Transcripts For CSPAN2 Key Capitol Hill Hearings 20140711

About whether or not things are made public. I feel for you, because part of me think that is youre captured by those you are supposed to regulate, but then youre supposed to regulate those you are captured by. I could tell whether youre in charge or whether youre a minute a minion to them. The notion that you will say ill go after this im you know, i dont sense that you feel like you have any control over the situation, and if you have no control, if youre merely a monetary passthrough, why should you even exist . Well, i think the the reality is that while the issue we are talking about here i dont have a vote on, and i dont get to set those policies, i can certainly set the tone on it, and i can certainly be someone who voices a very loud opinion and says this is not right, this is inappropriate, these are the conflicts that exist when you have a policy and a practice like this on on your campus. When i first took the job, the very first summit i held in indianapolis was a summit on sexual violence, a summit that led to the creation of a working group of experts, not College Athletic folks, but of experts from across the country to create a working group and a think tank. Well be issues the results of their work this summer, im now, thanks to your work, gull to go and make sure this issue is addressed in that handbook, and im going to talk to the leadership at our very next meeting in august that we need to find ways that athletic depends are not responsible, because of all the concerns that you raise. Thank you. Im over my time. I hope somebody else covers the questions about young people from families that cant afford to even travel to see their Children Play in the games. Yes. Because meanwhile, the universities are making millions off their children, but their parents cant even get a stipend to attend the game to watch their child play. There is something wrong with that scenario. And its going on college catch puss across this country every single week. I agree with you. Thank you. I want to start with which is the coach for the for the coach who has epilepsy. As you know, had a number of seizures, and the university of minnesota president said were not going to get rid of him. Our record has been rocky, the gophers, they kept the coach on. He had to coach from a box, he couldnt coach on the field because of his condition. During the entire season he coached from a box, and i was there when we beat nebraska with him in a box. It was a great moment. It was a great story, but it does make me think, as i hear all of this, that that kind of compassion, what was so captivating about the story is it kind of defied what had been become of so many of these big sports games and the cutthroat competition and how people were treated. So i think what youre hearing up here today is the hope that these are deliverables, these are things that can happen, when you talk about changing the Sexual Assault policy, making sure the players have the health care insurance, making sure thif the time to do the internships. They arent crazy hard things to do. That we have another hearing, whether its six months from now or a year from now to check up on whats happening with these things whether theyre at the high school level. I know that senator tom udahl cosponsored his bill. I know theres a lawsuit thats going on, just your opinion of it, but if you could talk about whats being done. I think its a critical issue and most heavy ily identified. It occurs in virtually every sport. First of all, as i had mentioned in my opening comments, we created when i first came into the office, i was a business sprited to find there wasnt a cheef medical officer, so when we went out, we hired a wonderful doctor who is a neurologist. Hes working unbelievably hard. We dont have good signs, its not as well understood as we all might think. So once they have done that, just this past handful of days they released the first ever consensus among the medical community on the treatment and the prevention of concussions, especially around football, a new football practice guidelines around contact and a variety of other things. We signed with the department of defense about two months ago, an agreement to do a 30 million project. Were putting up 150 million, dod is putting up there 15 million to attract longitudinally young men and women and try to get a legitimate history of the occurrence and treatment of the concussion. Were working with the youth all of the Youth Sports Organization to try to get better practice guidelines working with the envelope to try to get coaching, efully in people, and boys how to tack the so girl soccer coaches are saying we need to ban any heading until girls and boys are at least 12 years of age. So were looking at trying to lend our support to those kinds of efforts. Were making pardon the pun headway, but the factser we need a lot more understanding of where this disorder. Im pleased where we are, and im proud. Part of the reason why i stopped playing in the nfl to pursue medicine and go into a particular special of neurosurgery was because i saw a lot of my teammates with early onset dementia or some of these traumatic things you often associate with several concussive episodes. I saw it in the nfl, and now as an aspiring neurosurgeon, i would love to add expertise to that discussion, but one thing i noticed in the locker rooms was a lot of my teammates, fellow athletes, we want to be fast, right . Wrept to be quick, nimble, agile, so the protective equipment we wear, a lot of the guys would choose and select equipment thats lighter and maybe not as protective. So that may lead to more concussive episodes. I think education is incredibly important. And talk to us about the dangers of concussion. And then if you have a risk of getting a second concussion, your likelihood of getting a third, fourth and fifth goes up exponentially. The pressures of trying to be on the field, trying to compete, all at the same time as devin said, earlier if youre not on the field, nfl coaches cant see you, youre not exposed, perhaps you lose the opportunity of getting drafted high and getting to the next level. Its just to perhaps change the culture, change the focus of Big Coalition high velocity hits, and the idea that that is a part of the game. It is not a part of the game. If you look at the rule book, its to take a player to the ground similar to how rugby is performed, but you see the highlights and exposure on the big high velocity hits where guys are speering into another player. Thats what gets celebrated, and i think thats the wrong path. As i said, hopefully in a few years or so, i can add more knowledge to this discussion, but from my anecdotal knowledge, it is an issue. Ill ask questions on the record of the internships of you mr. Ramsey. I thought that was fascinating, on what a small proportion of the student athletes end up going into pro sports, thats most likely not going to be their career. They have to have that ability to pursue, and if its supposed to be 20 hours, then we have to find some way to measure that and enforce is. To me this hearing so far has been a lot of talk about a lot of things which have been around for an awfully long time, which we all think should be solved, but theyre not solved, and i think there are very clear reasons for it, and that is decisionmaking is flawed, fragile and useless. Florida, which has everybody recruits from florida, they have a law that transparency, how money is spent, has to be made public, because they have a law. And so, you know, in the contributions and when ncaa comes in, only a small portion goes to education and all kinds of things go to the stadium, that is all available to the public. So i commend them for coming from a state like that, and i just think thats the path with so many answers, which we just otherwise seem to be unwilling to deal with. Excuse me. Well, thank you, mr. Chairman. And i think a lot has come out of this Committee Hearing that should enable and help dr. Emmert to continue with the reforms that hes trying. So much has been said, let me highlight a couple. I happy to know, because i was mesmerized with mr. Rolle as a player at Florida State. For hi to do the interview for the rhodes scholarship, which was in the south, on a saturday, his president t. K. Weatherall had to get special dispensation so that they could get someone to donate a private jet for him that could fly him somewhere in the northeast when Florida State was playing up here, and even so, he made it only in the second half. But the emphasis you know, thats something thats so common sense that you would want a player to interview for the rhodes, and yet it was a big deal. It shouldnt have been. The fact of so of of these players that are coming from families that are dirt poor, and they dont have the opportunities that others do it seems to my its common sense, we should have sometime ends or whatever you call it, so it equalizes the Playing Field of the financial ability if those student athletes are contributing to the Financial Wellbeing of that university. So too with Health Insurance. That all to be common sense. If is hurt and thats a careerending injury, the best of medical care ought to be given to that player and for it to last for some period of time in the future. And of course, consuggestions just add a whole other dimension to this thing. I thought it was very interesting in another committee that i have the privilege of chairing, we did a hearing on concussions, and including professional athletes they would not recommend to their children that they play football. So times are changing. The ncaa has got to get with the times. So whatever this Committee Hearing has done to enible you as a reformer to get those schools the votes that you need to do a lot of these things that werealkout why should they have to sneak arounn the shadows in order to get money to be able to buy a ticket to come to the game and where to stay in a hotel and so forth . Mq1n it defies common sense. Mr. Rolle, you want to make any final comment . Sure. One thing that id like to say is that when you think about the and the oneyear renewable, aio lot of players that i was on teams with, it kind of felt like it was us versus them. And it wasnt a team. We didnt feel like the ncaa was protecting our best interests, wanted toc see us succeed and thrive and flourish. It was almost as if we had to do everything we could to promote ourselves and to better ourself against this big machine that was dictating and ordering the steps that we took. And maybe thats not true. Maybe theresc some miscommunication, maybern the information wasnt getting disseminated well enough. And thats another thing that is quite bothersome be today going back to the economic issue and the economic struggles. A lot of myc teammates, senator nelson, come to poor area this is florida, and they come to Florida State as the first person in their family to be a college student, and they dont have a lot of money to lean back on from their families. So that leaves them openc and susceptible to unsavory things. Nfl runners would come to our dorms and knock on our doors and say, hey, i can take you out to a nightclub, i can buy you a meal, i can give you a suit to wear, i can take you and your girlfriend out to eat, andc the players dont have anything else. Then they become uneligible because now they have a black mark or they just dont play anymore, so they end up back in polk county, florida, and that perpetuity continues, and its g and discouraging. I saw it often. That is the exact example that we need to use. Thank you, mr. Chairman. O use. Thank you, mr. Chairman. Thank you, senator nelson. I apologize. You could have run for the senate ten years ago. I dont want to be disrespectful to senator blumenthal who i think was here before me earlier. No . I will ask my questions now only because i have to preside, and if you would yield for five minutes, i would really appreciate it. Ive already been put in my place once. I will yield. Yeah, but youre bigger than i am. So [ laughter ] let me thank you, mr. Chairman, for having this hearing, which very sincerely i think is a very important one or a significant for the future of academic institutions. I want to thank all of the folks who have come to enlighten us and thank you to senator nelson. And i want to begin by saying, for what its worth, i think the law here is heading in a very unfortunate direction. As dr. Emmert and i have discussed, i think the law is heading in the direction of regardi regarding athletes at university more and more employees that is because of the growing asymmetry and energy, time, sweat, blood injury that is involved. That is classically the reason why labor law protections have applied to individuals who on potentially are victims of exploitation. Or construction sites. So i think the challenge is to dim minutic and truly and therefore the laws will move to and i say that with regret, because i too, as dr. Emmert has articulated well value the student athlete model rather than the employee employer model, but the more the reality is that athletes in effect function as employees, the more the law will recognize that fact. My opinion is worth what youre paying for it. Im just a country lawyer from connecticut, but i sincerely believe that thats the direction of the law. I want to first ask you, astonished and deeply troubled by the revelation that Athletic Departments on many campuses investigate i would like your commitment that you will work to change that practice as soon as possible and as effectively as possible. You have my commitment. I obviously want to understand the data more. I simply read a summary. Im not sure what the facts are on those campuses. As i said earlier, the data that senator mccaskills staff brought forward was shocking to meivities i am shocked and outraged by you apparent practice on many campuses with the effect of revictimizing survivors who may be in effect victims. I want to focus for the moment on Health Insurance. You know, individual colleges and the ncaa made billions on the talents of these young men and women, and i want to ask you, couldnt they offer Health Insurance for athlete for a certain amount of time after they leave college . That seems imminently fair. So i would ask for your commitment that you will work towards providing for Health Insurance for these needs and injuries that may extend beyond their playing years on campus or even professional settings, and id like to know what more assuming you are committed to that charge, what more you can do to encourage schools to provide this kind of coverage for its student athletes . Yes, sir. Well, today the coverage that exists right now is provided either by the campus itself or by the student athletes family, depending upon University Policies at most of the high resource schools, they provide the insurance so the student doesnt have to. We need to do several things. Wen, in my opinion, we need to make sure there arent copayment requirements of a young man or woman, especially from a low income family, and suddenly they have an injury with a 2,000 or 5,000 copayment, since it was a sportsrelated injury, so we need to make sure we dont have many of those circumstances out there. We have right now at the ncaa level catastrophic insurance, so if there is longterm disability issues. If there are injuries that require treatment over the course of a lifetime, there is a policy in place. We have some individual that have been on the policy for 20 or more years. We have taken a number of steps to make sure that policy doesnt kick in until you have 90,000 worth of bills. We need to make sure that, to your point im saying yes, i guess, senator, you have my commitment. There are complexities in all of this we need to work through, but i agree with you that no one should have to pay for an injury they suffered as a student athlete. Thank you. I welcome and accept your yes to both the Sexual Assault and the insurance questions. I would ask further for your commitment to work with us on sensible legislation that will impose a higher level of responsibility in both areas. Thank you. Certainly. Thank you, mr. Chair. Go ahead. Thank you, mr. Chairman. First of all, im grateful, we talked about this in my first days as the United States senator, this was an issue you wanted to cover, and you saw my excitement for doing that. A lot of that stems from i was back in the 90s an Ncaa Division i football player. I want to first say, its very important for me to say, i probably wouldnt be here right now if it wasnt for that experience. I am deeply grateful. I joke all the time i got into stanford because of a 4. 0, and 16 yards receiving yards in my high school year. And had lifetime experiences frankly that i could never, ever replace. It opened up extraordinary doors for me. So we could have a hearing that could go on for hours if not days about all the good things that are happening with the ncaa, so please forgive me if im not giving that appropriate light. What concerns me and what you and i have talked about chairperson for quite some time are the egregious challenges we have. I want to publicly thank dr. Emmert, he was gracious not only to come here, which he did not have to do, but took special time to come see me as a former athlete to sit down and hear my concerns. I was taken aback that you agreed with me across the board. Let me just reiterate those for the record and make sure we are in agreement. So number one, you agree the big problem that athletes dont get scholarships to get a b. A. . Yes. That is a big problem that we have, athletes that pour their lives, 40, 50 hours a week, and then end up having gone through their eligibility, but dont have a b. A. That is a problem . Yes. You agree its a problem that we have athletes, often very poor coming onto College Campuses restricted from working, they cant shovel driveways for extra pending money, cant meet the needs of travel, cant buy toiletries, clothesing, if theyre restricted from working, you know thats a problem we have to address . A minor correction, not banned from working. They can in fact work, and in many cases do, but the biggest challenge is they simply havent the time. So in other words they cant work because of whatever reason, you know thats the problem that the scholarship does not cover the full costs at the same time theyre being expected, whether by law or not, to work 40, 50, 60 hours a week. Completely agree. Thats a problem. You agree its a problem with the Health Coverage is inadequate and that we have people, many of whom i know and you know, who have blownout knees, and even though they have graduated now, theyre having to go into the pockets for copays and the like to deal with medical injuries that were occurred, really the root was the challenges they had when they were a athlete . I agree the insurance today is much better than most people think, but theres certainly areas that need to be closed. And its costing some athletes thousands into their lifetimes. Yes. You agree theres a real problem still with time, that as the two lease at the end of the table, its not just the practice time, guys, how many hours would you get your ankles taped, treatments . An hour . Two hours . Sometimes three hours, depending on how bad the injuries . We have athletes putting in upwards of 60, 70 hours a week, thats a problem . A huge problem. You agree that there is a at least an issue that hag to be dealt with to improve with the issue of Sexual Assault, it has to be improved in the way we investigate . Yes, and i think the way we educatg med right, and be this we didnt cover, and so it might not be a simple yes or no, but in terms of the due process when a young man like mr. Ramsay not even knowing that he could get a lawyer, he could get help, there are breakdowns, would you say that process could be improved . It certainly could, especially on most campuses, yes. So i guess i just turn to you, mr. Chairman, not having the time to go through more rounds and deeper questioning. This was a challenge for when i was an athlete some 20 years ago x. Athletes after athletes are going through and facing what i consider the exploitation of athletes. Let me be very clear. Its an exploitation when you have an athlete working 60, 70, 80 hours a week and yet not still being able to afford the basic necessities. Being put in horrible situations where they put their jersey with their name on it being sold making thousands and thousands of dollars, but they cant even afford to get the basic necessities of life. And if they try to sell their jersey for 50, they then get penalized and lose their thats exploitation of an athlete. To me, its exploitation when you give your body gentlemen on the end, how many linemen do you know today that played with you that have gone through four, five and six surgeries for their knees . A lot. Yeah. And if theyre going into their own pocket after giving up their knees to make millions of dollars for the university and then the universities arent even compensating them appropriately, thats an exploitation of a College Athlete that has to be addressed. If we have guys like was testified by the two gentlemen on the end who i know this because we spent hours. We did the math, my team, because so many players feel an assault on your dignity that youre putting 70, 80 hours a week. Youre giving up internships. You know more about your playbook. I can still tell you stonebreaker, todd light, i can tell you more about them because thats what i was studying at night. You spend all of that effort, and then your university is not in any way insuring that you get a degree at the end in Something Like engineering or political science. Theyre not honoring the fact that sometimes, hey, when youre working full time, you cant finish your degree in four or five years. In fact, when they could lord over you the removal of your scholarship because with it does still happen. Athletes are still exploited if they blow out their knee, if they somehow dont meet the mandates of a coach, they lose their scholarship. They dont get their degree. And so, to me, this is plain and simple the dark side of the ncaa where athletes are being exploited. And this is why i love that Taylor Branch is here, because occasionally and you use these words, dr. Emmert, you used a cattle prod to get us moving. I wrote that word down. Because i have seen the ncaa move quickly when there is money and reputation on the table. For example, you mentioned his name. On the highest exultation of victory he says on national tv what we know athletes, what coaches know is a truth, that some guys dont even have the money to buy shaving cream. To eat at night. But he says it on national tv, and within seven days because the shame and embarrassment, within seven days if im correct, the rules changed, and guys can actually eat. Yes, but id like so hold on because im already over my time, sir. [laughter] let me give you another example. Cam newton was going through the same problems you were at the same time. His eligibility was being challenged, mr. Ramsay. Cam newton, a guy who brings millions of dollars into a university, and his adjudication happened quickly. Yours did not. Youre not a name athlete. Your names not on jerseys and like, so it didnt. So what i want to say in conclusion, mr. Chairperson, and really why i love mr. Branch is here, that when theres a class of individuals who are being exploited and theres millions and millions and millions of dollars being brought in and guys cant even afford health care, cant afford to finish their degrees, then we have a problem. And i respect dr. Emmert in saying, hey, were going to try to address that, but where is the urgency that this has been going on decades in america . And so i dont trust, like the Supreme Court when they said we were going to integrate schools, they said do it with what kind of speed . Deliberate. All deliberate speed. And be it took them a long time to get around to doing the right thing by people. These are young people in the United States of america. And we cant afford to wait for all deliberate speed. There has got to be some accountability for fast action on things that the head of the ncaa says is a problem. That next season when football season starts there are going to be kids suffering from the same list of unfair things that somehow, someday is going to be addressed. So i think we need another hearing with the real rule makers, with College President s lined up here and ask them how fast are they going to address the exploitation of College Athletes. Mr. Chairman, thank you. Well, mr. Chairman could dr. Emmert respond . I have a sacred obligation to senator ayotte. She is next. Thank you, mr. Chairman. I appreciate it. Let me just say up front on this issue of Athletic Departments investigating Sexual Assault allegations, that is ridiculous. Youve got to get fix that right away. I am a proud graduate of the penn state university, and its obviously were it was so troubling and disappointing to see what happened at my be university. I loved the university, but the Athletic Department is not where you handle these kinds of allegations, so youve got to fix that. Dr. Emmert, walk out this door and fix that. What im troubled about when i hear the testimony today and i just need to understand, senator blumenthal asked about the change to an employer employee model. Weve talked about compensation potentially for athletes today. I dont want to see any athletes mistreated. I want them to be able to have a quality of life thats important as they serve and get the education and be able to be an athlete, the student athlete model. But as i think about what, for example, the nlrb did in its ruling, i know it applies to private universities allowing unionization at northwestern. And i think about this compensation model, the employer employee model. What does this do in terms of the schools where were not talking about the top athletes that may go on that are the revenuegenerating sports. And what will that do to womens athletics if we start down the road of a compensation model, what will happen in our schools in terms of the schools that or the sports that arent at the top where those athletes you can sell the jerseys, you can make money but are still very important to student life . And when i think about title ix and women and the opportunities women have gotten because of title ix, if youre on campus and this suddenly becomes an employer employee type model, what does that do for the womens sports if theyre not Revenue Generating . And how do we sustain them if this model changes . So its a big question, but with i would like but i would like you all to comment on it because the last thing i want to see is i want to headache sure that our athletes are treated well and certainly, mr. Rolle, what youve done, its really inspiring to see what youve dope. And thank you, mr. Ramsay, as well, for your inspiration of being here. But theres a whole category of athletes that werent quite at your level that are participating in College Sports x its been an opportunity for them to get an and education for women as well. That are at your level but dont always, our sports dont always generate the same amount of revenue, and i want to make sure that women still have the opportunity theyre had because of title ix. So if you could comment on that, id appreciate it. I would love to comment on that. I think its not a zero sum game. If some athletes are profit athletes who have a higher market value than the cost of their grant and aid, then we should treat them differently than athletes who are not profit athletes. Its not either or where they must be. If theyre employees, as the nlrb found, then we should treat them as employees. That does not mean that College Athletics or athletes in other sports, women or it doesnt its not an either or. Can i tell you, can i tell you, because my University Said if the unionization rule were applied, university of new hampshire, they feel this will diminish the athlete improgram, it will diminish it for women and nonrevenuegenerating sports. I understand what youre saying, but thats not what im hearing from other universities. Well, i would say probably a University President by the name of chicken little might have been the first one to say that because the sky will not, in fact, fall. By denying profit athletes just compensation in the market, it does not preclude colleges and universities from supporting Intercollegiate Athletics as an educational opportunity. If theyre employees, then they should have all the rights of employees. It does not title ix does not apply in an employee setting. I would like to see what mr. Bradshaw has to say about what i just said as well. Thank you. We probably dont have time, but i certainly would like to hear that model that works. I believe its going to be devastating to all those student athletes, including women, who dont produce revenue. Who arent seen as athletes or students who create that revenue. I really would like to see that model work. Because as we all know, thats going to mean who can afford to pay for that will and those who cant wont. Thank you. Again, if i could reiterate, and i appreciate the question, and im trying to articulate it as clearly as i can. If the athletes are, in fact, employees, then we have a moral obligation and an obligation under the law to treat them as such. If theyre not, it does not preclude them from participating. Title ix does not have to be held hostage by this because were only talking about 5 of the athletes. So i know my time is up, and i know others have to ask questions, but, so were just going to have a distinction . So some will be employees and some wont they already are employees. I dont know how that works. They already are employees. So by being open and honest about what we are using and exploiting these athletes for, honesty is a very good thing. So as a woman athlete, if im not a revenuegenerating athlete, then im not, i dont, im not going to be eligible for this employer employee relationship, so theres sort of a second category of athletes on campus. They already have that. That bothers me. We refer to them as revenue athletes right now in revenue sports and olympic sports. And thats fine. It does not mean that if we compensate athletes according to the market that everyone else has to go away. That is not what has to occur at all. Mr. Chair . So if the universities find that that opportunity is very important, they are still support it they will still support it. They will still support it. I see no, no way that womens athletics or olympic athletics is going to go away. Its not going to happen. It just isnt. Mr. Chairman . Senator scott. Thank you. Dr. Emmert, as i listened to kellys questions about the cost structure and the likely impact of creating some unions or some employees and some not employees, ultimately, the cost structure itself would have impact in universities and have impact in athletic programs. I just wonder how significant that impact would be. And let me say this before you answer the question as you think about your answer. To mr. Southall from its good to have you here from university of south carolina. I would be remiss if i didnt point out that at least you go to the right place, the gameconcludes. I like that a lot gamecocks. My story is very different than corys story and these rhodes scholars at the end who have done very well academically, and im very proud to see your success off the field as well as on the field. My story, i think, really plays an important part of why im asking the questions im asking about the cost structure. I grew up in a singleparent household. Had it not been for football, i would not have been able to afford to go to college as well. I played football for a year and earned a christian leader scholarship which took me to a different school. I realized the challenges i faced and made a decision to go a different route. But the fact of the matter is had it not been for that scholarship opportunity, i would not be sitting here today, because i would not have had the opportunity to finish or even start my education. And and i went to a small Presbyterian College back in the day. So when i think about the cost structure of this conversation on athletes that are not this those toptier schools, there is a significant unintended consequence i think we are looking at that kelly really brought to the surface that is hard to deny and perhaps even harder to figure out how to fix it. Well, i happen to agree with you. I think that the implications of converting a student athlete model to an employee employer model would utterly france form common transform common sports into something it doesnt look like today. The impact on the with all due respect, i completely agree with dr. Southalls interpretation of all of this. If if you simply look at the definition of an employee as has been provided by one nlrb administrator, that if a student is receiving a scholarship and additional benefits, thats compensation. If they are working more as a student athlete than they are in academic work, then theyre working. If they are summit to the oversight of a coach, then they have a boss. Im not labor lawyer, but thats, in summary, the definition of a student athlete. That would apply to virtually every athlete that has a scholarship. Man, woman, doesnt matter. The difference between a Womens Basketball player and a mens basketball player isnt that the mens basketball player works harder. It isnt that theyre more or less talented. The only difference is a singular difference, and that is theres more people in the stands. Thats it. In terms of their time commitment, their competitiveness, everything. The difference is one plays in front of a lot of people and one doesnt. The difference between a volleyball player and a Soccer Player is exactly the same. The only difference is whether theyre playing on tv or whether theyre not. Yes, sir. And so the relationship as dr. Southall pointed out, title ix has nothing to do with employer employee relationships, so it would have nothing to do with a student athlete thats now an employee, including a Womens Basketball player. It would be an irrelevancy for College Sports. Quick question for mr. Bradshaw. I know you played sports a couple of years ago. Five or seven years thank you. [laughter] thank you very much. I think it says four or five years ago, not 45. My question is youve had a lot of experience, and youve looked at this opportunity as well as the challenges that come with the opportunity from multiple angles. What kind of progress have you seen over the last three decades or so as we wrestle with some of the challenges that are going to be future challenges and certainly are present challenges . Sometimes we miss the progress that weve made along the way. And, certainly, all of us think we can do better, theres no question about it. And we should. And we should. And we spend most of our time talking about how we can be better and not patting ourselves on the back. As a former assistant coach back this the day and head coach and student athlete that its night and day, the changes, the quality of physicians, train ors trainers. I mean, we didnt know what a dietician was when we were student athletes or a head coach. I mean, the changes are enormous. Theyre compelling. And i think one of the things i would recommend that you get some student athletes to talk to. Theres a, that theres a balance. Obviously, theres outliers. Theres some horrible stories that have happened, and none of us one of those is too many. Whether its assault or date rape or whatever it might be. I would love to see a panel of student athletes come in and talk about everything, a balanced panel of that. Its been significant across the line, and im retired now. I can talk about it very objectively, be concerned about a College President or a faculty or a board of trustees. Its really just a incredible profession that were in. The changes that the ncaa are trying to make and, again, marks got to deal with votes. Hes got to deal with the institutions, the College President s, the board of trustees who pressure the College President s. And i think youve got something when you want to bring the president s in here. I think that would be a good move and something that could help everyone. But the changes that have happened that are just, you know, by leaps and bounds particularly even in the last decade. Final question, mr. Chairman . Do i have time for a final question . Sure. My gamecocker, dr. Southall, as lieu you look at the opportunity for collective bargaining, most institutions primary objective is to cultivate an environment that is conducive for academic achievement. How do you see the impact of the collective bargaining opportunity . I have grave concerns with it, personally. On College Campuses and its impact on that academic environment, or do you see one . I dont see that it would have any effect. Good enough. No. All right. Thank you, sir. Thank you, mr. Chairman. Thank you. I want to make and, senator coats, i know the question you want to ask, and mr. Emmert has answered most of those questions, and i know you feel a duty to ask the question, but there isnt going to be a second round. Im going to make a closing statement, and at then 5 15 we will be through this very long hearing. I want to say this or i have two impressions. One of them is superficial and the other, i think, is worrisome of this hearing. And i want each of you to either agree or not agree with me as kind of your closing statement. That on one level this has been an open conversation. Weve brought up all kinds of issues, and those issues have been discussed to a small degree or a large degree. And, but my real, my real feeling from this hearing is that we havent accomplished much and that people have laid down their sort of protective im not talking about you two gentlemen, but that there has been a sort of a selfprotection mode either for ones self or on behalf of others. Your point about getting the board of trustees in, that would be kind of interesting. Because they do have a big influence over College President s. But all i know is coming out of this hearing that i dont think ive learned anything particularly new except some anecdotes that i havent been hearing for 50 years. Which is how long ive been in this business. And that the answers, you know, of course theres progress. Of course theres progress on concussions and of course theres progress in other things. But is it in any way concomitant in effect of progress to what we should have been doing, all of us including this committee and this congress by not exercising our oversight rights . The head of the ncaa at one point said one of the first things i did was to make sure that and i forget what the example was, but it was a statement, i got something done. I dont believe that. I dont believe that. I think that the system is rigged so that you are separated from the possibilities of getting something done except as you testify or, you know, you probably couldnt write articles. Youd probably get blowback on that. But i dont think you have the power, and i think its constructed for that purpose. Im cynical. Im cynical about it. Its too easy to have, to complain in Senate Hearings about, or any other kinds of fora what progress has been made. Of course theres always progress thats been made, but does it keep up with what needs to be done . And the answer is, absolutely not. And this country is now so soaked in the culture of espn plus, i guess, a couple of other stations and watching football, baseball, world soccer, all the rest of it. E mean, its just, its i think its under my own view is its undermining our values. Ill tell you one thing for sure, i think its undermining our commitment to education. And mr. Southall, dr. South an all southall, i think youre talking about the different ways of jiggering our, the students who are not athletes actually doing a better job academically than those who arent. It was said by the head of the ncaa that that was true, and it was also in his testimony. I dont believe that. I just dont believe it. Now, i may be wrong, but this and then the different formulas you use. It was very interesting to me and something id like to know more about. But to me, its been, in essence, an important hearing but not one which points to progress. And, because i think everybodys going to leave this hearing, theyre going to go right back. Im not. I dont think senator booker is, and i dont think a bunch of others are, go back to doing what they do. But we got that one out of the way. Nothing, no harm there, nobody did themselves any great damage. Congress doesnt usually follow through. Congress doesnt get that much done. That happens to be true for the last three or four years. And then theres always the question of getting people from, you know, either trustees or heads of colleges and universities from are states and then members here which correlated to that might not want to have that happen. I mean, the world works in ways that protects itself. But this is a particularly ugly one. The question of rape and having i mean, i, i voted not to allow the department of defense to settle rape questions. I think thats ridiculous. It passed, what i didnt want passed passed by a not by a great be margin. But we want to get there. And i dont have a feeling that were on that path. I think this hearing symbolizes that we might be, but the substance is that we probably wont be. P react to that. Anybody who wants to. Then im going to close the hearing. Mr. Branch, i think you had some well, senator, thats a i think that some differences have been, i mean, there are big differences here between talking about the way things work and how to reform and the whole underlying structure. Frankly, i think some differences have been diminished. I agree wholeheartedly with one thing dr. Emmert said which is that a lot of these economic restrictions in the ncaa rules, if they were vacated as senator hellers or abolished or somehow vacated for athletes as they were for coaches, it wouldnt make a particle of difference for 90 of athletes. A small, an athlete a recruit at a Small Division iii school would be able to ask for better Health Coverage or a salary, and the university, the Little School would be free to laugh at him and say we dont do it, you know . Go somewhere else. It wouldnt just like if the pick low player said i want to be paid to march in the band, the schools are free to bargain that way. But it would make an enormous difference in precisely these 65 schools were talking about where there is gigantic money if an athlete can bargain at recruiting for Better Health care coverage, for more time to study, for a longer scholarship. It would change things because right now the model is that the schools do that solely at their dispensation. I mean, the coaches in these big schools even want to give money out of their own pocket to players like a tip because they know they dont have enough money to eat. So a model that recognizes that these athletes are trying to manage two very demanding careers at once that are in separate spheres is a step forward, but right now, to me, the least hopeful thing i heard today that we are looking to these same 65 schools that are the most commercialized as the engine of reform in the ncaa . I really dont see that. They may give higher compensation, they may give more tips, but theyre the ones that created most of these problems in the first place, and i dont think that the big schools are going to do anything other than be driven more and more by the market in athletics and, quite frankly, those schools exploit their athletes both as players and as students. Because i go around to all of these big schools, and the athletes tell me theyre pushed into, theyre pushed into certain majors that are easy. Theyre not allowed to take certain courses. So the sad thing to me i think that some differences are outlined and may be diminished, but i dont see the big 65 schools as an engine for much reform in the future because their record doesnt show that. Baseball does strike me i dont want to get metaphysical about this, the antimetaphysical school of baseball, but its a good sport to be the National Pastime of a democratic nation because democracy is about compromise and settling. You dont get everything you want, and baseballs like that. Theres a lot of losing in baseball. Everything that goes every team that goes to spring training knows its going to win 60 games, gonna lose 60 games. You play the whole season to sort out the 42. You win 11 out of 20 games, you win 89 games, youve got a good chance to play in october. So its the sport of the half loaf, as is democracy. George will on his latest book on baseball and Wrigley Field and the recent controversy surrounding one of his columns, sunday night at eight eastern and pacific on cspans q a. Heads of Cystic Fibrosis foundation and parents project muscular dystrophy as will as number of others. This is live coverage on cspan2. We expect it to get underway in just a moment. [inaudible conversations]. [inaudible conversations] capitol hill where the house energy and commerce subcommittee will look into efforts to modernize the nations Drug Development and approval system. Again this is part of a broader effort to develop Bipartisan Legislation that would update current law. We expect to hearing to start in just a moment. Live coverage here on cspan2. [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations]. Subcommittee will come to order. Well have early votes. So well have to start. We understand minority members are on their way. The chair will recognize himself for an opening statement. Todays hearing provides us with an opportunity to examine perhaps one of the most important aspects of the 20 First Century cures initiative. What does medical innovation or faster cures mean for patients . Keeping our work centered on the patient and understanding the Patient Perspective will bring muchneeded focus on results for patients who may lack adequate treatment options. Remember there are only effective treatments for 500 of the 7,000 known diseases impacting patients today. While fda has developed an enhanced structured approach to benefit Risk Assessment in regulatory decisionmaking for human drug device and biologic products, the committee recognizes the value of considering patients in decisionmaking about Therapy Development and access. Assessment of a drug or devices benefits and risk includes analysis of the severity of the condition treated and the Current Treatment options available and getting the patients unique perspective should be a part of that assessment. One of our Witnesses Today, pat furlong, of the parent project muscular dystrophy, ppmd. I might say, that pat is apchemicalled by mary bono mack, a distinguished former member of this committee. Welcome, mary. And pat will explain how this organization was founded, to create opportunities for families waiting for therapies to stop duchane muscular dystrophy from claiming young lives. To quote pat furlong, patient Drug Development gathers need from input from patients and their caregivers to get a more complete assessment of benefit risk equation, encouraging predictability and increased flexibility within the review process. The clock is ticking for patients who need and deserve access to promising therapies, end quote. I would like to applaud her tireless work drafting guidance ppmd recently released that actually quantifies patient priorities and preferences. This guidance will serve the duchane community and every other Patient Community because it provides a path for other patient groups to follow. This was an enormous undertaking and im confident it will make a substantial contribution to the entire medical community. I want to welcome our Witnesses Today and look forward to learning more about the assessment of benefits and risks central to medical product development, regulations, and health care decisionmaking. And the tradeoffs between desired benefits and tolerable risk. Thank you. Any member on the majority side seeking recognition . Chair recognizes wire chairman, dr. Burgess. Remainder of the time. Thank you, mr. Chairman and dr. Woodcock, thank you for joining us again. Always good to see you. Always good to have you as a witness. You always provide valuable testimony and our second panel representatives also want to acknowledge just as the chairman did many of the patient organizations that you represent, that work well with our office and myself over the last several years. Mr. Chairman, the laudable goals of the 21st curse initiative they indeed are laudable but we got to remember at the end of the day it is all about patients. Doctors want to heal, we want to cure. That is why we entered the profession. No doctor ever wants to tell a patient there is nothing more we can do. The good news is that the golden age of medicine is really right around the corner. The doctors of tomorrow will have tools at their disposal unlike any before in human history. The ability of tomorrows doctor to alleviate human suffering is going to be unparalleled and unmatched in history. In every day that goes by where these tools are not realized a day when patients and families have to struggle through the pain and suffering of their condition. Every day counts for these americans and for their families. For those who struggle with Rare Diseases, their struggle is only compounded by the lack of biomedical research. For those patients it is difficult to see over the horizon. We have much work to do on this committee and we have done a lot in the past. We particularly celebrate the twoyear anniversary of the food and drug reauthorization act that was a few days ago. It was a good template and good method moving forward and i appreciate the curse initiative isfollowing that template but there is no doubt we can do much more. I welcome the testimony of our witnesses and i yield back my time. Chair thanks the gentleman, i recognize the Ranking Member of the full committee of the, five minutes for opening statement. Thank you very much, mr. Chairman. This hearing is a fitting followup to wednesdays hearing on Clinical Trials. After all it is patients who live with the diseases and conditions for which treatments are being sought and this hearing which is called 21st century curse, incorporating the Patient Perspective illustrates we should take every opportunity to understand their experience. Congress has a long history of listening to concerns of patients. Thats what i did in 1983 when i wrote the orphan drug act. That law came up when i heard from a constituent, adam seligmann, who had a rare disease called turrets syndrome. Adam was forced to take a drug he could only get from canada because at that time there were no effective treatments available in the United States. When his drugs were seized at border, his mother made a desperate call to my office begging me to do something. I set out to figure out why there were no drugs in the u. S. For adams condition. We discovered that adam was not alone. There are 134 drugs for Rare Diseases but only 10 had come to mark keith soulias a result of industry. We knew we had a problem on our hands and we set out to solve it. The orphan drug act has been a resounding success. Today there are over 400 drugs for Rare Diseases and i want to welcome the National Organization for Rare Diseases here today and look forward to their testimony. Im telling this story about the orphan drug act not only as an example of how congress listened to the concerns of patients and acted on them, i tell it because it is an example of appropriate use of legislation. In the case of Rare Diseases, in the early 80s, there were very, there was very clear evidence of a market failure in need of congressional action. In the context of the 21st century curse initiative we need to assure both fda and the drug and Device Companies are listening to the concerns of the patients. Fda has a long history of engaging with patients both in the context of advisory committees and in its review of drugs and devices. In the 2012 fda safety and Innovation Act Congress pushed fda to do even more to hear patients concerns and i look forward to hearing more from fda today. From what i can tell, the agency has taken that mandate seriously and has engaged extensively with the Patient Community. We should ask today whether fda has adequate resources to continue to do this work. As i mentioned on wednesday, when we had our last hearing, when it comes to legislating in complicated scientific areas like the conduct of Clinical Trials, we need to proceed with great caution. For example, one issue in the area of Clinical Trials that is likely to come up today is how to incorporate socalled, patientreported outcomes. As i understand it, this is an area that is multifaceted and scientifically complex. Congress should insure that fda has the flexibility and authority to make use of these outcomes but not dictate how and when that occurs. I hope fda will tell us about how it is applying another novel approaches to Clinical Trials in their regulation of drugs and devices. I would also like to know whether the agency believes it has the authorities necessary to adopt new approaches and whether other new statutory powers are necessary. Mr. Chairman, thank you for holding this hearing. I look forward to the witnesses testimony. I must say in advance that there is another subcommittee scheduled at the very same time as this one. So i will try to be back and forth to participate both of them. Thank you and yield back my time. Chair thanks the gentleman. Recognize the chairman of the full committee, mr. Upton. Five minutes for opening statement. I yield back my time. I will submit my record, my statement in order chair thanks the gentleman. We have two panels today. On our first panel we have dr. Janet woodcock, center of drug valuation research, food and drug administration. Thank you again for coming today. You will have five minutes to summarize your testimony, written testimony. It will be placed in the record. So at this time, the chair recognizes dr. Woodcock, five minutes for opening statement. Thank you. We are here to discuss how Drug Development better meets the needs of patients. Decades ago health care was very physiciancentric and actually very paternalistic. We all recognize that today. It was kind of the doctor knows best, dont ask any question, right . Today the model is collaboration between a patient and the health care team. These changes show have evolved solely in our society and the thinking and Drug Development has slowly changed in parallel. The fda safety and innovation act of two years ago took significant steps in this direction of patientcentric development. It contained agreements under pdfa that fda would sponsor at least 20 patientfocused, diseasefocused meetings over five years. Eight of these meetings have been held to date and they have been very impactful. The first one we held on Chronic Fatigue syndrome the we have issued a draft guidance on Drug Development in this area of very serious unmet medical need. Also under pdfa there are agreements to advance development and use of patientreported outcome measures. These are measures that the patient can fill out to say from their point of view how well theyre feeling, how well the treatment is working, what adverse offense theyre experiencing. We are having Expert Meeting next week and were continuing to work in Collaboration Consortium to try to advance the science of patientreported outcomes. This is very important to really scientifically incorporate the patients perspective into Clinical Trials. Additionally under f d. J. Af fda developed ad benefit risk framework in drug approval decision. This work is underway, and it really exexplicitly provide for the burden of disease, impact of current therapies for good and for ill and tolerance of risk from the patients point of view. This is extremely important set of factors that need to go into the benefit risk decision but we really need to do this in scientific manner and structured manner and we rolling out this structured benefit risk framework. Now, pour people we know this, for people with very serious diseases, ho may lack good therapy or actually lack any therapy, access to new treatments is their number one priority and thats why expediting Drug Development programs in these areas is so important. If you look at the diagram that we have here that was provided this, the data and diagram were developed by the pharma organization, talks about, shows the Drug Development process and starting on the left, it shows you start with many thousands of compound, up to 10,000 compound at one end, the beginning, and after nine to 13 you may end up with one safe, effective drug on the market. The Clinical Development phase, which is the gray phase, the middle phase on this diagram is the longest and by far the most expensive phase. In contrast, fda review phase which much attention has been paid to is very small slice there, the white slice toward the end of the process right before the drug gets on the market and is typically at this time less than a year in duration. So fda has made strenuous efforts really to help reform and modernize the Clinical Development phase of Drug Development because that is the major bottleneck. We not only is it expensive and long, many products fail in this phase and theres a tremendous opportunity cost there where other treatments could have been developed. Now the f d. J. A included several innovations to this process and the most striking being the breakthrough therapy designation program. So if we could have the next diagram. So that we could help therapies particularly promising and designated we could help move them through the phase more quickly. The bt designation has been enthusiastically subscribed. We have had over 160 requests in the two years since the legislation was passed. Weve actually, and this is really surprising part, we have granted 52 designations. So what dr. Burgess said were on the verge of a new era in therapeutics is reflected by this. We would have not have seen this a decade ago. We have approved six products, four new products and two new indications. It is too early to judge really the impact of the breakthrough designation program. Is it really growing to be able to speed up Drug Development . However i will say the four products we approved, their Clinical Development time was 4. 5 . So, much shorter than what i showed in the earlier diagram. Also in fdja are clarifications of accelerated approval around we issued a final expedited draft guidance in may that includes a response to stakeholders request, examples of Rare Diseases. It includes information on use of Rare Diseases. Much more needs to be done to modernize the crunch r Clinical Trial process. That is the big bottleneck now in getting discovers to patients. This can not be done by fda alone. We dont execute that process. All the stakeholders need to participate and i think the series of hearings that have been held in the 21st Century Initiative can can provide the framework for significant reform in this process. The chair, thanks the gentlelady. I begin questioning, recognize myself five minutes for that purpose. Dr. Woodcock, what is fdas plan to advance biomarkers and the use of patientreported Outcomes Data during the Drug Development process and postmarket setting . Many years ago, a decade ago, we recognized that there was no structured scientific process to provide the evidentiary for basis of use of a biomarker in Decision Making. So doctors and biomedical researchers would float new biomarkers but there was no rigorous process which they could be evaluated to see if they were really useful. So we actually established a process for this. It is not really in our mission but we established it. And it is called the biomarker qualification process and we also worked with the European Medicines Agency and the japanese regulators so that this would be a worldwide activity and consortia can come into the fda and propose a biomarker, a new biomarker and well give them advice on what needs to be then and then, and also for patientreported outcomes and if in fact that evidence is developed, then well publish a letter thats public and so will the ema if they accept it and so forth and any developer can use that biomarker or measure in a Development Program and will rely on it for the context of use. We have 79 projects by different consortia in different faces of phases of this process right now. Good. Think, describe your plans for implementation of the structured benefit risk framework you mentioned that. Transparent to the public and the sponsor so that the assessment of data from Clinical Trials and other studies, fda rue veers can be better understood and acted upon. This is a iterative process. We had public meetings. Then we went back and were piloting this in multiple, in the different drug review decisions and having medical officers work through this framework we developed and see what the results are. When we have that, those results well go back through a public discussion and talk about how, get input how this can be improved. This is not something that can happen overnight. It is a scientific process and actually we feel that, we dont have the tools right now. They exist out in society in science but we havent applied them, these rigorous analytical tools to the benefit risk decision. So weve had workshops on this, various scientists come in and advise us. So we will have a public process once we have gathered more experience. Ive been hearing a lot about fdas efforts to improve the quality of pharmaceutical manufacturing. Where do u. S. Drug manufacturers currently stand when it comes to producing quality medicines . Can you tell me a little bit about your plans in this area . I think the major problem here that many of our Central Drugs are not made in the United States and theyre made all around the world and sometimes they may only come from a Single Source and this is i think a real vulnerability to medicine. In addition, we used to be a manufacturing powerhouse in drug manufacturing but those jobs have moved offshore. And i think, now we have an opportunity with new, modern manufacturing methods such as continue use manufacturing to actually build a hightech industry in the United States that will actually make the drugs we need here in this country and fda has been collaborating with the, this community, manufacturing community, to help bring this about and we are very interested in seeing this happen. Now we have recently heard a lot about lung map, the lung cancer master protocol trial. There are other examples of innovative designs like for breast cancer. What needs to happen before these types of trials are no longer front page stories . Thats a good question. We also have been advocating for this for many years and its wonderful to see it start to become a reality. The concept i think in Drug Development needs to be turned on its head in clinical Drug Development. Instead of for each investigational drug, there is a whole Clinical Trial program developed with different Clinical Trials that take very long time as you heard on wednesday to get started and so forth that there are networks that are available that investigational drugs can be plugged into. This will provide independence of assessment but also, really decrease the time and expense of assessing whether these drugs are safe and effective. But what need to happen i think is, we need to expand this to more diseases. The nih is very interesting in antimicrobeals and setting up a network and other groups are looking into this and i think you may hear today from some patient groups, say Cystic Fibrosis, has really successfully set up the infrastructure to have Cystic Fibrosis drugs rapidly evaluated once they reach the clinics. Chair thanks the gentlelady. Now recognizes the Ranking Member of the subcommittee, mr. Pallone, for five minutes for questions. I will have to i just got here. You want to yield to green . Yeah. All right, mr. Green. Thank you, mr. Chairman. Dr. Woodcock, welcome back. I want to thank our chairman, our Ranking Member and dr. Woodcock for testifying. Revolutionary science and Technological Development we have the opportunity to target specific patient populations transform how we approach the prevention and treatment of disease. One of the goals i think particularly worthy of exploration the idea of personalized medicine which a patient may be able to receive more tailored drugs and treatment suited to his or her particular condition. I understand human genome is key to that goal. Academics and researchers tell me and potential for researchers and developers to discuss these drug and device innovations with patients during the development phase. Dr. Woodcock, can you give us the view on upsides and downsides of any increasing permissibility of communication between patients and developers during the Clinical Trial phase of vesselment . Thats very interesting question. We have seen from the 1990s where only 5 of drugs were targeted, in 201345 of the drugs we approved were targeted in some way. There are barriers to locating patients and joining up patients who have specific conditions subsets with appropriate investigational therapy. And if diseases are fragmented into smaller and smaller subsets it is harder and harder to find these people who might be eligible for a given therapy. The lung map trial is one way of doing that where it has multiple investigational arms in one trial so people can come in and they can be spread out but there is great interest of course with more patient activism in using social media and other ways to actually match up the right patient with the right investigational drugs and i think, this is one of the challenges right now of the Clinical Trial enterprise. Well, increasing Patient Involvement in dea Decision Making surrounding drug devices is a significant challenging endeavor. Can you provide your suggestions how mechanisms need to be developed to accurately measure what Meaningful Outcomes for what patients are both in the clinical outcomes and quality of life . Can we do that . Yes, that is what i was referring to with chairman pitts is there is a science of measurement and patientreported outcomes is one science. How do you measure how a patient feels from their point of view . And there are ways to do this but these measurements have to be developed. We, we approve many drugs based on their impact on quality of life. So that is completely possible but what needs to be done is this science needs to be developed and were participating in that, as i said, we have an Expert Meeting next week on patientreported outcomes. Well in the Patient Involvement process has to be data driven and improve the overall efficiency of Drug Development to maintain fda standards of safety and effectiveness how can congress support the fda in incorporating Patient Perspectives in regulatory decisionmaking in a way that helps deliver, innovative ways and effective medicines to patients sooner . Do you need Statutory Authority or do you think you already have it . To my knowledge we have the authority to do this. And i think you will hear from the next panel, for example, how patient groups can develop draft guidance, submit it to the fda. They can run processes that actually incorporate all of their points of view and those of the expert scientists. So more of that needs to be done but i dont know that it need more Statutory Authority. Can you do it within current resources . Because again, youre specializing instead of a broad brush. I assume it costs more when youre doing individual. Yes. Well when you have 7,000 diseases that need good treatments and most of them dont have them it would be very difficult for fda alone to develop the standards for patientreported outcomes in each one of those diseases much less the clinical outcomes. So much more participation of the medical and Patient Community is needed in Drug Development and we need to find better ways to do that. But im not sure that it is through legislation. Okay. Without a doubt our greater resources but again our committee has worked over the years to try and provide those resources to the fda and look forward to working you. Thank you, mr. Chairman, i yield back. Gentleman yields back. I recognize myself for five minutes for the purposes of questions. Dr. Woodcock, again good to see you. Good to have you back in the committee. So, youve talked about how the fda routinely works with sponsors to apply flexibility, including the use of biomarkers, surrogate end points and nontraditional trial designs and other available tools to expedite the development of products to treat both common and Rare Diseases. With respect to the common diseases, how is the fda working with sponsors to apply these Innovative Development and review methods . Well, for example, hypertension is a common disease. We approve drugs for hypertension based on surrogate america sure, Blood Pressure, that is very wellaccepted. For a number of years ago, we looked at automated Blood Pressure monitoring, okay . We decided it was unbiased. And so, we decided that you really didnt need a control group in the same way that you would for most other diseases because you have an unbiased measure. So we issued new approaches to studying, hypertensive medicines. But that is an example. What, what could happen so that the fda could use this more frequently . Well, 45 of the drugs that we approved, over the last several years, used a surrogate end point. So we do use that when its appropriate and it is available. What, for many diseases we dont know what the right surrogate is and thats why many of the accelerated approvals have been confined say to cancer and hiv, the science, a great deal of science has been driven in those decisions and we understand the biomarkers but for other diseases there needs to be more scientific development. Thats why were using this, for example, biomarker qualification process to try and get more biomarkers developed that we can use. But we cant just dream them up and use them. I thought that was your job . Let me ask you this. Are there situations where majority of the scientific or Research Community believes that a certain biomarker sufficiently predict as clinical outcome but fda has yet to accept that . There may be. I think theres a lot of controversy around use of these. You heard some of that on wednesday. There are two side to this. So if you rely upon a surrogate often, especially when it isnt wellvalidated there is more uncertainty whether or not the drug is actually going to work or not. So there are different points of view. As we have all been saying, the community, the Patient Community really ought to have, treating community ought to have a lot of input how much uncertainty should be tolerated given the circumstances of that disease. So there is, there are situations where theres disagreement amongst various parties, external and internal, about the use of a surrogate. Are there any, are you able to give us any examples of that, of a surrogate that the fda may not right now be willing to accept . Well, for example, raising good cholesterol, all right, we had a series of trials on that. Everybody thought raising good cholesterol would be really good and in fact it turned out to be either neutral or in one case it actually increased mortality. So we no longer accept that surrogate. That is kind of example where, and there are many others like that in bone density, you know, fors yo borrows sis. But some other agents were tried and actually they increased bone density but they also increased fractures. So, we have to be careful when we use these surrogates, to make sure were getting intended result, clinical result. Thank you for that. Let me ask a question for followup when we visited in april. Do you have an up status of fda guidance of bio similars naming and when the guidance will become final . Well i certainly would like to get that guidance out as soon as possible. Were working diligently on that and i dont have any further update. But that was submitted as a question in april and we are awaiting an answer. Along with that i asked if anyone in the administration outside of the fda had provided the agency with suggestions or recommendations with respect to this guidance. Can you, if the answer to that is yes, can you provide us with the name or names of those individuals . We would have to get back to you on that. And again, we anxiously await your answer. My time has expired. I will recognize the gentleman from new jersey, Ranking Member. Five minutes for questions. Thank you. Mr. Chairman, you asked a lot of my questions so im going to have move on to other things. But, dr. Woodcock, we heard at wednesdays hearing about the accelerated Approval Program at fda and as you know the Program Allows for earlier approval of drugs that treat serious conditions until an unmet medical need and the drugs are approved on basis of sour row gaat end points which we also learned about on wednesday. Of course a critical requirement of the system is that companies conduct studies to confirm the clinical benefits suggested by the sure row got end point and these studies are called phase 4 confirmatory trials. So, a critical part, i wanted to ask about the phase 4 trials. What challenges has fda faced respect to phase 4 trials . Do sponsors complete them in a timely maner . It is sometimes difficult to complete these trials. If you had a serious and lifethreatening disease and we approved a treatment for it you would be somewhat reluctant to enter a trial where you had maybe 50 chance of not getting the treatment. So what we often do ask trials be conducted in a different stage of disease or something where it actually hasnt been studied yet so we can get results and that might take time. So i think in the early years of the program we didnt track this as well as we should and we did have a lot of trouble getting these trials completed. But, in the current era, we are on top of this and generally speaking the sponsors are diligent in trying to get them completed, generally, but they have difficulties sometimes enrolling patients in these trials. Another important component of the program is that when the surrogate end points do not ultimately show anticipated clinical benefit fda could be faced with needing to remove the indication or take the drug off the market and i imagine that is also no easy task. Can you describe what is involved with removing indication or taking a drug off the market and what challenges does the fda face there . We, generally if the confirmatory trials fail to show benefit, the first thing we ask the sponsor to voluntarily withdraw the drug or indication from the market. It is only if the sponsor does not agree to do that, then we go into a long administrative process which includes hearings and findings, formal findings and so forth. And this can take a long time. If the sponsor contests our finding that the drug isnt effective. Now, just a couple years ago we included some provisions to improve upon the accelerated Approval Program and nda safety and innovation act of 2012. For example, the law made it clear that the fda could rely upon evidence developed using biomarkers or other scientific methods or tools when assessing surrogate end points. Can you describe what impact the legislative changes had on the program and are there any other changes that feel are necessary to make use of most recent scientific developments with respect to surrogate end points . I think the legislation was very helpful. Weve taken quite seriously. We issued guidance, final guidance on expedited programs and probably the biggest change in the, that the legislation brought about was its focus on intermediate clinical end points and we had to have quite an internal discussion about what that means and i think you will see us approving more products under accelerated approval based on these intermediate clinical end points. Well, thanks. It is clear to me this is an extremely complicated area and one thats not necessarily conducive to further legislation. But i wanted to ask last about the master protocol. At the hearing on wednesday some panelists described some of the inefficiencies that existed in the way Clinical Trials are currently conducted and one of the suggestions for addressing those inefficiencies is to create a master protocol. So i just wanted to ask, first, can you tell us more about this . What is the master protocol . How would it help improve the way we conduct Clinical Trials . Has fda been involved in development of a master protocol and are there particular diseases that the master protocol is more appropriate for than others and if so which ones and are there other areas which might be expanded . Master protocal is one version of using Clinical Trial networks or standing Clinical Trials to evaluate investigational therapies where the Drug Development program isnt just for therapy. Its for any therapy for that disease. So a master protocol though has to be somewhat disease specific. You cant just have a general overall master protocol, right . It has to be focused on one disease. For example, the lung map trial is on cell cancer of the lung that is advanced and but five different agents right now are being studied all at once within that protocol. And thats a huge efficiency. But there are other versions of standing trials or Trial Networks that also could be used in other diseases and i said that Cystic Fibrosis foundation has a kind of a network of clinical excellence where they have actually sequenced the genome of all their patients. So theyre ready when a targeted therapy comes along. Theyre ready. They can put those patients into the protocol and that tremendously improves the efficiency. So theres a, it is a long conversation that probably cant be had in five minutes but i have longadvanced this concept and tried to push this concept because the current Clinical Trial paradigm is not sustainable. Thank you very much. Gentleman time expires, the chair recognizes gentleman from pennsylvania, dr. Murphy. Five minutes for questions. Dr. Woodcock, always great to have you here. Let me start off it is important for the medications and research to advance those but those already approved. Let me ask you, we passed the laws awhile ago, certainly, mr. Griffith just moved between me, thank you. That, that, helped, supposed to help us get more generic drugs in the queue, what happened is we have 1. 5 billion authorized over five years. What happens approval times gone up and there are fewer approvals even thousand the law was supposed to reduce all those. Can you give me indication what is going on and what fda is going to do about that . Certainly. Were well aware of these issues. In june we received 625 i believe generic drug applications. So its, the rate of submission is well above what was projected in the negotiations that we held. However on october 1 the deadlines kick in for submission, for timelines of review of generic drugs and we are fully prepared to meet those timelines. As well as deal with this large backlog of pending. We to hire a large number of people and totally revise our processes, reorganize the generic drug review offices and conduct many other changes. And thats what we have done over the past two years in preparation for the deadlines coming into effect on october 1. Thank you. Another question here about some labeling issues. The abbreviated new drug application that would allow generic everrers, this is proposal by fda, to change label without fdas prior approval but then come back later on. As the fda itself recognized, you say, quote, consistent labeling will insure physicians, Health Professionals and consumers that a generic drug is safe and effective of brand name counterpart. There is concern allowing these changes to take place and go backfill them later on can cause a lot of confusion in studies that for pharmacists and physicians. Im wondering where this issue stand in clarifying this . Well we have received comments on the proposed rule. It was a proposed rule. We received many comments. Were analyzing the comments and subsequent to that we will have to go forward with a rulemaking process. The proposed rule contemplated that we would actually have less disparities of labels in the marketplace. Because of this proposal, because would we be put up a website and we also require conformance ever labels which we can not carry through right now given the current system. Okay. But the committee, we, back in january asked to meet with mr. Hamburg and others about this and im not sure those things have taken place yet. So i hope this gets expedited and that these issues are addressed because i still think there is confusion. So im not clear yet in understanding, even why this proposed rule was set up there to allow this, individuals to change a label and come back later and ask permission . Well currently generic labels do not always match the innovator and they do not change their label in a timely manner. And so there will be labels out there for quite a bit of time, even with serious safety issues, like new box warnings that dont conform to the innovator label. So we are trying to address this situation and also as generics are now 85 of all drugs dispensed to consumers, that they should have the opportunity since, their drugs are the ones that people are being exposed to, to submit their findings of adverse events and suggest label changes, proposed label changes and actually execute them. Just hope that you will meet with Committee Staff members and companies to help clarify this because it is still not clear to me why this would be allowed. And i think it would be confusing. I want to bring up one last thing just while youre here. I had sent a letter a few weeks ago to dr. Hamburg. Im sure you didnt see this but one of the things that is out there too is complications often times reported in the media about caffeine whether it is, sometimes toxic levels it will take through overthecounter things or pure caffeine or so many supplements for athletes but also in everything from chocolate to coffee and things we promote all the time. Im hoping at some point fda can give some recommendations in terms of individual levels per drink, per dose, per day, for male, female, genders, for weight, age, whatever that is. Because it is still pretty confusing whether, whatever those products are, that they can be beneficial but i hope you will expedite that. Thank you. I yield back. Gentlemans time expired. The chair recognizes the gentlelady from california, miss capps. Thank you for the chairman holding this hearing and the Ranking Member. Thank you, dr. Woodcock to for your testimony. This is issue dear to me. Im incredibly concerned about our nations history excluding minority groups especially woman. Even when these groups are included in trials theyre are often too few participants in the groups to analyze the effects on them or the analysis are simply not run or reported. Im sure youre familiar with the case of ambien. Commonlyprescribed medication recently had its label change because it metabolizes differently in women than men, meaning women were receiving inappropriately high dose of this drug for over 20 years. In addition this spring a report, entitled, sex specific medical research, why Womens Health cant wait, was released which provides evidence for the further inclusion of sex and gender in Scientific Research and the fdas own august 2013 report which was initiated by the inclusion of my heart for women act in the fdja legislation shows there is still much work to be done to he make sure women are fully represented in Clinical Trials and safety i and effectiveness of clinical information is readily available. I know fda is continuing to work on an action plan to address these disparities. So, dr. Woodcock can you give us a update where the agency is on this . Certainly. Would i expect that would be released, we would be timely in its release. I believe there is a statutory deadline or not. There is some expectation. So yeah, were working diligently on the action plan, yes. But i will say, for Drug Development, which is what were discussing, or im discussing here, that we did a study, for example, in, of the 2010, the class of 2010, products that we approved. We found that 45 , more than 45 of, about 45 of the participants were male. All right . So, and we found that almost all of the submissions included the required gender analysis which has been required for drugs for 20 years. Because i oversaw that when i first joined the center for drugs in 1994. So, just by regulation. So we do have these but i think the transparency of the information is the problem and we are working on that and we are have, i really am committed to making making that informatie transparent so people understand what we know and what we dont know. I think that, i think you put your finger on something and i want to highlight a bipartisan letter i lead signed bit women of the house of representatives urging this agency to plan, to include clear, Actionable Strategies and i think what you said about transparency and the reporting, in the action plan, is a way to address it issue once and for all. At wednesdays hearing this week i also asked the panel tools fda is developing could supplement our Knowledge Base in light of less robust Clinical Trial designs. The fdas sentinel civil which i understand is making progress if slowly to conduct postmarket passive surveillance of drugs and devices could help spot issues like adverse drug interactions more quickly. I believe this Sentinel Program holds great promise and thats why i work to get assurance from, the sentinel assurance for effective devices act including in fdja to include progress on the program and designed for both drugs and devices. Could you update us on the development of the Sentinel Program, please, and what other resources or authorities do you need to get the system up and running to protect consumers more, effectively and expeditiously . Well i think use of Electronic Health data, which is rapidly becoming available and the Electronic Health records and so forth, has tremendous promise for actually finding out what happens in the real world for medical products both that are approved recently and those that have been on the market a long time. And that is what the sentinel system is intended to do. We have run the mini Sentinel Network for five years. That was between drugs and biologics. We paid for that out of our money that we have and we are recompeting that to put up the sentinel system. So that contract proposal is out on the street and we hope to establish the real sentinel system, which will be a largescale system for surveillance. Now as far as medical devices, we require a unique identifier or some kind of an identifier in the medical record, electronically, so that were able to capture that because the sentinel system uses those electronic records to get the information and i will repeat for everyone that it does not take any personal information and move it to some central database. It is strictly runs those analyses within the Health Care Systems and then the results only are combined. So that has tremendous promise. We feel very good about that. We actually are piloting running active surveillance on there. When we approve a drug and we have a question about it, we can watch over time and see what actually happens. So, and as more and more people get on Electronic Health records, we can really have more insight into what is happening. So that is where we are with that. And, it is resource limited. We have to pull resources from other activities to fund that but i believe very strongly that is the future. Thank you. I appreciate that. Chair thanks the gentlelady. Now recognizes the gentleman from georgia, dr. Gingrey. For five minutes for questions. Mr. Chairman, thank you. Dr. Woodcock, thank you for appearing. It is always good to see you. I understand that a number of the challenges that have led to the duration and cost of conducting Clinical Trials in the u. S. To increase essentially are outside of fdas per view. That being said, Clinical Trials are conducted to generate evidence used in the application for fda approval. So how early, my question is, my first question, how early do you typically communicate with these companies, pharmaceutical companies, to discuss their trial design before the visional of a new drug application is submitted . Well, we have agreements under pdfa that Prescription Drug User Fee Program. Testing a disease that really doesnt have any treatment. Companies can come in with a premeeting. That is meeting is before they start the their Clinical Trials, first in human studies and we talk about that Development Program so they can start thinking how that is going to be done. We do have information, it is preliminary, but looking at our information, it seems that companies that have more interactions with the fda, are able to get their products through more quickly, through the entire Clinical Trial process. Then companies that havent had interaction with the fda during the development process. But there are formal meetings held at different times under the User Fee Program and those minutes are tracked and we track the meetings and so forth. So theres quite a process for interaction during Drug Development. So, you as, a manager, would be, maybe at that particular time, that you make sure that your reviewers are not requesting overly burdensome data that is really not necessary, so the process can be speeded up . Well, theres always a push and pull. Scientists always want more data and that scientists in the companies and scientists in the fda. And so we have to walk that path between, you know, getting more data and actually the costs that is generated. Weve made a number of efforts under this city collaboration we do with Duke University and many, many other partners to try to figure out how to streamline Clinical Trials as far as data collection, for example. But, it is, it is difficult. We have 1600 meetings a year under the pdfa, when we meet with companies the supervisors are there, senior medical officials are also at these meetings. Well that is the whole purpose of 21st century curse of course. As we get to the second panel and we hear about from the associations and the families im sure they will talk about how we can speed this process up. The last question. First 21st century curse hearing, own cures. Have been approved by the accelerated approval pathway since 1992. I understand you wrote a blog post after that hearing a number of drugs considered under accelerated approval ultimately received traditional approval, so these statistics according to your blog were somewhat miss leading. Can you provide examples when that occurred as well as the process involved . Certainly. For certain Rare Diseases we may decide, for example, that the surgeon gaat is fine okay, and it surrogate is fine and correlates with clinical benefits. The term accelerated approval is misleading. Sounds like it facester than regular approval. Actually if we approve, give regular approval on a surrogate, it is just as fast as accelerated approval but you dont have to do confirmatory studies afterwards because we already buy leave the surrogate. Accelerated diseases where there is something missing you may be able to show when you replace that protein in the body you give the activity back to the person, right . So you may not have to show clinical outcomes. That is still a surrogate that we feel is good enough because we understand the problem that something is missing and you deliver an active drug to the site of action of where the problem is and that would be enough