diagnostics for bacterial diseases. and talked about moving the needle in monetary terms for companies by a reduction of the time for clinical trials. correct? >> yes. >> is it really possible to move the needle on that? >> well, i believe for the, say the limited population antibiotic development use, that is possible. that's only one factor. but if you have a very high bar getting on the market then you need much stronger incentives for, i believe, for those very rare resistant organisms, we could have very small development programs and that there is societal agreement that having a treatment available for those is better than having nothing. so we could have strong development programs. we could say to the clinical community no that this is different. no that this didn't is a huge development program.

we're offering a tool but you aught to beware, and be a stewardship in this tool. we have worked with new guidances to try to lower the cost of a development program. so that the pipeline can be, you know, more robust. >> you know, on the issue of judicious use and stewardship and i hear the words that are set on that. but you know, you talk about using things outside their area of indication. we tend to think of the world in which we live. but i'm from texas and i'm just a little bit south of texas there's a dirent world where there is not a prescription requirement and you simply go to the pharmacy and say, i need this. and the pharmacist may direct them to a particular drug or may just simply come in with a

recommendation from a family member and make that purchase. so it is an obviously harder to control that with the jurisdiction of the united states where it is happening right outside. is that correct? >> totally agree. everybody is outside with modern air travel. and so we are getting soldiers back from combat to have acquired very dire resistant infections. we have travellers coming back in the united states that is many countries with anti-microbials that you use freely available to consumers without intermediate areas. we want to put the oldest on the doctor, treating a patient in the emergency room, with a kid and concerned family. and putting the illness on our physician here. none of those constraints exist. i agree with labelling. i agree with making the

indications well known. and tried to put the federal government in the second-guessing the judgment of a physician. >> and we agree with that. because treatment is empirical, we can't indicate, you know. it has to be suspected. and you know, you can't say -- you can't treat a patient because this wasn't studied in clinical trials if there is nothing else available. or if clinicians, as you said, must use best judgment when a patient present before them. we agree with that. we want to give the best directions and information to the clinician so they are aware of not only what clinical situation they are dealing with, but how much information pertains to the drug and what kind of drug it is. >> okay mr. chairman, i will yield back. >> thanks, gentlemen. i now recognize the gentleman from texas. mr. green. five minutes. >> thank you. it is a pleasure to have you before our subcommittee.

i want to commend you and the fda on the efforts for the gain act. i know at left two drugs have been released. i want to thank you for your efforts on the adapt act legislation. i co-sponsor it with my friend. in talking about large clinical trial design, can you tell me your thoughts on how the unique nature and incentives or disincentives in the antibiotic space can makeprohibited? >> certainly. not only is it hard to discover new antibiotics, it is expensive to develop then. the reason is, it is what dr. burgess was talking about. you have a patient before you with pneumonia that could have all sorts of different organisms causing the pneumonia. without rapid diagnostics, you don't know what is causing the pneumonia. when you're trying to do an

investigational drug, have you a sick person in front of you. you have a prolonged consent process where you have to have informed consent. people are not going to wait often to go through that process to start a sick person on antibiotics. and so then we have the issue there pretreated with different things until they get into the clinical trial. and then you have all of the headrojenaity. it is not fair to have the noncomparison group with no treatment. you have to do the comparison trial, and those are called noninferiority trials. you want to show you are statistically as good as. so those challenges tend to increase the number of people enrolled -- needed to be enrolled in clinical trial in a

very large number. they are hard to get, hard to enroll. clinicians off t clinicians often don't want to take sick people and get them in a clinical trial. >> the scenario where more trials may help develops seek and create the next antibiotic effective against drug resistant bacteria, can you tell me how the act may pursue novel antibiotics? >> yes. we envision that you can trade-off like the medical need, and we do this in many cases, so if you have a tremendous medical need, people will die quickly and you have nothing to treat them with, then you accept a lot of uncertainty about the estimates around safety and effectiveness. in exchange for something that may work for that patient, right? that means can you have shorter, very small development programs if the need is huge.

on the other hand, if we're talking about another drug for pneumonia, not talking about that. we're talking about resistant organisms. where there's really very little. and we actually think there are multiple development programs that could be done depending on this level of need. in some cases, you may only have ten infections in the united states a year of this certain organism. in other cases, you may have hundreds. can you get more robust program there, right? but then you're exposing more people when you approve the drug because there are hundreds of people, maybe thousands of people out there, having the condition. so you would basically match the development program in the medical need together. and put that together. but then, we would like to have a very strong signal or symbol or whatever. not of a fearful significant until or whatever, but informative signal to the clinician that the drug had gone through this kind of development pathway. so they would understand that.

>> thank you. and i hope, you know, with this hearing today, we could move the adapt act across the line in the future. in continuing weeks and months, i plan on continuing the i do log. including with our panel today to strengthen this proposal and complete the next step in fighting our public health crisis. i want to thank you and your staff for your hours spent working with our offices during the august recess. and i know we can continue that effort because this is important. again, thank you for being here. i yield back my time. >> thank you for your leadership. >> thanks to the gentlemen and i recognize the gentleman from new jersey. five minutes for questions. >> thank you very much, mr. chairman. good morning to you, dr. woodcock. >> as members of the commit oo we hear the firsthand for the need for greater innocecentivei. >> some of the witnesses on the

second panel have recommended a wide range of incentives that would encourage greater development. do you believe that incentives we identify in the antibiotic space might also benefit other areas of unmet need, such as rare diseases? >> well, as i said earlier, i believe that there's a trade-off between the incentives you offer. there's always some trade-off there. and there are various orphan diseases that for which there are many for which no development is occurring. so i think that you have to determine whether, you know, those trade-offs. economic trade-offs. and i'm not qualified to say what is the right course. i think that's the position that congress makes those decisions. however, i can tell you that anti-microbial development is urgent and a public health

issue. the orphan drug says people are suffering from those. have a tremendous need for therapies to develop -- be developed and many, many are not being developed. we are doing things such as working with the national organization for rare diseases and so were to get better natural history studies, that would innocentvise and make it easier for the court of this orphaned disease. and what's needed to study it. however, there is still major financial obstacles. >> thank you. as you know, i share the rare disease caucus on the republican side. and i have in my office virtually every week parent of children who suffer from rare diseases where there are no medicines at all. and as a society, we have to do a better job. i've read the testimony of those on the second panel. and i hope we can move forward and you say you may not be qualified but i think you are one of the great experts in the

country on all of these issues and we look forward to working with you in that area. >> yesterday, the president announced an executive order on the five-year plan to combat antibiotic resistance. what role dr. woodcock will the fda play in helping facilitate the president's order. >> yes. we have been working with the planning group on this. and the fda has a wide range of responsibilities. ef everything from animal health and those issues. surveillance activity which are done of anti-microbial resistance which is primarily cdc lean but fda for example, the norm system which is mentioned in those reports, which monitors anti-microbial resistant organisms in food and so forth. and these things are intended to be strengthened. in addition, we will work on a

better doubling our efforts to innocent advise microbial development and an interest in better diagnostics put out in the report. >> thank you. and may buckwell win all of its games in autumn, except of course to lehigh. >> thank you. now recognize the gentleman from illinois. five minutes requested. >> thank you, mr. chairman. >> it is good to see you back here again. but i think you're being too i could. the business model to whether it's going to be in diagnostics or testing, is the same business decisions that we make in our home.

it is simple about risk and reward. >> aep so, what the reward and what is the amount of risk. aep i think that you all play a big role in that. >> and i'm very excited about this debate about the diagnostic space. and in the opening statement, i today go on to the world wide web. technology allows us to know. pastor born in 1822, certainly, if they can recognize our test prague seed urs now, we've got work to do to ramp it up, i think. and that's the whole, by a similar debate, and the genetic markings and all this other g gnome stuff that's going on, so i'm very, very excited. also, i've been involved in helping along with following dr.

gangry's lead. and i look forward to working with gene in the next congress and we are having discussion dose that. so you have the same questions, right, from us. so i think that what we really want to do and we'll hear from the next panel, is let's get a handle on this risk and reward. and i'm not so adverse to innocentadvising the private sector, in going through the process and helping them do that. than they taken a then go and, you know, and places that no one else is going to go. >> mm-hm. >> so one of the first questions was, as you have seen companies leave the field of antibiotics, are they small, medium or large? how would you classify them? >> well, i would say that the larger companies, most of them,

have left the area for bet are pastures, so to speak. where they see a business model return on investment. and similar with many, the medium companies. there are many small start-ups trying to get into the anti-microbial space. they may have one product they are trying to develop. >> and we have talked a lot about the adapt act today. and there's been success in that process. do you think there's additional things we can do to inventvise, like the adapt. what other things can we bolt on to encourage additional incentives for the adapt act or other processes we are talking about. >> well, i think you have to think about what are the alternatives, all right? i know there is some government development. there is government awards, usually under contract.

for certain entities. and there are few of those. but what is the -- what are the other ideas to develop a robust, you need drug discovery effort. that means people, scientist, working full-time in laboratories trying to figure out the new molecules. this is way before you get tested in people. and it doesn't involve the fda. what i understand from the community is anti-microbial discovers become hard. and i didn't know that until i talked to them. that they've screened like, large numbers of molecules and this pathways and so forth. and it's harder, it's hard to find the new generation. and so, that means a very robust scientific effort has to go on and a basic science of microbes and also in discovery of these new molecules. and do that, somebody has to have the faith that they're going to make money from that.

10, 15 years hence. okay. and they don't have that faith right now. i can tell you. so i don't think whatever has been done is enough. because you have to consider, if it's not commercial development, how is it going to happen? where is it going to happen? >> and would you help us as we go through this process, help us, this committee, identify ways to help innocentivise? >> absolutely. >> because you are helping with these people. and with this labelling debate, where i understand it, we also went through this debate with the paper labelling and information on pill bottle s s a that -- labelling through the web and labelling through, there has to be a better way tan just keep putting stickers on the pill bottles and things. and i would like to be -- that's

just a statement -- >> can i respond to that? >> the centers for drug says working on developing a patient information leaflet. a one-pager that you get either electronically or at the pharmacy that tells you every other country has this kind of thing. that tells you how to take the drug, what it's for and so forth. but we have proposed and we are interested in going to an electronic physician label. which is the thing that's folded up inside the pill bottle. we would like to move that to electronic with paper options for those who are still electronically impaired. shall we say? but most of the world can easily get that information at drugs at fda, at many other sites. >> thanks, gentlemen. i recognize the gentleman from florida. five minutes for questions. >> thank you, i appreciate it. thank you for your testimony, dr. woodcock. we ask questions. we submitted questions for the record in nop november and tove.

and i want to ask one question again. can you tell me how many treatments were used for the first time and within the last five years have any approvals, and with the marker, and never been before treated before within the last five years. and mou many markers with the fda used within last five years if you can provide that answer. >> we are working very hard and that is a very provocative question. and what we had a very long debate last week among the senior people and the definition of the biomarker. and which of the end point, such as fev-1, which is how fast you can breath into the machine, is that a critical point or biomarker? clearly in my opinion, it is a

biomarker. but not everyone agreed with that. so we are working very diligently on that. so the answer is yes, we have approved a large number of drugs on biomarker point all the time. and a very significant portion of a drugs don't approve. and there are novel ones. in the last five years. but to get you the count was more effort. we today resolve the definitional issues. >> where did you think you might get answers? >> i'm not in control of that timeframe. and i believe you will get this response. >> we will continue to follow up. >> there so good question, it really provokes thought internally. >> thank you. >> there was approximately 450 million in direct funding in fiscal year 2015 antibiotic crisis. this was across the dhs, dod and usda. about 75% was used for basic and applied research.

with the rest directed toward stewardship and surveillance. how do they coordinate their reference? >> there is a long standing anti-microbial task force at the agency level across the government. that was headed at hhs and fda has been a part of that. and the formation after higher level task force. that will direct the implementation of this strategy that was announced. that has long been coordination across the government agencies. and i believe the report discusses that. >> okay. on this, how is the u.s. coordinating with the world health organization? and they are working to come back the resistance. >> and we do have, we know others have relationships with world health.

we think the executive order yesterday and the strategy conceives of much tighter collaboration with who in a very concerted way. >> thank you. >> now recognizing the lady from colorado. >> thank you very much, chairman. i think this is an excellent discussion and i just wanted to ask you to clarify one thing, dr. woodcock. and on the next panel, talking about the report on initiatives by the eastern research group. and what that report concludes is that shortening clinical trial time frames is an unlikely contributor to innovation. we've been hearing counter arguments to this that without something like the approach taken in the adapt act that i'm

a co-sponsor you've, it isn't feasible to do drugs that create the most serious pathogens. so from that per spekspectivper may not have the most sufficient antibiotics. but it would also need to be paired by others -- be paired by other incentives. i'm punder wondering if you will give your issues. because i'm even wondering if we should go forward with the adapt act. >> there are barriers to apt eye microbial -- drugs for anti-microbial resistance. i do agree that i think theeye microbial -- drugs for anti-microbial resistance. i do agree that i think the i think the stream lining of clinical trials, streamlining

organism, will stimulate under that area. why? partly because developers have told me that. part two because we know from experience that if we have a clear path to market and people understand that, they are willing to put their money down on a kind of bat, that they will have a molecule that can get through. but there is clearly not sufficient. number one, we're only talking about the most resistant organisms here. in a small cadrey of drug to treat them. we also need a robust pipeline of discovery that will lead to new drug candidates for all kind of infections. so if the limited population idea and a streamlining of clinical trials which wouldn't just decrease the cost and you know, the number of people needed, so it would do a number of things. that is one thing that we can do at fda that we think would be

beneficial and be beneficial for patients but it is not going to fix this problem we have of investment. >> thank you, there chairman. i yield back. >> i think that concludes this round of questioning. we will have follow-up questions i'm sure from members. we will send them to you and ask that you please respond. again, dr. woodcock, thank you for being so forthright and clear in your answers. and we will now take a three-minute recess as we set up for the second panel. >> thank you. >> the subcommittee will reconvene on our second panel. today we have, and i'll introduce them in the order they will make their presentations.

first dr. kenneth hillin. chief executive officer of cajun. dr. barbara murray president of infectious disease society of america. third, dr. adrian thomas, vice president of the global market access and global public health jansen public services. and kevin adder sop, professor of law, boston university school of law. mr. alan cookel, drugs and medical devices of the pew charitable trust. and dr. john powers, assistant clinical professor of medicine. george washington school of medicine. thank you all for coming. your written statements will be made part of the record. you each will have five minutes to summarize your testimony. we will begin with dr. hillan. you're recognized five minutes to make your opening statement.

>> thank you. good morning and thank you mr. chairman and members of the committee for inviting me to testify today. it was heartening to hear the recognition of the work of alexander pleming, my fellow countryman. not only did he discover pepeni i'm chief executive officer we're a member of anti-microbial innovational lines. coalition to direct challenges we have heard of today. this is one of the most significant challenges our country faces fopd we are committed at trying to find solutions. our lead product candidate at which is engineered specifically

for multiresistance is in phase 3 clinical trial and patient with -- and considered to be our last line of antibiotic defense where antibiotics are no longer active. the trial is a superiority design for a reduced number of deaths in-patient. the best available standard of care, which unfortunately is not very good today. we have also developed the dying note offic used in the phase 3 trial at the blood levels to help individualize dosing for patient which we believe will help outcomes. the corporation of the diagnostic has close consultation and coordination with the drug and diagnostic of the fda. we find it to be extremely collaborative and serves a. >> a model for how the fda can serve with antibiotics and setting of urgent medical needs. the program is also benefitted

by receiving the first contract awarded through the broad spectrums programs from the research and development facility. this contract is designed to help advance plas plasma miosin. however, even with plasma miosin and a great team and the pipeline has successfully significant government support it has not been easy. and there remeans significant barriers for companies developing antibiotics and we can and must work together to address obstacles for effective antibiotics will be available for patient. we would like to propose significant changes in four key areas. first we believe new economic incentives are key. there is a need for reimburse the for antibiotics and additional incentives. the economics of developing new antibiotics is not currently attractive to the pharmaceutical industry and many exited from

that space. this is likely to decline in the approvals and harolding increase in antibiotic resistance. commercial returns for antibiotics are limited by the fact that the antibiotics are cheap. new antibiotics are used sparingly for use. hospitals is limited fixed payment system intended to cover the total cost of patient care and because longer term returns are by the unavoidable development of resistance. other areas such as die boaties and pharmaceutical companies have much better return on their investment. the act sponsored by pete and danny davis is reinvestment for qualifying product in the hospital setting p. we believe this would provide a powerful incentive as currently the payment is the same regardless of the price of the -- so they are innocent advised to use the cheapest but

not always the best antibiotic. with separate reimbursement for qualifying, eliminating an important barrier to the use of more expensive antibiotics. we would like to see reimbursement for qualifying and antibiotics extending beyond medicare and medicaid patient covered by private insurance. second, the fda needs authorization for greater flexibility for approval of antibiotics based on limited sets and we heard the rational for that today. plasma mio ss sin. and it demonstrates statistical immortality and the relative of these infection times the enrollment period for this study expected to take three years. in contrast if europe, guidance extend for flexibility in this scenario of unmet clinical need and does not require testing for antibiotic approvals. in forward new drugs to be

available ahead of the emergence of numbers of drug infections congress must enact legislation that authorizes the fda for limited patient populations paced on smaller clinical trial data sets but where the totality of the available evidence support favorable benefit risk profile for the antibiotic while acknowledging and reflecting the greater uncertainty with limited testing and product label. supporting passage of adapt for fda with increased flexibility that we believe it needs. >> third, there is a need for more rapid point of care diagnostic test and streamline approval path for diagnostics for serious infections and delay administration of the right antibiotic by just one hour significantly increases patient mortality. traditional diagnostic test as we have heard, 72 hours to complete. and we believe the federal government could make a significant impact by providing support and incentives for the development of rapid and cost effective point of clear

diagnostics that advance antibiotics stewardship and clinical care. there is also an opportunity to streamline the process for development and diagnostic tests. there is a need for expedited and approach to diagnostic development an approval through regulations that are anchored in consideration of the urge ncy o the medical need for patient. regulation should provide the fda with flexibility to streamline the required analyst cal studies as well as testing related to quality, manufacturing software and documentation for the diagnostic device. and fourth and finally, sustained funding for research and development we must be prepared to take a long term perspective in toward fully realize the health benefits from increasing funding and anti-pie oughtic research and development. the occasion from satisfying from the department of defense have been essential and we believe it illustrate how public-private partnerships can

successfully advance anti-bacterial research development. we support increased funding on an ongoing and predictable basis for broad spectrum program and expanse of bart to allow investment and program design a number lick health threat. we also support continued funding through nih and anti-bacterial at discovery development. we appreciate the opportunity to contribute to the discussion today and strongly encourage congress to take additional measures to mitigate the very significant public health threat by ground negative bacteria. >> chair, thanks to gentlemen and now recognizes dr. murray, five men fourts opening statement. >> thank you very much, mr. chairman. thank you for inviting to testify on behalf of the infectious disease in america. and on the public health crisis of antibiotic resistance and need for antibiotics and diagnostics. the subcommittee's continued leadership and the issues.

and with very serious infectious and all or almost all antibiotics. for example i saw a young woman with severe lupus and autoimmune disease with a very painful bile duct infection and surgical interventions and the infecting bacteria invaded her blood stream and developed resistance to every antibiotic available including toxic antibiotic usually of last resort. finally, all we could do is palative comfort care while she waited for the infection to claim her life after a very tro longed and expensive stay in the hospital. >> following prosthetic -- >> that despite removal of the joint and multiple antibiotics could not be droenld and he today have an above the knee amputation. two diabetic women with urinary tract infection or uti who had to be admitted not because they

are seriously ill but because their infecting organism is resistant to all oral antibiotics. for anyone with a uti with women in the room and some men having to be hospitalized for such a common infection is inconvenient, and markedly increases health care cost. antibiotic rnd faces significant barriers discovery is hard. scientific challenges lead to very high development costs. economically antibiotics have a very poor return on investment because they are typically priced low. use ford short duration and held in reserve by us to try to control antibiotic resistance. idsa thanks the subcommittee and especially representatives for its leadership and enacting the gain act in 2012 which is beginning to address some of the economic barriers. we hope can you now build on these efforts and address regulatory barriers. bacteria infecting relatively small numbers of patient making

it virtually impossible as you heard to populate ie large clinical trials but we need to develop new drugs before there is an epidemic. think about the fear for ebola if there were already effective therapies. introducing the adapt act, which would address this regulatory conundrum by allowing fda with antibiotics with smaller trials. this would only be to treat serious infections where there is an unmet medical need. adapt would make trials of highly resistant bacteria feasible, less costly and allow fda to assess the risk after new antibiotic relative toity potential benefit to this limited population. idsa is deeply concerned that without adapt many of the most urgently needed antibiotics would not be brought to the market. the strategy of a limited approval pathway was also suggested in the report you heard yesterday. adapt includes safeguard to help insure these drugs are used appropriately and contains important provisions to insure

that is you septemberbility tests, criteria for break point which will predict whether a patient will have a good response to a product is made publicly available. up-to-date information is crucial for clinical care and to be sure antibiotics are not misused or overused. isda urges the subcommittee to enact the act swiftly. additional economic incentives are required. investing in antibiotic research, improved reimbursement and tax cred credit. while new antibiotics are critical, idsa is committed to a multiprong response to antibiotic resistance including a well-coordinated federal lead leadership as mentioned in the

report. stewardships in every health care facility. research on novel strategies to prevent and control antibiotics resistant organisms. these steps are important to protect patient and the public. as you heard, it is extremely important to promote the development and clinical integration of new diagnostics. rapid point of care diagnostics can reduce use which drives resistance by lessoning the need for impuric for shotgun therapy. idsa has diagnostic research, regulatory approval bath ways and strengthening reimbursement and outcome research to demonstrate the impact of diagnostics on patient care. thank you again for allowing me to testify here and for your continuing efforts in this very important area. >> chair, thanks the gentle lady. now dr. thomas, five minutes for questions. >> thank you with be chairman. and members of this committee

for this opportunity to come before you today. i'm dr. adrian thomas from global market access and head of the pharmaceutical business of johnson and johnson. i applaud for for this hearing and commend the leaders in this room for giving the voice of the dire situation of antibiotic resistance p. we admit that the leadership as well as the leader shp of president obama on this important issue and we offer our support for the national strategy announcement yesterday. i bring the lens of a private sector physician for more than 30 years experience from public health for the early career and flying to my current role on the portfolio and product and servicis with high public health impact. i am a clinical pharmacologist and physician by training with additional expertise in a variety of areas under the health care industry. the majority of my 17 years in

the private sector has been with johnson & johnson. as many of you know, johnson&johnson is the world's largest and most broadly based company. that portfolio includes diagnostics as well as consumer products. we have innovation based business and it is critical as you think about this issue we address incentives that apply on a relevant to many different stake holders in the innovation, not just large companies but discovery academic research biotechs and start up and the public sector. and there is across the health care and ecosystem allows unique visibility and the number and statis of projects under way and including antibiotics. and as we consider incentives for anti-microbial resistance we should consider vk seens and diagnostics and if we are truly going to make progress against this terrible issue. our work brings this no proximity with pash wept life threatening illnesses including

patient with these infectious diseases. these stories are firm that we must do more to meet their needs. first and for most we must work together and think different for for therapies. we have heard in some detail today that despite the recent efforts to include it, the innovation climate for antibiotics and other anti-microbial remains optimal. that is in large part because the basic science for this field continues to be difficult with high rates of failure. if failure is no longer an option, given this critical and global health security of the crisis we need to take different measures. and learning lessons from one of the ebola crisis neglected and companies scrambling including our tone provide flu vaccines with unfeasibly short time frames and unfunded mechanisms. >> and vital in the fight

against resistance, current conditions demand we need a new framework for innovation in antibiotics indeed. we have to track the world's best and brights including the private secretary pore. the u.s. can and should lead the world in the conditions we cannot wait for the europeans flishtive to solve the problems for us. and it is our hope that the congress will give serious consideration to must proposals. there is a comprehensive set of push and pull incentive options to antibiotics that address the need for across a wide range of stake holders. we must create a broad set of highly attractive although financially manageable incentives to engage many different biomedical innovative companies large and small in this work including academic networks. and policies can and should be able to take into consideration and costs and risks of this. and o also the cost and risk of

developing and supporting developments worldwide and how those risks are different for different stake holders and incentives must address therefore the different stakeholder perspectives. i would like to talk about this exclusivity. and on the in-depth analysis of the proposals for r & d, it is many different proposals and evaluations and in addition to being an investment committee. and is ebola drug resistant, is diabetes, is cancer a more important public health question and is it also financially feasible for us to bl our research efforts in this area. spending almost $5 billion annually in research and pharmaceuticals these are not easy and have time frames of 10 to 15 years. thinking of the transform market, the notion of an exclusivity that can be provided

towards another product not only gives certainty to the investment made again in high risk areas and also disinnocent advice and the protection of these product an assets need to offer against emerging and encouraging to be never be use. we have to have more shot on goal, more basic research, more discovery and more biotech start-ups. academic partnerships. more companies investing in the in-house facility to recognize and take up assets and conduct the research to develop these product to the mark the place. in conclusion we welcome change in public policy. and thank you very much for your time today. >> chair, thanks gentleman and recognizes mr. outterman for the next statement. >> i also serve on the cdc and

prevention and resistance working group. and at the royal institute for international affairs in london as visiting fellow with chatham house. my remarks today are my own. at chatham house we have been working on in the past year is focused under linkage. and because the business model for antibiotics is broken. for other things that treat and prevent infectious diseases such as diagnostics and vaccine and infectious disease for devices. i have a couple of slides here to look at the business model and this is based on the slides are based on the sudden study done by the eastern research group of which i was a part. and coauthor of that study for the department of health and human services. and the first slide, we don't know in the community needs to see this hon lift we know this is a huge problem. the actual number of threats, deaths on the cdc threat assessment is 37,000 per year.

because they included -- it is huge problem. so let's look at the business model. this is, we're looking at net present value, from a private perspective. this is a company looking to make a decision about whether to invest in a molecule at early stage. this is a decision which tries to analyze for the company and what's the chance of failure in each stage and how much it will cost to advance the molecule through. every company usees a model like this. and everyone might use slightly different assumptions or numbers in it. this is a typical thing done in the industry. and in fact there's an in england right now, using after theo zen ka data, there is another study almost completed which comes out with i'm sad to say, much gloomier numbers than what we present here today. >> so the business model is broken. and the fda and health and human services look at six bacterial indications. it is hard to read, sorry for

that. what you need to see is that the companies were hoping for a hundred million dollar present value. that was the money they would get in return. and you see here on the error bars and on the colored things that for several of these indications they have a negative net present value. they will actually lose money after they build a factory to make this drug. for others, there is a positive one but nowhere near the $100 million threshold necessary for companies to move forward. the red arrow bars, the 90% confidence interval for every single ind kigs and confidence interval including a negative number. so it is really difficult for companies to commit to research programs and that sort of space. and the second thing we are asked to look at is the social present value. how valuable of these drugs to society? now we didn't have speculative numbers here. we didn't look at the effect on reducing resistance. we did model, how it would keep us all working, you know, the

ancillary effectets. we are just looking at the direct cost for society. and yet the numbers we came up with were huge. these numbers are in the billions. the error bar ranges are huge. social net present value for. drugs were two orders of magnitude higher. several billory for several of these drugs. in other words society would be getting a tremendous brg an if it was able to procure one of those drugs, and even a fraction of that amount. >> as a comparison. i compared for each of the six indications the social and private and if you look carefully, you can't even see the private on the same scale. because it's in blue. so small. and it is almost impact possible to see. there's a huge gap here. so i did just one and tried to stretch it out across the slide. and can you barely see the blue. and so, what i did here is i

truncated everything at a hundred million. those red bars go up another 15 feet on the wall, if i allowed them. that the gap between the social and private value. it is a tremendously under reimbursing for antibiotics. we also look at incentives and given that i have 30 second, i will get down to the key chart in which we model which incentives could we change in order to solve this hundred million dollar benchmark. we look at every incentive ever published. i promise you. and then, put them in the different categories and fed them into some model. the short answer, is that if you do something that affectets the cost of capital, it has to be fairly significant in order for it to work. so if we have tax credits or funding it bet are be significant in toward kick in. something on the range of a billion dollars per molecule, coming out the other side.

we're not talking small change, it's large. yesterday's proposal from the the president, i think it is a reasonable number. things that don't seem to work based on the model, we even had unlimited perpetual forever patent p. still didn't get the companies anywhere near the hundred million dollar threshold. you could wo have to reduce by 75%. so adapt can be very useful to bring a new drug to market for the people who need it today. but it should not be viewed as a powerful economic incentive for the company early in stages to decide, how is the moment to grown light this drug. it has a, you know, doesn't have that sort of effect. what the companies need is money. and not the promises of earlier approval. thank you. >> chair thanks the gentleman. now recognizes mr. kukal. five men fourts opening statement.ckukal.

five men fourts opening statement.okukal. five men fourts opening statement.ukukal. five men fourts opening statement.kukal. five men fourts opening statement.ekukal. five men fourts opening statement.lkukal. five men fourts opening statement.lkukal. five men fourts opening statement.ukal. five men fourts opening statement.kal. five men fourts opening statement.al. five men fourts opening statement.l. five men fourts opening statement.. five men fourts opening statement. >> i would like to thank you and the members today. ai my name is alan c oukell. as you have already heard, the dwindling pipeline of antibiotics is a potential public heal mg crisis every one of us will need at least one of these drugs in our lifetime. children and seniors are particularly vulnerable. as are members of the military. one-third of those injuries in iraq and afghanistan came back with an infection, some of them resistant to almost all drugs and among the broader population, 23,000 americans die every year from resistant infection. so comprehensive response requires infection prevention and surveillance and reducing unnecessary use and better doig nost iks.

my focus today is steps to reinvigorate the pipeline. a pew analysis included in my written statement, with 38 drugs, and antibiotics in clinical testing. five of them in advanced development have some potential to treat ground negatives which are the most serious immediate threats. that may sound encouraging but let's recognize just based on general trend that 80% of those won't reach market. they will fail because of reasons of toxicity or effectiveness. drugs now in development have novel mechanisms that significantly delay the onset of resistance. so it can be done. by passion the begin act two years ago this committee has taken the leadership role and gained introduced by dr. gangry and mr. green extends market exclusivity for antibiotics. this gives company a better chance after positive return on investment and insure eps swift fda review of these drugs. that's an important first step and more is needed. especially for the infections

that are hardest to treat. trials of antibiotics are hard because only a small proportion of the population, say pneumonia, has a resistant bug at any given time. so to help address these challenges, dr. gangry and mr. green and a list of cosponsors introduce the adapt act. adapt would create a new fda approval to treat patient with no or few treatment options. this approach called l-pad for limited pop lake anti-back tier yag drug helps streamline development. let me make it concrete with two different scenarios. imagine drug a approve ford range of bacterial pneumonias. some easily treated, some resistant. some has to consider the universe of people who might get it. some of them have lofts treatment options and won't be willing to accept greater uncertainty. now take a second drug, drug b,

l-pad drug, the patient with this infection may well die if he doesn't take dprug b. so the potential benefit may be greater against the uncertainty and the fda in making a benefit risk calculation only for patients like our patient can accept less date kbra under approving the drug. that reduces development costs. to be clear, this does not change the standard of approval. it merely target the specific population that's different from the general pop liegs. for l-pad to work as intended, health care providers have to know and understand that the drug is approved for the population, based on limited data. there is drug labelling and marketing materials. the concept, pew worked with the infectious disease society and stewardship personnel drug companies, health insurers, fda and others and this legislation has the support of numerous and diverse stake holders and

yesterday p-cast also called for such legislation. >> this committee has long understood the threat of antibiotic resistance and has done mch to bring it to the national stage and we appreciate the leadership and continued commitment. let me conclude with the observation that we face many problems and many diseases that seem intractable. this is not one of them. bacterial infection is a solvable problem. penicillin effectively conquered illness for a time. we can get back there if we commit and insure that we do it again. i thank you and welcome your questions. >> the gentleman now recognizes dr. powers five minutes. >> thank you very much, mr. chairman. >> thank you for invite meg to testify. i'm a practicing infectious disease and medical researcher who cares for patients. i was a scientist for almost a decade and co-chair of the inner agency task force.

and i'm a member of the who advisory group. i'm speaking today on behalf of the national physicians alliance. npa is hope to more than 40 medical specialties sharing commitment no patient centered health care. npa does not accept pharmaceutical funding. we believe in the advancement that the research is free and the transparent and peer reviewed. npa's task force to establish our work force and the rigorous fda. and studies of the diseases and a time when there are no effective therapies and the first to use the modern adequate trials today. investigators and members of congress with study edge otds critical and the problems of antibiotic resistance and regulatory response too are not new. the recent book, the antibiotic era with the rise of resistance,

and in the 1950s, and drug companies marketed numerous effective antibiotics based on supposed. he said, quote, properly conducted clinical studies may support the claims and justify the enthusiasm for these anti-microbial agent but it is incumbent upon those of us concerned with the welfare of our patient to wait until such data are accepted to claim any more angant or recommend them for general use. dr. finland made the same point in adding the requirement for effectiveness of new drugs. showing that like with other drugs antibiotic effectiveness cannot be assumed base owned test tube tests or mathematical modeling but only verified that studies with the right questions and right outcomes on the patient who might benefit from experimental drugs. the problem with antibiotic

resistance is the same as it was in years past. the unmet medical need exists in those patient with no effective therapies. the need for treatments is for treatments with improved effectiveness compared to older treatments on the outcomes of decreasing death or irreversible disability, not alternative outcomes. the program describe bid dr. hillan describe these populations and outcomes. drugs marketed should be shown to save lives and adequate well controlled studies and appropriate diagnosics such as those this morning and those in the p ksh-cast report. us is septemberbility cree tiera should be not mathematical modeling. showing those affects in well controlled studies and there for the sample size is how effective the drug actually is. it is edge lick i questionable it expose our patient who have any current effective and safe options to less effective

treatments and robust pipeline or economic stimulus to companies. it is scientific invalid, and patient who disease and organisms and older sicker patient with disease due to resistant pathogens based on assumptions for modeling individual anecdotes. new antibodies require warning of increased deaths compared to older effective drugs and despite promising test tube test and math mall cat modeling. a lack of evidence that this kind of mathematical modeling has been shown in better patient outcomes. preliminary information is not a substitute for clinical studies in-patient. patient who wish to take an informed risk should have access to these drugs through requirements for expanded access under existing fda programs for patient who do not qualify for ongoing clinical research studies as done in the early years of the hiv epidemic to allow access to new therapies while the drugs are continuing to be evaluated in adequate and well controlled studies prior to

widespread marketing. fda labelling should reflect the types of pearl harbor ept who benefits. se patients and formation used as the basis for approval. telling commissions the drug has not been studied probably does not help. our written testimony provides our plan for a comprehensive approach to development were disease prevention, stewardship and reimbursement strategies in line with recommendations from the pcast report released yesterday. we as physicians to agree with today when he said clinical investigators and authors of medical and scientific publications have the duty to protect the medical profession and the public against the abuse of eliminate scientific information and against improper and richer exploitation of conclusions based on inadequate data. thank you very much for the opportunity to testify. >> the chair thanks the gentleman, thanks all the presenters for their testimony. we will begin questioning and i will recognize oneself five minutes for that purpose. dr. thomas, you mentioned in

your testimony that a multi-pronged strategy is needed that includes both stewardship and antibiotic innovation incentives. these you think about the path to cure as being three faces, discovery, development, and delivery, do you believe that we need incentives in all three phases to have an effective incentive strategy? >> thank you for the question, mr. chairman, yesterday. because i think often the players or the stakeholders were conducting that research at those different stages are different. what it instead of ice is academic or biotech startup might be different for instant fires of multinational corporations, johnson and johnson different organizations that are involved in health care delivery. one incented is not, since we've seen since the incentives introduced, we still have an empty pipeline.

one incented will not solve the problem. it may well be that larg larger grants or so-called prizes will attract academic researchers and startups get a very different incented needs to encourage venture capitalists to go and back start companies with a higher level of risk. johnson & johnson, we look up a portfolio of investment opportunities to understand which of those is most important medically, but also which is widely able to be conducted and finally which enables us to bounce our risk and our return. >> all right. let's look at each phase. first of all, what types of discovery or are in the incentives do you believe would encourage companies to develop -- r&d -- to develop new antibiotics. >> look at the discovery incentives not just her and her buttocks but for all animatics and adjacent technology. it is critical we focus on point of care diagnostics, new

capabilities be able to diagnose and also to advance clinical research in this field. this endeavor, this is where larger grants, funding, prices would make the most sense because that will encourage broad-based academic research as well as broad-based technology company research that's often shorter in duration and is able to diminish in a different way. as we think about the incentives for development, development and the pharmaceutical process is most expensive piece. we recently brought a new product, an indicator for multi-drug-resistant tuberculosis, 13 years of r&d and early development. we had proof of concept that was compelling and leadership agencies like fda and european medical agency in the world health organization had a

conditional approval on early phases to resolve. we still have more than 15 years of clinical trials, evidence generation showing safety and effectiveness in children, showing safety and effectiveness to other drugs in the field, improving out the hope we saw in phase two studies to harry spent well over $209 today with no commercial return for siebel for this product nor nusra should it be we're now looking at a for the 15 years of investment in the hundreds of millions more. tax credits are not enough to spur that sort of asset on a broad-based across the industry. i think for drug developers we need to make sure there's an incentive for two things. one is, how can they justify maintaining the infrastructure in house, the confidence he to understand what is a good asset and how to develop not they have one of those assets themselves. and that's critical because

lightning doesn't always strike were headquarters is. lightning strikes all over and went to understand when it hits what that technology is worth. the second thing is we have to build a encourage companies to invest in a long range risk associate with a large dollars of drug development. the way to do this as not to hope that they have a certain expertise in one drug. the way to do this is to say we want as many shots on goal is of possible bias the large players as possible so that we can see a sustainable and continual pipeline to revolve. this is where the concept of exclusivity comes in. what you're not doing is incentivizing people, saying we have to understand you to go and profit making path in some of your business and we've tried -- trade off against these activities. in the area of delivery side, this is problematic. by the nature of these with research we conduct to get

products approved for at the micro the resistance, we are looking at studies. from a payments perspective that means in most countries in the world that you get price parity despite the fact your price parity is with what's on the market, with the costs that were achieved many, many years ago and may not, no longer be relevant and that's why they're usually negative. so the notion of a price premium our reimbursement incentives are attractive in that area. i would posit, however, and use as an example our own experts and multi-drug-resistant tuberculosis but when you talk about highly resistant bugs, highly transmissible blogs, you want the drugs used only in the people who need them, only for the bugs that need and other people who understand how to treat and use those products in an appropriate way. that's not a very strong economic model to understand how your product even with the reimbursement incentives is going to be successful. it's probably a negative commercial model in most areas.

>> the chair thanks the gentleman, no recognizes mr. waxman for five minutes. >> thank you, mr. chairman. last congress we passed that gain act to provide new incentives for the development of important antibiotics. and under that act, antimicrobials and antifungals intended to treat serious or life-threatening infections can be designated as qualified infectious disease products, or q. -- q. idp, these received a priority review. that's hopeful. if they're approved they get an additional i've years of protection from generic competition. that's a strong incentive. fda has already granted q. idp designation to almost three dozen different antibiotics to companies clearly are interested in this program.

major -- for today's hearing there's a need for new and biotic seeing the growing number of life-threatening pathogens. that are resistant to all or the chew and biotic. however, in your testimony, you know there's nothing in the law that requires qidp designation's the only given to antibiotics intended to treat resistant pathogens. as result you assert that essentially every and biotic ever approved by the fda will qualify as a qidp. some of us during the fda safety and innovation act negotiations try to limit it, that designation to this antibiotics that would fulfill an unmet medical need. however, we were unsuccessful. can you tell us how many or what percentage of the qidp's are for antimicrobials entity to treat highly resistant pathogens?

on their public health impacts we should be concerned about as a result of the failure to prioritize drugs to resistant pathogens, and how can we better incentivize the development of the drugs we most need? >> thank you for your question. the definition of qualified product is built on the previous definition of a qualified pathogen, and that list does not require any of the pathogens to be resistant. it includes most species known to cause any disease in human. that was done because it's difficult sometimes in these trials to run them are historically have been done to run them on people only with resistant pathogens. so you are correct in saying that the qualified infectious disease product will apply probably to every antibiotic that will be approved in the next decade or two.

which is a question about whether the incentives are properly targeted. on the incidents themselves when i talk to companies privately, ma large countries as well as small they all say that incentives in game with the correct direction but there's a quiet walk when what we should be doing is running. that the economic value to them of these incidents is really very small. they will take them and register, but it's 1% of the way to where we need to go to change the economic model. it's a small change and we should be doing something about it. >> tell us how to change the economic model. you talked about that. how much do we have to keep giving in order to give the right incentives? and we have to know how much this is going to cost the american people and whether it's going to be successful spent to use of the three steps, stages the chairman mentioned, on the discover side our budgets need to be dramatically increased.

we need basic science. it was in the pcast report yesterday. >> and we've been cutting back on that. >> it has been flat line or slightly negative to the best of my knowledge. on antibacterial research, nih. the second piece on developing, i think tax credits are a piece of that. i think barnett is a huge piece of the. some of the best brand negative malik is not have a lot of money in them -- >> we want to shorten the time that fda to get this review done as quick as possible to get the drug out there. we want to help companies decide if it's in their economic interest to do this. what do we need to do a? >> the last pieces one that was delivered to the public and i would agree with dr. thomas there's a reimbursement problem. i don't particularly like the solution. at the chatham house work were

looking at the linkage which is using the companies will be generously rewarded on something that has nothing to do with molly. i think everyone would agree we don't want but i $100,000 prize on a drug into the company a reason to over promote it. so there needs to be significant price type or bardic rant type reward for companies -- barda, which is what glaxosmithkline has suggested. to give significant rewards to the companies after they delivered a drug to the market. >> i would suggest that we may be better off with much more money in biomedical research at nih at the universities around the country. because they don't have the profit motive and what they do helps the companies because science use for these products,

but if the governments are having too difficult a time without if incentives to make a lot of money, let's make sure we get the work being done at the public expense because otherwise we're going to be a lot of money and we may not see the results that we need. do you agree the? >> i completely agree. if we do not have enough basic science, the pipeline that flows to venture capital and into the larger companies runs dry. >> i.t. thank you, mr. chairman. >> chair recognizes the gentleman from georgia, dr. gingrey. >> that was a very interesting line of questioning from the distinguished ranking member of the committee. and your response was not unexpected, but there is something to say for the profit motive as well. you get more and more and more money, taxpayer money to nih or

whatever the basic research is being done and you don't have this profit motive you're talking about in the wrong instead of misguided incentive. but if you don't have somebody with a profit motive, a pharmaceutical company, big or small, you can sit there doing basic research for 100 years, and maybe some brilliant scientist, many of them could be very comfortable in their labs, you know, and joy that fairly well. i think i would. but you never really get to where you need to be in regard to drugs that treat patients that q. are these -- that q. are these terrible bugs that are killing them. so i'm going to shift my question to doctor murray as president of the american

society of infectious diseases to basically ask you the same question, dr. murray. the business model by antibiotics, diagnostic and vaccines is broken. i think we will all sort of agree with that. that's what we learned this morning, this rather long to panel hearing, but it's been good. but it's a broken model. what specific steps do you think congress should take to address this crisis works do you agree with mr. outterson, or do you agree with mr. waxman? what do you think? >> well, i could take dr. woodcock's approach is that i'm not an economist, but i will try to address that. i think basic research input is an important component. i am biased. 90 basic research in my in the laboratory but i agree also there has to be a reward at the end. the suggestion i've heard from others, and they're not my own, including taking certain drugs out of the drg so they're not

part of the total hospital budget which means everybody is trying to attack on antibiotics as one place to decrease costs. that, the other model is buying up a certain number of doses at the end of a product so it is, there bought up, i think that's what you meant by the insurance model. so you hope you never have to use them. they would be there but it guarantees the industry some return on their dollar. so those are the to come in addition in the development phase the tax credit but at the end product, i mean, i've heard it for many years there has to be, the interest, the answer to talks -- consular, the answer to stockholders, they don't answer to taxpayers. tom pernice cannot just be motivated by the greater good. >> it's kind of like when we talk on this committee about

energy. the energy policy we should have have, and all of the above policy is the one that i like the best. and i think really in regard to this. because as mr. waxman said, talking about tax credits. you're talking about what you just said, dr. murray, buying back a certain volume that's not used because you don't want to just incentivize based on sales. and more grants to the nih. all of the above really. i think that's what got to look at it. i've got a less than a minute left and want to shift to dr. hillan. you mentioned in your testimony that half of the investment costs necessary to support your drug -- will be required.

half of investment costs necessary to support it, that drug come will be required after the point of united states regulatory approval. what drives the cost of these investments post fda approval? >> it's a big -- what's the big cost drivers? >> i'm not sure what you mean but i am certainly happy to answer. there's an ongoing process after drug is approved so you actually understand the significance of use of the product in the real world. there are additional pediatric studies which are important, we believe -- >> let me shift just, i've got no time left but trying to come if you'll bear with me because i really -- and think you dr. hillan. i really wanted to address this question to dr. thomas. so if you could quickly respond, mr. chairman, if you'll bear with me. >> sure, and thank you for the question. getting approval is a start of a long process of paying for

regulatory approval all over the world on a sequential basis of maybe over 100 countries. there's completion of commitments, unknown questions about basically that is 15 years of pediatric research. so if antibiotics that sometimes, started in a 15 year-old, proving that, drug safety reporting requirements. when you have a commercial product these are all cost of doing business. we have a product with the aim is not to use it unless your absolute have to, it's just a tremendous overhead that you can't really get out of the way. it's the right thing to do and the way we do it today, but it's significant overhead. >> and i think both of you for your response to the question. thank you very much, mr. chairman to i yield back. >> the chair thanks the gentleman and now recognizes ranking member, mr. pallone. >> mr. pallone, would you yield me one minute? >> surely. >> i think you for yielding.

i would want anyone to believe that we thought you don't need a profit. you don't need a private enterprise, and to argue we need to put much more in the research of scientific. but we do need a business model that system the company, if you do this work, you're going to make a profit. you've got to make a profit otherwise they're not going to do it. had to make a profit we don't want them to sell more antibiotics. we want to be sure they get a profit so that we want to guarantee -- we could take their investment, guarantee a certain percentage and say that's a much the government will pay you. that's what i did. i don't think it's the only ideas but it's a different kind of incentive that we have in other areas. i thought dr. gingrey was right when he said all of the above. we've got to do everything we can under the a lot more public investment. because the pharmaceutical industry will not make a lot of investment in this area when the

research investments can be result in a blockbuster drug. this is a social need and they've got to do what we need them to do but they're not going to do it without making a profit. so thank you for getting the chance to add an additional thought. >> thank you. thank you, mr. waxman. i wanted to ask dr. murray and mr. coukell, i know that you have worked very closely with the adopters of the death act and are strong supporters but i like to get your views on a few aspect of this legislation. first unconcern is truly drafted fda may not have adequate authority to require an untapped antibiotic labeling the way the calls attention to the fact that it's intended only for special populations. i don't think in clean secretary of state in the prescribing information is adequate and i'm concerned if those drugs are used more widely at appropriate that we could in that both harming patients and losing the

effectiveness of the drugs to antibiotic resistance. what are your views about the accuracy of the language in the bill? do you agree it's critical to be a strong and prominent labeling statement to settle to find they should use the drug only in circumscribe situations? i guess we could start with dr. murray and then go to mr. coukell. >> i think it is important to have some label there. in a practical sense what we do in the hospital to prevent overuse of certain drugs is we already have stewardship in place. in our county hospital, whatever reason have to go through an infectious disease approval. that's already in place. another thing we sometimes do is we don't report on the chart of the report that goes to the patient's chart, the susceptibility certain antibiotics. if you're in infectious diseases or are smart enough to know what's going on you know to call the laboratory and ask for that so the doctors that are caring

for this multi-drug-resistant infections know to do that. usually is done because there's certain combinations that even though the antibiotic is susceptible you wouldn't use it alone. the third way with electronic records that might be possible that i was speaking about last night was that when this drug is written for there's an automatic pop-up. with all sorts of automatic pop-ups now an automatic pop-up could say this has been approved in a limited population. i think in many ways that may not be as much of a problem as people are imagining. these infections occur in -- their complicated. infectious disease physicians are usually involved in these patients. for someone to try to use this drug or a special drug that has been approved in this fashion for an ordinary e. coli infection it is not a need to do that. the companies are not going to be able to be out there

marketing for the purpose. fta will be overseeing what goes into the promotional materials. so not sure the ordinary physician -- certainly the one in the community will never think about thinking about using a. i think there's some inherent safeguards. >> mr. coukell, did you want to respond to? >> let me build on what dr. murray has said. we worked closely on this bill and we think this is the one place we really would like to see some improvements. it's so important that we convey to the provider community the special status and nature of these drugs and let's recognize the labeling is not just effective when somebody goes and looks at the fine print of the labeling is the start of the process of how information about the drug is promulgated into the committee for the medical records, marketing materials and so on. we have called for a local dentist in which these drugs. there may be other ways. as long as it is clear these drugs are different but that's part of what congress is doing by creating this designation.

>> all right, thanks a lot. >> one more point. the other thing in the bill we think is important, they need to monitor how the drugs are used when they're out there so we have feedback and we know the indication is working as intended. >> all right, thanks. >> the chair thanks the gentleman and now recognizes the gentleman in illinois, mr. shimkus. >> thank you, mr. chairman. this is make a menacing and i'm glad i stayed but i think you see the importance that the subcommittee puts on these issues. you all on the panel turn around and just, turn around and see dr. woodcock is right there. wave to her. i want to make sure everyone knows she state and i applaud her for doing that. it's a silly question but it's really, would you consider you all facebook friends with the fda, or in a relationship? [laughter] >> anyone want to answer? are your friends? or are you not have a friend

notification out there and they didn't accept? >> maybe i can speak to that because obviously it's important that pharmaceutical industry is regulated by the fda both in terms of drugs and also in diagnostics. i don't know if we call ourselves friends but we are professional colleagues that work together. we have had -- >> the point is, i mean, the point is this can only get solved with the people in this room. it gets solved with you, the panel. it gets solved with the fda and it did solve with the policy, public policy folks here. so we have to have that communication. we have to be in a relationship. that's what i'm taking from this. a lot of ideas. i couldn't believe it, i was also looking at stuff. the pentagon was a groundbreaking with september 11, 1941. the dedication was january 15, 1943. so on this issue these are

timelines. 13 years to get to one point, 15 years still down the road. we've got, we've got to squish those timelines. there's people who are willing to accept some risk. as we've heard in numerous testimonies on this 21st century cures debate, and had we do that effectively. the question i have by listening to the testimony is, government is historically bureaucratic and not flexible and we are very rigid. but in this process, you're the expert, you're the doctor, you want the scientists and stuff, can there be -- how do we ride -- right into legislation the flexibility to incentivize while protecting public health? and can we do that? then that's where we are going to move on legislatively. am i right in that analysis, and

do you think we can get the? i only have two minutes left so why do we just go down and that everybody went into that if you would like. >> so it has to be done properly but much of this is about building trust. we are working towards the same goal of bringing pharmaceutical and bionics -- animatics to patient there but interact with the fda and they have facilitated the development of -- they came up with good ideas com,totally appropriate ideas. the company hadn't thought about barda has broad expertise to the table as well. so we can work effectively together and we're all working toward the same goal. i would hope we can continue to do that in future and it does need to be flexible. we need to trust people to use good judgment so we can always cast our patients. >> i think one of the benefits of the pcast report and the new structure that they would be, include external stakeholders, be included. and i certainly agree with that,

extra to the government and i think input is needed and that may help in keep driving the process. >> i think it's also impossible to write legislation that is flexible as well as impactful. i would also like to say that we want to be part of that discussion. we believe it does take a different way of thinking and we have to be willing to test things that may not necessary same so paula double. i want to finish this thing, it's no accident that breast cancer is almost a curable disease today but it's no accident many bone marrow tumors are curable today but it's an accident pashtun is because of incentives for everyone are anything in those areas but if you don't just get accident we need to design the right incentives. >> we need billion dollar incentives hanging out there for companies. big incentives, not little. it's hard to write what you will need in 10 years ago into legislation we don't know what the disease is exactly look like. barda is a wonderful model. one of the most encouraging things i took from yesterday

from pcast was a significant additional funding being proposed for barda because they can contract given flexibility based on what's happening now. the only other person is not in this room are appears to some like to see blue cross blue should come in to campus, medicare, this is a pay-for-performance, pay for value issue. pay more to keep it viable. >> there's no single solution to the are things that congress can do nothing to quickly and should do. there are places where there needs to be continued collaboration. i think we've seen that with fda incompetence stakeholders and pcast called for more of a big or important basic science questions that an industry questions or academic questions but questioned the resolve women have them effectively working together. not just with more money but with smarter science. there's no one size solution but the things we can do no quickly that moves us along. >> i think we talked a lot today about the history of resistance

until we got to this point. and actually there's already tremendously to the bill into fda's revelations already. when you kick them out in 1970 on what inadequate study was, the pharmaceutical companies immediately sued. what went to the courts, the courts actually found the regulations allow tremendous flexibility for fda and that the studies can be designed. i think what we are trying to say this morning, and doctor brought this point up several times is these studies should show added value for patients, that was what we're trying to say is if we're going to get perks for companies that have to be perks for performance, not perks for potential. the studies should show as doctor who pointed out, but the drugs save lives and the people we need to use them in. >> thank you. i want to end on this -- >> that i had want additional comment speak with yes, you may. >> thank you very much. would get back to the point of barda being a good model and that is a wonderful model. they could serve the parallel

role of helping to develop drugs for things that barda is not currently applicable to and they haven't antibiotic leadership group whose task is to design trouser antibiotic resistance organisms but i think the barda model is a good one. it doesn't message of have to be barda that would carry it out. >> i appreciate that. the last comment. always say that these companies, i really, mr. waxman just -- it's not perks. these guys raise capital, assume risk to try to save lives, employ thousands of people and pay taxes. so they are the ones who are raising the capital and assuming a risk. if we go down the route of trying to beat up corporate america in this process, we're not going to be friends.

we will be befriended and again. we've got to be all in this together. and without i yield back. >> the chair thanks the gentleman. the gentleman from georgia want to make a point of litigation. >> mr. chairman, thank you. i don't disagree, i do agree with the comments of my colleague, the gentleman from illinois, mr. shimkus in what he just said. but also doctor powell, let you know that the concerns that you expressed in your testimony -- dr. powers, are not lost on me. i don't think other members of the committee, and also the ranking member of this house subcommittee, mr. pallone, his concerns about labeling. that's not lost on me either. and staff is working almost as we speak on the issue, frank, to try to that right and to lay those concerns. mr. chairman, this has been fabulous. you all are great, both panels.

dr. woodcock, we are so grateful to you, and i like the other members who stayed over and didn't get that early flight back to atlanta. i'm grateful that i say because this has been most informative and we are deeply appreciative. thank you very much. >> the chair thanks the gentleman. i would like to say it's good to hear the collaboration that is occurring between the public and private sectors. and that is so important. and i might mention, dr. woodcock has been before this committee many times, and she is one administrator that always stays through the whole thing, and you should be commended for that. we thank you for your responsiveness. now, other members will have questions and without follow-up questions. we will send a those to you. we ask that you please respond promptly. i remind members that they have 10 business days to soviet questions for the record. that means they should submit their questions by the close of business on friday, october 3.

very good hearing, exciting, very informative. thank you very much for your participation. without objection this subcommittee is adjourned. [inaudible conversations]