>> guest: i think the significant is yes, it's that president himself really putting his stamp on a global policy, and that in turn puts pressure on u.s. allies and on allies to fall in line. there has been a lot of quiet or criticism of the president that he hasn't kicked or cracked down hard on some of the countries in the region who have been accused of, if not supporting isis, then at least turning a blind eye to the funding of isis or other extremist groups inside syria. one of them is the al-nusra front which is an al-qaeda affiliate and tha get some workg relationship with isis in the past. turkey as i mentioned before, qatar, kuwait. the u.s. treasure and some of the financial arms has seen a lot of money going to militant

groups inside syria from these three countries. i mentioned a lot of it is money being raised through social media, charities. a lot of times it's kind of a complex situation where you have money that's being raised, allegedly or essentially for human train operations and then gets used for military purposes. so i think having a president chairing this security council meeting tomorrow, it will up the pressure on these countries to cut off the flow of money and funding to the islamic state. and if you don't get in line, you know, you could potentially get targeted yourself. not military but sanctions have always been a tool used is used to try to force countries banks, individuals not to provide money

to terrorist organizations. i think that would be a big part of his speech, kind of outlining the conflict and how the financial element of it, the foreign fighter element of it, the ideology. there's been a lot of diplomacy led by secretary kerry and others over the past few months to get the most important muslim countries, saudi arabia, egypt, to basically promote religious tolerance, to have the islamic leaders in the countries to speak out against isis, to push back against his ideology which, despite being so gruesome, has attracted a significant number of followers, not just from ever most world but we've seen fighters from the u.s. and from europe went in as well. all of these issues will be the focus of the presence speech come to security council presents and it's going to be interesting to see how some of

these countries are strong on defense, their rings, the russians, how they're going to respond to the president personally outlining his vision. >> host: stand in new jersey is on our line for independents this morning. >> caller: yes, good morning. i have, my first question is, is there any current death toll out there in syria since we started the airstrikes ask the second question is, are we going to just -- when is this going to end? is there in ending to this? because it just seems like another group popped up an indigo attack them. along with the allies and then another group comes up. and then my third question is, what role is israel playing in this? because as you know, they were doing heavy bombing in syria

what, the past year or a couple of years ago. and we don't hear much about that anymore. so are they still involved in this? i'm going to hang up. thank you. >> guest: i haven't actually heard. the military operation started last night and continued overnight so i haven't heard of the death toll numbers yet. the pentagon report hitting islamic state had the in the province of raqqa. i'm sure there will be deaths reported over the next day. i'm not totally sure of where those numbers stand. he raises a good question though, the question of the scope of this conflict and the duration. it is unclear. president obama has me pretty general statement that we are going to degrade and destroy isis, which is something that

could take decades or maybe never totally possible, some and some was to present bush's speech after 9/11 that is going to destroy al-qaeda. more than 10 years on it's still around. mib been weakened but it's still there. that's an issue the cards is concerned about and the public is concerned about. what really is the duration and what is the objective of the conflict. it could go either way. myself and the managing editor of "the wall street journal" last night india each its new president and he is calling for a much broader campaign saying yes, isis is a threat but also how these terrorist threats in libya, in the sinai, incenting and. so some of our allies, maybe for the own political reasons are trying to draw the u.s. into an even broader conflict which is something i think is present in statically going to resist. but at the same time he wants to

keep these countries on board in iraq and syria so that's going to be a difficult balance to sort of balance on one hand what our allies, the arab states in particular are calling for and what i would assume would be president obama's limited objectives, which is to hurt and degrade isis. but even that could turn into a much longer campaign. so i think that is something that president obama in the last two years in office, this week at the u.n. he really needs to sharpen his message about how do we declare victory? how do we know when the conflict is going to end? and it is a difficult to do that with such a murky organization, an islamic state that has its tentacles in a lot of places. his last point unusual, i'm not exactly sure what he was referring to in syria to the israelis in 2007 dead launch airstrikes to destroy what was

basically a nuclear reactor that the a side regime had been preparing. there have been a few strikes on and off over the past couple of years. intermittently where the israelis have targeted supplies going from syria and hezbollah, overnight there was a report of the israelis down a civilian aircraft that was flying over the disputed golan heights region. that's the region that israel controls that syria still maintains is syrian territory that they lost in one of the arab-israeli wars. i don't see the israelis playing at least publicly in any way a role in this conflict. israel -- the official was was brought in indivisible what it would sever the coalition. i think you would find many of the arab states will be able to participate. their own publics would be outraged. so i think the u.s. has been

telling the israelis, you know, that they're not going to play a role in this conflict. i'm sure their intelligence is being used by the u.s. because they have good intelligence on syria as a neighboring state. i think israel's role will basically be in the shadows. i would look for anything public. you could still see them hitting targets in syria that they think are direct threats to israel that are kind of outside the campaign against isis. >> host: all right. is a couple of minutes left so this will be our last call for the segment. melvin and mount pleasant south carolina democrat line. >> caller: good morning. is going to give credit to our president. he's got a tough road ahead of them. he's doing the right thing. they keep trying to put notes on the ground thing on in.

your guest how i thought he was very good that he's taken all our time. we didn't have time to call in, he's taken 20 minutes to answer, but to all democrats, let's go, midterm and let's do this. that's all i have to say. >> host: jay solomon, any last thoughts? >> guest: i'm sorry i talk so much. it's a complicated situation. yeah, it is kind of interesting i think had the syria conflict, the iraq conflict lays into the november elections. a number of callers have said, democrats, you know, they voted president obama in twice because they didn't want another war. they were tide of conflict. so is the president, after democrats going to be able to campaign on look, we are strong, we've been taking on this conflict, or are they going to be somewhat boxed in in the sense they did something the president and democratic voters didn't seem to want? and republicans, how are they

going to play it out? it's unclear. they are traditionally the hardliners on supporting military force. i think you'll probably see the president waited too long combat he allowed this threat to grow and now we're going at now we're going added julie. but you think it will be an interesting issue during the coming election, how this conflict is fun in different ways and how it might impact what is expected to be a very close election, and that could throw the senate into the republican camp, which would make president obama's last couple of years in office their difficult. so it will be an interesting, the politics will be very interesting to watch. >> host: jay solomon is a foreign affairs correspondent for "the wall street journal." it's a busy day. thank you for spending part of it here with us on c-span. >> live now to new york. president clinton and shortly president obama speaking at the clinton global initiative. spent a couple of weeks ago i

was honored to join president of the white house to celebrate the 20th anniversary of americorps. it was my proudest achievements because all those 900,000 young people who have done that are now out making a difference in the world, like you are. and astonishing two-thirds of them chose a career in some form of public service and although not all governmental. a lot of it was ngos work. so i'm grateful to him for continuing the movement. and parking places around the world, people are still not free however to join together to do this kind of work. and that reminds us of the importance of government. at least empowering people to do the kinds of things that you are advocating spending your lives on. every successful country needs a smart government, a strong

private sector, and a vigorous civil society. i know from hillary's time at the state department that the president has always supported this, and has done what he could to support people like you from his current position. so for many reasons, i am especially grateful to him for being here, for continuing to believe that as he strives to stop bad things are happening around the world, the rest of us are supposed to do more to make good things happen. so please join me in a warm welcome to president barack obama. [applause] ♪ ♪ ♪

>> thank you. thank you so much. thank you. thank you, everybody. please have a seat. well, good afternoon all of you are i was just discussing with president clinton that if chelsea begins delivery while i'm speaking, she has my motorcade and will be able to navigate traffic. [laughter] because i shall it's pretty smooth for me during the week. i don't know, i do know what the problem is, everybody fights the traffic. [laughter] i haven't noticed. [laughter] always wonderful to follow matt damon. i saw people trickling out after he was done. [laughter] [applause]

these are the hard-core policy people who decided to stay. for me. i want to thank president clinton for your friendship and your leadership, and bringing us together as only he can. bill first asked me to come to cgi when i was a senator, and as president i've been proud to come back every year. as president, bill asked americans to serve the country, and we recently celebrated the 20th anniversary of americorps on the south lawn. and bill asked all of you to make commitments to better our world, and together you touched the lives of hundreds of millions of people. and it's a testimony i think to any later -- any leader, not just what they themselves do but the degree to which they are in

able to inspire action from others. and by that measure obviously bill clinton has continued to exert extraordinary global leadership for decades. and i suspect for decades more to. [applause] now, and agree to come i had an ask as well. i think one of the best decision i've made as president was to ask hillary clinton serve as a nation secretary of state. [applause] so she just welcomed me back stage. i will always be grateful for her extraordinary leadership represented our nation around the world, and i still have a lot of debt to pay though because the two of them were separated far too often. hillary put in a lot of miles during her tenure as secretary of state.

she has the post administration blow right now. she looks much more rested. [laughter] so that's wonderful to be back to cgi. i cannot imagine a more fitting audience with whom to discuss the work that brings me here today. and that is our obligation as free people, as free nations, to stand with the courageous citizens and brave civil society groups who are working for equality and opportunity and justice and human dignity all over the world. i am especially pleased were joined today by our many partners in this world. governments, civil society groups, including faith leaders, and men and women from around the world who devote their lives at a time, risk their lives to lifting up their communities and strengthening the nation's, and

claiming universal rights on behalf of their fellow citizens. and we are honored by the presence of these individuals. as we do every time this year, presidents and prime ministers converge on this great city to advance important work. but as leaders we are not the most important people here today. it is a civil society leaders who, in many ways, are going to have a more lasting impact because as the saying goes, the most important title is not president or prime minister. the most important title is citizen. it is citizens, ordinary men and women determined to forge their own future who, throughout history, has sparked all the great change. it was citizens here in america who worked to abolish slavery, who marched for women's rights and workers rights and civil

rights. they are the reason i can stand here today as president of the united states. its citizens who right now are standing up for the freedom that is their god-given right. and i've seen it myself. in the advocates and activists i've met all over the world. i have seen in the courage of the leader of the cube was ladies in white who endure harassment and arrest in order to win freedom for their loved ones and for the cuban people. i've seen in the determination of russians in moscow, in st. petersburg who speak up for rule of law and human rights. i've seen it in a passionate advocates in senegal and nurture their democracy, and young africans across the continent who are helping to marshall in africa's rise. i've seen in the hope of young

palestinians in ramallah who dream of building their future in a free and independent state. i sit in the perseverance of men and women in burma who are striving to build a democracy against the odds. these citizens remind us of why civil society so essential. when people are free to speak their minds and hold their leaders accountable, governments are more responsive and more effective. when entrepreneurs are free to create and develop new ideas, economies are more innovative and attract more trade and investment and ultimately become more prosperous. win communities, including minorities, fre a free to live d play and love as they choose, when nations uphold the rights of older people, including perhaps especially women, and girls, then those countries are more likely to thrive.

if you want strong successful countries, you need strong, vibrant civil society. when citizens are free to organize and work together across borders, to make our communities healthier, our environment cleaner, and our world safer, that's when real change comes. we see this in the spirit of the new commitments you are making here at cgi to help the people of west africa in the fight against ebola. we've also seen the spirit in other cause, the global campaign against antipersonnel landmines, and comes advocates like jody williams who fought for the ottawa convention. leaders like patrick leahy who led the charge in washington. 20 years ago president clinton stood at the united nations and pledged that the united states would work toward the elimination of these landmines. and earlier today we announced that will take another important step outside of the unique circumstance of the korean peninsula where we have a

long-standing commitment to the defense of our ally south korea. the united states will not use antipersonnel landmines. [applause] so we will begin destroying our stockpiles, not required for the defense of south korea and will continue to work to find ways that will allow us to comply fully. and the united states will continue to lead as the world's largest donor of global de-mining efforts to free countries from these weapons. the point is this started in civil society. that's what prompted action by president clinton, and by myself. and promoting civil society back and surface issues and push leadership is not just in keeping with our values. it's not charity. it's in our national interests.

countries that respect human rights, including freedom of association happened to be our closest partners. that is not an accident. when these rights with the press it feels a sense of injustice that over time can fuel instability or extremism. so i believe america's support for civil society is a matter of national security. it is precisely because citizens and civil society can be so powerful, the ability to harness technology to maximum and mobilize at this moment so unprecedented that more and more governments are doing everything in their power to silence them. from russia to china to venezuela, using relentless crackdowns vilifying legitimate defense as subversive. in places like isa by john laws make it incredibly difficult for ngos even to operate, from

hungary to egypt, endless regulations and overt intimidation increase we target civil society. around the world brave men and women who dare raise their voices are harassed and attacked, and even killed. but today we honor those who have given their lives. among them in cameroon, eric. in libya, -- in cambodia, and russia. we stand in solidarity with those the were detained at this very moment. in venezuela, and marunde, in egypt, in china, and now -- in

vietnam. and so many others. they deserve to be free. they out to be released. this growing crackdown on civil society is a campaign to undermine the very idea of democracy. and what's needed i isn't even stronger campaign to defend democracy. since i took office the united states have continued to lead the way and the suggested hillary clinton helped champion our efforts. across the globe no country is more to strengthen civil society than america. one year ago here in new york i pledge that the united states would you even more. and i challenge the world to join us in this cause. working with many of you, that's what we have done. today i'm proud to announce a series of new steps.

first, partnering and protecting civil society groups around the world is now a nation across the u.s. government. so under a new presidential memorandum that i'm issuing today, federal departments and agencies will consult and partner more regularly with civil society groups. they will oppose the -- and they will oppose efforts by foreign governments -- [applause] >> and they will oppose efforts by foreign governments to restrict freedoms of peaceful assembly and association and expression. so it's not just a matter of the state department or usaid. it's across the government. this is part of american leadership. second come we are creating new innovation centers to empower civil society groups around the world. i want to thank our partners in this effort including the government of sweden and the

development network. starting next year civil society groups will be able to use these centers to network and access knowledge and technology and funding so they can put their actions. we will start with success in latin america, sub-saharan africa, the middle east and in asia. oppressive governments are sharing worst practices do we can civil society. we're going to help share the best practices to stay strong and vibrant. number three, we're expanding our support and funding for the community of democracy to better coordinate the diplomacy and pressure we bring to bear. this means more support for those are fight against the laws that restrict civil society. in recent years we worked together to prevent new limits on civil society from kenya to cambodia, and would help expand the space for civil society in countries from honduras to tunisia to burma. standing together we can do even

more. and final where increasing our support for society groups across the board. we're going to increase our emergency assistance that and battle ngos. will do more to match groups with donors with the funding they need, and in the coming months our treasury department will finalize regulations so they will be even easier and less costly for your foundation to make grants overseas. [applause] we will increase our legal assistance and technical support to those pushing back against onerous laws and regulations. and through our open government partnership we will help more governments truly partner with civil society. we will continue to stand up for a free and open internet so individuals can access information and make up their own minds about the issues that the countries confront. and through our programs to engage him leaders around the world we're helping to build the next generation of civil society leaders.

our message to the young people is simple. america stands with you. we stand with educators. in his village near the border of somalia, young people without jobs are tempted by drugs, recruited by terrorists. so he offers them counseling, business classes and small plots of farmland, helping them rebuild their own lives and their communities, and giving them options for the future. he strides he says not just for the idea of democracy but it's been the practice of democracy. so we thank you, whalid, for your extraordinary efforts, and we stand with you. [applause] we stand with humanitarian like miriam -- where is miriam lex there she is right there.

[applause] you know, in communities that are wrapped by horrific violence, children are so terrified to walk the streets that many begin that dangers and often deadly march north. and miriam's outreach centers give them a safe place to play and grow and learn, and she says her dream is that people in honduras can walk free, and young people of opportunities in their own country. we couldn't be prouder of you, miriam, and we stand with you. [applause] we stand with activists in cambodia. there she is, sophie. [applause] sofie saw a fellow human rights advocate hauled off by the police, and she could have led by she says she never thought of

leaving cambodia even for a minute so she keeps organizing and marching and mobilizing youth in demanding justice. ..

on how to teach objections to accept each other and said we have rights that we can't can achieve in a peaceful way. john is the future and that is why we stand with him. [applause] these individuals are a small sample, just an example of the extraordinary joy and courage and commitment often times outside of the head lines people don't do stories on them but they are her asked but when you look at the surface and the news, they are those who are pushing the border up the hill to make sure that the world is a better place. now, we live in a complicated

world and we have imperfect choices. sometimes for instance for the sake of the national security, the united states works with government that do not respect the universal rights. these are choices that i as president constantly have to make and i will never apologize for doing everything in my power to protect the safety and security of the american people. that is my first and primary job. [applause] but that doesn't mean that human rights cannot be simply sacrificed for the sake of expediency. so although it is uncomfortable, although it sometimes causes friction, the united states will not stop speaking out for the human rights of all people and pushing the government to uphold those rights and freedoms.

we will not stop doing that because that is part of who we are. [applause] and that is a part of what we stand for. [applause] and when the governments engage in the taxes against such civil societies hoping no one will notice, it is my job to shine a spotlight on that abuse. when individuals like the ones i introduced are being held down it's our job to help lift them back up. when they try to pull you off from the world, we want to connect each other. when the government may try to pass the law we will try to oppose them and when they try to cut off funding and give a lifeline and try to silence you, we want to amplify your voice. and i made all of the restrictions and the fear they try to tell you that the world

doesn't care and that your friends have forsaken you, do not believe it, because you are not alone. you're never alone. your fellow advocates stand with you and your community stand with you. friends around the world stand with you. the united states of america stands with you and its president stands with you. no matter how dark the hour we remember the words of doctor king. the time is always right to do the right thing. doctor king also said the universes long but it bends towards justice. the reason that we support civil society is because we have seen in this country of ours that it does in fact band towards

justice but it doesn't do so on its own. it does so because there are hands of ordinary people doing extraordinary things every single day and they pull that in the direction of justice. that's why we have freedom in this country. that's why i'm able to stand before you here today. and that's why we will stand with them tomorrow. god god bless you all and all of those that are working. thank you cgi. [applause]

♪ ♪ ♪ ladies and gentlemen the session is now concluded. the next session will begin as soon as possible in the respective meeting rooms. thank you. ♪

here is some of that debate. >> let me come back to what mr. ross is speaking of. he is talking about an ad from an out-of-state group that we do not have control over into which in his ad he attacked my character and that's what -- whenever i look at that happening i'm thinking does this encourage any 18-year-old to

vote, does it encourage anybody to participate in the political process and to me that it's a test for us because an obligation as candidates to make sure that we are encouraging people to say public service is good coming and we all encouraged that and the negative advertising doesn't work that way. so, i can't control the senate race i can control my own message and that's what i want to do and mike is right. it's about our vision for what we are going to do for the middle-class tax cuts and veterans would we want to do so that is what we are going to be talking about. >> he says he can't control ads that are being run by the republican governors association on a the fairly and untruthfully attacking me when he came out with this ad. my wife is a pharmacist and she's been 14 years going to work every day building a successful business. she would get a bit night and go get medicine for sick kids. yes it's america. she sold her business for profit in america. imagine that. he attacked her for that and for

him to say that's not me that's the republican governors association, you know when that began airing? when the chairman of the republican governors association was in arkansas raising money for congressman hutchison's campaign. he could have said this is unfair david on the three stories, two editorials and they have reviewed this and said there is no truth to it that he didn't. he let them continue to go ahead and get after my wife and i think that he owes my wife an apology right here and right now. >> well, mr. ross, do you control the democratic governors association at that they've run attacking me? you know better than that. of course i have no control over those advantages i don't know about the sales of your pharmacy. i will let you answer those questions. i have never, ever attacked you on that issue. if you remember me attacking you on that in any way, tommy right now

the three branches and you. showing how the policies, the law or action by the executive legislative or judicial branch of the government has affected you or your community. there are 200 cash prizes for students and teachers to $100,000. for the list of rules and how to get started, go to student can.org. next a look at antibiotic resistant infections. last week the director of the center for drug evaluation and research outlining her concerns about the increasing number of resistant infections and the decline of antibacterial drug research. doctor janet woodcock testified before the house and energy subcommittee on health as as

president obama signed an executive order creating a task force directing the federal government to create a national plan to fight such infections and illnesses. other health-care experts and pharmaceutical representatives also testify. if they are here i will yield. >> the subcommittee will come to order. the chair will recognize himself for an opening statement. according to the world health organization's antimicrobial resistant global report on surveillance, 2014, the anti-microbial resistance is an increasing serious threat to global public health. british minister david cameron warned in july that if we do not confront the threat of

antibiotic resistance we could be cast back into the dark ages of medicine where the treatable infections and injuries will kill once again. just yesterday the president announced an executive order focused on efforts his administration plans to take to the antibiotic resistance issue. in 2012, the committee sought to help combat this threat by passing the act as part of the food and drug administration act of 2012. it was an port and first step in the fight against antibiotic resistance and a great example of how the bipartisan collaboration on this issue can save lives.

including the representatives gingrey, green, shimkus, degette and eshoo for their leadership i also want to commend the role for making it a success since its passage. again didn't fully fix the problem and much more is needed if we are to incentivize the type of drug development needed to combat this global threat. to that end, they've introduced another piece of the decision. at. the bad acts which would seek to address problems related to the fda approval process of the antibiotic drugs. it's one of a series of proposals that warrant serious consideration by the committee. i want to thank them for their continued efforts in this space

and all of the witnesses for being here today and yield of the remainder up the remainder of my time to the vice chair of the subcommittee. >> thank you mr. chairman. and certainly appreciate the fact that we are having this hearing today. it is necessary as we proceed with the initiative to talk about some of the things that are most important and some of the things that are relied upon and familiar in our front line of our ability to fight infections and antibiotics. antibiotics resistance is a growing problem. equally troubling despite wide support is the lack of the pipeline of new drugs that can improve on the previous generations or fight drug-resistant strains. a lot of facets to this issue and there is no single silver bullet solution. but here's the deal. our drug arsenal is our drug arsenal. today the committee continues to probe the various market reasons why we are producing new antibiotics and if the proper

market incentives of the registry pathways exist to encourage the development of drugs. there are important strides that have been made in the fda safety and innovation act most notably through the game act, but that was just the first step. part of the deal is once it adapts it is hard to force the nature to adapt. these resistant strains are out there and they are not going away. once this has taken place we are not going back and that is why we need a continuous pipeline of new drugs. i would also point out on a historical note, since the election was yesterday and is going to remain part of the empire it was a famous scotsman sir alexander fleming who developed and is credited with the discovery of penicillin but sir alexander fleming is only -- he couldn't produce a lot of penicillin and it was andrew

moyer from indiana who actually developed the deep fermentation process that allowed penicillin to be mass-produced and it really made a significant difference in the lives of our soldiers returning or the saving of lives of passengers returning from world war ii and parenthetically drop the cost of the course of penicillin from $20 at the time a significant amount of money to less than 50 cents. so, we know we can do this and we know we should do this as we have done it before so the forefront of innovation, that is what steers the issue you all about and that is an important part of a discussion and i will submit this article for the record it will be entered into the record. >> thank you chairman. a 17-year-old honor student named rebecca went to the hospital and within days died

from a resistant strain. they were able to identify the infection and treated with the available antibiotics and it failed to respond to treatment advancing rapidly and cutting her life short. stories like this are all too common in all the more frustrating given the remarkable advances in the american medicine. the threats posed by antibiotic resistant bacteria superbugs is growing at the supply of the new antibiotic drugs and dwindling due to drug manufacturers declining interest and ability to produce new drugs to meet the threat. and the cdc reports last year they find that's 2 million americans that 2 million americans are infected with antibiotic resistant bacteria each year and 23,000 will eventually die as a consequent of their infection. additionally, five to 7% of the patients in american hospitals will acquire an infection during the course of the treatment and though the majority of these infections can be treated, this comp if the recovery process and ultimately imposes greater coastal patients and health-care

system. due to the current state of the market manufacturers are incentivize to focus their efforts elsewhere at the expense of our anti-with new antibiotics to combat these rapidly evolving strains of bacteria. this is why congress included provisions since the days of the legislation which was signed into law in 2012. it was an important step towards solving this problem. in the introduction of new drugs the largest use of the marketing exclusivity. so far we've seen meaningful progress. it has improved a number of new drugs for the qualified infectious disease product designation and with priority review here able to combat the threat and reach patients at an accelerated pace. we should also remember why other walls are so successful. if they decide to intervene in market the market using the

market regulatory exclusivity is we should ensure that it achieves the effect of the pipeline impact of the pipeline of new drugs to safeguard the public health. in pursuit of the greater good, the government strikes the balance between the interests of private industry in and the public and the society. so, that is why i have concerns about the ideas such as transferable exclusivity, the practice of giving a specified period as exclusivity to a company to use on any product it wishes as the record for developing a new antibiotic. this is a recipe for the higher course cost of drugs with no direction to the cost of developing new antibiotics. but there are some ideas that are worth further examination such as the adapt act introduced by the congressman green and gingrey that would establish a limited duration approval pathway that would permit the fda to approve drugs based on a smaller clinical trials. so mr. chairman there are a number of angles that the commission can take to meet this problem head-on and i think that

we all agree this is an issue that warrants further action and i welcome the opportunity to hear from the witnesses today and a special welcome to adrian thomas from johnson and johnson which is headquartered in my district and i'm always pleased to see represented in front of the committee. i would like to yield a remainder of my time. >> thank you to the ranking member for the issues in the public health is great and the combating of the threat of anti-biotic resistance. i'm pleased to learn that the white house announced the executive order and the national combating antibiotic resistant bacteria strategy we need to control bacteria and carbs i guess. recently both of the world health organization and united kingdom joined the united states and recognizing antibiotic resistance is a global threat hiding antibiotic resistance as with a public health and national security priority. it's a threat i take seriously and i believe congress is a strong role in serving. they played a central role in this important effect and effort and i think the agency for the

work. we must all work together to ensure that we that the effect of antibiotics for the future. in 1929 l. at xander fleming had the process for the first antibiotic wonder drug penicillin. such discoveries for the 21st century can happen as well. we encourage greater investment and develop a new novel antibiotic drugs. antibiotics have saved millions of lives by treating infections caused by bacteria then he threw therapies like surgery, chemotherapy and care for the neonatal but by nature the bacteria that can become resistant over resistant overtime in addition to misuse and an adequate diagnosis contributes to the antibiotic resistance and most antibiotics are less effective or ineffective against infections. the consequences of the resistance must not be underestimated. with each day more patients will have few or no therapy options because of the resistance. i think the chair and ranking member for this hearing today. antibiotic resistance is to be a high priority for the committee

and we treat and cure disease in the 21st century. i look forward to the hearing and again i want to thank my colleague for partnering in congress and also on the adapt act and i yield back my time. >> the chair thanks the gentleman and recognizes the gentleman from georgia for five minutes for an opening statement. >> mr. chairman, i want to thank you for calling these hearings. within the 21st century, we are in initiative titled ways to combat antibiotic resistance and the new drug development. let. let me first comment at the chair man and our colleagues in colorado ms. degette for spearheading this bipartisan that looks at ways we can address emerging challenges in the healthcare industry. i have participated in a number of the hearings and the roundtable discussions and have found each to be beneficial to all of the members of the subcommittee.

mr. chairman, we, we'll understand antibiotic resistant 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 get infections resistant to antibiotics resulting in the death of some 23,000 people and costing a healthcare system barely $20 billion in direct costs probably $35 billion more in indirect cost, lost time from work etc.. is your this year alone with the world health organization and the uk have acknowledged this looming threat. just yesterday the obama administration took action on antibiotic resistance as well. for the signed executive order, the national strategy on the combating antibiotic resistant bacteria and the president's president's council of advisors on science and technology referred to and they will be issuing a report.

this is an issue that is now receiving global attention. unfortunately though, according to the fda, the new antibiotic approval has decreased by 70% since the mid-80s. a combination of barriers including of course, the high cost of drug development and a small pocket margins have helped drive companies out of the anti-infectious space to the markets where the return on investment is much higher. you think of your favorite drug whether it is for arthritis or whatever. they simply can be done with more money and there is a lot bigger market. these incentives produce more antibiotics and have yielded a stagnant research and development pipeline for antibiotics and is ill equipped to keep up with the evil than bacteria. mr. chairman, i am glad that the congress has been a leader in this arena. with a partnership of my colleague from texas and is the author into the sponsor of the act, we were able to find the

path for the legislation to be signed into law and it was in the july of 2012. it is by focusing on economic incentives to keep companies and again, in the market. however, despite these advances it's still wore work than needs to be done. that is precisely why mr. green and i authored hr 3742, the adapt act or in this congress. this legislation is the logical next step to the act and develops a new pathway at the fda for and biotic aimed at treating the emerging threats and limited as the high need populations when they have no available options at their disposal. the adopt act also streamlined the process by which the fda updates great plains in the

information so there is another medical research that has the most up-to-date information which to expedite the decisions in the drug approval process the model of the 21st century initiative. they continued on both pieces of legislation. earlier this morning both of us spent an hour on the washington journal discussing our efforts addressing drug-resistant bacteria with a sense of comedy fit into our committee. and i think that mr. green and the moderator and hopefully all of the viewers and listeners would agree with that. in the first and the second panel i had the pleasure yesterday of meeting with doctor barbara murray two will be on the second panel. and the president of the infectious disease society of america. and after hearing some of the

anecdotal accounts of the life-threatening infections for their own patients i'm even more motivated to the fight against drug-resistant bacteria. i will give a really quick anecdote mr. tran and i know i'm running out of time, but my brother is one year older than me and in the 1941 was sick home with ammonia and the family doctor came to the house and told )-right-paren but he was going to die unless they get a shot of this new antibiotic called penicillin. fortunately he lived. there have been some days since then but i wish he hadn't. [laughter] he beat me up every day since then and still does. but that is my own little anecdote, doctor larry. mary. mr. chairman, as we continue the 21st century initiative, we must work in a bipartisan manner to address this growing problem across the country. ultimately, i believe that the

adapt act is the next step in the fight. it is my hope that we will mark a palletization during the lame-duck session leader next month. until then, i welcome the testimony that we will be hearing today to further educate members of the subcommittee on this critically important issue. make no mistake, the cost of inaction and the fight against life-threatening infections is great. and the cdc has already provided us with a statistics to prove that. at today's today's hearing will serve as a great way to use awareness on this important issue. mr. chairman, thank you for allowing me the time normally reserved for chairman upton and i look forward to continuing 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. >> the chair thanks the gentleman for his leadership on this issue. now, recognizing the ranking member of the full committee, mr. waxman for five minutes for opening statements. >> thank you very much mr. tran.

we have hearings in this committee in 2010 on the problem of antibiotic resistance and the fact that it is a growing and dangerous threat to public health is an issue that deserves the full and complete attention of the committee. to make sure people continue to benefit from these life-saving treatments both here and in 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 antibiotics. rather than use it or lose it, but antibiotics is use it and lose it. so we are at a great risk of losing 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 all the ways as well. it would lead to the annual health-care bill and it would've taken a multi-pronged approach to overcome this very serious problem. it is dangerously low today as it results in the antibiotic resistance. so, we need to replace ineffective antibiotics with new ones. in the new user fee legislation, we enacted a law designed to create incentives and the companies to replace those antibiotics. it was the generating antibiotic incentives now act and that

granted a five-year period of exclusive marketing for new antibiotics for serious life-threatening diseases. i look forward to hearing today the witnesses. the exclusivity rewards drug companies by allowing them to charge higher prices. as a result, it also imposes a significant burden on the patient's overall. that opinion is the concept of the transferable market exclusivity for just sometimes called a wild-card exclusivity. this form of exclusivity would give the company that developed the new antibiotic the ability

to transfer to a term of exclusivity to another drug. any other drug that they have. and this is a hugely costly idea that leads to unfair cross subsidies. they develop a specified antibiotic can earn the term of exclusivity. the second grossing drug a year and over $6 billion. it's almost $300 billion. that means the next the impatience 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 make in. i hope to discuss today another approach to getting the new antibiotics on the market. that has been referred to as the adapt act or the antibiotic development to advance patient treatment. this bill would that bill would establish a limited population approval pathway that would permit the fda to approve the drugs based on smaller clinical trials. this is an idea worth examining. if we do create such a pathway, any drugs approved as a result with me to be clearly marked with a prominent signal to alert providers and patients that the safety and effectiveness of the drugs has only been assessed on a limited population requiring a designation is integral to the idea of a limited population of the approval pathway because the

providers have to know that these drugs are to be used only when absolutely necessary. otherwise, it is not only putting the patients at risk but it would contribute to the more rapid development of the antimicrobial resistance to the drugs. in addition to the incentive for the developing new antibiotics, we ought to find ways to cut back on the use and misuse of drugs. patients cannot expect to give them everything they can do with a cold. and the physicians should only prescribe them when they are truly necessary. perhaps most important of the animal agriculture authorizations need to stop. we should mandate an end to this practice, but if we cannot take that step, we should at least have a better data about how and where the antibiotics that are important for humans are being used to know practically nothing about the situation.

as a recent article points out, the data exists in the hands of the major corporations producing these animals like perdue and i have a bill that would finally give the public access to this information. i hope this commonsense bill can be included in the 21st century legislation. i think the witnesses for being here today and for their testimony. and mr. chairman i would like to ask unanimous consent that a statement repaired by the congresswoman would be included in the record since talking about ways to combat antibiotic resistance and foster new drug development. >> without objection so ordered. i have a unanimous consent request i would like to submit the following for today's hearing record. first a letter from the general officers network and a bushel by

one c. 19 veterans organization representing three quarters of all living u.s. armed forces general officers. second a statement from the pharmaceuticals a global pharmaceutical company headquartered in lexington massachusetts and third, the statement from the california healthcare institute to the 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. opening statements will be made a part of the record and at this point, we have two panels to present testimony on the first panel today we have again doctor janet woodcock in the center for

drug evaluation and research at u.s. drug and food administration thank you very much for coming. 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 recognized for five minutes for your opening statement. >> thank you members of the committee for holding the hearing on this important issue. there is broad agreement that antimicrobial resistance to the resistance is a world wide crisis that is going to require major efforts to combat. in 2012 the congress took a significant step in passing the act. in europe the innovative medicine initiative which is a public-private partnership has launched a major research effort on antimicrobial resistance. yesterday the administration released a national strategy for combating antimicrobial resistance. a high-level task force was

established by executive order two. out in detail and action when to carry out the goals. the strategy is a multi-sector effort to attack this problem in all of its diverse forms by bolstering basic research, and enhancing product development, and in proving the surveillance which has already been eluted to the resistance into that use antimicrobials and that use of antimicrobials modifying the use of antibodies in food animals and strengthening international collaboration. the president's council of advisors on science and technology also released a scientific report and scientific recommendations yesterday. over the past year the center for drugs at that the fda has been very busy on this issue. we have issued many new or revised guidance is on antimicrobial drug development. the approved three drugs designated under the game act

and recently cosponsored a workshop on the topic with a national institutes of health and of course our fellow center for biologics has been working on vaccines another way of addressing the problem and the device center working on testing methods. despite all this progress we must recognize a robust pipeline of new investigation antimicrobials does not currently exist. the discovery laboratories are out there working to bring forth the next generation of candidate drugs. so we don't have a robust pipeline. the reason for this is primarily absent of commercial incentive to antimicrobial development. this problem must be solved one way or another if we are going to prevail in the fight against the ever-changing microbes.

we don't just need right now which we do need urgently. we need to keep introducing additional treatments against the common conditions as well. since the existing is inevitably so don't just need to respond to the crisis that we need a robust pipeline going forward. because of it is scorching multidimensional problem we must work together to prevent the loss against the critical disease. i'm very happy to answer any questions. doctor hamburg posted a blog post entitled to take on the executive order national strategy to combat antibiotic resistant bacteria where she

wrote. it is critical and time urgent in the threat of antibiotic resistance is a high parity for the fda to work with our partners to find solutions for the serious public health problem. >> at a stated for public health we are already seeing excess staff into seeing people who impact cannot be treated with any existing therapy that we have and the threat here to public health is that we can have emerging epidemics they will spread and will be in the situation where we literally can't treat an infection that is unfolding in the wide sense.

in addition, each year we are seeing greater and greater resistance problems for the ordinary microorganisms and so the doctors are having to turn to what we would call second or third line antimicrobial agents. as that occurs more resistance to those will leave off and eventually we are going to be empty-handed. >> in the case of antibiotics come even slight variations in the genetic makeup can be the difference between the drug working or not working. understanding that bacteria resistance compounds this problem many times over, why is it important for the antibiotic drug pipeline that we have multiple drug options for the same class or family of drugs? >> what we know when we developed the antimicrobial develops over time after that is

used and after time it can be effective against certain forms of an organism and not against other resistant forms and the mechanism of resistance is different. there are many different mechanisms of resistance. that's why having a large number of drugs in the class or even improvements in the class can be extremely helpful in this situation because you can match the antimicrobial to the organism that you're trying to treat. >> do we have that type of drug redundancy highlighted above that we needed to effectively combat this problem right now? >> we do not because the cutoff line of the anti-microbial that are used against many infections is getting higher and higher every year in the certain types of bugs. >> do you beat me that we need to further incentivize the new drug and diagnostic development if we are to appropriately

address the issue of antibiotic resistance and if so, what would you recommend? >> idb leave we must incentivize it because the current situation shows. so, for the drug development apparently the anti-microbial is not attractive enough and it still doesn't appear that it might not be a loss to the business but there isn't an eight track illegal attractive enough business model to build those robust programs that are needed to both discover and then to develop the new classes of anti-microbial. in the diagnostics i would tell you that alexander fleming would recognize the methods that we use today because they invented them so very is a lot of room at the top for improvement using genetic sequencing for purchase

huge compared to the microbe real. using the clinical practice of advanced methods is not the norm and that improving the diagnostic was a tremendously simplified trials and the treatment. >> we are talking about incentives. do we bb that such could be in the other areas beyond just antibiotics? i believe that is possible. mr. waxman said there are trade-offs. we have to balance there are always trade-offs putting the incentives in place and being a physician i am not the most qualified person to make those trade-offs. i think the congress has to weigh those out. i can tell you that the urgency, the public health urgency for this problem is severe.

you will hear that from won't hear that from other experts as well we are not over the hump. we haven't succeeded in developing a system that would continue to generate defective new antimicrobial. we don't have that. we have sort of heroic efforts here and there. >> thank you. my time is expired. the chair recognizes the ranking member for questions. >> thank you mr. chairman. those. both the executive order issued yesterday and the report of the president's council of advisors on science and technology emphasized the danger of antibiotic use in the agriculture industry. while it is clear that we should do more to encourage greater research into the bucket of the drugs also it makes sense that we should be investing the further spread of drug-resistant bacteria strains and make the best use of existing drugs so they can remain effective for longer periods.

i would like for you to evaporate on the initiatives lead out in yesterday's executive order. both in the human use of antimicrobials as it has already been said about half of cdc estimates the outpatient prescriptions are not necessary given the condition the patient has. that means especially if people only take the drugs for a little bit it can lead to big problems. and also, in the animal world, in the human area, they are collaborating with the cdc on these efforts but the cdc is the lead on improving better use in healthcare and that is a multifaceted effort. in the animal health space, the fda had put out a guidance

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

certain aspects of the adapt act as i understand the purpose of the bill is to facilitate the fda ability to have been tested only in a limited population and for which a need for the drug is critical. the drugs for rare diseases i would like you to explain if and why the existing sublimated approval mechanisms are not getting the correct me if, and also i can address whether you believe the act is currently drafted it provides the fda with sufficient authority to ensure that the antimicrobial would be led in a way that clearly distinguishes them is different from other antimicrobials. it seems that the are considering allowing drugs on the market tested the limited trials when it be confident that the patients understand the care with which the drugs must be used. >> we think the act has elements that we have been discussing for a long time. let me explain some of the

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

definition if you are going to get these drugs on the market for the small population of the resistant organisms, you are going to have to have small trials and you will have more uncertainty about the effect. so, more uncertainty about the effect, worry that they will be used in conditions where it is not warranted. those are the two issues that we are trying to address. in the working conditions, yes there is uncertainty about the effect, but effects, but the community that uses these drugs, usually those are 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 and adopted may be the only drug ever studied for that condition. so, our thoughts come and we have the administration isn't taking the position on this we have thought about this to offer small developer and programs is

a big incentives, but the quid pro quo is to send a signal to the community, some kind of signal to some kind of message that this is a special. there's more uncertainty and also, really good stewardship about this particular product because using it in a loss of conditions where lot of conditions where it isn't warranted would also more rapidly increase the development of resistance. >> the gentleman from georgia for five minutes for questions. >> mr. chairman, thank you for recognizing me. i know that the vice chairman of the subcommittee, my colleague was scheduled to go next. thank you for allowing me to ask my questions now. thank you. as a witness we had you before the committee many times as i've been on the committee. and you are just always so

straight so straightforward and explained things that are 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. colón started. i have limited time so let me get right into that. congressman green and i have been working on this adapt act as you know, and it's a legislation that supports the fda flexibility to consider all forms of evidence in addition to the data from the clinical trials when considering novel antibiotics. how important a dvd that adapted and unique trial designs can play in encouraging new antibiotic drug development? and before you answer that part, and i'm sure that everybody in the hearing probably knows this,

that in your typical phase three trials before the drug can get to market, you're going to have to have a population of a thousand or more people that you are treating. and there are also other requirements that they cannot have had an antibiotic within 24 hours at the start of the trial were at one point it was three days i think and then we got it down to 24 hours. but you know, you're going to have a limited population of people that have these diseases. and when they get to the hospital sick as heck out of, the first thing the doctor is going to do is they are going to hang some antibiotic even if it is wrong they are going to start treating them and then all of a sudden they are not eligible and you have a limited number of people. wait until you get a thousand.

it's too late. so, if you will kind of takes a step further and discuss that for us. >> thank you and thank you mr. green for your leadership on this. i think it's very important. yes, there is a range and i think that is what people have to recognize. there is a range of development programs that are needed for common condition, outpatient pneumonia. we have a lot of drugs out there that still work. if we introduce new drugs we wanted to be just as good as the other drugs and they are going to need larger development programs and that is true for many. but for these very rare resistant organisms that are multi-drug-resistant there's almost nothing to treat them, the cases are occurring sporadically here and there were outbreaks or something like that. we have to think of different ways of evaluating the new treatments. we can't just set up a a tried away and wait for this to happen

and expect that we would be able to enroll thousands of people. and it is true in fact if we enroll thousands of people there will have been too late. so it is true that all antimicrobial drug development is very difficult and in addition to the economic problems there is a huge difficulty doing the trials especially in people who are really sick you can't use the placebo obviously and you don't know because of the problem with diagnostics and you may not know for a few days would organism they are infected with. and so, there are all these technical problems that make it very difficult to get antimicrobial drug development. so, because we have a tremendous amount of gold need for people where there is no treatment available, typically what we do in that case is we accept more uncertainty. and that's been novel trials that we might do.

>> speaking of that uncertainty, i think that that's probably why i commend the president for this in his executive order that just yesterday the 20 million-dollar award for the development of the point of care diagnostics, so someone could take a pill or piece of tape or something and then put it inside of their mouth and if it turns a certain color coming you know what you're dealing with right. you don't have to just shotgun the approach. you can immediately go to what you need. >> i agree. if we can bring the diagnosis of the infectious disease into the 21st century we would make a huge advance and accelerate the development of therapies that it is a good thing. >> thank you. i yield back.

>> mr. waxman five minutes for questions. >> i also want to say to you this may be the last hearing where you and i will have the opportunity to publicly talk like this, but you have done a wonderful job at the fda, and your responses to questions on both sides of the aisle have been a very, very thoughtful and i want to commend you for the work you've been doing. i want to echo the comments about the importance of strong legal and statements in the context of the adapt back and in the statement in the abbreviated pathway by which it came to market without this requirement it would be much less likely to achieve its purpose of fostering and facilitating the development for the pathogens and for the appropriate and the judicious

use of the drug developed in the pathway could result both in patient harm and more rapid drug-resistant, so i just want to underscore that point. i want to ask about a concept that you mentioned in her testimony desiring to your testimony desiring to spur the development of new antibiotics that is the linkage. as i understand under this model, the sale of antibiotics would be from the returns on the investment. after all, we don't want -- if we want more antibiotics sold we want to make sure the antibiotics that are used are effective for as long as possible. so, some other funding mechanisms would be created in a judicial way of selling more drugs to assure that the company is able to make a profit from the developing antibiotics. as others have noted the pharmaceutical business model doesn't fit very well in the case of antibiotics.

we need to however recognize companies need to be able to reconsider investment and make a reasonable profit. others have the exclusivity as i mentioned in my opening statement i think it is a very dangerous idea and we wouldn't want to force patients taking one type of drug to fund the development of another. ..

answer these incentives are sideways to each other and are countervailing. and so that's one idea that has been raised that we mention to delink the need to have a large volume of the antibiotic use which within lead to faster development of resistance. so if that were delink from -- >> do you have ideas on had to get? >> as i said i'm really not good at financial matters, and so sorry. >> we depend on you for everything, economic advice as well as pharmaceutical and food and other things the fda does. let me talk to you about another issue that's stewardship. using and a box judiciously seems to me this is a critical part of any effort to address the antibiotic resistance problem. just released report on combating antibiotic resistance from the president's council of

advisors and science and technology, or the pcast, stresses the importance of increasing double jeopardy of current antibiotics by improving the appropriate use of resisting antibiotics and discussions need to look at both human use and animal use of existing antibiotics. we know there's a lot of inappropriate use of antibioti antibiotics, both on human side and i believe on the animal side. the pcast report describes important role the diagnostics can play in reducing this type of inappropriate use. do you agree the diagnostics, and you alluded to this order, but can you describe the widespread diagnostic tests would help preserve resisting antibiotics and fda taking any -- >> i believe diagnosis should be the foundation of therapy. and, unfortunately, in the infectious disease space, often

you're treating well before you know or before you ever know like what the person has. this is a fundamental problem. like i believe the advent of rapid strep testing has really reduced the use of drugs for presumptive strep but often is called, colds or something, upper respiratory infections in one sort or another. so if we could get more certainty into the diagnosis earlier, be able to reassure the doctor and the patient or family that no, this is not a dreaded bacterial infection that needs antimicrobials. we go along way i think to lowering this inappropriate use. so diagnostics are the key. it's just we are far away from that right now. we need to stimulate that. >> more incentives for that? >> i believe so. >> thank you. thank you, mr. chairman. >> chernow recognize the vice chair of the subcommittee,

doctor georges -- dr. burgess for five minutes. >> dr. woodcock, welcome. your last statement, diagnostics are the key. it's not, this is not part of this discussion but we've had discussions on diagnostics and i realize it's not your part of fda that is talking about increasing the regulation of testing particularly laboratory diagnostic tests or laboratory development test rather, but that factors into the equation. we are talking about the length of time it takes drugs to get through the pipeline but if it also takes a testing long to get to the pipeline, we are actually making things harder on ourselves, are we not? >> yes. well, we have recently, for example, we've had a workshop with brookings on this issue as the codevelopment and technical issues, the final guidance that we put it recently on

codevelopment and diagnostics for life-threatening disease, we're going to quit and approve the drug even if the test isn't fully baked yet. there are technical problems in getting these tests developed right now. and having all of us believe that for many of the genomic test that next-generation sequencing is really going to be a key and really rapidly improving such situations. five great hope that that will be coming soon because we're facing now, every disease, cystic fibrosis for example, the our 150 different communications in the gene. each of which may translate a slightly different phenotype and prognosis. and so we need ways to rapidly -- that goes with cancer and many other diseases. and so we really need to rapidly get to point where we have a true standard that we can all agree upon so that we know we're dealing with. yes, it will rapidly improve development of drugs for the

serious conditions. conditions. >> i share your enthusiasm for genomic testing. i am somewhat more pessimistic because it seems like i could remember in my first room on this committee, many, many years ago, talking about some of the same things. it's sort of like the jetsons flying car. we are still waiting for that to happen. on the issue and at hhs, your study on antibiotiantibioti antibiotic initiatives, incentives for development of new drugs, vaccines and rapid diagnostics for bacterial diseases. and talked of moving the needle in monetary terms for companies by a reduction of the time for political trials, correct? >> yes. >> is a really possible to move the needle on the? >> well, i believe for say the limited population, antibiotic use, that is possible. that's only one factor.

but if you have a very high bar getting on the market, then you're going to need much stronger incentive. i believe for those very rare, right now, resistant organisms we could have very small development programs and every societal agreement that having a treatment available for those is better than having nothing. and so we get every small development programs to we would like to have a signal than to say that clinical community, no, that this is different. know, that this didn't have a huge development program. we are offering you a tool but you want to be aware that, and provide good stewardship of this tool. so we do believe in most cases it is possible and even for common diseases we have worked with new guidance is to try to lower the cost of the development program so that the pipeline can be more robust. >> on the issue of judicious use

and stewardship, i hear the words that are sent on that, but when you target using things outside the area of indication, we tend to think of the world in which we live. but i'm from texas and just a little bit south of texas there's a different world where there's not a prescription required and people consume the go to the pharmacy and say i need this, and the pharmacist may direct them to a particular drug, or they may just become in with a recommendation for a family member and make that purchase. so it's obviously harder to control that jurisdiction in the united states when it's happening as i can is that not correct? >> totally agree. and/or is right outside with modern air travel. and so we're getting soldiers back from combat who have acquired very dire resistant to

infections. we have the travelers who are coming back in the united states who have been -- there are many countries with antimicrobials that are used very freely and may be available to consumers without intermediaries. >> it concerns me that we want to put the oldest on doctor treating patient and emergency room with a concerned family, putting all the onus on our decision here while the greater wide world none of those constraints exist. i agree with labeling. i agree with making the indications well known. but i don't think we should ever try to put federal government in a position of second-guessing the judgment of the physician. >> well, we agree with that. because treatment is empirical we can indicate, you know, it has to be -- you can't say you can treat a patient because this was a study and clinical trials if there's nothing else available.

our clinicians must use their best judgment when it patiently since before them. we agree with that. we want to give the best direction and information to the clinician so they are aware of not only what clinical situation there dealing with but how much information pertains to the drug and what can a drug it is. >> thank you, mr. chairman. i will yield about. >> chair thanks the gentleman and a recognizes that jump from texas, mr. green, for five minutes. >> thank you, dr. woodcock, for being here this morning. it's always good have you before subcommittee. i want to commend you on efforts to open again act. i know lease to drugs and i want to thank you for efforts on adapt act legislation. i cosponsor with my colleague and good friend dr. gingrey. when doctor hibbert participate in last year's roundtable she spoke about the troubles of large clinical trial designs in the antibiotic space. can you tell me your thoughts on

how the unique nature and incentives or even disincentives inherent to the end of the space can sometimes be, make large clinical trial prohibitive? >> certainly. not only is it kind of hard to discover new antibiotics, it's expensive to develop them. the reason is it's really what dr. burgess was talking about, you're the patient before you with pneumonia. you could have all sorts of different organisms causing pneumonia. without rapid diagnostics you don't know what is causing pneumonia. so when you're trying to do an investigational drug, you of a sick person in front of you, you have a prolonged consent process we have to of informed consent. people not going to wait often to go through that process to start a sick person on antibiotics. in so doing of the the issue their pretreated with a different things, and till they get into the clinical trial, and then have all the heterogeneity.

and then you have existing therapy. it's not ethical to treat, to have the comparison group have no treatment usually, all right? and so you have to compare it, to the comparative tria trial at existing therapy. doesn't particularly called noninferiority trials because you may not expect to be better than existing therapy, silver want to show your statistically as good as. so those challenges came to increase the number of people enrolled, need to be enrolled in a clinical trial for a very large number. they are to get, part to enroll because clinicians often don't want to take sick people and go through all the paperwork to get them in a clinical trial. >> the adapt act envisions is an area where more adaptive clinical trials may be used to drug developers seeking to create the next antibiotic effective against drug-resistant bacteria. can become your thoughts and have the path we laid out in the

adapt act may benefit drug companies in pursuit of these new and novel antibiotics? >> yes. well, we envision that you can trade off like a medical need, and we do this in many cases. so if you have a tremendous medical need, people are going to die quickly and you have nothing to treat them with, ma then you will accept a lot of uncertainty about the estimates around safety and effective as. in exchange for something that may work for the patient. and so that means you can have shorter, very small development programs if they need is huge. on the other hand, if we're talking about another drug for pneumonia we are not talking about that. we're talking about resistant organisms where there's really very little. we think there are multiple development programs that could be done, depending on this level of need. in some cases you may only have 10 infactions in the united states a year of the certain organism. in other cases you may have

hundreds. you could get a more robust program, right? but then you're going to be exposing more people when you approved the drug because of their hundreds, maybe thousands who have the condition. he would match the developer program and the medical need together and put that together. but then we would like to have a very strong signal or symbol or whatever, not a fearful signal or whatever but informative signal to the clinician at the drug had gone through this kind of develop an pathway so would understand that. >> thank you. and i hope, you know, with this hearing today and we will be able to move the adapt act across the line in the future, in the coming weeks and months i suspect it can be a dialogue with stakeholders include our second panel today on ways to strengthen this proposal and complete the next step in fighting our health, public health crisis. i want to think he understands for your hours spent working with our offices during the august recess. i know we can continue that

effort because this is important. again thank you for being here at i yield back my time. >> and i thank you for your leadership. >> the chair thanks the gentleman and a recognize the gentleman from new jersey, mr. lance, five minutes for questions. >> thank you very much, mr. chairman. good morning to you, dr. woodcock. as members of the committee we have heard first hand the urgent need for greater incentives, to encourage new drug and diagnostic development in the antibiotic space. some of the witnesses on the second panel has recommended a wide range of incentives that would encourage greater development. do you believe that incentives we identified in the end of attic space might also benefit other areas of unmet needs 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 for which there are many, for which no development is occurring. so i think you have to determine whether 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 say that antimicrobial development is urgent and is a public health issue. the orphan drug those people are suffering from those ever tremendous need for therapies to develop, be developed and many, many are not being developed. we are doing something such as working with the national organization for rare diseases, and so to get better natural history studies that would incentivize development and make it easier to understand what is the course of this orphan disease, so we understand what's needed to study it.

however, there are still major financial obstacles. >> thank you. as you know i chair the rare disease caucus on the republican side and i have in my office virtually every week parents of children who suffer from rare diseases where there are no medicines at all. 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. 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 a budget plan to combat antibiotic resistance. a role, dr. woodcock, will the fda play in helping to those of the th the presidents order spek with yes. well, we've been working with the planning group on this, and the fda has a wide range of

responsibilities. everything from animal health and those issues, surveillance activities which are done of antimicrobial resistance which is primarily cdc lean but fda for example, the norm system which is mentioned in those reports which monitors antimicrobial 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 incentivize antimicrobial development and, obviously, there's an interesting better diagnostics which is put forth in the report. so we have a multiple role to play. >> thank you, and finally, dr. woodcock, me but now when all of its games in football this autumn, except of course against lehigh. i yield back the balance of my

time. >> the chair thanks the gym and recognizes the gentleman from illinois for five minutes. >> thank you, mr. chairman. dr. woodcock, it's good to see back here again. i think you're being too coy. the business, the business model, whether it's going to be in diagnostics or testing is the same business decisions that we make in our home. it's simple about risk and reward. and so what's the reward in which the amount of risk, individual will play a big role in that, and we hope you will work with us to do that. i've been very excited about this debate about the diagnostic space. and in your opening statement, and i had to go onto the world wide web come on new technology,

allows us to do that without telling staff to go find and get it back to us. pasteur was born in 1822. surely if they can recognize our testing procedures now, we've got work to do to ramp it up i think. that's the whole, by summer debate, and the genetic markings and all those other genome stuff that's going on. so i'm very, very excited. also i've been involved in helping along with following dr. gingrey sleet, appreciate the work he's done, and gene green, i look forward to working with him as we move forward in the next congress and we're having discussions to do that. you know, you get the same questions right, from us. and so i think 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

incentivize in the private sector and something they're moving on that's going to the process and helping them do that. then they're going to take and then go, you know, into places no one else is going to go. 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 better pastures, so to speak, where they see business model return on investment. and similar with many medium companies. there are many small startups that try to get into antimicrobial space, and that's good news, but most recognize they aren't always as successful when they have one product they're trying to develop. >> and we talked a lot about the

gap act today and there's been some success in that process. -- adapt act. you think are some additional things we can do to incentivize like the adapt, what other things can we hold on to encourage additional incentives with the adapt act or other processes that we're talking about? >> i think you have to think about what are the alternatives, all right. i know there's some government development. there's government awards. those are usually under contract. they are for certain entities, so there are few of those. but what is, what are the other ideas to develop a robust -- unique drug discovery effort, and that means people, scientists working full-time in laboratories tried to do the new molecules. this is way before you get tested in people and it doesn't really involve the fda.

what i understand from the kennedy, the discovery community is actually antimicrobial discoveries he come hard. and i didn't know that until i talk to them, that they screamed like large numbers of molecules and this pathway and so forth. it's harder, hard to find the new generation. and so that means if a robust scientific effort has to go on in the basic science of microbes and also in discovery of these new molecules. and to do that someone has to have the space that they're going to make money from that 10, 15 years 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 going to be commercial development, how is it going to happen? where is it going to have been? >> would you help us as we go through this process, help us, this committee, to identify ways we can help incentivize? >> absolutely. >> because you were talking with these folks, and we will, but we

need a lot of airs on and i'm going to end with this. this labeling debate, the way i understand it, i also, we went through this debate with a paper labeling and information on till bottles that -- and no one reads these things. everyone knows that. so labeling to the web and labeling through -- that's got to be a better way than just keep putting stickers on pill bottles or things. because they are just overwhelmed. and i would like some simplicity in that. that's just a statement. >> could have responded to that? the centers for drugs is working on developing a patient information leaflet. a one page 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 then we have proposed a we're interesting going to an electronic physician label,

which is that thing that's folded up inside the pill bottle. we would like to move to to electronic with some paper option for those who are still in electronically impaired, shall we say. but most of the world can easily get that information at drugs at fda, and many other sites. >> the chair thanks the gentleman to recognize the gentleman from florida, five minutes for questioning. >> tremble in, i appreciated. thank you for this money, dr. woodcock. we submitted some questions for the record in november, and to my knowledge the committee hasn't received many responses to i want to ask you one question again. can you tell me how many treatments were approved with biomarkers within the last five years? have any approvals occurred with a novel marker? and never been before treated before within the last five years. how many new markers does the

fda except for the person is in the last five years? if you could provide that answer. >> yes. we are working very hard on this. that was a very provocative question. we had a very long debate last week among our senior people on the definition of a biomarker, and which of these endpoints such as fev1 which is not that she can breathe into one of those machines, is that a clinical end point or is that a biomarker? could in my opinion it's a biomarker, and that everyone agreed with it. so we are working very diligently on that. the edge is yes, we have approved -- we approve a large number of drugs i biomarker endpoints all the time. a very significant proportion of the drugs we approve are based on that and we have approved on novel once in the last five years. but to get you to count as big of a bit more effort because we had to resolve these definitional issues.

>> when do you think we might get some answers? >> i'm not in control of that timeframe, but i can tell you we are working very diligently and i believe he would get the response. >> we will continue to follow up. >> it's a good question but it is invoked -- provoke some thought into what spin the rep oxley 459 indirect funding fiscal year 2014 to address the antibiotic crisis. these funds are allocated across hhs, fda, dod and usda. about 75% was used for basic and applied research, with the rest directed towards stewardship and surveillance. currently have these berries agencies coordinate their efforts? >> well, there's been a long-standing antimicrobial task force at the agency level across the government that was headed at hhs, fda has been a part of that. the executive order directs the formation of a higher level task force in the government that

will direct the implementation of the strategy that was announced. but there has long been coordination across the government agencies and doubly the pcast report discusses that. >> how is the u.s. coordinating with the world health organization? and other organization as well as other countries working to combat antibiotic resistance? >> we do have, fda, cdc and many others have relationships with world health. and i think the executive order yesterday and the strategy concedes as much tighter collaboration with heavyweight joe in a very concerted way -- of uh oh. >> thank you very much and i yield back. spent the chair thanks the gentleman and i recognize the gentlelady from colorado for five minutes. >> thank you very much, mr. chairman. i think this is been an excellent discussion and i just

wanted to ask you to clarify one thing, dr. woodcock. our next panel is going to talk about the report on initiative by the eastern research group, and what that report concludes is the shortening clinical trial time frames is an unlikely contributor to innovation. ..

>> clearly there are multiple barrs to antimicrobial resistance. i do agree that the streamlining of clinical trials for resistant organism will stimulate development in that area. why? partly because developers have told me that, two, because we know from experience that if we have a clear path to market and people understand that, they're willing to put their money down on a, you know, on a kind of bet that they will have a molecule that can get through. but this is clearly not sufficient. number one, we're only talking about the most resistant organisms here in a small