Philosophy. Very much local, very much consensual, neighborhoods, coops, things like that. David grabner, i think thats his name, one of the lead anarchists, worked with occupy wall street. Hes teaching now in england. He was pushed out of yale university, considered too radical. And hes he wrote this book 5,000 years of debt, which is a fairly good best seller. And so when this question was posed to me, i didnt take it as a frivolous question. Its not like were about to abolish the institutions, but we can develop a lot of local selfreliance as Neil Silverman indicated. Local selfreliance as a way of drawing consumer dollars and other energies away from the giant corporations. Its a way of you can regulate them, and they have power. You can litigate. But drawing away for a Community Institution is another good way, and s yes magazine, which is free out there, is a chronicle of Community Businesses that in effect provide goods and services that big business provides, but in much more accountable and often improved manner. Another question is, with respect to global issues like Climate Change on which levels should activists focus most of their attention, federal, state, or local . Take your pick. They were all crucial. Cant do one without the other. And i think right now, theres more local activity than whats going on in congress which is gridlock. And as a result, most of the rich people like tom ste dwr er, george sorrows, glore, who are big on Climate Change issues will not fund a major lobby here in washington whose only purpose, several hundred people, to go up on capitol hill and turn it around, connecting with grassroots efforts. So you cant politics is not a oneclap effort. You have to have two to clap, a local and the national. Fifth question if you were to propose an alternative to our present government, what good examples would you follow, and how would you avert problems like our society in the future . Well, tweaking, i would like to have public funding and public campaigns, instant runoff voting, gets rid of the socalled spoiler which is a politically bigoted word directed to thirdparty candidates only. And proportional representation which makes every vote count. Right now, for example, in germany, if the green party gets over 5 , it gets over 5 of the parliament. If it gets 10 , it gets 10 of the parliament. If it gets 3 , it doesnt get anything. So the cutoff is 5. What do you think the cutoff is here . You get 49 . If your opponent gets 51, all the votes for the 49 dont count. Proportional representation. Thats one reason why they have a bigger voter turnout in other countries. And i would also have voting as a universal duty. Theres a whole bill of rights, we have no duty in the constitution except the seventh amendment, jury duty. And i think if youre going to have to obey a lot of laws, legislated by a lot of lawmakers, you should have a role in choosing those lawmakers. And some would say thats a violation of my civil liberties. No, it isnt. Not if you can pick none of the above. If you have a none of the above choice which means i dont want any of them, im going to have a protest vote and its binding and it wins, it cancels the election and the candidates, and you have new elections in 30 days with no candidates. That comes in at about 85 , 90 . People wont have to stay home where they dont count. Half of them stay home, 2 3 of them in primaries stay home. They can vote none of the above. And if you dont like that, you have a writein vote, you can write your own name in then. That takes care of that. In terms of a more fundamental thing, system of government, parliamentary governments do not gridlock because they in effect the executive and the legislature are one. So you have members of parliament that are ministers of foreign affairs, ministers of the environment. If they win, they can get things done. In our country, if the good person wins the presidency can be blocked by the senate or the house and the filibuster, and Critical Issues are no longer treated with any measure of human time. A system that we are having is becoming more and more destructive of our democratic process and the ability to make government work. In 1840s when the main employee of the federal government was your postman, maybe it wasnt that serious. Now its extremely serious, especially when the Congressional Branch can give up its right to declare war and to propose budgets initially, and other duties under the constitution, and get away with it. Next question is are there any statutory regulatory protections for whistle blowers after theyve made their disclosure, support financial or otherwise for finding new employment with back paid benefits, other remedies . Okay, sometimes when they win the case, they then can file for back pay, and sometimes they get a portion of the win, you heard about it from professor vaughn, a percentage of the fraud that was inflicted on, say, the department of defense. And other times theyre cast aside, its the saddest, saddest situation you ever can see, that these heroic whistle blowers saved lives, saved money. They were right, and theyre thrown aside like plot to soflo je jetsam. And they help people after theyve taken their conscience to work, blown the whistle, done what they were paid to do, and then left without any job and stigmatized. What would you say to the claim that racial equality in Police Violence is more importance than classaction lawsuits to compel corporations to produce Safe Products . Why do we have to choose . It so happens that street crime including Police Violence is a fraction of the number of preventable deaths and injuries and diseases that corporations inflict on people. I mentioned some earlier. You can see hundreds of thousands of people weare dying due to vileative standards in hospitals, air pollution, product defects, occupational diseases. So we have to do both. But its a good idea to sensitize people to the reality that silent forms of cumulative violence end up in cancer and respiratory diseases, are given a fraction of the attention by the media that street crime is given. On the very day that the bomber put the bombs in a trash can or whatever in new york, it was blanket 100 coverage on the tv for two days. There were 29 people injured, none serious, thank goodness. In those two days in the new york area, 60 people died from preventable malpractice or hospitalinduced infections. Nobody writes about that. Politicians are not asked to talk about that. Daily, the question is, i get solicitations from organization against citizen united, the Public Citizen move to amend representative represent us democracy spring, democracy awakening, and citizens united. Please speak to the dilution of a United Movement to get big money out of politics and democracy reform in general. I dont think its diluted. I havent been enthralled by all these groups should get together and form one giant group. That creates bureaucracy. And it stifles initiatives. What i do want is to see these groups get mass media. The idea that weve given up 24 hours of Public Airways largely to advertisements, comedic shows, sincesational news partially, and junk programs when all these activities that citizens are engaging in all over the country, the only way they can get through to people is through cspan. Cspan only has so many cameras and so much time. And so we have to be far more demanding of what we own. What we own these asettle. And i think you should, for example, go to your friends and neighbors and say what are you doing on saturday afternoon, and they say nothing much, what have you got in mind . Lets turn on the network tv and see how theyre abusing our property. People say, hello, how are you . Sometimes youre not okay, but you say, oh, fine. Why dont you ask, hows your civic life . And teachers say to their students, can you write 1,000word essay on your social life . Sure. Can you write a 1,000word essay on your academic life . Sure. Can you write a 1,000word essay on your athletic life or lack thereof . Sure. Lets start with the 1,000word essay on your civic life. Can you do that . Very few. Few can do that. Teaching is a wonderful accordion. The more you expand it and squeeze it the more delightful is the music. And we have to expect our teachers to do that through strong Parent Teacher organization. Last question, if we are so united on the issues, why are we so divided on the policies and politicians . We vote for gridlock, and what can we do about it . First of all, you dont have enough choigs ce on the ballot. Most district, state, and congressional theres one incumbent, and the other is flailing away or not even on the ballot of the two parties. Thats called gerrymandering. The politicians now in the Great Republic of the United States of america, land of the free, home of the brave, pick the voters and get away with it. I mean, i think voters are entitled to be a little jig dignant. Hey, what are you talking about . Were supposed to pick you. Were supposed to have choice. And not just tweedledum tweedledee on military issues and on wall street and on Campaign Funding even though you may be different on social network issues. We got to be more demanding. Its amazing how people can get really upset about small things and be completely oblivious to the big things because they dont feel they can effect the big things. Thats where the civic selfconfidence, the sense of leadership, comes in. So what can we do about it . Every time we we want to meet a politician, you know, it only takes 300 people on a petition to get a senator to come to your community. Thats how few people turn out. They say, wow, 300 people . And you tell them with a p. S. In your letter of invitation, you want 600 . Well do it. That will really freak them out. And then you set the agenda. Youre up here, and theyre there. Listening to you. Can you can anybody stop you from doing that . When anybody says the powers that be, the big boys who control, the big corporations, ask yourself what you can do to start counteracting them that no one can stop you from doing. Like summoning your members of congress or state legislature to your own town meetings. Who can stop you from doing that . There are all kinds of things. Nobody can stop you from doing to get the ball rolling until you become a critical mass. I have a question to ask the audience. Everything starts kn with know about the problem in your head and having the requisite moral indignation to be your engine of action, okay. So theres an old chinese saying, 14th century ming dynasty, when you hear it you wont forget it. Here it is to know and not to do is not to know. To know and not to do is not to know. Couple that with cicero saying freedom is participation and power, as i note earlier. Youve got a pretty good formula. Couple that with your own selfrespect and estimate of your own significance in making this world better. From the neighborhood to the international atmosphere, and youll get the requisite moral indignation. So i just want to ask you, from my own information base, how many people in this audience now are more morally indignant than when they came in this morning. [ applause ] youve got the fire in your belly to make the difference. And the fact that you even showed up tells me that youre a special audience. I hope youll come in the next three days and you will call people and say come to these convocations. They are not put together like this very often. And we want to see people here as well as through cspan and through live stream. If you want more information on how to come to these convocations, go to breakingthroughpower. Org, all those of you around the country, or go directly to ticketmaster if youre in the general d. C. Population area. Lets see more of you in the next three days. Thank you very much. [ applause ] congress has wrapped up its legislative work until after the november elections. Before leaving town, both the house and Senate Approved temporary Government Spending through december 9th. Current funding was set to expire friday. Both chambers also came together to override president obamas veto of the 9 11 victims lawsuit bill, the first time a veto had been overridden in the obama administration. Later in the week, the two chambers agreed on funding for flint, michigans, contaminated drinking water. Any further legislative business not expected to resume until november. The next president making appointments to the Supreme Court of the United States will be president donald trump. With Hillary Clinton in the white house, the rest of the world will never forget why theyve always looked up to the United States of america. Cspans campaign 2016 continues on the road to the white house with the Vice President ial debate between republican governor mike pence and democratic senator tim kaine tuesday night, live from Longwood University in farmville, virginia. Beginning at 7 30 p. M. Eastern, with a preview of the debate. Then at 8 30, the predebate briefing for the audience. At 9 00 p. M. , live coverage of the debate followed by viewer reaction. The 2016 Vice President ial debate. Watch live on cspan, watch live and any time on demand at spin on. Org cspan. Org and listen live on the free cspan radio glaepg. Next, a rrg on the approval process for generic drugs. Director of the fdas drug evaluation and Research Center talked about the lack of generic alternatives for brandnew medicines. Specifically epipen. This is just over an hour. Good afternoon, everyone. Thank you for joining us. Senator merkley, the ranking member, is en route. And his proxy is at least hes described himself as the senator merkleys proxy is here. Well begin. Ill give my opening statement, and perhaps by then senator merkley will be here, and then well go to testimony. And the senator from montana has a scheduling issue. Well try get to him very quickly. We are pleased to have with us and i thank dr. Janet woodcock for joining us. She is at the fda center for drug evaluation and research. And their mission, that agencys mission, is to make certain that the public has access to safe and effective drugs. Earlier this summer, kansans and people, families with allergies, children had allergies, they had allergies, were faced with the dramatic increase in the cost of the epinephrine injectors or epipens. And in my view, that raises issues for us as appropriators for the food and Drug Administration in this sense the food and Drug Administration does not have jurisdiction over cost or price of drugs. Theyre be a regulator in that regard. But their role is to make certain that drugs are efficient efficacy, and as well as safety. Part of that process of safety and efficacy is bringing generics to market, and i think it would be useful for our subcommittee to hear to hear th developments fda, in regard to that process. I think all of us have an interest in making certain drugs that are effective and useful are made available to consumers across the country at prices that are affordable and one of the ways that i think we can address that that is of benefit is to make certain that the process that fda utilizes to bring generics in the sense, competition, to market is working the way it should. So, this hearing is designed for us to aindianapol elicit inform the role that we should pursue as members of the appropriations subcommittee responsible for the food and Drug Administration. Congress approved the generic drug user fee act in 2012. It was designed to address the issues i talked about, speeding up the process to bring generic drugs to market. In the past three years under this act, the fda collected 1 billion from generic drug manufacturers, which is translated to the hiring of an additional 1,000 employees at fda and replacing an Antiquated Technology system. Despite that, despite the 1,000 employees and a new computer system, there are more than 4,000 generic drug applications awaiting approval and the average time it takes for fda to approve a generic is 47 months, nearly four years. Its also my understanding that fda is close to finalizing negotiations with the industry on a new round of fee and regulatory requirements to address that backlog and my guess is that dr. Woodcock cant speak about the details of those negotiations, but im hoping this hearing will allow us to get a better understanding of how fda plans to tackle that backlog and that extension of the waiting time. All in a process that provides safety and eth ka si. I would like to take the opportune toy acknowledge your efforts to advance the accelerated approval process for patients that have no other treatment options. I know that in this regard, i want to talk or just mention particularly the muscular dystrophy issue that has occurred at fda and i want to express my efforts for my support for the efforts to bring that drug to market in a timely way. I look forward to discussing these topics with you. We look forward to the witnesses, im sorry, my colleagues asking you questions in a moment. Senator tester, we can defer to senator merkley when he arrives. You have a scheduling issue and i would be glad to yield my time to you to begin the questioning . Does the doctor have a statement . Yes, but i want to be sure dr. Woodcock, the floor is yours. Thank you for this opportunity to testify. Fda has no role in setting drug pricing. Our actions serve to enhance competition, which has been shown to decrease drug prices. For example, i would like to go through some of the actions we do take that enhance competition. We often approve multiple drugs in a therapeutic class. They are separate drugs. For example, there are a lot of receive indianapolis born anti biotics. Within a class, there may be a lot of drugs that compete in the market. Also, we often approve different versions of the marketed drug once the patents have expired that are not exact copies under our 500 b 2 program, which is not generic but part of the legislation. These copies also can compete with the marketed drug. Under the generics program, multiple, more less exact copies of a brand of drug can be approved once all exclustivety and patents expire. We frequently approve several copies at once. For example, recently, very recently, we approved eight crestors on the same day. So, theres a first generic, but there might be eight first generics. The introduction of multiple copies into the market can really lower the pricing of the drug. Finally, our new bisimilars program authorized by Congress Years ago introduces competition for bilogic drugs, which of course, generally are very expensive protein drugs. We have approvedapproved, so fa biosimilars area. In the generic space, particularly, there have been a number of misconceptions circulating about the generics program. Its ease stoi understand understand the program. First one is the Program Takes 47 months overall to approve a generic application. Senator, you said that. Are you telling me im under a misunderstanding . Thats fair. For the old products in the backlog before the new program started, User Fee Program started, they already are four years old. They are not getting any younger. As we approve them, they are going to have very long times to market because they started before that program even was put in place. But, starting october 1 of this year, if a Company Sends us an approvable generic drug application, we will approve it in ten months. Part of the problem is, the generic industry does not have a high level of meeting are standrds on the first try. So, they have to go through multiple cycles. After the Prescription Drug User Fee Program was put into place, now its been 20 years, we have extremely high rate of first cycle approvals for new drugs, which are much more complicated. So its possible to approve those drugs very rapidly, if, in fact, the application meets our standards. But, we cant approve substandard generic drugs. That would, first of all, those are our standards. It would erode the confidence of the public in the Generic Drug Program and really be take us back to the time when generic drugs were not well accepted by the medical community. Another misconception is a lot of first generic drugs are motoring in this backlog thats been there for so long. Thats really not true. There are fewer than 100 applications in that backlog that havent already manufactures havent gotten feedback from fda on their application. We had a goal of reviewing and providing deficiencies for 90 of the backlog by the end of the program, thats next, not this coming october, but next october. We already exceeded that goal 15 months ahead of schedule. 90 of those backlog applications have already received communications from fda about what their deficiencies are. Theres a large number. Theres 1700 applications, most of them from a backlog with the manufacturers awaiting them returning them with improved information. We have really exceeded the goal that was set for us under the first User Fee Program by 15 months of dealing with this backlog in the first iteration. 500 of those with the manufacturers have been there longer than a year. It may be that our huge activity in getting all these questions and applications back to the manufacturers for repair has somewhat overwhelmed their ability to get back to us promptly. Theres also a belief that a large number of important generic applications are sitting untouched at fda. There are almost no applications that are not touched, except ones that are recently submitted to us and going through the filing process. So, it is true, however, that we are not a steady state, yet. We built up a huge backlog as i said in the testimony, before the generic drug User Fee Program started. We are still working our way through that in a sense that they will return again and again until they meet our standards and can be approved. This year alone, as you see in the slides i left at your places, we have approved 1700 applications. Or this year, we approved 700. In the program, we have approved 700 we have approved 2,207 approvals and tentative approvals since the gadufa program started. Thats the number. So, i we also prioritize generic applications that may have Public Health implications. Sometimes we have those that are first generics that are sole source. In other words there might be one product out there and its a generic. We still priorit
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