012 generic drug user fee amendments for the food and drug administration act. specifically those are the fees that are negotiated between the fda and the generic drugmakers to give the agency additional resources intended to speed the review of safe and effective generic drugs. this is the first oversight hearing since those amendments were passed in 2012. it comes at a crucial time, since 2012 the fda has received nearly a billion dollars in user fees. and performance does not seem to be living up to congress or the patients' expectations as the number of generic drugs approved each year remains about the
same. the user fee agreements are due to be reauthorized next year and so now seems to be a good time to take a look at what's happened. the generic drugs program is a success story. i think anyone would have to say. started 30 years by one of our committee members, senator hatch and henry waxman. it's increased competition and lowered drug prices. the program was created to make it easier for generic drugs to come in. generic drugs, of course, are those drugs that are allowed to come into the market after a drug manufacturer's patent expires over a period of time. generic drugs have to have fda approval also, these copies, but they don't have to have full clinical trials and so a lot of expense is avoided. as a result, more generic drugs on the market create competition and lower prices for consumers. over the last 30 years what
we've seen is that today now 80% -- 88% of prescription drugs purchased in the united states are generic drugs. 30 years ago that number was zero. however, in 2012, 26 years after the first law passed, it became clear the drug approval program needed an overhaul. more generic drugs were coming from overseas. companies in china and india were inspected less frequently than american companies. this put patients at risk and companies at a disadvantage. there's a backlog of 4,700 applications waiting to be reviewed and the median approval time to get review of the generic drug was 30 months. that far surpasses the 180-day time frame for review that was laid out in the hatch/waxman amendments in 1984. additionally, in 2012 many generic sterile injectable drugs were in shortage causing doctors
and hospitals to scramble to ensure patients were getting the best treatment possible. so, congress passed these amendments in 2012. the idea's based upon similar agreements with other manufacturers and the fda. congress anticipated that generic drug facilities abroad would be brought up to the same standards as facilities in the u.s., that american patients would benefit from faster approval of generic drugs and those two actions together would create more come tpetition and lower the price for the drugs. as i mentioned in 2012 there was a backlog of 4,700 pending applications, and the information we have shows that that's dropped to 3,500 applications. the hhs inspector general has reported that the fda's improving its inspections abroad, but the troubling news is that it seems to take fda longer to get generic drugs through the approval process. approval times, the median
approval times, have slowed from 30 to 48 months. and the original number hoped for was 180 days. as we discuss these issues today, i think it's important to keep in mind that drug pricing is a legitimate, real concern of americans, but it's part of a larger concern of rising health care costs. congressional budget office announced this week that federal spending for the major health programs, medicare, medicaid, et cetera, represents the largest fraction of the projected growth in mandatory spending in 2016. two, while we're lowering prices, we want to make sure we continue to invest in and incentivize the development of lifesaving therapies. congress responded to that. senator murray's leadership and senator blount especially, adding $2 billion to the appropriation process for nih. that's $32 billion for nih in a
year but the pharmaceutical manufacturers spend $50 billion in a year coming up with new cures and treatments. and, third, to try to balance the growth -- restraining the growth of drug prices and encouraging investment and incentives for lifesaving therapies, we need to avoid unnecessary regulatory burdens that drive up costs, and we need to do our best to keep the marketplace competitive. for the last year we've been working in a bipartisan way on ways to avoid unnecessary regulatory burdens. in the aging committee senator collins and senator mccaskill have been examining what improvements may be necessary to ensure the fda expedites applications for generic drugs to keep the marketplace competitive and drug prices down. but, still, over the last 30 years, this is a success story. generic drugs have gone from zero to 88% of the marketplace. it's hard to imagine what the prescription drug market today would look like without them.
i look forward to the testimony today. senator murray? >> well, thank you very much, chairman alexander, director woodcock, thank you very much for being here and take the time to be here and for all your work on behalf of our families and communities. i'm really glad that we have the opportunity today to talk about the fda's generic drug program. this is a program that is absolutely critical to helping patients get safe, affordable, high-quality treatments more quickly. generic drug user fees have significantly improved the fda's ability to keep up with the large volume of generic drug applications, and it has helped build on the important work done in hatch/waxman to both incentivize innovation and expand families' access to the best treatments and cures available. there is, of course, room for improvement. while it was certainly a big undertaking to establish this program on an aggressive timeline, i hope that going forward we can encourage more communication and efficiency. it's important to remember that both hatch/waxman and fda
programs are the result of strong, bipartisan work, and as we move forward the re-authorization of the generic drug user fee program next year is critical that our committee's tradition of bipartisanship on these issues continue. so, i'm looking forward to working with the chairman and all of our colleagues to ensure the fda has the tools and resources it needs to serve families and communities safely and effectively. today's hearing is also an important opportunity to talk about the related larger issue of prescription drug access and affordability in our country. nearly half of our country's population and the vast majority of our seniors take prescription drugs. but families across the country have made clear that paying for prescription drugs is an increasingly unsustainable burden. nationwide spending on prescription drugs was nearly $374 billion in 2014. that is an increase of roughly 13% in just one year.
and we expect to see continued cost growth. so, we need to face up to some tough questions. for instance, how can we continue to afford to make critical new treatments widely accessible to patients who need them. sadly, the status quo is working all too well for some bad actors at the very top, and they're doing everything but putting patients first. when someone comes along to rig the system in favor of profits above access without regard to research investments or patients' outcomes, we need to act. we are on the cusp of major breakthroughs in personalized medicine and there's real momentum around tackling some of the greatest medical challenges of our time, like cancer and alzheimers and we have to ask ourselves how we are going to guarantee that we have the research, the market, and the access to make sure the benefits from that lifesaving progress are felt across the system as a whole. we also have to make sure that
insurers are covering their fair share. we made important progress capping out-of-pocket spendve spending as part of the affordable care act, but there's more work to do to make sure patients are not being saddled with too heavy a cost burden. and i'm especially concerned that we must prevent carriers from discriminating against patients with the most expensive illnesses. in addition if our goal is to make sure that patients have access to and can't afford the best, safest, most effective cures and treatments we have to consider the resources we're putting into this effort, because the truth is we simply can't realize the goal of access, quality and affordability, without the fda and the nih at full throttle. if you want the fda to be able to approve drugs more quickly without rolling back the gold standard of consumers' safety and protection, then the fda is going to need more support to do its job. and if you want the nih to be able to drive innovation that delivers on so many patients'
and families' hopes, that is also going to require sustained investment. i was pleased that democrats and republicans were able to come together to boost support for the nih through the spending bill last year. but i see no reason to stop there. in fact, as i've made clear, i believe as part of our committee's effort to advance medical innovation for families, it is critical that we increase mandatory funding for the fda and for nih. and i hope that's something we can continue to work on together. as we look for ways to improve health care for families making sure that prescription drugs are accessible and affordable has to be a top priority. finding solutions won't be easy. these are challenges that cannot be ignored and i'm confident if we all come to the table ready to join together towards the common goal of ensuring our health care system works for families and puts their needs first, we can make real progress and deliver results that so many families and communities are waiting for.
thank you, mr. chairman. >> thank you, senator murray. i'm pleased to welcome dr. janet woodcock as the witness or today's hearing. thanks for being here. we know you're very busy running that important center at the fda. dr. woodcock's been director for the center of drug evaluation research at fda which performs the critical task of ensuring safe and effective drugs are available to improve the health of americans. she's been at the fda about as long as we've known generic drug approval, about 30 -- about 30 years. and she's led many of the fda drug initiatives, including the critical path initiative. she's been a senate director since congress passed the generic drug user fee amendments in 2012. so, she's the leading expert on this program. dr. woodcock, we thank you for coming and look forward to your testimony. if you can summarize it in about five minutes, you have several senators here who would like to have a conversation with you abo about your testimony.
>> thank you, mr. chairman, ranking member, members of the committee, i'm very pleased to be here to talk about this very important issue. the hatch/waxman legislation that established the generic drug program has been extraordinarily successful for the public. as chairman alexander said, about 88% of dispensed prescriptions right now are generic, it's estimated to have saved the public $1.7 trillion. in the last decade, the generic drug industry being very successful grew very rapidly. and it also globalized its manufacturing making drugs all around the world. fda's generic drug review program, in contrast, did not grow significantly, and we fell behind in both review and inspection capacity. and a backlog accrued and began to build up of pending applications. in response to this, in 2012 congress enacted gadufa
reflecting a negotiated agreement between the industry and the fda to address this and modernize the program. it's a five-year program during which industry would pay 3$00 million a year in fees for service and fda would attempt to meet a progressively more difficult series of performance measures. that have to do with review, but many other activities as well that are summarized in my testimony. in the three years since this was enacted, fda has met, and in many cases, exceeded all the performance goals that have been established. this has been a formidable task. these three years we've been managing over 6,000 generic drug applications. about 2,500 that were piled up at the start of the program that we had not gotten to, and then almost 3,000 that were submitted since that time.
far exceeding expectations for the number of applications that would be submitted each year. over 90% of all these applications have received some review by the fda at this point. 90% of the 6,000. they've received some kind of communication also. and over 1,700 have been approved or tentatively approved. we tentatively approve when we can't approve yet because patent is still blocking full approval. last month alone, we approved or tentatively approved 99 generic drug applications. how this was accomplished is detailed in my written testimony. it's a very complicated picture, required us to rebuild the entire program from the ground up. but none of this could have been done without the incredible dedication and passion of a lot of people at the fda.
i will tell you, mr. chairman, ranking m ining member, that th at the fda share your passion for ensuring that the families and communities in this country have access to affordable drugs where at all possible. i'd really like to publicly thank all the people who worked so hard and so long over the past three years to make this program work. it has been an incredible effort. the staff in the office of generic drugs who have worked extensively long hours, overtime continued, got the job done. the staff in the newly formed office of pharmaceutical quality that has totally revamped how we do the quality review. the staff in the office of regulatory affairs, which is our field organization, that not only has ramped up and hired and done more inspections, but actually volunteered and help do some of the review work so we could get these applications reviewed.
and all the other people who pitched in. and we had people in our laboratories and ora la laboratories who put aside their experiments, put their experiments on hold, so they could review parts of generic drug applications that they were qualified to review. the heroic staff who really launched our new informatics platform. we all know the story about government i.t., huge i.t. implementation, it is never pretty. and we had multiple legacy systems, all the data had to be transformed and cleaned up and put into a single system, and we were in the depths of despair a few times. but we have gotten through that. we are running off a new i.t. system, it's already proven its worth, and i thank them, because they really went through a lot. the financial staff who had to set up a fee collection system from scratch. and collect all these fees and allocate them appropriately, and
our hr and admin staff who helped us hire over 1,000 people, more people, to get this job done. we would not have done it without all of them, and i think we owe them a great deal of thanks for making this program work. now, discussions about the backlog and so forth i'd like to have in our back-and-forth conversation, because this is a complicated issue, but i think the news is good news. it's not bad news. and i recognize that there remain a number of challenges that we all need to address collectively, but i am really sure, because we have gotten through the worst of this, that we can deal with the challenges we have ahead. and i really look forward to your questions. thank you. >> thank you, dr. woodcock. we'll now begin a series of a round of five-minute questions. dr. woodcock, i think all of us on the panel, maybe every senator, are interested in drug prices low as is reasonable.
the statutory mission of the fda is safe and effective drugs. it's not to set drug prices. am i correct? >> correct. >> is it also correct, though, that one of the effects of the -- and you just said in your testimony over the last 30 years of the hatch/waxman amendments and the generic movement that's gone from zero to 88% has been a massive reduction -- or lowering of drug prices. >> did you say $1.7 trillion in savings? >> estimated. $1.7 trillion has been estimated. >> $1.7 trillion. and it would make sense, then, that we should focus our attention on ways to continue to make generic drugs available to as many people as possible. two ways we've sought to do that in the committee are to avoid unnecessary regulatory burdens and to make sure we have a competitive marketplace, where
prices are low. i want to ask you -- and you invited this really -- about the backlog. 30 years ago the hope was that generic approvals could be 180 days. there's a backlog of 4,700 applications waiting to be reviewed, i guess, in 2012, if i'm not mistaken. then there have been a lot more applications since then. you described those. the median approval for -- time to get review of a generic drug was 30 months 4 years ago. today the approval time seems to be higher. 48 months. and you're approving about the same number of new drugs. yet over that period of time, you've collected a billion dollars and hired 1,000 new people. what can we do about the backlog
and the approval time? help us understand what the facts are. >> well, let me walk you through this. it's a little complicated. the back -- the backlog applications that were sitting there in 2012 when we put the program in place, okay, have been there for 40 months. we've approved a lot of them. we've taken action on 82% of these. all right? some type of action. we've gone back to the manufacturer. they've withdrawn some and so forth, right? but they have been there since 2012. so, even if we approved all of them tomorrow, their approval time would be 40 months because that was 40 months ago. and the longer it takes, just like the rest of us, they're not getting any younger, okay? so, those applications that were sitting there in 2012 are going to at minimum have approval time -- total time to
approval -- of 40 months, because they started 40 months ago. the ones that we're getting in now have a due date for a complete response of 15 months. we have already approved some in the previous cohort last year that had 15-month time frame. we approved a drug in nine months on -- >> so, you're saying the new applications have a different median time. >> they do. they were the first ones that had goals. none of these others, the 2012 pending and then the first two years of the program, had no goals assigned to them. >> what about the number of approvals today as compared with a few years ago? >> if you look at the chart in my testimony, you'll see that we didn't do -- in the first two years of gadufa, we didn't jump up approvals. it was pretty much up and down. in april of last year, approvals went up and they have stayed up and as i said last month we approved or ta'd 99 generic
drugs. so, we're on a path to get these efficiently out the door now. we had to build the program. we had to get this i.t. system. we had to hire and train these people -- >> let me ask, if i may, one more question, and i don't want to go over my time. i want to make sure that you're making the distinction between what a guidance requires and a regulation requires. i know the office of management and budget is interested in that. and i've heard some concerns about one proposed guidance on quality for generic manufacturers that would impose new obligations to submit reports. are you making a distinction between guidances which are -- don't have the rule of law and regulations which may have the rule of law but do require certain amount of public comment? >> we certainly do. and we have, as part of implementing this program, we've put a policy office in the office of generic drugs and
established a new policy office in the office of pharmaceutical quality, which does the quality regulation. and both of those offices, part of their function, they're staffed partly by lawyers, is to make sure we follow good guidance practices and follow the appropriate guidance for regulations. >> senator murray? >> as i mentioned in my opening statement, hatch/waxman has been an incredible success and has provided patients and families with access to high quality, lower cost drugs. and building on that success, this committee's bipartisan work to pass the user fees provided fda the resources to tackle existing backlog. some are now see iaying that th backlog of generic applications remaining at fda is part of the reason that patients and families are experiencing high drug costs. how do you respond to those
claims? >> the high drug costs are driven by multiple factors. but one would be -- might be lack of competition, so is there a generic competitor for the innovator product and those we call the first generic. the first generic to get on the market which begins to lower the price. we've looked at all these backlogs, and there's nothing in that backlog that would be a first generic potentially, even if it's one or two applications, either of those could be the first generic that we haven't looked at. now, we can't approve applications, even as a first generic, if they don't meet our standards, if they are substandard in some way or if they are incomplete. so, we may not always approve every application that comes before us. it's a first generic. but we expedite those products. >> the first generic. >> we absolutely do. and they get a fast track through the process and we make sure we pay attention to those. so, i can assure you that in
that backlog that was sitting there in 2012 and that we're working on now, that we've largely worked on, that there's nothing that hasn't been looked at and given attention. and certainly that would provide a first generic. >> when fda does approve those potential first generic applications, do companies usually market those generic drugs right away? >> no, we don't understand the behavior of companies, and, of course, sometimes difficult to ascertain what they're doing in the market as senator collins' hearing with the aging committee demonstrated. but we have noticed that often companies will not market a product. sometimes for a significant amount of time after they've received an approval for a first generic. >> okay. yesterday the hhs assistant secretary for planning and evaluation came out with a report about the generic drug market, concluding that generic drug prices are not the primary
driver of the high drug costs facing many families and patients across the country. it found the generic drug market as a whole is quite competitive although some segments have experienced large price increases. what type of competition exists for innovator drugs currently on the market? what does that mean for patients? >> with your permission, i'd like to bring up a slide, if i could. this one i think would be good. now, this shows -- it's just a simple bar chart. it shows the 99 on the left is the number of innovator drugs that only have one generic competitor. there's 66 that have two generic competitors. and all the rest have three to ten generic competitors which is shown to really bring the price down when there's that much competition in the market. in addition -- could i have the pie chart? if you look at this pie chart, this is all -- it's a picture of all the drugs that would be out there.
if you look at the silver slice, that's innovator drugs that could have a generic competitor but don't. and many of those are orphans are very small market drugs. >> okay. >> so, there is a remaining group of products, it's small, but that's where we see a lot of the action as far as price changes when generic competition is possible. >> okay. i'm told that it typically takes three approved generics before we see real pricing competition kick in and prices go down. how many innovator drugs have reached the level of having three generic competitors? is that your number there the -- >> yes. you can see the vast majority have large enough sales, i imagine, that multiple competitors get in the market. >> and that's what drives the price. >> yes. yes. >> okay. you mentioned how the fda generics program is on its way to being a real success story because of the resources congress provided. i wanted to just ask you, can
you describe the current status of fda's generic's workload? >> yes. if you -- could i have another chart. there we go. this chart shows the entire workload at almost the current time. at the top the number -- this is too complicated, i'm afraid. but at the top the 62018 is all the applications we've had to deal with since the program started, all right? the bottom number, 600, those are the ones that haven't entered review yet, so that's only 10% that haven't entered review, and some of those were submitted very recently, all right? 2,400, we're in the stage of back and forth with the companies, all right? so, we're going back and forth. we're trying not to have these multiple cycles like we had in the past, but get the issues resolved during the review process and try to get to a first cycle approval. >> so, when people say backlog,
it's not like the drug is sitting there, nothing is happening to it. it's part of the backlog even if it's been withdrawn by the company or you're going back and forth with the company. >> well, the -- this is simply the overall workload. the backlog was something that existed at 2012, right, bingo, there it was. in the future we're not going to have any backlogs. we're going to have -- if we get 1,000 drugs submitted a year, applications, we're going to have a bunch in process. they won't be in backlog because they'll have goal dates. they'll simply be moving down the process. but because we have a lot of them that don't have goal dates now, although we've assigned them action dates, this is a better description of where they are all, i think, even though it's overly complicated. so, you see that almost 600 have been withdrawn by the firms and we've approved 1,500 and tentatively approved 268. and we're working on these
2,400, so that's 4,000 that have either been approved, tentatively approved or we're talking to the. companies. >> thank you very much. >> thank you. >> thank you, senator murray. the next senator collins and casey and franken. senator collins? >> thank you, mr. chairman. dr. woodcock, first, let me thank you for your many years of public service and all that you're doing to expedite generic drug applications in order to make prescription drugs more affordable for consumers. i know that you're familiar with the investigation the aging committee is doing in to the sudden, very aggressive price spikes that some companies have implemented on drugs that have been on the market for literally decades. one deraprim is 63 years old,
and yet there's been a 5,000 percent increase in its price by a company that invested none one dime into the research and development that led to this drug. so, i'm concerned that our current regulatory structure doesn't take into account situations where there is essentially a market failure. because the population of patients may be small. there's no generic application. whether it's pending or not. it just hasn't happened. now, i know that the fda currently provides an express lane review for certain generic drug applications, including first generics and those that would help solve medical drug shortages. could you give us some idea of
what the timeline is for the expedited review for drugs for the first generics or those that are in the medical shortages category. >> well, they get to the front of the queue, okay? and, of course, we -- with so many applications coming through, we can expedite different things. we have to treat them fairly. all would get expedited in the same way. so, they get extra attention. they get moved to the review queue front, so they get reviewed first. and people shepherd them through. but if they are substandard in any way, under our new process, of course, we'll call the manufacturer and try to get that application repaired. but say we go inspect the facility, and it is substandard, we're still not going to approve that drug. but we do move them along as fast as possible. now, for the cohort that comes in after september of this year,
there's going to be a ten-month review clock. that's the goal. so, all -- that's for all generic drugs. so, somebody who submits a generic drug october 1 of next -- of this year can expect a ten-month review. and if we're successful, they will get an approval at the end, not, you know, a lot of questions about their application. so, that's pretty expedited as it is, especially since they have facilities often in china and india and different places around the country may have to check. >> let me ask you about a situation with two of the drugs that we're looking at the aging committee's investigation, isoprel and nitropress. and these two drugs once had fda approved generic competitors, but over time, those competitors left the market. and now there's only one manufacturer left.
so, if a new manufacturer were to come in now, would that application be expedited? >> yeah, that's a good question, and we will take it back and try to figure out what our policy should be on that. because it would be aking#w1÷ t first generic, although technically not a first generic. >> that's why i ask it. >> part of our problem is knowing who has marketed when. these people sort of come in and out of the market. if they don't withdraw their applications, it's hard to say if they're marketing unless we get notified of a shortage, in which case it becomes clear. >> the other issue, related issue, that i'd ask you to work with us on as we try to come up with solutions to these market failures, is figuring out what the length of time for an expedited approval should be that would discourage the company from buying up a
decades-old drug and increasing the cost of it. if it's a short enough time, it's not going to be worth the amount of money that the manufacturer -- well, they're not manufacturers. they're more like what i call hedge fund pharmaceutical companies. would pay to get the rights to that drug. so, one of the ideas that i'd like to work with you on is whether there's a way to take away the incentive by having this expedited approval that would encourage a generic to come in and discourage the company from buying up the decades-old drug thinking it's going to have a monopoly long enough to make a great deal of money. >> uh-huh. we'd be happy to work with you. we also have to consider there is development work the company has to do. they can't just turn a switch
and start manufacturing a drug tomorrow. so, there is that time that has to go in as well. >> what we're finding is that a lot of these companies are not doing the manufacturing, and so it's a very new and interesting business model. and i'm convinced that it's one that is really negative for patients, providers, hospitals and for federal and state health care programs. >> mr. chairman, may i just make an editorial comment? >> sure. yes. >> thank you. you know, we have -- we've talked to some members in the house and some of you all about advanced manufacturing and our efforts on this. why we like advanced manufacturing, we're trying to push it with the industry, is that allows them really to turn very quickly and really ramp up very fast -- >> you want to define advanced manufacturing, what you mean by that. >> certainly. the potato chips and m&ms and
all sorts of food in this country and fine chemicals are made in continuous manufacturing lines that are computer controlled, automobiles, even with robots. pharmaceuticals are not made that way. they are made almost like cooking would be familiar or pharmacy compounding steps. and we are really trying to push to move to modernize computer-controlled continuous manufacturing. it's much more efficient and effective, but, of course -- >> talking, like, 3-d printing? >> well, we did approve this year, we approved a 3 d printed product, the first one this year. that's one of the aspects that enables doing things like that, yes. so, that's something -- an aspect i think that we really should explore to provide agility into the system. thank you. >> thank you, mr. chairman. i apologize. >> no, thank you. and thank you, dr. woodcock, for that. senator collins we know in the
committee on aging you and senator mccaskill have done a lot of work on this subject. we know also you don't have legislative authority, so we welcome the work product from your committee over here as we work on our legislation. on our legislation. senator casey -- senator franken. >> thank you. i appreciate senator collins' questions and part of your answer on -- it seems to suggest that the data that you have on the market is not totally complete. >> that's correct. >> okay. and is there anything you can do -- is that an aspiration of yours to make that data complete, more complete? >> it's very difficult to figure
these things out. >> who would do that, do you think? >> well, i believe senator cohens hearing they talked about the contracts and the rebates and all the different things in the u.s. distribution chain that nobody really knows the answer to. and the insurers, i think, would really like to know how these drugs are moving and what is actually being paid for them at different steps. but they don't know, that's what i took from the testimony. and we can find out sort of expo facto by what was put together in a picture at the end of the day. but it's very difficult -- >> trying to figure that out would inform what you're approving, what you're taking up to approve. 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'm sure you've read it. it was by the thoe of a drug company. he was pointing to something his company did. and we took up compounding in this committee and a number of us, including chairman and senator roberts, but he was basically saying that he -- he did successfully compound a drug generic that had been one of these drugs that they exploded the price on. and he got to market by compounding this we saw the risks associated with compounding but we also gave the fda the authority to regulate
compounding. did -- you read this piece, did you -- do you think there are risks to this? or are there -- what is the up side to the risks? >> i believe there are very great risks. we -- congress established an outsourcing facility as part of the reestablishment of compounding several years ago. but those were for sterile injectables. the tablets would be compounding, could be compounding by any compounding facility under this -- what was being proposed. and in the last two months, we've dealt with two outbreaks, all right? one was vitamins where they compounded vitamins in excess e
excessive -- vitamins were way compounded into tablets and people were hospitalized with kidney failure. >> those are vitamins considered supplements that you don't -- >> we regulated those. >> oh, okay. >> and we intervened and were able to track the people down. the second one was a hormone. it was a thousand times more potent than it was supposed to be. >> okay. >> people ended up in the hospital very sick. and these were small outbreaks. so the pharmacy and us were able to track these people down, the people still not in the hospital, make sure they were -- the drug was recalled. but a mass production of drugs such as to substitute for generic or an innovator drug that's out there under noncontrolled conditions. i know everybody talks about regulatory burdens, but what we ask them to do is make sure they do the right thing each time. and this is what happened.
they put in too much. they used the wrong source. they use an ultra sons traconce source and put people in the hospital. if they were making thousands of tablets, it could have put thousands of people in the hospital. so that's what we face if alternative sources that don't have good manufacturing practices are going to go into mass production. >> so -- i'm out of time. but so -- i'm out of time. i'm out of time. >> that was a very important question before this committee. that's a very interesting discussion. >> thank you. >> senator robert, senator cassidy. >> thank you. i echo senator collins' compliments of your work. and i appreciate your straightforwardness. couple things, rófirst, to playoff -- i forget who it was, but someone regarding backlog communications, you said 85% of
those prix this legislation have had some action. that means 15% have not. i can imagine if you are one of the 15%, you're just like, oh, my gosh! secondly, 85% have had some action. that action may have been the kicking back. so any comments on why is that 15% still kind of in purgatory? and the 85%, et cetera. >> when we negotiated this agreement with industry, they were realistic that we weren't going to be able to review 6,000 applications in three years and hire a thousand people and rebuild our entire generic drug system and totally reorganize. all of which we have done. so the goal was that we clear out 90% of the backlog applications by the end of the program, five years. that was the agreed upon goal with industry. all right? with no other interimmediate goals. what we have done, we have already gotten back to them or
worked on 82% of them. >> gotcha. don't mean to interrupt, i just have a short time and have so many questions. >> okay. >> now, i've also told by industry, i've also learned to say what i've learned, not what i've been told. the interval between when it's submitted and reviewed, the standards have changed. so now it is low quality, not because it was low quality at the time of submission but because it's low quality at time of review. are those applicants notified when standards change? and the implications of that change is standard upon the initial application? >> absolutely we tried to do that. that's our policy office issuing many more guidances. those often are product specific guidances. they are like a cookbook or recipe. >> so then the follow-up question, therefore it implies that it's not the case that it has been made public. the guidance as to what is a good quality application.
>> we try. i mean, there are things such as we've gotten applications where they have cut and pasted portions from another application, totally the wrong application in there. it's hard to think of everything that people can do that isn't right. but we do try to give guidance in having a policy offices. we definitely aspire to put out much more guidance and training on what is acceptable. i have a slide in the -- >> can i just move to something else? >> yeah. >> i'll accept your explanation. >> believe me, i'll hear from them. next, following up on what senator collins has said, but also relating back to testimony that you gave to the energy and commerce committee a couple years ago when i was on that committee, one of the reasons for drug shortages is that there's been a concentration of drug manufacturers. if there's a quality problem with that one concentrated facility, then my gosh, it ripples through. now, what i'm told is that
kadufa has a facility fee. and if you only have one facility or contract out to a cmo, a contract manufacturing organization, that somehow you lower the facility fee. it would require us to change that. but because of this we've had a concentration of manufacturing units. is that a fair assessment? >> i don't know whether that's driven concentration or not, all right? i think there are many factors but that could have been one. and we are certainly considering that in discussions for the next program. >> so then we should consider that. because it requires say a substitution of a product fee as opposeded to a facility fee. fair statement? >> there are many different ways this could be. we try to make the fee structure as fair as possible. that the burden is shared appropriately among the people who benefit from the program. >> do you have a list of how many manufacturing units, if you will, there were or how many cmos were active before and what
was the number of manufacturing facilities now post-gadufa? >> one of those is self-identification. we have one in 2012 where everybody had to put up their hand and say we are making a generic drug or making an active pharmaceutical agreement. so we have it for those three years but not before. that was one of the defects. >> still, if you had when it started and now, how many -- in '12 and now, do you have that number? >> we can get back to you on that. i don't have that. >> could you acquire, we are making these drugs and we're contracting out the cmos for this and kind of have that as a realtime database. because we need to know if we're concentrating manufacturers. and if so, because you have told us that that is a major cause of drug shortages, and some of them are bad actors because you also told us that, some of them have a lot of problems, some not.
if they were made public we would know how good they are and two if they were good or bad actors. is that possible to make to us? >> i think we can give you the overall numbers. we can try. but i think making the actual people public would probably require either regulation change or something congress -- >> a statute we need to do. >> yes. there's registration and listing that is done now. but we have different problems on that we can get back to you on. >> thank you, i yield back. >> thank you, senator cassidy. senator warren. >> thank you, mr. chairman. everyone is here looking for ways to bring down the cost of drugs. both brand name and generic drugs. but we can't do that if we don't correctly identify why the prices are so high. some people want to blame the fda for high prices, saying that if the agency would approve generic drugs faster, then the drug pricing problem would go away. so i just want to dig into that claim a little bit.
let's begin with generics competing with brand name drugs. according to an analysis by harvard researchers, it takes an average of 12 1/2 years for a brand name drug to face competition by generics. and no doubt if those brand name drugs had competed with a generic drug 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 any form of exclusivity or past, is that rirght? >> that's correct. >> okay. so then let's look at the time after illegals are genetically allowed on the market. how long does it take the fda to approve a new application for a generic drug? >> well, that's something that's in flux. but this year it will take us 15 months on average to get back to the firm. if they have sent in a complete
application, we can preapprove it. >> for a new application. >> the ones submitted this year. >> and what commitment time are you looking at going forward? >> next -- in september, in october of this year, if you would submit a generic drug application, you could expect to get an answer back in ten months. >> in ten months. >> right. >> we're going from 15 months to 10 months and you feel like you're on target, at least getting the pieces in place that it's going to work. >> that is doable, correct. >> okay. so i just want to measure that against the claim that the average time for fda approval has increased. now you talked about the backlog and the difficulty of dealing with applications that date back years, but the average time for new applications, is it going up or going down? >> the new applications haven't reached their sort of time to get approved yet. so we can't really say that the goals only kicked in last year.
that was a 15-month goal. but as i said, we approved one at nine months and a number of them that's been shorter than the 15-month goal. >> that's right. and you're committing to a shorter time period. >> we are committed to meeting the goals for each cohort. that's correct. >> let me ask you one other question about this. when a company suddenly raises the price of a generic drug, obviously approval of a competing generic drug would probably bring the price back down. dr. woodcock, does the fda expa indict these contracts when there's been a price spike? >> no. >> why not? >> we don't really know. we have to be fair. there's a lot of lawsuits around generic drugs and so forth. we have to be fair to all. we don't know what a price spike is. is it the pill that costs 10 cents or 30 cents? is it 10 cents and now costs
$835? >> that kind of sounds spikey to me. >> right. and we don't have the expertise to determine. we aren't economists or finance people. we are doctors and lawyers and scientists. so what we -- >> is it legally clear that you could do that? could you use that as a criteria for deciding to expedite on a particular drug? or is there some legal am bbiguy to that? >> i don't know the answer to that but i imagine it might be possible if there were some bulletproof definition of what a price -- what if you doubled a price from a dime to twenty cents? >> this is something to look at. i think that's helpful. we'll look at the proposals on the table today. yes, congress could make sure the fda has the funding and personnel it needs. yes, there's some room to improve generic drug approval processes as the new user fee
program is fully implemented. yes, there could be limited situations where the fda might be able to expedition review of generic drug to help lower prices. we're already heading toward ten-month approval so that should help. but let's not kid ourselves. making those tweaks won't solve the drug pricing problem. the market for prescription drugs has little transparency. it has broken price elasticity and has very long legal monopoli monopolies. ed sure, we can make small changes to how the fda approves 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, dr. whitcock. thank you, mr. chairman. >> thank you, senator warren. now, i have senator roberts, senator casey, senator burr and
senator murphy. so senator roberts. >> mr. chairman, thank you. thank you also to the ranking members who called this hearing. everybody knows about the cost of prescription drugs that continue to make headlines. and i truly appreciate dr. woodcock's view. you are an excellent witness. and thank you for your clarity. and your comments. in addition to new user fees in 2012 as has been said, the fda proposed a regulation in 2013 regarding generic labeling. that according to one testimony, increasing generic drugs by billions of dollars. in 2015 a proposed quality metrics program through draft
guidance, draft guidance, that would require manufacturers to collect new information and also to collect and record information from the cmos. the generic drug manufacturers have raised significant amounts of money regarding the confidentiality. this has increased the burdens on manufacturers and require significant efforts to resolve. we want to ensure high quality drugs. shouldn't this be done to rule making? i will pause here to say this is the first time in my house or senate career i have proposed more rule making. but rule making rather than a guidance to where there's no way to look at impact of small
business and those involved can't respond to comments, that which to me seems very important. >> well, both of those, the regulation you mentioned first and then the draft guidance that we have issued some time ago in quality metrics, we're -- we're requesting comments. it is not actionable. it's simply requests for comments. so we did receive a great deal of comments on both of these. and we are in the time of digesting the comments and take appropriate steps after we have gotten feedback. but we have gotten a great deal of feedback from the quality metrics draft proposal. both in the innovator industry and the generic industry. and actually it's one of the few times where they appear to be united in their opinions. so we will certainly take that into consideration in what we do next. >> i appreciate that. i think most of the questions
that i have here have already been asked by members. the definition question that was raised, i think, by senator murray in your testimony highlights this submission quality. and the question was have you made public guidance or otherwise in standard for what quality submission is? when was that released or have you released that? >> well, it's a whole series of different guidances, for example, we issued products specific guidance. if you're going to copy this inhave to they or tvo thave toh. >> how many folks are in this?
>> guidance development? >> how many are interested in 2015 and everybody left behind and those in the future? how many people you got what, a thousand people doing this or -- >> yeah, there are maybe a thousand people in the office of generic drugs. there's maybe 800, 900 people working on this in pharmaceutical quality. and then our inspectors, we added 70 new inspectors to do some of these foreign inspections and stuff. so the program is probably perhaps 3,000 people in all. >> appreciate that. i have 30 seconds left and will yield back to senator franken who needed more time. >> it's going to take me about 25 seconds to recall -- so i will yield my time. >> thank you for this outburst
of bipartisanship. senator casey, doctor woodcock, thank you for your testimony and for your service. i wanted to focus on an area that i know you spoke to, but i'm not sure this specific question was asked about the so-called, we have to be careful with acronyms, r.a.m.s., risk assessment management strategy. and the safe use -- the question i have is when you testified about the challenges and implementing a shared evaluation system, can you outline for us the challenge that you face, if any, and i assume there are proposed solutions.
>> well, when congress in the fda amendments act put together r.e.m.s., risk evaluation management systems, we approve drugs if they are particularly riscy. if we go generic, the generics need the risk system around them. and congress in order to increase the burden on health care said that if at all possible, it would be an interesting shared goal r.e.m.s. among the innovator and competitors. this is proven to get competitors to work together so that the competitors can get a marketshare from the inhave to they or the and has proven challenging to get that done from the fda. and that delayed access. in addition, the r.e.m.s. program may restrict who gets
the drug. and that has been used as a -- excuse or whatever to not give the drug to the generic so they can compare it to their drug. so all of these have caused barriers and delays in getting generics on the market. more broadly, though, the companies on their own behalf have strict programs that we don't really understand. but they aren't related to r.e.m.s. we have over 100 inquiries from generic companies who can't get ahold of the innovator drug to compare their drug to. we have done everything we can to -- we have written a letter saying that, you know, that r.e.m.s. doesn't require it for this purpose and you can give it out and so forth. and we refer these to ftc, but we still continue to get complaints from generic companies that they can't get ahold of the drug to make the comparison they need to do. >> so that's the basic -- i want
to make sure i understand the problem you face. why has it not worked in your judgme judgment? what's -- >> i think the innovator companies feel it's their duty to stockholders to stay in competition as long as possible. we get citizen petitions and all sorts of things to delay generic competition. and this is yet another opportunity. >> what would you hope that we would do, if anything? >> well, the part of the r.e.m.s. provision that requires a single system. it's a practical matter. they want the generic system to have a separate system and equal. if that is removed from the system, potentially we could just go to that and not have a delay involved. however that won't fix the
instance where the innovator company actually is not providing outside of r.e.m.s. so just have a way of, you know, not providing the drug to the generic company. and i think that would require discussions. >> thanks very much. >> thank you, senator casey. senator hatch is next but nobody will mind me saying that it is not often a united states senator has a chance to introduce a significant piece of legislation and 30 years later see it be successful as this has been taking the number of generic drugs prescribed from zero to 88% of all the prescription drugs. so we welcome you to a hearing on your bill. >> thank you, mr. chairman. i'm happy to do that. it was a real battle in my office between the generic industry and the pharmaceutical industry. the phrma companies and at one point they both jumped up, all three of them, and decided to
ram out of the office. but two of them, they got to the door and two of them got there at the same time and got stuck in the door. well, we all started to laugh and i said, come on back, and they came back. but there was a point when i said i'm going to kill both of you. there were three but two of them got really bad and i got irritated. i had a bad tooth at the time and that aggravated it at all. to make a long story short, we have been very pleased with t henry who deserves a lot of time for cooperating on this. at the exception of the generic drug program received in 2012, there were approximately 2800 generic applications. and the average approval time for an application is 30 months. going into its fourth year and
the $1.2 billion later, the backlog increased to 4,000-plus applications and the average approval time for an application has steadily risen from 30 months in the fiscal year in 2011 to 48 months in fiscal year 2015. now this is eight times longer than the statutory six-month review time called for by the hatch-waxman act, which is one of the bills i feel very pleased about. further, since 2013 the number of approvals show a declining time in approvals in generics in 2012 and 535 in 2013 and 246 in fiscal year 2015. a critical in the first generics
are usually the opportunity for them to be approved on the earliest date, as i understand it. it is staggering to think of the savings 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 work that you do. you do a terrific job. and i recognize it. but would you agree that this backlog can save low generic drugs off the market and reduces competition? >> yes. >> i would you would say that. going back to the start of this -- >> we have already acted on 82% of communicating with the
company on 82% of those. >> okay. how many applications referred generic products has the agency received since -- >> that i don't know. we can get back to you. it is about 15% of the workload and we expedite all those. >> how many first generic applications have missed approval at the earliest possible date over the last three years if you have that knowledge? >> i have to get back to you on that, too. it's a small number, though. >> okay. we submit to the record the target dates pending for the agency. without naming the applicant and the associated reference products. that would help us up here. >> we can do that. >> how does the fda track prior applications such as those associated with public health needs, drug shortages and first generics? and what is the average approval time for these critical
applications? >> we track them through our new i.t. system and we have project management over all these applications now. so we have a project manager aware of each one of them and making sure it moves properly through the system. and we can get you the numbers. >> well, thank you. my time is just about up. mr. chairman, may i make kind of a statement here at the end. >> yes. >> the reason hatch-waxman was essential, there were only 16% to 18% of generics on the marketplace back when we did that. today it's approaching 90%. and that has been a very good thing. however, some people played the market, too. and have distorted it even with regard to generics. we want to get to the bottom of this. and i personally want to thank the chairman and ranking member of this committee for coming into this and i intend to help
him every step of the way. i also want to thank the fda. it's a hard job and you have all kinds of pressure on you. you have all kinds of comments and screaming and shouting about these things. and we don't give you enough help to do it. we also know you need huge facilities with 30-plus offices all over the area. so all i can say is i hope you keep going because the generics are absolutely critical to this country. and critical to our federal budget. and absolutely credital to the successful portion and reputation of the fda. so hopefully if you see any changes in hatch-weather
conditions wexman and other bills let us know. >> i may have made a misat the same time misstatement, dr. woodcock. what would be the accurate way to describe generic drugs? >> i believe there were some but they were not uptaken because of quality problems as well. so -- the program that was put into place improved the quality and acceptability of them as well. but there were some generic drugs at the time. >> okay. senator murphy. >> thank you very much, mr. chairman. welcome, dr. woodcock. thank you for your service. a comment and one question. the comment is just an extension on the point that senator warren
was making. i am hopeful that we are going to spend some serious time and attention to this question of spiraling drug costs important for consumers. it's certainly important for the federal budget. but i agree with senator warren we won't place too great of a share a blame on the regulatory process. there are certainly efficiencies that we can gain. but i agree with her and think it is worth restating that what is exceptional about the united states and the way we structured the 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 capping and controlling drug costs. the result of that is that american consumers and the u.s. government bear the lionshare of rnd costs for the entire industry globally and the rest of the world consumers are free riders. second, and more difficult to talk about, is the fact that if
you take a look at the 16 publicly traded companies that sell 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 rep search and development. and that's 2014 numbers. we certainly have discovered and dispensed life-changing drugs because of the profit mode built into our system. but those are pretty stunning numbers. my question is a very specific one. you, i think, ended your testimony with a set of challenges and barriers. one of those that you outlined was this problem in which we don't have a convincing bioequivalence test method available. and i think that's worth exploring a little bit. you've got money to try to develop those pathways.
and so you also caution us that it takes time. so can you tell us a little bit more about the timing of that research, how we should judge its effectiveness? and then to the extent that we have been successful in getting another $2 billion over nih, what's the degree of cooperation with nih? what more can they be doing to try to solve this problem? >> thank you. nih doesn't typically do this type of research. this is very applied research. and what we're talking about here is that drugs that aren't systemically absorbed and go through the blood are hard to determine whether they are bioequivalent to the innovator drug. so that would be all the creams and lotions and different topical agents. as well as inhalation drugs. and then we have a new category of very complicated drugs out there that also are going to
pose problems in characterizing them and making sure they're the same as innovator, kind of similar to the biosimilars problem. the research we're doing, you can judge if it's going to bear fruit because we would issue draft guidance and the draft guidance would have a new b bioequivalence test in it. we might do workshops in that and other things to get the scientific community on board. but we would say instead of having to do clinical trial and all that entails, imperative clinical trial, you can use this bioequivalence test. you put the cream on these people and the other cream -- maybe their other arm or whatever and measure something, whatever you do, whatever we say, and that would stand in for the bioequivalence results. and that would really improve uptake in a generic competition in these areas where they aren't systemically absorbed drugs.
>> forgiver my ignorance, but these are for classes of drugs, types of treatments or for specific drugs and treatments. >> it would probably be for drug classes sometimes and for specific drugs other times. >> and do you have enough funding to get to where you think we should be five years from now or ten years from now in terms of the amount of guidance necessary to keep up with the pace of tech nnologica change in these drugs? >> i have to get back to you on that. we have invested substantial amount, although compared to nih, we have invested $24 million. and we are having a lot of research done. but it takes time as i said in my testimony to get that research finished to understand the implications, translate it into policy and guidance and then educate 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 because it's too expensive or almost impossible or infeasible for them to figure out how to show they are the same. >> thank you very much, dr. woodcock. >> senator whitehouse. >> thank you, chairman. thank you, dr. woodcock for being here. i'll continue on this same theme. it strikes me -- let me put it this way, i'm not an advocate for government price controls, but it does seem to me that there are circumstances in which very clever people have either observed or created a monopoly for themselves and then used that monopoly power to extort prices that the market wouldn't support if it were actually operating correctly. and it seems to me there's some pretty obvious signals of when that might be taking place. to me it's not a determined
factor but a red flag. if pharmaceuticals are in the business of speculation, that aught to put up a red flag to me. if a price hike is beyond a certain amount, let's say 1000%, not fully determined but maybe that should end up a red flag. if there are no alternatives to which a certain set of customers or patients can readily turn, that would seem to be part of the monopoly posture. and i'm wondering if your organization is looking in any way at trying to define where the marketplace is taking place or saying, these are red flags or if you see that as somebody else's job. >> well, the report issued yesterday on some of those pricing issues around
pharmaceuticals next to some of those issues. and the economics, i believe, are better suited than the fda. as i said, we are doctors -- >> not looking at that. >> we look at the sole source. because that's a red flag that there could be a shortage. because there's only one manufacturer. and if something goes wrong, that's a big problem. and we also -- if you could show that -- >> from a shortage point of view opposed to a price manipulation point of view? >> yes, that's right. if you could show the bar chart. yes, we look at those that have few competitors, okay. so some of the ones in that chart there where they only have one generic, that could be the only drug on the market. actually, the innovator may be off or there are only two or there's two. those are areas where there isn't a lot of competition and where there could be a shortage or loss of product. but we -- >> it just strikes me if we
correctly define the characteristics of the bad behavior that everybody sees and acknowledges exists, then going the long way around to try to figure out how your drug approval process can resolve that problem is a very inefficient way to do that. so right now the problem is, speculators don't have drug competition and create massive price increases. if you say we're not going to allow that any longer, people go away and find more productive things to do with their time. let me ask you a different question entirely. we have had conversations about the device regulating side of the fda. and about drug regulating side of the fda and about the need for there being new track in the fda for drug device combinations. and this committee is obviously 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 price combination would look like? what is your recommendation to us for that? >> well, i believe that the fda is ready to work with the committee on this and we're very interested in looking at some solutions to this problem. >> have you proposed any? >> i don't know that we have proposed specific legislation. and i don't know where the administration is on that. however, i would say from my own technical point of view that it is a problem. we need more clarity and probably need a different path. >> both you in charge of the drug side and the device side have both said the same thing to me, which is you can't do drug device combinations using our process. there's got to be a new process that emerges. so do you think it would be wise for you on the device side to sit down and spend a little time making a recommendation to us as to how you think those drug
device combinations might be best regulated? >> certainly. we have had numerous conversations about this with our colleagues at devices and in the combination products and gone through multiple scenarios. so i think we would be very eager to discuss it with the committee. >> the a proposal from the agency that would be obliged to implement it would be helpful to the committee. thank you, chairman. >> thank you, senator white house. do you have any further comment? >> no further comments, but i want to thank dr. woodcock in your expertise in these questions. this has been an excellent hearing and i look forward to working with you in a bipartisan fashion to move forward. thank you. >> thank you, senator murray. and let me add my thanks to you, dr. woodcock. that is a -- i mean, you've been there 30 years in one position or another, but it's hard to
imagine there would be a more exciting time than right now given the rate of innovation. you have a -- we have the logical tension that exists between prices, safety, effectiveness and then incentivizing and encouraging a supply of new treatments and cures and devices that will save lives. we're talking about the next generation of cancer treatments and innovative therapy for als and infectious diseases. we have seen what's happened with hepatitis c and cystic fibrosis. you have had a role in all of that. we know and are told in alzheimer's that if we delayed onset for five years that could save our health care system $367 billion by 2015.
and the grief and the anguish is inca incalcuable. so my hope, at least, is while we are working on safe and effective ways in the market to keep prices as low as possible, that we don't do anything to disencentivise this. members may submit additional information if they would like. the next session in our committee will be an executive session on february 9 to begin the step by step process to produce legislation. there will be several bills considered with amendments. these are all bipartisan bills in that sense they have been
spon ssored by members of our committee on both sides of the aisle. perhaps they could grow into the 21st century curious package that the house has already passed. the president is vitally interested in what we're doing with precision medicine and also now with his cancer initiatives. we welcome the administration's input on that. so we look forward to february 9 and we thank you, dr. woodcock for coming today. the committee will stand adjourned.
saving lives by anecdotes. and also treating addiction. we are trying to encourage better addiction treatment or additional treatments on the market. they are underutilized. and they actually have very effective for some people. so that broad strategy is where we'll be taking a lot of actions. >> talking about the hearing today, do you believe that you have all the resources you need to maximize your competition? do you feel like there are other steps, legislative steps they could take? >> the congress hasn't vested in the fda authority to oversee or have anything to do with drug pricing. we know that we have no authority in that area. but we are charged with making sure that products that could get on the market get -- are developed and then reviewed as efficiently as possible.
and we have the huge strategy on that. i believe that we have sufficient resources on the review side now. and hopefully on the inspection side. we're still working on our inventory. senator roberts or cassidy was asking me about that. but the research side we're going to get back to them. i mean, that is a question. it could be a very large research agenda. because we have -- not only do we have the nonsystemically absorbed products and we need different equivalence methods, often a different one for each one, but we have the xlecomplex drugs. and we are seeing more and more oz who have the. we have approved heparin and a generic to -- that took a tremendous amount of effort, but obviously it was a benefit or the consumer. so i think that was a good question they asked us. do we have enough resources to carry forth the anticipated
workload of research and effort that we'll have moving forward to continue to be able to approve these. >> when talking about clearing out the backlog by upping this, you said absolutely to senator hatch that this would be cleared out. >> yes. >> why so certain? >> well, we have to take first action. that's a commitment under, what, 90%? >> by the fiscal year. we are already at 86%. >> we are at 86% now and have two more years. so there will be strays. that's why we never have a 100% goal. there will be a stray here or there and some policy reason or another unknown reason we can't take action. we are blocked by some patent dispute or different things like that and we can't help that. but we know because of our performance so far that we're going to achieve that goal. >> i'm sorry, you say 86 right now, in the hearing, i thought
you were talking about 82? >> it depends on what you count. it's 84 if you count just the original applications. it's 86 if you include the pre-approved numbers. but those numbers change every day because we are really cranking out -- i understand the senators frustration because of the performance of the program the last several years hasn't been -- we gave all this money, why didn't we -- we redid everything. we redid everything about the program and built it to modern review process. and we are just really going to crank the next two years, i have no doubt. >> do you think that the fda should, i mean, you were talking about there's a bright line here, we shouldn't be dealing with price, but as price becomes a bigger and bigger issue nationwide, do you think the fda needs to expand? >> no regulator similar to the
fda in the world is involved in that way, okay? they have separate entities that are tech assessors and others that manage drug pricing. so the regulators -- however, what i told one of the senators, if they give us directions to prioritize in a certain way based on certain criteria somebody else develops, we could do that. but we can't -- you know, it's a slippery slope to get us involved in that part of it. we need to stick to the science, i think, in that safety and effectiveness and the level playing field and the fairness. we are thrilled the other part of the generic review process, we don't talk about much and didn't put statistics in the legal maneuvers from approving generics. and that's a very massive workload. and if you have ever read any of