and markets are always looking for long-term signals. we just gave a very bill long-term signals that i believe in what i am hearing is opening

the door to investments in the united states and that is a very good thing but people should also keep in mind and be converted by the fact that our climate decisions have been referred three times by the supreme court. there is no where else did go. they said move forward and that is what we are doing and so i think it is the strong a signal as we can possibly have, that the u.s. is open to looking at how to devise a low carb and economy and get it moving and running in a way that will entice investment. that is good for everybody. >> madam administrator, let me tell you we deeply appreciate your taking time with us and the work you are doing and if i get it right i would like to borrow an expression from your book, you did wicked good. >> thank you.

[applause] >> that is all right. the media at a going to have a little press availability right here. [inaudible conversations] [inaudible conversations]

[inaudible conversations] >> that you think there is particular scrutiny by the agency as you work towards time lines? >> as you probably know we took a broad comment on this rule and we should have because this is a big move and it deserves it. i mentioned making sure people understand how to translate the intensity. we also put in the proposal an alternative on how to address renewable energy sources and how to account for as those. there has been a lot of feedback and positive way on that, a lot of discussion how to handle nuclear energy. questions about whether we are clear enough about the range of compliance options available to states, for example where we

count noon natural-gas plants and those kinds of things which we can clarify but a final rule should. there are a variety of things that have been raised and the reason i am excited about it is there are generally complex things the agency needs to think about. they are exactly what you hope for. i am excited about it. >> the new commentary deadline extends the finalization you are expecting in june and how important is it to get this finished before the administration, is concerned republican might drag his feet or not implement? >> i actually made the decision to extend the comment period because we had more to talk about in the kind of setting we are a lot to do in a comment period. we are working through the june deadline because i don't want anyone to think that we are

arbitrarily cutting off discussions for any purpose other than to make sure we get this rule right and focus on implementing it as quickly as possible and that is will be a going to do. >> number of stakeholders are concerned about the way early action would be treated. is that a particular area? >> look at whether or not there are other things we didn't consider and think about but one of the reasons i brought up the idea of a market-based approach is this isn't about developing a market-based approach. we look at a particular year, it is all about where states are today with these facilities, what is available to them and how far they can move forward but we appreciate the suggestions that really fall within the category of fairness, are we being asked too much? we will take a look at those and we think there are some adjustments that can be made and

we will look for in them. >> the rest of the administration's climate plan, it typically how countries respond to that at the summit. people on the side. >> a lot of things i saw being discussed that relate to the president's plan. most of the meetings i went to work with industry so it was a lot of fun. large industries and small. we talked about the 111 dep proposal in the broader context about the game changing nature, the strong signal to the u.s. the president's deal was another strong signal. we had discussions with oil and gas on making commitments, some great opportunities to work internationally and we had the

largest companies participating throughout climate -- what is it called -- climate and clean air coalition which is an international sort of collaboration with dozens in the business sector. there were big commitments on h s cs. there was a lot of discussion over the development of renewables and how expedited they are and how much is being installed. it is quite amazing so all in all it was the full range of things the president has put on the table. and a commitment to business is willing to make and generate this transition we are in. >> can the epa get beyond the 17% target when the president brings forward a commitment next year? how much can he be a player rolling going beyond 17%? how high would you like to see

that? >> that is a discussion that is happening now. >> what can epa contribute beyond a clean power plant? where else do you go? >> epa will look at its obligations under the clean air act as well as where it is heading as part of a larger climate initiative the president laid out and we will do our best to calculate the reductions we anticipate. >> looking at 6%, higher number. >> we don't know what the response is going to be and part of the challenge is that dialogue is continuing and we will take a look at it. we all know that nuclear plays a significant part of the strategy in terms of providing a lot of capacity in this country for electricity and that needs to be factored. we pretty much in the proposal

put a sort of marker down that we needed a broader discussion and we are in the middle of that discussion now. >> there are some industry representatives concerned what the epa rules might do. is there any economic transition package you are looking at or some sort of program under way already to help affected communities, coal country, to adjust? >> we certainly do have programs available and the white house as a liaison looking at those specific issues with communities but all in all, we know that by giving states the opportunity to design their own plans we think in this end you will see a variety of different energy sources that will be available and affordable in 2030 and neither cold -- coal is not going to be out of the system. it is still going to have a

significant part of the portfolio but how every individual state response in terms of developing a plan is going to be up to them and i think they have great opportunities state and local become a the best approach for them economically and from an energy perspective. >> the money that would go through those assistance plans you are talking about? >> there are many programs and i will get back to you on what those might be. >> the president today >> you met with oil and gas committee and as for two years for a meeting with you. i am appealing to you we need to meet with you and show you our evidence. last year and today we met with your people. my water has been poisoned by gas activity. >> we will talk afterwards if you like. >> to make a decision by fall on whether to regulate methane emissions from oil and gas.

the first day of fall was yesterday. >> another few months yet. >> how close i you to making that determination to >> we tallied all the comments up and we know what the options are but it will be a pretty long discussion. oh yes, we did say fall and that is what we will shoot for. >> thank you very much. [inaudible conversations] >> here are a few comments we recently received from our viewers. >> c-span2, booktv, i really enjoyed that. it looks like you are an experiment in a new format. i want to discourage that. i think booktv is one of the smartest things on television.

when tv was first invented, everybody hoped television would be. too bad there isn't a cable channel devoted to it. i am glad c-span is doing it. it is really important. i can't tell you how many books i bought because i watch that and i get information too. >> i don't watch booktv anymore because i can't figure out what is going to be shown. i used to watch it over the weekend and comcast in massachusetts does not tell me. it just keeps saying to be announced or they will be talking about some book but only give you the first two words of the chapter, they don't say it -- it doesn't tell you what is coming on. because i don't know what is going to be on i don't know whether to stay home or watch it or take it or anything.

>> the best news source i have at the moment. i love your show. i watched it for years. keep up the good work. >> continue to let us know what you think of the programs you are watching. said 202-626-3400. e-mail us at comments@c-span.org or send a tweet to c-span@comments. like us on facebook, follow us on twitter. next on c-span2, a hearing on the rise of antibiotic resistance infections. live at 8:50 eastern the family research council hosts its 2013 values voter summit. today the family research council opens its 2014 values voters summit in washington d.c.. speakers include congressman jim jordan of ohio and senator ted cruz and rand paul.

live coverage at 8:50 eastern on c-span2. >> today, outgoing attorney general eric holder speaks at the congressional black caucus 44th annual legislative conference. you can see his remarks live at 9:00 a.m. on c-spanfree. c-span2 providing live coverage of the u.s. senate floor proceedings and keep public policy events and every weekend booktv now for 15 years the only television network devoted to nonfiction books and authors. c-span2 created by the cable-tv industry and brought to you as a public service by your local, cable or satellite provider. watch us on hd, like us on facebook and follow us on twitter. throughout this election cycle we are bringing you coverage of raises from all over the country. you can see the debates we covered on our web site c-span.org.

here's a look at the candidates in the texas governor's rays where democrat wendy davis is facing republican greg abbott. >> moderator: senator davis, the regret voting for barack obama? davis: what i am working on right now is running for governor. this incredible state and bring in policies forward that will benefit this state. i am working to make sure every hardworking texan, no matter where they start, has an opportunity to go as far as they dream. 30 years ago i couldn't have imagined that i would have the privilege when i was a young single struggling mother sitting on this stage and having the opportunity to ask texas for its vote to be the next governor. texas is at a turning point and that is what is important in this election. will we create a 21st century

future economy that works for all hard-working texans or just some? i believe we need a governor and who will fight for all hard-working texans every single day because their future depends on it and we need a governor who is going to make sure our children receive a world-class education because our future depends on it. >> moderator: your turn to ask a question. >> moderator: mr. abbott, the judge recently ruled against you and in favor of the schoolchildren of texas, ruling that our schools are unconstitutional the underfunded. the only thing right now coming between our children and appropriate funding of their schools today is you. on behalf of the 5 million children of this state, will you agree to night that you will drop york appeals and allow our

schools to be appropriately funded? abbott: there is another thing coming between me and that lawsuit and that is the law that you voted on and helped pass in 2011. the attorney-general has the ability to settle lawsuits just like this. is important to understand that what i want to do is focus on creating as governor a better education system in this state. it is time we put our partisan differences aside when it comes to building a better future for the next generation. what i am focused on is not a school system that was constructed in the last century. i am focused on building a better education system for the next generation. >> hearing examining the increasing number of antibiotic resistant infections and the decline in antibacterial drug research. the director of the fda's center

for drug evaluation and research testified before the house, energy and commerce subcommittee about the issue. this is an hour and 20 minutes. >> they are here. i will yield. the subcommittee will come to order. chair will recognize himself for an opening statement. according to the who's anti microbial resistance global report on surveillance 2014, anti microbial resistance is an increasingly serious threat to global public health. british prime minister david cameron warned in july that if we do not confront the threat of

antibiotic resistance, we could be, quote, cast back into the dark ages of medicine where treatable infections and injuries will kill once again and just yesterday the president announced an executive order focused on efforts his administration plans to take with regards to the antibiotic resistance issue. this committee sought to help combat this global threat by passing the gain act as part of the food and drug administration safety and innovation act of 2012. an important step in the fight about eggs dyadic resistance and how bipartisan collaboration on this committee can save lives. i want to commend the bipartisan authors that made gained

possible including representatives greg abbott, green, of shimkus for your leadership and the fda for making gained a success since its package but what is clear to many in this room is gain did not from the fix the problem and much more is needed if we are to incentivize the type of drug development needed to combat this global threat. congressman gingrey and green introduce another legislation, the adapt act which would address problems to the fda approval process. it is one of the serious of proposals warranting serious consideration by this committee as part of our 21 -- 21st century cures and i thank them for their continuing efforts in this case. i think our witnesses for did

being here today. and the vice chair of the subcommittee doctor, wendy davis 18. >> i appreciate the fact we are having this hearing today. is necessary as we proceed with the cures initiative to talk about some of the things that are most important, some of the things that are relied upon and familiar in our front line to fight infections and antibiotics. and the buyout resistance, specifically resistant strains is a growing problem. equally troubling despite widespread support, the lack of a pipeline of new drugs that can improve on previous generations or fight drug resistance strains. and the silver bullet solution. our drug arsenal is our drug arsenal. the committee grows market reasons why they are not

producing new antibiotics and regulatory pathways' exist to encourage development of new drugs. the safety innovation act, but they were the first steps. part of the deal is once nature adapts it is hard to force major to adapt. these strains are out there and aren't going the way. once this week has taken place, the continuous pipeline of new drugs. on a historical note since the election in scotland yesterday, made part of the british empire, it was a famous scotsman for alexander fleming who developed -- is credited with discovery of penicillin. alexander fleming is only -- she couldn't produce a lot of

penicillin. it was anteroom where from indiana who actually developed the dep fermentation process that allowed penicillin to be mass-produced and made a significant difference, the saving of lives of our soldiers in world war ii and parenthetically dropped the costs of penicillin from $20 at that time, significant amount of money to $0.50. we know we should do this, we have done it before and the forefront of innovation, what the cures initiative is all about. this is an important part of the discussion. i will submit this article for the record. >> without objection entered into the record. now recognized ranking member of the subcommittee for an opening statement. >> in 2006 in my state of new jersey a 17-year-old honor student named rebecca went to the hospital and within days die

from resistant strain of mercy. after the infection, treated with the available antibiotics and failed to respond to treatment advancing rapidly and cutting like short. the more frustrating given the remarkable advances in american medicine. antibiotic resistance bacteria resistance is growing as the supply of new antibiotic drugs is when dwindling due to drug manufacturers declining interest and ability to produce new drugs to meet this threat. the cdc report finds 2 million americans are infected with antibiotic resistance. 23,000 will eventually die as consequence of the infection. additionally 5% to 7% of patients in american hospitals will acquire infection during the course of their treatment and the majority of these infections can be treated but this complicates the recovery

process and ultimately -- the health care system. due to the current stage of the market manufacturers are incentivize to focus their efforts elsewhere at the expense of are in the with new antibiotics to conduct these rapidly involving strains of bacteria. this reason is why congress included many provisions of the gain act in today's legislation. the gain act was an important step for solving this problem. we are supporting manufacturers in the development and introduction of new drugs larger to the use of marketing exclusivity. so far we have seen meaningful progress, and a number of new drugs through qualified infectious disease product designation. these drugs were able to combat an imminent infectious disease threat and reach patients at an accelerated pace. we should also remember why other laws like the waxman act are so successful. if congress decides to intervene

in the markets, regulatory exclusivity, we should be sure it achieves the necessary impact on the pipeline of new drugs to safeguard public health. in pursuit of the greater good government struck a balance between the entrance to private industry in the public and society reach benefits. that is what i have concerns about transferrable exclusivity. the practice of getting a specified period of exclusivity to use on any product it wishes as a reward for developing a new antibiotic. this is a recipe for higher cost drugs with no direct connection to the cause of developing new antibiotics. there are ideas worth further examination such as the adapt act introduced by congressman green and wendy davis to establishing a limited population approval path way that would permit fda to approve drugs based on smaller clinical trials so mr. chairman there are a number of angles the government and private industry can take to meet this problem head on and we all agree this is

an issue that warrant further action and i welcome the opportunity to hear from our witnesses today and a special welcome to adrian thomas from johnson and johnson. i would like to yield the remainder of my time to mr. green. >> thank you, ranking member for review and two issues, a growing period of antibiotic resistance. i am pleased that yesterday the white house announced the national combat antibiotic resistant bacteria card the strategy. we need to control bacteria and carbs. the who, united kingdom joined the united states in recognizing resistance as a global threat. and about resistance as public health and national security priority, a threat i take seriously and believe congress has a strong role in answering. the fda played a central role in this important effort and i

think the agency for the work. we must all work together to ensure we have effective antibiotics for the future. in 1929 alexander fleming invented the process for the first antibiotic wonder drug penicillin. such discoveries for the 21st century can happen as well if we encourage greater investment and development of new novel antibiotic drugs. antibiotic saved millions of lives by treating infections caused by bacteria made through therapies like surgery, chemotherapy, neonatal entrance, by nature bacteria evolve and become resistant overtime. in addition miss use and inadequate diagnosis have contributed to antibiotic resistance and most antibiotics of less effective or ineffective against infections. antibiotic resistance must not be underestimated, more patients have no therapeutic options because of their resistance to available therapies. antibiotic resistance and development must be a high

priority for this committee. i look forward to the hearing and thank my colleague congressman gingrey for partnering the gain act and the adapt act. i give back my time. >> i now recognize the gentleman from georgia, dr. gingrey. >> i want to thank you for calling today's hearing in the 21st century, cures initiative titles ways to combat antibiotic resistance and force new drug development. let me commend our colleague from colorado, mr. degette for spearheading this bipartisan delegation that looks away is to address emerging challenges. i participated in a number of hearings and roundtable discussions and found each to be very beneficial to all the members of this subcommittee.

we all understand antibiotic resistance pathogens are a growing concern not only across the country but across the globe. according to the cdc in atlanta each year more than 2 million americans are resistant to antibiotic. a health care system, nearly $20 billion, probably $35 billion more in indirect costs, lost time from work etc.. this year alone but the who and the u.k. have a knowledge of this looming threat. the obama administration to catch an antibiotic resistance as well. through a signed executive order, national strategy on combating antibiotic resistant bacteria and the president's council of advisers on science and technology and they will be

issuing a report. this is an issue that is now receiving global attention. unfortunately according to the fda new antibiotic approval has decreased by 70% since the mid 80s. a combination of barriers including the high cost of drug development and the small profit margin have helped to drive companies out of the anti in fiction space to markets where the return on investment is much higher. think of your favorite for arthritis or whenever, they simply can make a lot more money than -- a lot bigger market. these incentives for companies to produce new antibiotics have yielded a stagnant research and development pipeline for antibiotics and is illegal to keep up with the evolve in bacteria. ..

developed a new pathway at the fda for antibiotics aimed at treating emerging threats in limited and i need populations when they have no available option at their disposal. the adopt act will also streamline the process by which the fda updates breakpoints information to doctors and medical researchers have the

most up-to-date information which to expedite the decisions in the drug approval process. mr. chairman, a model of the 21st century choose initiative work on the game act and adapt act has been a true bipartisan product and i commend mr. green force continued effort with me on both pieces of legislation. earlier both of us spent an hour on "washington journal" discussing our efforts addressing drug-resistant bacteria with comedy, befitting argument at a thank mr. green and the moderator and hopefully all of you would agree with that. i had the pleasure yesterday of meeting with doctor barbara murray will be on the second panel, the president of infectious disease society of america and a adhering some of r

anecdotal accounts of life-threatening infections with her own patients even more motivated to continue the fight against drug resistance bacteria. i will give a quick anecdote, mr. chairman, i know i'm running out of time but my brother is one year older than me, and in 1941 he was sick as a board home with pneumonia and the family doctor came to the house and told my parents that he was going to die unless he gave him a shot of this new antibiotic called penicillin. my brother james got that shot of penicillin, and fortunately he lives. there have been some day since been i wish he hadn't. he beat me up every day since then, and still does, but that's my own little anecdote, dr. murray. mr. chairman, as we continue with initiatives must work in a bipartisan manner to address this growing problem across our country. ultimately, i believe that the

attack act is the next step in the fight and my hope we will mark up this legislation during the lame-duck session later next month. i welcome the test and we'll be hearing today to further educate most of the subcommittee on this quickly important issue. make no mistake, the cost of inaction in the fight against life-threatening infections is gravy and the cdc has already provided us with the statistics to prove that. today's hearing will serve as a great way to raise awareness on this important issue. mr. chairman, in q4 allowing me the time normally reserved for chairman upton. i look forward to continue to work with all of my colleagues as this process moves forward. thank you for the extra time and being a little soft on the gavel, as a you back. >> the chair thanks the gentleman. now recognizes iraqi number of the full committee, mr. waxman for five minutes. >> thank you very much, mr. chairman. we have hearings in this

committee 2010 on the problem of antibiotic resistance and the fact that it's growing and dangerous threat to public health. certainly an issue that deserves the full and complete attention of this committee. simply sure holding this hearing. our overarching goal should be to ensure that people continue to benefit from these life-saving treatments both here and the united states and around the globe. this is an inherently difficult goal to achieve. after all, when we use these antibiotics it leads to the development of pathogens that can no longer be treated by those and a by alex. rather than use it or lose it with antibiotics, kids use it and lose it. so we're great risk of losing much of the progress that has been made in fighting infection and subsequent disease. many americans die or are

infected each year from antibiotic resistant microbes. we pay a high price in other ways as well, additional hospital stays, hospital readmissions, increased doctor visits all and unnecessarily to the nation's annual health care bill. it will take a multipronged approach to overcome this very serious problem. there's no question that our arsenal of effective antibiotics is dangerously low today as a result of antibiotic resistance. we need to replace ineffective antibiotics with new ones. in the 2012 fda user fee legislation we enacted a law designed to create incentives for companies to replace those antibiotics and develop new ones. that legislation included provisions from what was called the generating antibiotics incentives now act called again

act, they granted a five year period of exclusive marketing pressures of life-threatening diseases. i look forward to hearing today from our witnesses about what impact that legislation is having on investments in these drugs. exclusivity rewards drug companies by allowing them to charge higher prices. as a result it also imposes a significant burden on patients and on health care system over all. so we need to approach this particular form of incentive with great caution. one bad idea, my opinion, is the concept of transferable market exclusivity which is sometimes called the wild-card exclusivity. this form of exclusivity would give the company that developed a new antibiotic the ability to

transfer a term of exclusivity to another drug. any other drug that they have. this is a hugely costly idea that leads to unfair cross subsidies. if astrazeneca were to develop a specified antibiotic, it could earn a term of exclusivity that it could transfer to nexium, a treatment for heartburn which is the second highest grossing drug last year, and earned over $6 billion. even if the term of exclusivity were just six months, that would result in a report of almost $3 billion. that means nexium patients pay higher prices for longer even though they may never actually take the antibiotic itself. as we tackle the problem of antibiotic resistance, we need to ensure that whatever form the incentive takes, it bears some

reasonable relationship to the amount of the investment the company is making. i hope we will discuss today another approach to getting new antibiotics on the market, that's what's been referred to as the adapt act or the antibiotic development to advance patient treatment. that bill would establish a limited population approval pathway that would permit fda to approve drugs based on smaller clinical trials. this is an idea worth examining. if we do great such a pathway, any drugs approved as a result would need to be clearly marked with a prominent symbol to alert providers and patients that the safety and effectiveness of these drugs has only been assessed on a limited basis -- population. requiring a designation is integral to the idea of a limited population approval pathway because riders have been

a that these drugs are to be used only in absolutely necessary, otherwise they will not only put patients at risk but will contribute to the more rapid development of antimicrobial resistance to the drugs. in addition to incentives in developing new antibiotics, we ought to find ways to cut back on the overuse in this use of these drugs. patients cannot expect to get it every time they come down with a cold, and physicians should only prescribed in when they are truly necessary. perhaps most importantly, indiscriminate administration of these drugs and animal agricultural operations needs to stop. we should mandate and into this practice. but if we cannot take that step we should at least have a better data, have better data about how and where antibiotics in humans are being used in food animals. we know practically nothing about this situation. as a recent reuters article points out, the data exist in

hands of major corporations producing these animals. mr. chairman, another 30 seconds. >> go ahead. >> i have a bill that would finally give the public access to this information, a data act. i hope this commonsense bill can be included in the 21st century church legislation. i thank the witnesses for being here today and for the testimony. mr. chairman, i'd like to ask unanimous consent that the statement prepared by congresswoman louise slaughter be included in the record. she's talking in her statement about ways to combat antibiotic resistance and cost up to new drugs. >> without objection, so ordered. and i have unanimous consent request i'd like to cement the following for today's hearing record. first, a letter from the flag and general officers network, an

official veterans organization representing three quarters of all living u.s. armed forces flag in general officers. secondly, a statement from cuba's pharmaceuticals, global pharmaceutical, headquartered in lexington, massachusetts. and thirdly, a statement from the california health care institute, a statewide public policy organization representing california's leading biomedical innovators, over 275 research universities and private nonprofit institutes, venture capital firms, and medical device diagnostic, biotechnology and pharmaceutical companies. without objection, so ordered. all members for nothing since will be a part of the record. at this point we have two panels to present testimony. on the first panel today we have again dr. janet woodcock, director center for drug evaluation and research, u.s.

food and drug administration. thank you very much. your written testimony will be made a part of the record and you will be given five minutes to summarize your testimony before questions. at this point you are ready to provide minutes for your opening statement. >> thank you, mr. chairman and members of the committee for holding this hearing on the truly important issue. there is broad agreement that antimicrobial resistance is a worldwide crisis that's going to require major efforts to combat. in 2012 that congress took a significant step in passing gain act, we've been implement them. in europe the innovative medicines initiative which is a public-private partnership has launched a major research effort on at the micro the resistance. yesterday the administration released a national strategy for combating antimicrobial resistance. a high level task force was established by executive order to carry out and develop an

action plan to carry out the goals. the strategy is a multisector effort to attack this problem in all its diverse forms, by bolstering basic research, enhancing product development, improving the surveillance which is our event alluded to, resistance and use of antimicrobials, modifying the use of antibiotics in food animals, and strengthening international collaboration. pcast which is a president's council of advisors and science and technology, also released a scientific report and scientific recommendations yesterday. over the past year, the center for drugs that fda has been very busy on this issue. we have issued many new or revised guidance is on antimicrobial drug developed. we've approved three drugs designated under gain act.

we recently cosponsored a workshop on this topic with the national institutes of health. and, of course, our fellow center, the center for biologics has been working on vaccines, another we addressing this problem, and the device and working on testing methods. despite all this progress we must recognize that a robust pipeline of new investigation of antimicrobials does not growth exist, nor are there large number of drug discovery laboratories out there working to bring forth the next generation of candidate drugs. so we don't have a robust pipeline. the reason for this apparently is primarily absence of commercial incentives to antimicrobials development. this problem must be solved one way or another if we're going to prevail in our fight against the ever-changing microbes. we don't just need right now,

which we do need urgently, new treatments for resistant organisms, although we need that urgently, we need to keep introducing additional treatments against common conditions as well. since our existing -- is going to weaken over time. so we don't just need to respond to the current crisis. we need a robust pipeline going forward. because this is such a multidimensional problem, we all must work together to prevent the loss of these critical weapons against disease. so i'm very happy to answer any questions. >> the chai chair thanks the gentlelady. i will begin the questioning and recognize myself five minutes for that purpose. dr. woodcock, yesterday fda director hamburg -- she wrote quote few issues and public

health at the they are as critical and as time urgent as combating the growing threat of antibiotic resistance. it is a hybrid for fda to work with our partners to find solutions or the serious public health problem, and code. would you explain the urgency of the situation for public health and national security? [inaudible] >> as many of the members have already stated for public health, we are already seeing access to data nursing people who, in fact, cannot be treated with any existing therapy that we have. and i think the thread here to public health is about we can have emerging epidemics of these organisms that they will spread. right now they're fairly limited and sporadic, but they will spread and we will be in a situation where we literally can't treat an infection that is unfolding in a wider sense. in addition, each year we are

seeing greater and greater resistance problems for ordinary micro organisms, and so doctors are having to turn to what we would call second or third line antimicrobial agents, agents we used to be served for very selected situations. and as that occurs, more resistance to those will evolve. eventually will be empty handed. >> in the case of antibiotics, even slight variations in the bacteria's genetic makeup, can be the difference between a drug working or not working. understand that bacterial resistance compound this problem many times over, why is it important for our antibiotic drug pipeline that we have multiple drug options for the same class or family of drugs? >> yes. well, what we know when we develop an anti-microbial evolves over time after that antimicrobial is used. and after time it may be that it

can be effective against certain forms of an organism and not against other more resistant forms. the mechanism of resistance is different. there are many different mechanisms of resistance. that's why having large number of drugs in a class or even improvements in a class can be extremely helpful in this situation. because you can match the antimicrobial to the organism you are trying to treat. >> do we have the type of a drug redundancy highlighted above that we need to effectively combat this problem right now? >> we do not because it sort of the cutoff line, the antimicrobials that are no longer useful against many infections is getting higher and higher every year, especially for certain types of drugs -- types of bugs. >> do you believe that we need to further incentivize new drug and diagnostic development if we're to appropriate address the

issue of antibiotic resistance? and if so what would you recommend? >> i do believe we must incentivize it because the current situation shows that the incentives have not been enough to stay my development in this area. so for drug development, apparently developing antimicrobials is still not attractive enough. it still doesn't appear that it might not be a loss to business. that there isn't an attractive enough business model to build those robust programs that are needed to both discover and then develop new classes of antimicrobials. for diagnostics, i will tell you that louis pasteur and alexander fleming would recognize the methods we use today. because they invented them. and so there's a lot of room at the top for improvement. we are using genetic sequencing of human genome, which is huge

compared to the microbial genome, but using the practice of advanced methods is not the norm, and that improving diagnostics tremendously simplified medical trials and also treatment. >> talk about incentive. deeply such incidents could be used in other unmet need areas beyond just antibiotic? >> of course i believe that is possible. however, as i think mr. waxman said, there are trade-offs. you have to balance -- there are always trade-offs in putting these incentives in place, and i being a physician and a scientist, i'm not the most qualified person to make those trade-offs. i think congress really has to weigh those. i can say that the urgency of the public health urgency for this problem is severe.

and will continue and i think you hear that from other experts as well. we are not over the hump. we have not succeeded in developing a system that will continue to generate effective new antimicrobials. we don't have that. we're sort of heroic efforts uintah. >> thank you, doctor woodcock. my time has expired. the chair recognizes the ranking member for opening questions. >> thank you, mr. chairman proposed executive order issued yesterday in the report of the president's council of pfizer's on science and technology emphasizes the danger that the biotic used in the agriculture industry. while it's clear we should do more to courage greater research and develop in of new drugs, it also makes sense we should be investing in efforts to limit the further spread of drug-resistant bacteria strain to make the best use of existing drugs so they can remain effective for longer periods. so, dr. woodcock, into just one viewpoint to fda's cooperative effort with cdc to promote greater stewardship including

they get smart campaign and unlikely to elaborate on this partnership and on fda's role in the initiative laid out in yesterday's executive order. >> obviously there needs to be better stewardship, both in human use of antimicrobials, as has already been said about half cdc estimates that antimicrobial outpatient prescriptions are not necessary, given the condition a patient has. and that leads, especially people only take the drugs for a little bit, can lead to big problems. and also in the animal world. now, in the human area, fda is collaborating with cdc on these efforts, but cc is primarily the lead on improving better use in health care and that's a multifaceted effort. in the animal health space, fda has put out a guidance, the

center for preventive medicine calling on manufacturers to cease use of discontinued use of important human antimicrobials for growth promotion in food animals. and they have secured the cooperation of all the manufacturers who are engaged in that space, my understanding, and then there will be a process whereby those indications are withdrawn and then use in food animals would be required under the supervision of a veterinarian for a health condition in the animal. so that would be a great improvement. also as was discussed in a report yesterday though, we need better surveillance and data to understand the link between antimicrobial use in animals, or humans come in the development of resistance. that's still rather poorly understood. >> thanks. i want to get fda's views on

certain aspects of the adapt act. us understand the purpose of the bills goals is to facilitate fda's ability to approve and about seven tested in only limited population for which the need for the drug is critical. i know you do approve drug test and limited populations, for example, drugs for rare diseases. i'd like you did when it's in white existing accelerator approval mechanisms are not meeting the current need, no slinky dress with you play the adapt act is going to did provide fda with sufficient authority to ensure that at that antimicrobials will be labeled in the way that clearly distinctions them as different from other antimicrobials. it seems that if we are considering allowing drugs on the market tested only in very limited clinical trials we need to be confident the providers and patients understand the care with which these drugs must be used. >> yes. well, we think the adapt act has elements that we've been discussing for a long time. let me explain some of the

situation to we approve drugs for limited population all the time, orphan drugs, rare subsets. that generally speaking the clinical community is not tempted to use those or somebody with a cold. it's for some rare enzyme deficiencies or some cancer, rare cancer or whatever. with antimicrobials the big problem is really the used outside of where it would really clinically be indicated. and one of the barriers for these highly resistant organisms is the occurrence is erratic. we are very lucky that they are not widespread outbreaks, but because there are not widespread outbreaks it means that testing of the event brought populations is difficult. and actually that's good news because otherwise we would really be in trouble if there were large numbers of people suffering like this.

so that means by definition if you're going to get these drugs on the market for the small populations of resistant organisms you're going to get small trials and you'll have more uncertainty about the effects. so more uncertainty about the effects, worry that they will be used in conditions where it's not warranted. those are the two issues we are trying to address. and orphan condition, yes, there's uncertainty about the effects of the orphan community that uses these drugs, usually those are some specialists who are treating a very rare disease and they have a very good understanding of what the study was done on the drug and so forth to get off and maybe the only drug ever studied for that condition. so our thoughts, and we have the administered has not taken a position on this, but we have thought about this, that do offer very small development programs is a big incentive. but the quid pro quo really is

to send a signal to the clinical community, you know, some kind of signal, some kind of message that this is special, there's more uncertainty. and also really good use, good stewardship about this particular product. against using it and a lot of conditions where it's not warranted would also more rapidly increase the development of resistance. >> thank you. >> chair now recognizes the gentleman from georgia, dr. gingrey, five minutes for questions. >> thank you, thank you for recognizing me. i know that vice chairman of the subcommittee, my colleague dr. burgess was scheduled to go next, and i thank you for letting me ask my questions now. dr. woodcock, thank you, also, as a witness we've had you before committee many times since i've been on the committee, and you're just always so straightforward and

you explain things in a very clear way. and i mean that sincerely. you do a great job, and we appreciate that very much. i want to continue in the line of questioning that mr. pallone started. and again, i have limited time so let me get right into the. congressman green and i have been working on this adapt act, as you know, and it's legislation that supports the fda's flexibility to consider all forms of evidence in addition to data in clinical trials when considering novel antibiotics. how important do you believe a captive and unique trial designs can play in encouraging new antibiotic drug development? and before you answer that part, just, and i'm sure everybody here probably knows this, but in your typical phase three trial

before a drug can get to market, you're going to have a population of 1000 or more people that you treating. and there are also other requirements that they can't have had an antibiotic within 24 hours of the start of the trial court one point it was three days i think until we got down to 24 hours. but you're going to have a limited population of people that have these diseases, and when they get to the hospital sick as heck, the first thing the doctors wanted to come the emergency room physician, is there going to hang some antibiotic, even if it's wrong. they're going to start treating them. and then all of a sudden they are not eligible and you have limited number of people. if you wait into the get 1000, it's too