founding fathers. return choice to the american public. that would be my little olive branch. you want to do bipartisan reform , eliminate the individual mandate and put the states back in charge of defining and regulating insurance project :

>> [inaudible conversations] [inaudible conversations] [inaudible conversations] >> reminder if you missed any of

the discussion on cybersecurity you can find it in the video library that c-span.org. >> matthew continues its past toward florida. lawmakers ar warning their residents to follow evacuation orders. roll call, marco rubio wrote in an e-mail meteorologists are calling the storm the storm of the decades and it's not something to take lightly. the sign was paid for by marco rubio 2016. 50 messages people donate to the red cross and the salvation army. south carolina members are tweeting to resident. 10 scott riding as the storm continues to move towards the carolinas make sure you and your family have a plan. stay informed.

>> earlier today white house press secretary josh earnest provided an update on president obama's latest briefing on hurricane matthew and the expected impact on the coast of florida, georgia and south carolina. here's what he has to say. >> the president was updated once again on a preparation underway to prepare for the likely landfall of hurricane matthew. the weather forecasters at the national hurricane center and noaa anticipate the impact of the storm and the trend is likely to be quite significant. we strongly encourage people who live in the areas that are likely to be affected to heed the warnings and instructions of local officials, including evacuation orders.

the instructions that are being offered by local officials are informed by information they are receiving from scientists and from federal officials, and those instructions are geared towards protecting people. we believe it's important people listen to those instructions. we also encourage people to stay up-to-date on the weather forecast for those of you have been covering the story now that the weather forecast, the forecast track of the storm has changed multiple times just this week. it is not outside the realm of possibility it could change once again. we want to encourage people to stay up-to-date on that. out what we did learn overnight is it's likely the storm could strengthen further before making landfall and that obviously is deeply concerning. we want people to be prepared. the last thing i will say about this is there are those who doubt the intensity or severity of the storm. they need only look at the

images that are coming back from haiti. the storm had a rather significant impact in haiti, and that is pretty good evidence of what people in the southeast could be facing. for those americans were interested in offering up their assistance to haiti we encourage people to visit cidi.org, a place were you can get more information about how you can help a country like haiti that has had the resources that we do to deal with such a significant storm. but obviously this is a pivotal day. people need to be making preparations and following orders today. the storm is likely to begin being felt this evening. served over the course of the day those of us who don't live in potentially affected areas will be sending our prayers to those who are potentially in harm's way, but people should

take confidence from that federal officials have been working very effectively with officials at the state and local level to prepare in advance of the storm. we have developed an expertise and we intend to use our resources and expertise to protect the american people. and it will be put to the test in the next few days. >> we are just learning president obama has declared a state of emergency in florida. you can see all of that at c-span.org. the second of three presidential debates takes place this coming sunday. washington university in st. louis, missouri. live coverage will start at 7:30 p.m. eastern we will have a preview program and the debate starts at nine. you can watch it live on c-span, listen on c-span radio and stream online at c-span.org. >> the weekend booktv brings you $40 of nonfiction books and authors. here are some of our programs this weekend.

>> i think leagues are going to be a part of government life, and the speed at which and the multiplicity which we can make it with each other not only in long cables, à la george kennan, but short e-mails, text, social media, tweets, all that is going

to be part of the body politic. >> go to booktv.org for the complete weekend schedule. >> the senate appropriations subcommittee on the food and drug administration heard from dr. janet woodcock, director of the fda's drug evaluation and research center. she discussed the review and approval process for generic prescription drugs and address senators concerned over the lack of generic alternatives for certain brand name medicine. specifically the epipen.

>> [inaudible conversations] >> good afternoon, everyone. thank you for joining us. senator merkley, the ranking member is in route and his proxy, at least describe itself as senator merkley's proxy is here and will begin. i will give my opening statement and perhaps by then senator merkley will be and then will go to testimony and the senator from montana has a scheduling issue and will try to get him very quickly. we are pleased to have with us today and i think dr. janet woodcock for joining us. she is at the fda center for drug evaluation and research, and their mission, that agency's mission is to make certain that the public has access to safe and effective drugs. earlier this summer, kansans and

american families discovered that, particularly those families that have allergies, their children have allergies, they have allergies that interface with a dramatic increase in the cost of 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 doesn't have jurisdiction over the cost or price of drugs. they are not regulated in that regard but their role is to make certain that drugs are efficient as well as safety. part of the process of safety and efficacy is bringing generics to market. and i think it would be useful for our subcommittee chair developments at fda in regard to that process. i think all of us have an interest in making certain that drugs that are effective and

useful are made available to consumers across the country at prices that are affordable. one of the ways i think we can address that that is the 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. and so this hearing is designed for us to elicit information from fda, from dr. woodcock, as to that process. and what role that we should pursue as numbers 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 that i talk about speeding up the process to bring generic drugs to market. in the past three years under this act, the fda has collected

$1 billion from generic drug manufacturers, which has translated into hiring an additional 1,000 employees and replacing antiquated information technology systems. despite that, despite the 1000 employees and a new computer system, there are more than 4000 generic drug applications currently awaiting approval, and the average time it takes for fda to approve a generic is now 47 months, nearly four years. it's also my understanding that fda is close to finalizing its negotiations with the industry on a new round of tv and radio to requirements to address that backlog. and my guess is that dr. woodcock can't speak about the details of those negotiations but i'm hoping this hearing will allow us to get a better understanding about fda plans to tackle that backlog and

that extension of the waiting time, all in the process that still provides safety and efficacy. on a final note, doctor, i'd like to take the opportunity to acknowledge your efforts to advance the accelerated approval process for patients who have no other treatment options. i know that in this regard, i want to talk or just mention in particular the duchenne muscular dystrophy issue that has occurred at fda, and i want to express my efforts, my support for the efforts that bring that drug to market in a timely way. i look forward to discussing these topics with you, and look forward to the witnesses, i'm sorry, my colleagues asking questions in just a moment. senator tester, we can't afford

to senator merkley when they arise. you have a scheduling issue and i would be glad to yield my time to see can begin questions. >> does the doctor have a statement? >> yes. i want to make sure -- after woodcock, the floor is yours. >> thank you, mr. chairman, and members of the committee for this opportunity to testify. as always at fda has no role in setting drug pricing. but our actions are to enhance competition which has been shown to decrease drug prices. for example, i'd like to go through some of the actions we can take that enhance competition. we often approve multiple drug and therapeutic class. they are separate drugs that, for example, there's a lot of stuff was born and about its out there, say within a class or antihypertensive of certain class, there may be a lot of drugs that compete in the market. also we often approve different

versions of a marketed drug wants patent and exclusivity have expired that are not exact copies fund our 505 at two b. program which is not a generic but is part of legislation here these copies also can compete with a marketed drug. under the generics program, multiple more less exact copies of the branded drug can be approved once all exclusivity and patents have expired. we frequently approved several copies at once. for example, very recently we approved a generic crest doors on the same day. so there's a first of generic but there might be a first generics and the introduction of multiple copies into the market often can really lower the price of the drug. and, finally, our new

biosimilars program which is offered by congress a number of years ago introduces competition for biologic drugs which, of course, generally are very expensive protein drugs. and we've approved so far three biosimilars and with a robust program going in the biosimilar area. now, i think in the generic space particularly there've been a number of misconceptions circulating about the generics program. it's that easy to misunderstand the generics program. first what is the program takes 47 months overall to approve a generic application, all right. senator, you said that. it's really -- >> are you telling me i'm under and misunderstanding? >> well -- >> that's fair. >> for the really old products that when the backlog before the new program started, use of the

program started, they already are four years old. so they're not getting any younger. and as we approved and they will 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 10 months. part of the problem is that generic industry does not have a high level of meeting our standards on the first try. and so they have to go through multiple cycles. after the prescription drug user fee program was put into place, now it's been 20 years. with extremely high rate of for cycle approvals for new drugs at a much more complicated. so it's possible to approve those drugs very rapidly, if, in

fact, the application meets our standards. but we can't approve substandard generic drugs because that would first of all, those are our standards but it would erode the confidence of the public in the generic drug program and really that would take us back to the time when generic drugs were not well accepted by the medical community. another misconception is that a lot of first of generic drugs are moldering in this backlog that's been there for so long. and that's really not true. there are few that actually 100 applications in that backlog that haven't already, manufactures haven't gotten feedback from fda on their application. and we had a goal of reviewing and providing efficiencies for 90% of the backlog by the end of the program.

that's next, this coming october but next october. we already exceeded that goal 15 months ahead of schedule. so 90% of the backlog applications have all received communication from fda about what their deficiencies are. there's a large number, 1700 applications, most of them from this backlog to do with the manufacturers awaiting them, returning them with improved information. so we've really exceeded the goal that was set for us under the first user fee program by 15 months of dealing with this backlog in its first iteration. and five of those are sitting with the manufactures have actually 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 have somewhat overwhelmed their ability to get back to us probably. and there's also a believe that a large number of important generic applications are sitting untouched at fda. there are almost no applications that are not touched except maybe once that are we so submitted to us and going through the filing process. so it is true, however, that we are not a steady-state yet. we had built up a huge backlog as i said in the testimony before the generic drug user fee program started and we're still working our way through that in the sense that they would return again and again until which time they meet our standards and they can be approved. but this year alone as you see in the slides i left after place and we've approved 1700 applications. this year we approved 700, and

the program we've approved 700 -- we've approved 2207 approval's and tentative approvals since the program started. so that's a number. so i come we also prioritized generic applications that may have public health implications, sometimes we have those that are first generic, that our sole sourced. in other words, there might be only one product out there and it is a generic. so we still prioritize the second one. and, of course, shortage of drugs, if there's a shortage we will prioritize generic applications. we will move into the front of the line, like the express line, to try to get them through. i'd like to say i'm really proud of the work that our staff has done in setting up the new generic programs and the biosimilar programs.

they were very tough it can be quite multiple changes, very heavy lift and i think we are showing that we're getting that work done. it's really been an enormous amount of effort though in many peoples part, and that continues. i'm confident we will continue to improve these programs, it will provide a pathway for competition in the market that will be very robust. i look forward to your questions. >> dr. kim thank you very much. let me now turn to the ranking member for any opening statement you would like to make. >> thank you very much, chairman moran. i think there's a lot of interest in this hearing and the role of generic drugs and the role they can play in diminishing drug prices in america. which are a significant factor in the oval cost over health care system, and so a significant factor for families that have deductibles as so many

working families do have. we've had a series of cases where a drug company controls a single product in a particular segment of the medical market, single drug or has a large share of the market, putting them up for sale at a vastly increased prices very sudden, very dramatic price increases. it seems about every month there's some prominent star that catches the attention of america. the most recent of those is the epipen, and the mylan company. the dramatic increase from of the $100, to $600 for a pack of two. despite the fact that the drug within them i understand, costs very little in terms of what is inside those injectors. so as we ponder all of these

cases, we are very interested in the approval process. there are other dimensions of this as well such as the challenge when companies buy up generics in order to keep them off the market, or use patent changes to try to keep them off the market, or pay generic companies to keep them off the market. market manipulations of this kind. this may not be things that you were able to be part of in your role of looking at the effectiveness and reliability of drugs but they're part of the broader picture that's of great concern to americans. to look forward to hearing my colleagues and hearing from you, and explain this because we have, there's a lot of room for improvement. thank you. >> thank you very much. i would use my time to the senator from montana. >> you are very kind, mr. chairman. i think you for the courtesy, and you're right, this is a

very, very important issue. as i go i hear from not only patients and friends and family but i hear from doctors about what's going on with pharmaceuticals. even though my questions do ultimately end up applying to many, the deal is with with your job. and that is, at the making of a talked about this briefly but can you tell me how a company can take the generic and change it to what doctor says very, very slightly, ended up to build ago take it back on the market and jack the price up when it is based going the same generic it was before they modified it very, very modestly, if, you know there's been talk to me about how that process works. >> served. the generics have to be copies of the reference listed drug. and so they have to -- they

can't substantively modified the generic. they may make it look different or something like that but in our experience the price rises for generics or innovative products as you are referring to, have to do with where there's no competition in the market, where they may be the only game in town. overall, generic drug prices are going down, have been going down, but in these cases that you are referring to where, for some reason, there is no competition, then maybe other approved generics but as senator merkley said, their market share may be so small or for other reasons that they are not effective competition. >> i appreciate that, and that any problem with the pharmaceutical company getting the research and development money back. i also think if we are funding

part of that r&d we have to get a break on some of that money but that aside, i think it's important they are able to do the research. that i forgot many doctors, not just one or two, many that say the company will pull that back, somebody pulls back or changes it not significant at all and then put back on the market for five or 10 times the money. or more. >> what you may be referring to is the change in ownership changes. the one generic company may own a product, it's been sold so it looks different, it has a different manufacturer -- >> but it's the same stuff basically. >> it has to be under the generic law. >> is anything we can do about that or is it just the way it is? >> fda, as i said earlier, doesn't regulate the prices. we have nothing to do about that. what our actions to, if we try to come it is the sole source,

we try to get more coffee into the market. >> i got a friend who got a child diabetes at the age of age 13. he's in his 60s. this is 1970 when he became a diabetic. i can't remember the number. it's been over a month ago my memory doesn't last that long. he told the insulin back in 1970 was less than $10. and now it's significantly, much, much higher than that. has insulin changed over the last four years or is insulin insulin? >> there are many new forms of insulin. modern diabetic care usually include a long acting insulin and some short acting insulin's. there are insulin pens that people can go and check so it's less painful. so have been different changes in technology. some of the basic insulins have not changed.

>> why, i mean is a pure greed they would increase the prices like that? >> well, i can't comment on the motives behind can say that congress passed a number of years ago legislation for biosimilars so that the biologic products, malcolm insulin but not his regular as a drug. this is complicated but it will be regulated as a biologic under the biosimilars act. of a transition over and, therefore, the insulin will be subject to the biosimilars copy. >> i appreciate your testimony today. i'm going to have to get the companies in and visit with them to find out what's going on. like i said i did forget to recoup your costs for research and develop a. develop. i hear so many stories on the street where there's minor modifications or a drug the truth is a drug that's around for 45 or 50 years, getting priced out of the marketplace

and we are driving people into poverty and the process. quite frankly that concerns me. thank you very much and thank you for your courtesy, mr. chairman. >> there is no doubt that what the cost and price of drugs is an important public policy issue. it has significant consequences to kansas families, have significant consequences to taxpayers as we look at medicare costs. and i think our focus, i hope our focus in the string will continue to be how do we make sure fda is doing its job well to create competition and opportunities for families to make other choices and to hold down the cost of those prices of those drugs as a result. let me ask a couple of questions. first of all, epipen in particular is a kabul, a combination between a device and a drug. are their unique circumstances that make the generic to be more difficult in that circumstance

because of the combination? >> yes. the firm that markets begin has patents on the device component that goes through 2025. so any from wishing to make a generic would have to be able to get around those patents somehow, not infringe upon those patents come or challenge them successfully. >> i think your colony of britain, i've read, he talks about generics for the drug, but they're not widely used? >> okay, this is confusing, too, all right? there is another brand of epinephrine autoinjector, all right, that fda has approved. we have approved a number of them but they are in the first category talked about, they are all stand-alone new drug applications so they are not generic copies. they are each one separate.

each of them does the same thing, decrease anaphylaxis. one of those -- it treats. something people call an authorized generic. it's very confusing because it is not generic. it is when a brand name company decides to market their product, usually along with marketing their brand product. they take the brand name off and then make it look like a generic end in a market. usually at a lower price. so some people have the brand loyalty and stay with the print but then they can also compete in the generic market with this version. it's the same product. they make in same plant. just has a different label on it, okay? and so the other manufacturer of current epipen, current epinephrine autoinjector which is not called up in, that one has to authorized generic and that's what is currently being

marketed. >> thank you i think for the clarification. [laughter] >> sorry. >> you indicated that facility ask this question. i indicated in my opening statement about backlogs. you get a pretty persuasive set of statements that indicate that there really isn't aacklog. if we're asking you what you going to do to solve the backlog problem, you would tell us that the fda is on path in the way that it should be, is that fair? >> at the very back of the slides, the papers i passed out, there's his chart and what it shows is right now there's 2300 generic drug applications in the process of fda reviewing them. the pre-gdufa program ones come with a backlog of a comeback in. we're redoing were doing them again.

not all of them. and then each year the goals become shorter for us to do the first review. and as i said next year, 2017 will be 10 months. so to be honest, and completely straightforward about this, these are more applications and would like to have in process. it would be better if we had fewer applications in process. i've given authorization, or manufacturing reviewers to hire 50 more people, temporary people who are going to work on trying to get this down. but mainly this is going to be up to the manufacturers to submit to us approvable applications. and then we will be able to end the cycle of proven. if they still have deficiencies then they have to go back, and it takes longer. >> the way i understood your testimony is what i described as a backlog, really is

applications that are pending data been reviewed to some extent but not yet approved, sent back to the drug manufacturer for further actions on their part? >> that's correct. there's about 1700 with the manufacturers. >> are those problems with the application, are they process in the proverbial since they didn't cross the t. and dot the i, on these of substantive issues, didn't provide the necessary justification for fda decision? >> we have tried to make this all substantive. part of the changes we made for gdufa was that we are calling the people all the time while reviewing their application. we called it information request, so that these minor issues do not delay a decision on application. and so we are back and forth, we send out thousands of these information request and try to get the application fixed up as

much as possible, but then when we send it out as a complete response, then the manufacture has substantive work to do. >> i have a series of other questions but let me turn now to senator merkley. >> thank you very much, mr. chair. and you mentioned, dr. woodcock, that there is a competitor, i believe the name is -- >> yes. that considered also as an injectable device. but you also mentioned that anyone who wishes to compete has to get around the patents, that epipen or mylan has. what is the difference in these two products and how much a barrier of those patents and to the also the onset of patents so the world to figure out how to easily inject something is now wrapped up by these two companies? >> we actually have approved over the years five different

epinephrine autoinjector. we are not on the market right now. i do know what adrenaclick's patents might look like. we can get back to you on that. we don't know. but that doesn't mean copies can't be me. it's it remains that because of the intellectual property rights that they would it have to be challenged or an autoinjector would have to be made that performed similarly but did not use the technology. >> but it sounds like you are safer than five different approaches that all been approved at different points in time. >> none of them a generics, correct. >> so adrenaclick has one of the authorized generics that you refer to come a version of itself i gather. that epipen is planning to sell. how much come what is the cost of the actual amount of epinephrine that's in one of these pins speak with the cost of the epinephrine is probably

insignificant. there is a cost, obvious is a chemical but it's been around for 100 years. >> i've been told it's about 1 dollar. does that sound feasible? >> that would be probably a generous estimate. >> if i'm somebody at risk for this challenge of my throat closing down and unable to breathe and i would suffocate, can i legally acquire a little amount of the road and put into a syringe to inject myself? >> yes. that doctor can write a prescription for you to have those, have that available for you. and my -- i myself have treated patient because i ran an allergy to it for a while and it didn't have an autoinjector. i injected them with epinephrine. the problem is if you're suffering an acute reaction as you're sick, he got to be fast. if you don't do this all the time, it's not something that intuitive. so it's not as good as using an

autoinjector. >> unchallenged to understand why competition doesn't take in more quickly. if someone out in our audience today said there are three other companies that have approved auto injectors, out go to one of them, i'll rid of their technology, i'll get a pin up on the market that will cost instead of $600 for two pens, i will sell it for 200, i will make a ton of money and -- why doesn't it happen? issue agency so difficult to deal with that it's just a huge inhibiting factor to people who would ordinarily see an opportunity? >> according to my staff, we have approved for autoinjector so we can't be too difficult. not five, but for. we can't be too difficult to deal with. it's harder though to get a generic copy approved because of the patents that have to be -- >> but you said these others are no longer in the market, so

somebody could conceivably make a purchase, license, rent the patent, pay a payment for the patent. and that's not happening, and yet this is a vast amount of money being made. what is the barrier of entrepreneurs stepping into this gap? it seems like it's a dysfunctional market. let's say somebody wanted to do this. they have to go through an approval process, three from scratch even though the pain has already been approved? >> now. companies particularly as were discussing earlier, sell the rights to something to someone else, including a new drug application can be sold and then pick up by someone else. they can reintroduce the product. they have to show us their manufacturing and so forth in. but they don't have to go through again showing safety and effectiveness. >> when you ask why hasn't someone to jump into this gap, is it because in getting their

manufacturing approved at that is so difficult that although there are zillions of dollars to be made, they just think it's an unworkable process? what is this huge barrier to market into in the available pens out there that are not being utilized for autoinjector? >> i do not know. we have approved as i said since gdufa daughter we've approved 2207 approvals or tentative approvals for generics. so clearly that barrier isn't -- from a compass to get generics onto the market. >> i'm open summit with and entrepreneurs. will jump in here tomorrow and figure out how to great some competition. we would like to see generics certainly but as you pointed out that there's easier pathways if an auto injectors event accrue to my time is up. i'm going to defer to my colleagues, but there's something, something is fundamentally difficult that is

preventing ordinary investments and market entry from occurring. i think we're to understand that better. >> the senator from maine, senator collins. >> thank you, mr. chairman. good to see you, dr. woodcock your i know that you are very familiar with the investigation that the aging committee under my leadership and senator mccaskil mccaskill's leadership has conducted into the pricing of certain prescription drugs. i want to follow up on your comments about mylan decision to introduce what's called an authorized generic of the epipen. i have to say that that strikes me as gaming the system. essentially what mylan is doing, and as you confirmed, is just changing the label on its

product and then selling it for a lower price. but doesn't that have the effect of reducing the incentive for a true first generic to come onto the market? i know that you have approved others, and that some of been recalled due to problems, but in general the idea of a brand name company simply swapping the label on its product and then issuing it as a generic strikes me as greatly reducing the incentive for a true first generic to come on the market. could you comment? >> i'm no economist but i would say that would depend on how much money a generic company felt they could make in the market, based on what they could price the generic at.

and gdufa i believe congress asked us to require companies to tell us if they're making authorized generics in their annual report and for us to post that information. and so far we have noted 980 authorized generics that we've been notified about of different drugs. so it appears to be a relatively common practice in the industry. >> and i think it is one personally but does need more examination as far as its impact on discouraging a true first generic, or second generic, to come onto the market. let me switch to a different issue that came up in the course of our investigation. and that is, we found that certain drug companies are putting their drugs, their brand name drugs, into restricted distribution systems.

and that made it difficult, according to our investigation, for generic companies to get a sufficient amount of the drug in order to conduct the bioequivalent studies that fda requires. what can be done about that? >> well, we agree, we've received over 100 inquiries from generic companies about problems they have been having in getting enough of the reference listed drug. in some cases it relates to raise we have, restricted program for safety. however, we have tried to remedy that by writing a letter to the reference company saying, you know, use of the product for this purpose is acceptable, and doesn't violate. nevertheless, companies even have their own restricted distribution outside, and clearly this is competing the

ability to update in of the drug to compare. with respect to what can be done about it by congress, we remain concerned that there's so much to many of these drugs are so valuable that companies will do a great deal to delay generic competition. it's worthwhile. to any type of legislation that have a lot of extra steps and so forth, each one of those would be an opportunity to see us or send us a citizen petition or so we didn't get the process right, or whatever, giving the court and delay introduction of the generic or delay availability of the product. so i think considering which might do about this yet to consider it is a very, fines might be considered the cost of doing business because there's so much at stake in dealing generic competition.

>> i think this is another real problem, because the system is not supposed to work that way. the rems system is as you said safety oriented. it isn't intended to restrict distribution in a way that prevents the generic company from gaining access to a sufficient quantity of the drug so that they can do the bioequivalent studies. i hope you will work with us to try to come up with something that doesn't have the kind of unintended consequences that you said, and yet prevent companies, and we got all sorts of examples of this and other music companies were using to try to block or delay the introduction of generics thank you. >> senator collins, thank you very much, and know that your

committee with your leadership has a significant interest in the topic and appreciate your presence today. senator udall. >> thank you, chairman moran and ranking member merkley. dr. woodcock, it seems like every few months we hear about another pharmaceutical company raising the cost of a certain drug or device to a new astronomical price. the epipen autoinjector is the most recent to draw national attention. the epipen has become so expensive that families in my home state of new mexico and across the country are struggling to afford it, even though the doctors say they must carry it in the event of an allergic reaction. but violent, the manufacture, has increased the price in the united states by over 480% since 2009. and i've received messages are many of my constituents in new

mexico who are directly impacted. i've heard from word parents across the state took one of them like a woman named page from truth or consequences, new mexico, her daughter suffers from a severe peanut allergy. she needs to care and epipen with her at all times to prevent a possible life-threatening reaction. page wrote to me about her family struggles to pay for the medication. she even had to change jobs in order to get insurance that would help cover the costs. you know, change jobs in order to get the medication for her child. i'm also worried about the impact these price increases will have on families who can no longer afford the epipen. linda thompson wrote to me that because of rising costs in recent years, she has stopped buying and caring and epipen. she's forced to go up against the advice of her doctor who prescribed the epipen after severe reaction to a piece thing. to know what you have to go

without a medically necessary product because of how much it cost. -- bee sting. i wrote last week along with lives of the mexico congressional delegation requesting that the fda utilize all available resources to build a robust type line of epipen alternatives. listening to those constituents, i'd like you to answer for them, because i think the real question they have a view and the fda is how did we get to this point? what happened to treat this situation? how we got into a monopoly situation that we are talking about. and could you just describe it as simply as possible, i do think you got your? isn't it terribly troubling that this company now is further trying to encroach into the market because they are

apparently going to put out a generic come and so they're trying to keep the market to themselves. they have their own epipen, this brand name, but then they're going to put a generic out on the market. so could you try to answer that except as possible? how did we get here? >> well, for most drugs once they lose their patent protection, and so they can have generic, most drugs do get generics. but some drugs don't. either they have large market, they have patents that say this one, the epipen has ties that go through 2025, and so it's not easy to make a generic that doesn't infringe upon those patterns and still works, i'll write? in other cases it might be a small market, talking about for other patients in new mexico has seen price rises, or a single source of drug, in other words,

only one company sells it. and so in all these cases they don't have competition. in the united states that's what keeps prices down is competition. and so for many of the situations when we looked there some reason that competitors have not effectively entered the market and brought the prices down. >> and what is causing that? usage of approved for these, and yet as senator merkley ask her why isn't someone stepping up and saying there's a lot of money to be made. who do you point to to say what caused this situation that has these astronomical prices speak with her is one other competitor to the everything on the market. >> this adrenaclick. >> right. several others were pulled off for performance, one was pulled off for performance problems.

one thing for a drug like that is, in a situation like this, you want it to work. so you don't want to say fda should rush something through in so it might not work all the time. if that were your life that were at stake, you would want it to work every time. so we have to make sure that if there is competition here, that it still works, epinephrine autoinjector and/or deliver the life-saving medication when we have a life-threatening anaphylactic happening. >> mr. chairman, just to wrap up, you mentioned the patterns over and over again that seem to be part of this, and i think i know it's not in the jurisdiction of this committee but i think that's something we really should be looking at, is what the patents are doing to create monopoly situations. we appreciate your service, and thank you very much for being here today with us. >> thank the senator from new mexico now recognized the

senator from montana. >> thank you, mr. chairman, ranking member. doctor, thank you for coming here today. we are here today because of huge spikes in the price of the specific prescription medications. i shared senator udall's concerns what he sees in new mexico where we've seen a 40% increase in the price of the epipen. it's the poster child of late as what's going on in pricing. at the life-saving drug, it's a delivery system that not only people in new mexico rely on, people in montana at all across the nation. without competition the spikes will go unchecked and unconcerned about the impact on montanans, some of us to choose between buying their prescription drugs and buying food. we need increased competition as you already mentioned, trading market checks on the price of drugs, and decreasing costs for those who need them. in your testimony highlight the savings generic drugs afford, saving someone $.68 trillion over the past 10 years.

in montana that is translated to $682 million saved in 2014. for example, according to the jerk pharmaceutical association fourth, generic drugs report, lipitor and was $3.29 appeal before the generic was introduced in 2011. that generic now sells for 14 cents a pill, a 96% savings. so my question is what is the fda and the office of generic drugs doing to incentivize the production of more generics, particularly when there's little or no competition while maintaining of course drug quality and drug safety? >> well, what we do is, number one, would expedite applications where there is no competition. so if it's a first generic, if there is just a brand, we expedite the competition.

as i said, often nowadays with a modern program we are we up with multiple copies at once because that often will drive the price down more than a single copy. if there's just one generic and the reference drug has been withdrawn, so we have a sole source situation, then we will expedite that as well. that application. or multiple applications because we don't know which one is going to actually get approved. >> going along that line of thinking, reducing the bears to generics entering the market would clearly help create other examples like lipitor reducing the turbulence we see in the market and decreasing cost of the fda has proposed a rule for generics but there are significant concerns it could prevent some generics from actually getting to market. the final rule now until next year, what provisions are considering to help bring generics to the market?

>> well, this rule isn't about helping bring generics to the market. we got a lot of comments on the role. we have a public meeting after the proposed rule was published, and we've received a large number of comments from stakeholders. and we are still evaluating those comments. >> now, and looking at turbulence, a concrete example, it was brought to my attention there are certain applications being assigned what they called target goal dates instead of target action dates. as you know a gold it is not binding, giving little clarity to the applicant. what he doing to address those concerns? >> under the agreement we made under the generic drug user fee act, okay, we agreed to have goals for 2014, 15 and 16. and so in 2016 there will be a

target goal of 10 months. if someone sends in october 1 this year, if they send in an approvable application, it can be reviewed and respond to another market in 10 months. >> but a goal it is not binding. >> well, sometimes there are other factors that come in. we have goals. our goal is we would use 90% of them within 10 months. that's how our gdufa program uses. >> by shifting more to these goal dates, it would speed up the process and create more certainty? >> the earlier dates that target action date were for the backlog that didn't have any goals associate with it. our agreement under that was we would take action on 90% of those by the end of the five

years. we already did that. so we exceeded that by 15 months. we acted on almost all of those. >> my time is up. i'm sorry. just to conclude, i understand there's going more than 14,000 approved generics at ugly incentivizing new safe and effective check promoting competition is very important for montanans and all americans. so thank you for thoughtful comments. i encourage you to facilitate this by reducing the barriers to entry and by providing stability for manufacturers to be able to plan effectively and continue to bring safe and quality generic drugs to market. clearly we see a lot of great successes there. >> thank you, senator. doctor, you indicated our that have the ability to prioritize within the backlog, and she listed a few criteria by which he might prioritize. i'm interested in knowing come you also indicated i think in your comments to my colleague

from, the ranking member, that use the word only game in town. what you mean is little or no competition. is that a criteria by which you can prioritize from the backlog? >> just. >> educated? >> yes. it's not just the backlog because there really are not so many in there. even an application we did today or tomorrow court october 1, we would still try to amortize that if you're a single source i get there was only one drug on the market. >> okay. and you indicated that in your testimony, in part in response to my questions, that often substance within the application process, substance within that application is insufficient for an approval and, therefore, that application is still pending and would be considered, in my words, part of the backlog. but it's really waiting on in

the applicant to do something more tmake the application more viable and potentially approvable. is that a summary of what we're talking about? >> yes. >> you indicated to me which was pleased or that this is not about crossing the t.'s and dotting the i's. these are sensitive issues as far as whether the drug application should be approved. and then again you indicated you let the drug companies to start the process where there might be problems company the opportunity thing to correct those issues as the processes, as the application is going through the process, still to? >> that's correct. >> and so it's not like starting over the and. you don't deny an application and say to the drug company i'm sorry, you don't qualify, you don't get our approval, go fix something and come back and apply again?

>> now. what we do is send what's called complete response to we don't send out denials. we sent out a complete response. these are the things you must do before your application can be considered approvable. and that has to include the facilities. and often an application may have say 14 facilities around the world that they are relying upon safer testing, this part of the manufacturing, this part of the packaging. we have to make sure all those facilities are in good standing and so perhaps they meant to work on improving a facility it might be in another country or switching to a different facility. these are the kinds of problems they faced sometimes. >> does that approval process and fault inspection of the facility or is this a paper process speak with yes. there are a large number of facilities around the world that make drugs, generic drugs for

the united states, or test the drugs or to the bioequivalence testing. so we can't have a schedule for inspecting those and inspecting them every several years on a regular basis. but sometimes there will be new inspections, new facilities that will come in with the application, or they will be doing something never did before like making a stellar product, which is very different than making a tablet. so we would go in and inspect them as well. sometimes there are inspections if it had a fairly recent inspection and a good standing we were not inspected again. >> is there a common denominator for drug companies who are required is the additional information during the approval process, those better quote in the backlog? is that a smaller company as compared to a larger company, someone who's new to the market, a new entrant to the drug pharmaceutical business? >> we wish. i mean, we have tried to discern

this and what is causing this problem. because before the generic drug user fee act program, almost no generic drugs were approved on the first cycle. they were all deficient. and often they went through four cycles but i think that was the median. so there's a tremendous amount of work and kind of picking it up and looking, it was a long period of time. of course, many of them could submit before the patents expired so they have some time to work on their application. we are trying to do a lot of analysis, to answer your question, because we want to know that. how can we remedy this situation. in gdufa, the prescription drug user fee act, we are way up to like way up in the 85-90% first cycle approval. so over the 20 years of the program we have taught the condition what they need to do to send in an approvable application and we meet with

them before and so forth, so that we can get to the application efficiently. >> i will follow up on that as soon as i turned to senator merkley and he is concluded his questioning. >> go ahead. >> so the competitor that was taken off the market, came off at their own decision to they were not forced off. roughly a year ago. .. from one company to pay another

and -- it certainly is the type of issue that has been widely discussed in the public sector about companies paying other companies to keep their product off the market. >> okay. >> also, buying up with other companies to keep their product off the market. in your interest, you mentioned, i don't want to put words in your mouth, but essentially, you refer to generics having a potentially powerful positive effect on lowering the cost of jugs. >> right. >> in the interest, should congress be looking at strategies in which namebrand drug companies keep generics off the market. >> yes, we believe we are subject to some of fees as senator cohen was talking about with the problems with the brand

drug and to do bioequivalence studies using the rims or a restricted product of stacy. >> i was appalled to hear that somehow a namebrand company can prevent their competitor from getting enough of the drug to do the very studies that you are requiring and shouldn't that be grounds for them being penalized in some way for eventually preventing a competitor to legally enter the marketplace. >> yes, we have certainly been talking to the members about these problems and we have a long history which congress had taken some actions on before filing a citizen petition to prevent the availability of generics based on various scientific issues that are

raised. >> are they currently trying to get approval for modified product to address the jet dosing issues that it had. >> i'm not allowed to discuss anything like that. >> if they were attempting to do so, would you be prioritizing their application? >> if we were doing that, if another new drug application came in because that's not a generic, those those have a very rapid time frame already for review and approval. >> we are talking about a combination product, the drug is already approved so it's really. [inaudible] >> i'm saying it would be under

the new drug app review process which is governed by the prescription drug user fee which is very speedy. >> you have authority in cases where there is market dysfunction to prioritize applications. is that correct. >> market dysfunction didn't enter into our statutory language. what we have done under our procedures for generic is we prioritize for public health. >> let me put it differently. >> when there is a single product in the marketplace and the costs are so high people can't afford it, do you have the ability to help address that by prioritizing an application whether it is a competitor or a generic? but that at the top of the list to try to address a big problem faced by millions of americans who can't afford the drug and whose lives are at risk because of a dashed you have the ability

to prioritize that. >> we do prioritize that for a single source. >> how about for a. >> we do not have a procedure to do that. >> so we have heard some real horror stories about devices getting approved. if a company comes back and they say we had a slight manufacturing defect that caused us to have a dosage problem. we've fixed it, here's our new version, are you going to send them back to clinical trials that cost $10 million, i'm exaggerating, in ten years or are they going to be able to get that modification approved and back on the market? >> if you're talking about epinephrine autoinjector, they really don't need clinical trials. you need to show that you are injecting the epinephrine were supposed to go and that you can do that reliably every time under emergency circumstances. >> i'm trying to get some sense how much money, how much time for slight modification of

injector because their injector had a problem. is that a big obstacle for them reentering the market? >> i don't know about big obstacle. >> how much time, how much money , in general terms, the public would like to know how big the obstacle is posed by the fda to enable the market function. i understand it's very important that things work. it's also very important that there be a functioning system to allow products to get back on the market. how much time, how much money would it take? >> i would say the time might take them, if they they were able to solve a manufacturing problem, and they had to change things, then they might have to, depending on how they change

their autoinjector, they might have to do human factor study again to make sure people could use it properly or they might not, depending on the change. if the change was just inside they might not have to do that. if the change was how do you actually go about injecting yourself, they might have to test that again on people to make sure it would work for them >> we are talking about a preloaded syringe that cost $600 and people can't afford it. it shouldn't be impossible to enter the market. i'm wrapping up so i will turn this back to you. encourage you to ponder from that direction of whether there are unreasonably difficult, expensive procedures that make it very hard for competitors to enter the market. if that was easier, there would be people entering the market and we wouldn't have this problem. then we have all the tricks of the system in which the name brand is seeking to prevent those competitors, and if you are complicit in that, that's a problem.

we really need to examine that very carefully because it's not this one drug. this is a whole systemic problem in our drug approval process. the price of drugs are making health care the most expensive in the world here in the united states, out of reach to millions of americans. they bypass their drugs because they can afford to buy them under their deductible. this is a very big deal. think you. >> i think were about to wrap up our hearing assuming i don't talk so long that other senators arrive. just a couple of follow-ups, i indicated in my opening statement that the understanding is that the fda is close to finalizing negotiations with the industry on new fees and regulatory requirements. you indicated in your response to my question that again, it

goes back to a definition of a backlog, this is a process that takes a number of steps. are you able to tell me, is that part of the negotiation with the industry, from their perspective i don't know whether they say the same thing, that you you indicated. were there issues that could be negotiated with the companies in this process with the times that's necessary to have application reconsidered? >> i think that's definitely on their mind and on our mind. to mr. merkley's question, one of the things we need to do is get a process for generics where we give advice to pay generics before they send in an application. that's what we negotiate under the prescription drug ask for the new drugs and that something that there is great interest in, having a program that isn't just the pill. we can interact with companies

and give them advice and tell them what to do. both this workload, part of which is inherited from the things that are cycling multiple times is on everyone's mind and is definitely part of our discussions as to how to deal with that. >> can you report anything about the status of those negotiations? >> i could say they have been industry and can be concluded and we would have to have a public meeting as described in the statute and of course we hope to provide the consequences to congress. >> are there are timeframe in which you expect those consequences to occur? >> i think that was written in this statute.

>> sorry, i wanted to give you accurate information. we hope to post those notices soon and we would transmit to congress by january. >> and that's your expectation. >> i would certainly hope so yes. >> i also mentioned that you were able, i know this is not a generic drug, but we were talking about the drug, it's not a generic but the reports are you found a way to accelerate the process. is that an accurate analysis or statement or description of what occurred. >> the description of what occurred is that the product was approved under something called accelerated approval. that may be a misnomer but that's what it's called. what it means is you don't have clinical trials that showed the product gave benefit to patient

to prove on a stair get an point that we feel is reasonably likely to predict clinical benefit. how we approve a lot of hiv drugs and many other drugs have been approved under accelerated approval. then the company has to prove with later studies that the product really does have the predicted benefit. is there anything to learn from that process that would apply to generics? >> i don't think so because that has to do with showing effectiveness and generics get their effectiveness by showing they are the same as the reference drug. >> different standard. the generic is more easily met? >> yes, they are not allowed to do clinical studies or they can't be a generic. >> do you have anything you would like to tell us, dr., that we have not gotten from you from our questioning?

>> i do think we are very focused on making sure that any drugs that can be approved and are safe and effective can get on the market and that the pathways are clear, there aren't unnecessary barriers to getting on the market. however i would say our standards have to deal with making sure those drugs work for patients and they are reasonably safe and they are of adequate quality so the drug supply in the united states is a very reliable high-quality drug supply. we do try to x but i where we can to improve availability. we are sensitive to that.

>> thank you very much for your testimony today. in my view this hearing was what a congressional hearing in most cases should be, an opportunity to be educated and to learn and you have certainly helped me in that process. for members of the subcommittee, any questions you would like to submit for the hearing, record should record should be to herndon within one week which is wednesday the 28th and we would appreciate if fda could respond within four weeks thereafter. i think everyone for their attendance and i will conclude the hearing. the meeting is adjourned. [inaudible conversation] [inaudible conversation]

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>> coming up friday night at eight eastern, oral arc argument dealing with race and the death penalty. the case centers on dewayne buck who is convicted and sentenced to death for the murders of his ex-girlfriend and their friends. they called an expert witness to the stand that testified he was more likely to be dangerous in the future because he is black. under texas law, a jury must unanimously agree that a felon will be dangerous in the future before given the death penalty. we'll have that oral argument from the case friday at eight pm eastern on our companion network, cspan. coming up sunday, it's the second of the three presidential debates. it will happen at washington university in st. louis

missouri. live missouri. live coverage starts at 7:30 p.m. with the preview program and the debate at nine. watch live on c-span. listen on c-span radio and stream online at cspan.org. >> every weekend, book tv tv brings you 48 hours of nonfiction books and authors. here are some of the programs this weekend. saturday at seven pm eastern, hillary clinton's e-mail controversy is the topic of a panel discussion with peter sweitzer, author of clinton cash then author of partners in crime and tom fitton, author of clean house. at ten pm eastern, afterwards, mary thompson jones details the day-to-day work of u.s. diplomats and her book, to the secretary, leak embassy cables and the foreign policy disconnect. she is interviewed by the former undersecretary for democracy for democracy and global affairs during the george w. bush administration. >> i think we agreed to be part of government life and at the

speed and multiplicity of which we communicate with each other now, not only in long cables, but short e-mails, texts, social media, tweets, all of that is going to be part of the body politic. >> on sunday at 645 eastern, they discuss the future of the euro in his book the euro, however, and courtesy threatens the future of europe. go to book to booktv.org for the complete weekend schedule. >> up next, tim kaine in philadelphia addressed supporters yesterday, the day after debating indiana governor mike pence and the only vice presidential debate. he talked about his performance in donald trump's taxes. this is about 40 minutes. [applause] ♪ listen baby, ate no mountain

hi, ate no ballet low, a no river wide enough baby ♪ ♪ if you need me call me >> hey philly, how you doing? >> what a great room. around of a applause for arielle. isn't she fantastic. [applause] she is telling it like it is. she's talking about this nominee donald trump, and nominee unlike we've ever seen, someone who is claiming to be a big success but has a track record of stepping all over small people and that is how he defines success, just like he defines smart as not paying taxes to support our troops and our vets in our teachers. that's what's at stake. it's great to be back in philadelphia. you ran one heck of a convention. thank you so much.

[applause] that was the best week of the entire campaign with the exception of maybe last week. wasn't hillary fantastic in her debate. >> i'll get to me in a second. hillary's debate last monday was so wonderful. she did such a great job and it turned out to be the gift that kept on giving because donald walked off the stage so mad that he lost that he, his fingers couldn't stay off the tweet button. it kept going down and down and down, and so i think she's in a pretty good spot going into the debate on sunday with donald trump. [applause] here we are 34 days away. let me do some thank you's and's and i want to talk about my debate last night, which i had a blast at, and some of the issues

that we raised and we talked about and then i will close with how we win this thing. let me do some thank you's first. i definitely think arial for sharing her story. so many people have stories like that, of, of trusting trump and then getting tricked by trump. businesses that worked with him and then found that they got stiffed were sued or strong-armed and i'm glad ariel share that with a spread we have two great members of congress. thank you very much brendan boyle and mr. brady, and then we are in the house of labor with the sheet metal workers. [applause] not only sheet metal workers, give all the labor applause. >> i'm lucky that i have special folks with me here, where our mom and dad.

my mom and dad are right here. [applause] my mom and dad are al and kathy kane. they are from kansas city. they are the best parents anybody could ever have. my dad ran an organized and iron working stockyard in kansas city my mom and my brothers and i grew up working with my dad and his employees. i learned from my father, the dignity of craft and trade like ironworkers and the partnership between owners and workers, management and laborers, it doesn't have to be a fight. it doesn't have to be an adversarial relationship. we work better in life when we work as a team. stronger together. [applause]

after the debate i said mom and dad, after the debate, i have a plane with my name on it. i've never had that in my life. at least for the next couple of weeks my name will be on it. we are having fun traveling together. great folks here and it's great to be back with 34 days left. we are in the midst of making history. do you feel in the air? all elections are great. i was a missionary in honduras and it was a military dictatorship so you couldn't vote for your leaders and people i knew prayed for the day when one day they could pick the leaders of their country and i came back from that 35 years ago, i realize i take this for granted and i shouldn't take it for granted and i need to be serious about it. look working on any election is

so important but when you're working on an election that will make history, you just have to stop and savor that a little bit. we are in a history making time right now. the kind of history we can do and that's been a story of our country since philadelphia and jamestown in the earliest days of our country, we set out this vision for ourselves and even people who couldn't live that way were smart enough to say the quality will be our guide and we were all created equally. thomas jefferson wasn't living that way. no one was living that way. when they said that no one was living went that way, there there was something, there is a spark in their brain that made them say that will be the northstar that we will pursue. our whole history is about waking up one day and saying we promised ourselves that quality would be our goal.

how can we justify slavery and so the pain in a war in rewriting the constitution and years later we said this about ourselves by how can we justify that women can't vote. then in the 1960s, how can we justify voting restrictions that keep others away from the pole. this generation struggles, how can we justify that lgbt people are treated equally like everybody else. so now a major party, for the first time in our history, 96 years after women get the right to vote, we have nominated a woman to be prodded president. a strong, courageous woman and we are on the verge of making history. that's just to say it's an

exciting time to be doing what were doing paradigm so proud to be on this ticket with hillary. i talked about another really important woman at the debate last night. the debate was in farmville virginia which is a rural, southern community, prince edwards county virginia and i talked about a beautiful woman, a 16-year-old kid in 1951 named barbara john. i just told the story and i will tell it to you quick. it's the story of us going ahead and it connects to hillary. barbara was 16 years old and she was going to a segregated school in farmville virginia. one day she and her friends decided we don't want to go in a second class school. this was 1951. she is 16 years old. they waited they waited until the principal went downtown, they actually faked a call and made him go downtown and then barbara called everybody into the auditorium and said let's have a meeting. let's walk out of our high school. let's walk out and say let us go

to the nicer school a few blocks away were all the white kids can go. they led a walk out. then they called the civil rights folks in 1951. the parents are telling them not not to do it. their teachers are telling him not to do it. they call a civil rights lawyer and say we want to bring a lawsuit and they do. that suit, 175 of the suit students signed on and that became brown versus board of education. that led to equality for everybody in our schools. it was tough. barbara ended up having to move away from farmville because of threats against her family. when i was governor of virginia, we had a civil rights memorial on our capital square and there was a beautiful sculpture of barbara and her peers walking outside the school that day. i said we were standing in a special place. a place were barbara john showed that even a 16-year-old girl in

a time of segregation, everybody can stand up and be a leader. barbara johns believed in our values, she believed we are stronger together and i said i'm happy to be on a ticket with a courageous history making woman who believes we are stronger together and that's hillary clinton. the debate was a little feisty. i have to admit. i am irish. there were a couple of important things about the debate. first, my opponent, mike pence who is a good debater wanted to lay some gloves on hillary clinton and didn't get to do anything. i've never played hockey, but i think think i'd be a good goalie

nothing was going in the net last night. then the second thing was, my opponent, he is a pretty good debater. he is pretty smooth, but there is one thing he can't do and that is defend donald trump on anything. so again and again and again during the debate, i would say something that trump said, i can't believe governor pence will defend that and he wouldn't defend it. we went one, two, three, three, four, five, six, seven, eight, nine times and i put that out there and each time he thought about it and said decided i'd rather talk about something else. about two thirds the way through the debate i pointed out what was happening. you are doll trump's running mate and i'm putting these things down on the table and i'm asking you to defend them and you won't defend them.

if you can't defend your own running mate, how can you ask one person to vote for your running mate. [applause] your running mate ought to be able to defend you. your running mate ought to have something nice to say about you. so for me, i got dinged a little bit, even by my wife, for, for interrupting too much, okay, but the key part of that debate was, at some point i felt like both me and mike pence were debating donald trump. i was going after him and he was kind of going after him with me. i can't imagine that made the donald to happy. there may have been interesting conversations about that on the other side of the isle. we were just there to debate. it's not just sitting around trading words. we were talking about important issues. some of the things i was challenging our issues that are

really at the heart of the campaign. just to go over a couple, we talk about the need of immigration reform. we really need to do it. i laid out a plan that hillary and i have that i worked on as a senator to do it in a comprehensive way, to look at all of the immigration reform issues and do it comprehensively. to have a path for citizenship and people who are here and working hard, paying taxes and living by the rules. we also need better border security. we can do both. to put as our top priority that we don't separate families, that's so important. [applause] i challenge the other guys, i said donald trump's plan is that we would become a deportation nation and have a deportation force that will go house to house, school to school and

deport 16 million people. of course, when i said that, the deportation thing, governor penn said donald trump never said that. well, they went to the tape. if donald trump is anything, he is like a human highlight reel and there's a lot of it on tape. they played it this morning. donald trump, again and again, we have to have a deportation force. this is a fundamental choice fundamental choice but we want to be a nation of laws and immigrants or do we want to be known as deportation nation. i think that's a clear choice hillary and i have the right side of it. no matter how much they said fuzz it up, donald trump is a scary guy when we get to this. we talked about criminal justice reform. this this is a very tough, challenging and very important issue.

i was a mayor of richmond with the police force working closely with my police force and when i got elected as a city councilman, we had one of the highest homicide rates in the united states. we brought it down dramatically, cut it cut it in half over eight years by building what we call communities where the neighborhood and the please respect each other and worked well together and we trained everybody on how to do it and the great thing about community policing is by narrowing the gap between neighborhoods and police, you actually reduce danger for people and police. when the gap is wide between neighborhoods and police, it's dangerous for people like mr. casteel, this poor beautiful young guy in minneapolis who was killed. of all of these shootings, they're all horrible but this one really grabbed me. this guy in minneapolis, maybe it grabbed me because he is working in a school in minneapolis and one of my school

works in the rack and park departments. i know he gotta job as a janitor and then he worked his way up to become a janitor supervisor. i bet everybody, if you think about elementary school, you will think, there is a there is a janitor or a health worker or a nurse that you loved even more than your teachers or a bus driver that was really good to kids. he this kind of a guy. they called him mr. rogers with dreadlocks. he was so friendly. he was killed by the police in a minneapolis suburb a number of months back and when they went into the story, what they found was mr. rogers with dreadlocks had been stopped by the police 50 times over the course of the previous years and he had never done anything wrong. he was going to work in helping kids and paying taxes and he was a great citizen but he had been stopped 50 times. i've talked about him and about the fact that we have to grapple with these kinds of challenges

and talk about biases and gaps in our system and how we can respect each other more. governor penn said why do we always have to bring up institutional bias. why we have to bring up biased issues at all. i said we have to because of a guy like mr. casteel. [applause] if you're not able to talk about something, how do you ever solve that thing. if you can't sit down and be honest about challenges, how do you ever improving it better? that was an issue that we talked about, two very different approaches, community policing or a donald trump who says what we need is nationwide stop and frisk policies. these are important issues. we talked about women's health. we had a good exchange.

we talked about women's reproductive rights and it was a good exchange because it was probably the one part of the debate where we were not really being feisty back and forth but we were sharing who we were. we were sharing our own religious feelings about tough issues like reproduction and abortion and how to do the right thing, but the point that i made is, you guys have points of view but you want to mandate them on everybody. donald trump says, there's got to be a punishment for a woman having an abortion and mike pence says we have to appeal rove versus wade. some of you are too young, you don't remember roe versus wade, 1973. we've got some young folks here. what was it like before roe versus wade. all tell you. before roe versus wade, states would pass criminal laws making it a crime for which you could be prosecuted and jailed if you

made the choice to terminate a pregnancy. you can have all the moral discussion you want, but use the criminal law to bludgeon or prosecute people for making their own decisions, that is what donald trump and mike pence want to go back to. they want to go back to that. the point i made was look, we can have all the moral discussions we want to. that's. that's good. it's good to have discussions about hard issues. at the end of the day, we have just got to trust women. trust people to make their own decisions on moral issues. we can trust american women. we can trust all women. the notion of a big government that decides working to make the decision for you, congress that

is 81% male, why would we want a a -- 19% female is the best we've ever been. we are 75th 75th in the world. we are below the national global average. this is an important topic that even in the back and forth we expose the differences in the ticket. the last thing i want to talk about is the economy before i get to how are we going to win this thing for this is a big difference. hillary and i have an economic land. we are going to invest in manufacturing, research for new energy jobs of tomorrow and infrastructure because if you are investing in manufacturing and you're your investing in infrastructure, you are hiring people today and you raise the platform for success for 40 or 50 years. that's number one. number two we are going to invest in our workers. from pre-k to celebrating great teachers and debt-free college and career and technical programs and union

apprenticeship programs, we are going to invest because the more skills your workforce has, the better off society will be. third were going to be about fairness. in him wage should be raised to a level where if you work minimum wage you won't be under the poverty level. that's pretty basic. equal pay for women. what a radical concept. that's pretty basic. that is pillar three. pillar four is let's focus on's small business. just like arial talked about small businesses in atlantic city, 65% of jobs in this country, out of small businesses. my bet dad's business business was a small business. hillary clinton's dad had a small drapery. that's where you get started and small businesses get bigger and hire more people.

we will focus on small business success. finally, on the tax code, we have said if you are $250,000 or below, no increase or below, no increase in taxes. you'll get tax relief for childcare and paid sick leave but to pay for the educational investments, we will also add the individuals where the wealthiest and the businesses that have done the best, especially as we come out of this recession. a small group has done really, really well and we are going to ask them to pay more so we can make those investments to create an economy that works for everybody. if we do it will be better for everybody, even those even those were paying more at the top end. that is what we want to do. we got into a back-and-forth about this because the trump economic plan is very different. it has two components. the first one, donald trump says wages are too high.

donald trump thinks we ought to get rid of the federal minimum wage. when mike pence was in congress, he voted against raising the minimum wage above $5.15. now as governor of indiana, he has fought very hard against minimum wage, even passing laws over the city in indiana decides we are going to raise the minimum wage in our city, state will crackdown and say you can't do that even if your voters want you to. okay. low wages as their thing. that's number one. second, the other thing, on taxes they want to give massive tax breaks to people at the very tip top. trillions of dollars of tax cuts for people at the top and the plan says about 8 million middle families would get tax increases under the trump proposal. hillary clinton challenged him

and he waved his hands and said look, if you did those tax cuts, all these jobs would be created by those at the top that you give the tax cuts too. it was kind of like this. but the problem is, trumps wrong because that's exactly what congress did when mike pence was in congress and george bush was president. they gave tax cuts to people at the top and it didn't create a lot of magic. it put america's economy into the worst recession since the 1930s. i remember those days. i've got a feeling you remember those days. trying to tell me that you do the same thing now and it's going to work, we have a saying in virginia, i may have been born at night, but i wasn't born last night. don't tell me about that, i remember what happened last time we tried this thing.

that is the difference. people's if you do what hillary clinton says in four years will have ten and a half million new jobs. if you do what trump says you will lose four-point $2 million. what's the difference, it's 14 million jobs. i tell people that's the difference between a you're hired president anna you're fired president. why would we want to have a "you're fired" president? one more thing before i get onto how were going to win this thing , because were on the subject of taxes, let's talk about donald trump's taxes. what taxes? i need a speechwriter. what taxes. this is a really important issue

because it's about taxes, but it's even more portly because it's about character. step one. every president since richard nixon, including richard nixon has released their tax returns to the american public. it was interesting the way nixon did it. he didn't do it during the campaign, but at some point he was being audited when he was president when that news got out, he said i'm being audited and you might have some suspicions about me. i'm going to release my returns because i'm being audited to show the american public that i am not a crook. that's what president nixon said. that started a tradition. after president next and, every major party candidate, upon getting the nomination has released their tax return. that is step one. step two, donald trump, 2014, he gets asked, we release your tax returns if you run for president.

he says absolutely. no if's, ann's, no well, if the other person does this or that, absolutely, i will release them. first promise he made in the campaign, first promise he has broke. third, we are in the campaign. he's breaking his promise, he's not releasing his returns and he said it's because he was being audited. that has nothing to do with it. in fact, if you're being audited maybe there's more of a reason we should see your tax return. then we get to the heart of the matter. what's the matter. why won't he release it. is it that maybe he's not so wealthy or so charitable where he's doing business with people that would scare the daylights out of people or may be he's not paying taxes or all of the above did you see what happened during the debate with hillary last

week. hillary was going after him. i bet it's going to show you're not so rich, you not so charitable and he didn't respond to those things but when she said i bet it's going to show they don't pay taxes he got a smirk on his face and he said that just shows i'm smart. so i guess you're smart for not paying taxes but those of us who pay taxes to support teachers, those who pay to support vetens, those who pay taxes to support our troops, what's he saying about us? he saying that we are stupid and were suckers and were chumps and that he is smart. i've got a lot of words for him and smart 81 of them. i'm not even going to get into the words that i'm thinking about right now.

i have a boy in the military whose deployed overseas and when i see a guy stand on stage and smirk about how i don't pay taxes and that shows i'm smart, it makes me very angry. can i just extend it to two more points. let's talk about him not paying taxes and where he lived in when he didn't pay them. the new york times came out with the story that he took a billion-dollar loss in 1995 that would probably mean he would have to pay taxes for 18 years. now he said that's because he's brilliant and a genius, he lost $1 billion billion dollars. i guess it takes a lot of genius to lose $1 billion. i guess this is just the kind of genius that we want running the american economy, you you have to be kidding me. he said, the story came out and he didn't deny it, 18 years years of not paying taxes. one of those years was the year of 911.

let me focus on that year in particular in a couple years after. hillary clinton and donald trump's hometown, new york city, was attacked by terrorists on 911, the worst terrorist attack in the history of this country in new york city and virginia, the pentagon and the plane went down here in pennsylvania. what happened after that attack. first, thousands thousands of young men and women went down to recruiting offices and they signed up through our voluntary military to fight terrorism. that happened. second, hillary clinton who is a u.s. senator from new york goes to the world trade center within 24 hours when they're still looking for survivors and bodies and she goes back down to washington and she fights to get funds to rebuild new york and then she fights to get funds to provide healthcare for the first responders who rushed into the world trade center, police and fire in new york city and in the

pentagon in virginia, she worked with democrats and republicans to do that and then a secretary of state she worked with president obama's national security team to make sure they revived the hunt for bin laden and found them and waved him off the face of the earth. that's what hillary clinton did when her hometown was attacked in new york city on 911. what did donald trump do? those were the years that he was being smart and not paying taxes, not paying for the fight against terrorism, not paying for the funds to rebuild new york city or for first responder healthcare, not paying for the salaries of the men and women who signed up fight terrorism after 911. he saying he is smart. he saying he is smart. i asked governor pentz last night i set i know you had to

give your tax returns to donald trump to show you were qualified to be vice president. the answer to that was he did. he didn't dispute it. we knew that had been true and it had already been recorded. if you have to reveal your tax returns to show that you are qualified to be vice president, then how in the world can you claim that you do not owe the american public are tax returns if you want to be president. it would be like me coming to you for a summer job, young man have you ever work before, can you give me references, i'm sorry, i'm sorry i can't give that to you. will you just graduated from college. can i see your grades no, i'm not going to give this to. running for president is a job interview and it's only a job interview for the most important job in the world. there are some basic questions that the voters want to know and

the voters have a right to know and that the voters are asking. if you go into that job interview and you say no i think i'll take a pass on that one, i don't think i'm going to answer it, you do that with the expectation of maybe i can put this over on these people. that's what donald trump is thinking. are we going to let him get away with that? absolutely not. we can't. let's talk about how we will win this thing. it's close. i like the vote of optimism. i'm an optimistic person but just eight days ago the polls had closed that even an eight days later it's looking pretty good for us but i don't know where it will be eight days from now. the polls have been up and they been down. pennsylvania has looked pretty

good. [applause] i think you guys just got into city of brotherly love convention mode and stuck with it. you stuck with the spirit in philly and pennsylvania has been looking good,'s solid, stable, not only inside but we have a lot of other states that are dead heat. we have a few. i like the way that sounds. let's be honest, if it was a dead heat nationally a week ago, it could be a dead heat nationally and next week we can't take anything for granted. i know that's what hillary say.

she would say the same thing. no matter how close it looks, it's been a season of surprises and poles and pendants have been wrong. we can't take it for granted. we are living has citizens united and people can dump anything on tv and say anything they want and that can change the race. i'll go back to where i started. were trying to do something that's never been done before. if it was easy to elect a woman president, there would have been in a woman president. she is just trying to do something that's not been done. when donald trump says about hillary, she doesn't look very presidents presidential, does she, fellows, fellas, we know what's going on with that. we have to assume, if you're doing something that's never been done, you have to do your best work. :

there's not many professions were 51%, you are doing just fine. you're a winner with 51% of the people like you and 49% not liking you. now, you are a winner. that's politics. [applause] but i'll tell you, the reason i barely when my race is because virginia has been tough. virginia is not the bluest state in the crowd. we are better now than we used to be but races are close because they are tough. the way i win races as i put this thing in my head and you're the underdog you are the winner. that's about. but that thought in the back of your