Transcripts For CSPAN2 Health Care Policy 20171027

Academic group in the country focusing on this matter. Its my pleasure to be here and i want to thank American University for putting together such Great Program and the American Society of law medicine and ethics and other sponsors of this conference which have been a fantastic conversation. We spent a lot of time talking about the future of healthcare policymaking. Industry plays an Important Role in bringing these products forward, but in recent years, drug crisis has continued to rise which has made some of these breakthroughs unaffordable for patients and leading directly to bad consequences when patients are unable to afford the medication as well as driving healthcare spending with spending on pharmaceutical by some estimates making up 20 of healthcare spending overall. We are extremely fortunate during this lunchtime to have one of the key players in helping, who helped establish this pharmaceutical marketplace in representative henry waxman who served as a member of the u. S. House of representatives for 40 years from 1975 to 2015, overseeing a number of important legislations, not only, but also the orphan drug act, Prescription Drug user act, the fda amendments act, and other pieces of legislation that helped establish the environment today. He currently serves as chairman at waxman strategy as well as an advisor at Johns Hopkins University Bloomberg school of Public Health we are hoping he can talk with us today about his reputation as one of the main drivers in these important pieces of legislation. Id like to let him give a few comments and i will get down to some discussion and hopefully have some time for audience q a. Please start thinking about your question. Thank you. Mac. I am delighted to be with all of you today. Ive looked over the schedule for the conference, and it looks like a fantastic conference. I know cspan is filming this, perhaps i can get a copy of the record of what has been said in the last and half. I think aau for hosting this conference and i think aaron for inviting me to join you today to talk about Prescription Drugs. I was in the house of representatives for 40 years, and in the 1980s, we were focusing on the farms and pharmaceutical issues at the time. The issues we were looking at were that we needed more of an incentive for development of new drugs. We needed new incentive for drugs to be manufactured for the broad population, and we also needed to address the problems of people with Rare Diseases. In 1983, we passed a law called the orphan drug act. These were called orphan drugs is the number of people who were affected by a disease were very small in number and it wasnt in the interest of the manufacturer to even produce a drug that was known about let alone develop new drugs for people with these Rare Diseases. We tackle that problem from the point of view of giving an incentive for developing drugs for Rare Diseases that did not look like they would be profitable because so few people would be using those drugs and they adopted the orphan drug act which gave incentive to the tax system an incentive through an exclusivity. Of seven years. The next year, we looked at the problem of incentives for development of new drugs and the pharmaceutical industry complained they had lost time while there drug applications were being reviewed by the fda , and they had only, within the last decade before, had to come up with not just proof of safety, but proof of efficacy, which required many trials to accomplish that goal, and of course the drug cannot be marketed until the approval was accomplished and finalized. They said they are to have more time restored to their patents for the time lost at the fda. On the other hand, generic drugs were very, very small in number because generic manufacturers who were making the same drug as the brand name drug had to go through all the test to show it was the same drug in terms of effectiveness and safety. They had to go through the whole procedure to help these generic drugs by saying they could have an abbreviated drug. They just had a show its the same drug on the market and that had already been established. We thought we got a balance. Consensus for development of new drugs and also being available to lower the drugs on the market. That balance is completely out of whack. It has been affected dramatically by a lot of changes from the 1980s. Insurance is now paying for pharmaceuticals, there have been through pharmaceuticals and we are grateful for that, but the drugs are exceedingly highpriced when they are first being rolled out and theres no competition permitted or sometimes when they are being rolled out and theyve been on the market for a while, but the prices go up and theres no reason to explain the prices going up except for the fact that the manufacture has either a patent and or an exclusivity which means no competition. Weve seen drug prices are rising faster than wages in the past several years drug costs are an ever increasing problem for people to pay for their drugs, even if theyre only making the copay. I think it has helped increase the prices. As we look at these ever increasing frustrating problem. There is no Silver Bullet to the prescription of drug pricing. All we have to do is negotiate prices. If you negotiate prices with the patent holder, negotiations are not going to go very far because you cant substitute an alternative drug. There are other problems in the negotiation, but negotiating prices for drugs is no magic solution. Some people say what we need to do is import drugs. After all, we manufacture drugs, exporting them to canada or europe, and its a lower price and those places. While we import those drugs from these other countries and we will get the prices that are being paid for in those countries. Importing drugs can work in a very narrow way, but its not an answer because by importing drugs, there is no way we can ask the drug manufacturers or expect the drug manufacturers to manufacture drugs for the use in canada or in europe and to supply the United States through that mechanism. So, what we have done, we are with you, bill corr who used to be deputy secretary of hhs, Kristi Martin who also worked on Health Reform at hhs, and sofia who had worked at hhs as well, we tried to figure out is there something we could do to approach this issue. There is no one answer, but in an incremental way, that would lead to bipartisan support that would lead to legislation that would require to get legislation passed. Most of the bills that i was associated with in my decades in congress were not passed on bipartisan basis. Whether it was the drug act or expansion of medicaid, or dealing with medicare or any of the other laws. It was very bipartisan. The truth of the matter is, we do better when bills are bipartisan. I always thought i was wellinformed when i introduced a bill, but when you hear the comments of those who are critiquing it, you learn more about your legislation and often make a much better product. I wish some of the laws that we are having such difficulty dealing with right now, especially the Affordable Care act, had been bipartisan. Its the only law i ever had a role in drafting that was only partisan, but it was based on a political decision that republicans didnt want to participate and they did not want to be part of it. Didnt want to be part of it and president obama had proposed so they were against the stimulus bill, they were against the regulation of wall street, there against trying to do something about Climate Change which they deny even existed, they didnt want to deal with the Affordable Care act, even though the Affordable Care act was based on many of the principles that the republicans had supported, especially in their alternatives to what president clinton and his wife were trying to do during that administration to address the problem of pharmaceutical pricing. There is no Silver Bullet, but we think even in a divided congress, progress can be made but we have to start with a discussion, not a bunch of solutions, but what are the drivers of healthcare cost. Look at those drivers and see what members are willing to take on. You cant answer all of the drivers, but you can start making some progress by addressing those issues. We looked at the following kinds of drivers of healthcare. High launch prices, high annual increases for patented brandname drugs and orphan drugs. What can be done about it . What are some of the possible approaches . Secondly, some manufacturers create or take advantage of natural monopolies, the drugs that enable them to significantly increase prices, and we saw this with manufacturers such as turing and retrofit and valiant, they had limited any opportunity for competition. Not because they had the patent or exclusivity, they didnt have anybody competing against them. Sometimes it was a natural monopoly and sometimes it was a contrived monopoly. Third, lack of robust Competition Among manufacturers including generic and bio similars, and that resulted in less competition for there is a real problem with the bio similars from the fact that when we adopted the law dealing with bio similars as part of the Affordable Care act, we gave an enormously long exclusivity. I think it was 12 years. It was so long in comparison to what we had done on the waxman act, it made it difficult from the start to provide competitio competition, but there are some aspects of competition but the fda needs to take action to establish the pathway forward for bio similars and bio generics to be approved. The system is difficult to analyze because it does not make a central pricing Information Available to the patients, the providers, or the payers at the point of care when the decisions are being made, and we have a lack of information about competitive effectiveness of drugs at this very important time. Another thing i want to touch on is the federal law limits what the states can do under their authority to negotiate prices for medicaid and implement other price related measures to reduce high drug prices. We might want to look at some things the states can do and some of the things the states are already doing on their own. The state of california adopted a new transparency law. Other states are following along. I think that is all to the good, and we could have more state experimentation if we permitted it in the medicaid drug formulas. There are things we can do shortterm and things we can do longterm. Our approach is to talk to the key senators and the house and get them to Start Talking to each other. If we could get members from across the out to talk with each other, we could get them to Start Talking about things they could agree on. That is a real problem now and its been a problem for some years, that even in the most difficult times, when i was in congress, we were able to get things done just by working on a problem. It might not have been the Big Solutions or problems, but weve gotten bills through for a long time. The only bills that have gone through, especially in the last eight years are so were those that were bipartisan. Now the republicans inc. They can pass bills on a bipartisan basis. Period [applause] all right. So let us start with since the passage of the act, generic drugs made up about 20 of prescription back when you passed the bill and today they make up 8890 of prescription. of prescription. Gao has estimated the availability of generic drugs has saved u. S. Consumers 1 trillion over the last ten years. Is this the source success you envisioned when you created the statute . When we passed these laws we didnt have a model to know what to envision for the future. The drug act is an enormous success. Very few orphan drugs had been approved. Manufacturers without even looking to see if some of the drugs they knew about my help people with Rare Diseases. Didnt want to be bothered, no profit potential sufficient for them to have an incentive. The generic drug market we knew would provide competition and that was all to the good, but we never expected that it would be as great a a success as that hs been. 1 trillion, very few members of congress can have anything to say that they did that helped save 1 trillion. Thats the good part. I want to get back to the orphan drug act, but what you notice also and what you touched on in your opening remarks is over the last decade brandname manufacturers have figured out a way to game theres aspects of the hatchwaxman act even by obtaining socalled secondary patents on peripheral aspects of the drugs like the coding of the pill or metabolite of the pill or metabolite of the bill, listing those with the fda in the orange book, pay for delay settlement theyve engaged in with generic manufacturers, refusing to supply samples so generic manufacturers can get the basic testing that you envisioned. If you were rewriting the hatchwaxman act today, would you do anything differently . There are things you can cant predict and think you cant predict. What sorts of things might you change . We might have predicted the brandname companies were trying to discourage people from buying generics thats always been the case. They would talk about generics not being the same, not being as good as the brandname drug. Their Public Relation campaigns from the very beginning, try to make that point. But i think the public has come to accept the idea that if you can get a generic you usually get a better price. Thats led to the success of the law. The manufacturers have looked for lots of different ways to keep out competition, and you mention several of them. Pay for delay . We envisioned generic drug to compete, and to give a generic drug manufacturer an incentive to in effect come out and say they can break the patent because the patent was no longer valid and they could now manufacture a generic drug. Weve was said we would get a 30 month will give an advantage of the first generic on the market. That was to encourage generics to stand up and do the work and get approved. And be rewarded. Well, then if you get a pay for delay, reduction of a generic, you are not only blocking the generic youre paying sums of money to not to compete but you are delaying the other generics that were lined up that would also like to get on the market. We never envisioned these things, and i think what congress has got to look at all these issues very carefully and see what they can do to address these issues. Theres some things that are already on the agenda with bipartisan support, and i would Hope Congress would move forward, theres the creative act. Senator grassley has introduced the bill on a bipartisan basis to be sure that, generic compared to could find out whas in the brandname drug. Theres a bill to stop pay for delay. Even if the Supreme Court has nailed it greatly, but theres a reason to have pay for delay. Theres reasons i i suppose ine legal sense if there is a dispute if you want to stop fighting legally with all the suits and countersuits. The court said it should be looked at very much askance and some were just completely outlawed. So somethings i think are being considered now and other things need to be looked at very carefully to see if we can have a consensus to start addressing some of these problems. There is no solution again. Theres no magic bullet, but if you start addressing some of these problems, narrowing the difficulties, the next up is easier. Great. Talking about the generic markets you mention a couple examples of off patent drugs that have increased in price and i guess i would add to the also concerns about consolidation into generic drug market. Weve heard about shortages of generic drugs that are present ticked with the ongoing tragedy in puerto rico. These episodes reveal maybe the generic market isnt as stable as we might help. How might we update the hatchwaxman act to address these sorts of concerns . Well, the world has changed since the 80s in this area. At one time you had a brandname drug manufacturers on one side, and the generic drug manufacturers on the other side. And there was a lot of hostility. Now you brandname drug manufacturers, also generic drug manufacturers. Theres a crossover. Sometimes they have their own conflicts, but they rise above them by saying if they have a monopoly, and want to continue it and if they want to compete, we think they should be able to compete which is of course the position of not just one side of the industry or the other but the fact that they represent both sides of the industry. We need to look at these problems, break them down and see what congress can agree to do in the various aspects of the generic market. There was some good suggestions that came out of senator collins committee, aging committee. The stop sole sourcing of drugs and restoring the monopoly that. There are ways we get asked the fda to do more. I think dr. Gottlieb casella suggestions about things he can do to other more robust generic drug industry by getting these drugs approved more quickly, trying to see if theres some way if theres a solesource manufacture we can get a competitor, or to at least know in advance if theres going to be a solesource situation around the corner. I think importing drugs, in a narrow issue, i think it helped. It ought to be on the list of things that might be done. So i think we need to look at it, break it down and get something that the fda can move, somethings the congress can do. One thing the fda needs to do is to establish a pathway for generic drugs to be approved, especially for the biotech drugs. Have them approved, and they have a lot of other issues related to that, such as the naming questions and when they can designate a generic drug as a drug that could be substitutable. I have Legal Authority to do it pick fda needs to figure out the very difficult criteria so that we can get drugs that will be substitutable. The big gain that we had in lower prices from generic, traditional generic drugs, is that when they were the same drug as the original one, that was an immediate competition especially when there was a substitutable generic. And most states allow the substitute, substitution of a generic drug for a brandname drug. But right now we have the brandname companies in the biotech area going to the states and making it more difficult for the states to allow, then fda figures of the criteria, how to substitute generic biologic. I think that we have to overcome that as we look at the reform in this area. I do want to get back to the orphan drug act. Thats incredibly long, long list of things we can do and it also think points to the fact that its going to take interventions for people at every any level. Its not just federal legislature to its date, the regulators, physicians and patients themselves. But is there, do you think there is a better or a worse and five in which to have these kinds of conversations . How do we foster the kind of bridges that we need to build between all of these various constituents . I think its come the problem gets to be a difficult one. And suddenly people are concerned about it. Their representatives need to take on that issue in a way that could get some progress. And theres no good time, especially if you accept the fact it has to be bipartisan. And thats true even now with the republicans having the majority of the congress and republican president. Because theres no parson proposal that can get these things done. One of the laws i worked on for over a decade before we ever got any progress on it was the Clean Air Act. In 1982, the chairman of the energy and commerce committee, mightve been called the oversight, interstate and foreign commerce committee, was john dingell from detroit. And the newly elected administration of Ronald Reagan came together on a bill, and the bill was to reform the Clean Air Act which wouldve allowed autos to increase the amount of emission, set standards that could be weakened, and allow the air to be dirtier. It looks like he was going to pass, but we fought very hard and were able to stop it. After we stopped it, we said that we still want some things to do that will accomplish certain goals. We need to strengthen the Clean Air Act to do with the acid rain problem, the toxic pollutant problems, all these other issues. And so we tried for a decade to see if we could reach an agreement. Not until we had president george h. W. Bush elected president who said he wanted to do something but the problem of acid rain did we finally get a law passed that was absolutely bipartisan, almost unanimous. He didnt want the laws that we passed particularly. He proposed a law that moved in the right direction but moved in a way that wasnt strong enough. The epa may do it. The epa may do this. We kept on saying if they may come it also may not. Lets require them to do things under certain circumstances. And through that fact we had a president who wanted the job done, we were able to get bipartisan cooperation in the negotiation to get a good bill. And i knew that when president bush signed the bill he was going to say the same thing, this is a terrific bill. I know now that the present we have imparted will say this is a great deal, just as he says all his ideas are great, whether they are great or not. But the fact that President Trump has said he wants to do something about pharmaceutical high prices may be is an opening it the congress could work on a bipartisan basis if we just leave it to the administration and held a conference and listen to what farm had to say, came up with a lot of proposes that didnt do much. Pharma others seem to want to do things that were to become a catalyst for helping move the ball forward to accomplish some of these goals. I do want to ask the question about the drug act before we get audience questions. When you created the orphan drug act, the attempt was to identify come address the fact of the business interest in bringing drugs for patients over diseases. As you said you provided incentives including tax breaks and 70 or Market Exclusivity type it in in in 30 years it has turned out that manufactures can make substantial revenues by selling drugs to patients with Rare Diseases and heres the secret. You just price the drugs really high. You capitalize on the wellness and the flexibility of the fda to approve them on the basis of less rigorous evidence. Numerous manufacturers have their entire Business Model based on selling drugs for Rare Diseases, and at the same time that advances in biochemistry and genetics that is allowed such that many previously coming diseases previously to be considered, are now understood to be made up of a different of Rare Diseases. Is the orphan drug act still relevant in this current political context or are there ways that we could improve it to address the Current Issues that are facing patients with Rare Diseases . The orphan drug act is still very relevant, the lead to many drugs that are not even profitable but essential for people who otherwise had no hope before. The manufacturers are working on these drugs, which were not originally profitable but now are profitable, Insurance Coverage, profitable because they can get Insurance Coverage for the drug and lower the price people have to pay outofpocket. Its become a profitable business. But we never envisioned the most successful highly marketed drug of the orphan drug space would be to mirror. No one thought of that. And that you shows the creativity of the industry using all the levers that were possible humira. Would you see Something Like that yet to start peeling the onion skins off to see how did they get to that kind of a situation . And what can we do to put it back in perspective . There are patents and there are exclusivity. They run often together at the same time. There are some things that extend that patent or monopoly time, but a lot of efforts are used to try to keep it going. And so we have to decide are the things that allow the exclusivity still valid today, what kind of changes do we want to do in the orphan drug act area that can still continue the very purpose for which the law was adopted. We do want to throw the baby out, cliche, with the bathwat. We need a strong orphan drug act and we need to find out what our the problems that might help hold down the prices of drugs and the sequential monopoly one on top of another of a drug that we thought was going to be rare but its rare under certain specific circumstances, but not all that rare under others were sometimes the drugs were originally approved for a much broader use. So these are the kinds of things we Want Congress to look at. There are members of the house and the senate that are reviewing them. We want to push them to go forward and a lot of times when we pass new laws we call them modernizations. Well, we need a modernized orphan drug act for sure. I want to offer the opportunity to anybody who would like to ask a question. The microphone is right there. And begin to fashion your questions and make your way up. Meanwhile, i can feel the time by bringing back to the question of come you talk about some of the states. Weve seen in the last year and number of states have stepped in with her own reforms. Maryland passed a price gouging statute relates to offer contractor california riesling tried to ban drug coupons when you are brandnew and generic available so Drug Companies are not pushing patients to use brandname drugs. Do you see that the state capital of a great impact on drug prices or do we need a federal intervention . A lot of federal interventions that we adopt based on state expert mentation, and i think states and try things out. Im not sure of this conclusion, but states to do more in their Medicaid Programs that the pharmaceutical benefit, if we let them try. They cant try because of the other law i had a role in authoring, that was we would provide the discounts for drugs under the Medicaid Program but had to take, on the other hand, fidgeting all the drugs. They couldnt figure out a formulary to chew some of drugs and that others which would mean they had put leverage in their negotiations. We could try some experiments. By the way, i think a lot of things that people think mighty answers, we could try. We dont have to turn the whole National System around. We could try certain things out. For example, medicare could try certain things out on a demonstration project and see what works and what doesnt. The state laws help, and i know many cases where states laws were different enough that we had to push for national intervention, one standard, but ive seen a lot of examples where people will push for prevention so they dont have to try, dont have to deal with jennifer thinks of the state level that might have been worthwhile. All right. Do you mind telling us who you are . Alicia. Im the project manager of Georgetown Medical center and also a student. I wanted to know what your thoughts were on the recent controversy of allegan transferring their patent rights to the mohawk tribe for their drug restasis to avoid review patent, and senator mccaskill for both provoked legislation from happening from happening in the future . Thank you. That was a very creative way [laughing] to try to hold onto the exclusivity, to hold onto their monopoly. I thought it was a little too pleasant anything get your attention to that attempt that may well lead, should lead some corrective legislation i have looked at senator mccaskill spills particularly but i know she is very smart, dedicated neighbor of the senate who tries to stop abuses in the marketplace. I think this becomes absolute abuse. Its not a foreign country. Its just, its to keep the company with that monopoly, and what we need is more often competition, more competition and less monopoly. My name is craig at harvard medical school, and my question is actually related to the last question. On november 27, the Supreme Court will hear a case referred to in short form as oil states, in which the existence of the patent trial and appeals board is being challenged. This is a board within the uspto that allows generic Drug Companies to challenge integrity of patents of brandname Drug Companies. If this board is basically found to be unconstitutionally developed and is basically overturned, it will eliminate that pathway for Generic Companies to challenge brandname patents, and probably will reduce the efficiency with which Generic Companies can get to the market. So i wonder if either of you, chairman waxman, dr. Kesselheim, are followed in this case and if you have any comments . Im aware of it. Dr. Kesselheim has followed it in details so i will defer to our discussion. I would also add one of the nice things about the patent trial appeals board is it not only allows generic manufacturers to challenge but it would allow any challenge bring to a patented in the news you saw theres a a consumer gp that is brother johns against them, of patents related to one of the hepatitis c drugs when he out some them may lack the basic novelty and requirement that is required for novel, for new products to earn patents. I think this issue of patents that are not sufficiently novel being used and listed in the orange book to allow pharmaceutical manufacturers to oftentimes extend their Market Exclusivity past some of the basic boundaries that you helped set up in the hatchwaxman act is a big problem, and that this patent trial and appeals board is a potential avenue to try to challenge those in an efficient way without having to rely on extended and expensive litigation. I have been following case added you think its an important one coming up, and it is another avenue that we can use as you talked about trying to address this public a lot of different strategies and i think this is one. Its not in magic bullet like nothing is, but i do think it is a potentially effective strategy thats i think of the ever interesting to find out what the Supreme Court says about it. And whether or not the challenge has any merit. Im really interested in biosimilars and im interested in what you think the appropriate strategies are for how to make the Biosimilar Market look more like the generic market. I know there are key fundamental differences between biosimilars and generic drugs but how do we achieve some of the success weve had with generics in the Biosimilar Market and try to come while still accounting for a lot of those differences . Ive mentioned a few already, fda needs to establish when a generic substitute when a generic is substitutable. They need to establish a clear path for approval of a generic biological drug. They have the authority to do that. We need fda to be much more involved. And insofar as we dont get clear substitutable generics, we need more biosimilars that can compete with each other. In fact, i think thats one of the ways we have seen the price drop for dealing with the hepatitis d epidemic that we didnt get a generic but we got a competing biotech drugs. We need to look at all this area very, very carefully and maybe the fda can be the leader in helping this. Again i would also second that and add followon biologic drugs are being used and have been used in europe for the last decade. Or are dozens as on the market that it venues safely. I think we need to be concerned about the safety of these products but that there are mechanisms we can use to try to get products out and be able to then use them and follow them and make sure that we are adequately addressing the safety issue. But right now even though the fda has approved Something Like seven or eight biosimilar drugs well have one or two out of the park because of litigation over patents and other issues that have prevented these products being approved. That was just a settlement, i dont know if we want to call it a pay for delay but a settlement between the manufacture humira and i biosimilar manufacture that they will not put, there were not market their biosimilar in the u. S. Until 2023 even though the market, they can market in europe in 2018. Those agreements are problematic and to the extent they reduce competition and we are unable to get the same reductions in prices for some of the very older biosimilars theyve been using in europe. One of the presentations i made a couple of senators, senators stood up and said look, if theres competition thats the way to set the price. Let the market work. If theres a monopoly then you have to regulate. Well, we are in that unusual situation with pharmaceuticals, and theres no easy answer because weve got to get competition. Thats our first goal. We would rather have prices set through competition but weve got to do something when the public is put in a position where lifesaving drugs are unaffordable and we have new miracles coming on the market, already on the market with more coming with the law that congress adopted last year. So i think we have to think hard about how a recorded as a country, are we going to have lifesaving drugs that are just not available to people whose lives ought to be saved . That deals with the price of the drug and how we can make sure that drugs are available to people who need them. Could you imagine today if we had a vaccine for polio and wages said, not everybody can get it, if you cant afford it . Well, they make sure that didnt happen. We have some Public Health emergencies that are going on, hepatitis b situation. Theres a particular section of the law that some are trying to invoke to require that there be a lower price for it. But it goes to the bigger problem, we want new lifesaving drugs, we want new breakthroughs but we want life to be saved because these drugs are also affordable. So i think thats a really powerful statement, and looks like we will have one more question. I want to also jump in and talk about the concept of the market and bring it back to the physicians and patients as well because its been commented before that its hard to imagine an efficient market in a situation where the people who are making the decisions, the physicians, are not paying for the product, and the people who are paying for the product which is a patient, the Insurance Company are not the ones making decisions and then makes for very inefficient market. Are there things that you think that physicians and patients can also do in this area . This is the problem in health care generally. We have a thirdparty payer, and it distorts the two parties who are performing the service or buying the product and the one who is selling it. But theres a further distortion because of the fact that we dont know what extra value we can get out of medicines. And we need to know that. We need to know it when its being prescribed. Providers dated note. Payers need to know it, and especially patients need to know whether they are getting something thats going to help and improve with the already have available for them. And i was very disappointed that the law that was about, was part of the Affordable Care act, just didnt produce what we had hoped it would, for a lot of reasons. There was a lot of provisions put in it at the behest of the pharma who didnt want anything that could be used for formulary, even though you could obviously get the information without the formulary, but just so the medical system knows best drug, and prevents that may be available. Last question. Im from American University and i work in our intellectual property program. I wonder, id like to give you a moment to speak about nafta. Theres a trade negotiation going on right now. The rumors of the u. S. Have proposed a quite Aggressive International property chapter including a lot of higher protection for pharmaceutical companies that existed in the tpp or pass agreements. Its been degree should, a process that fit close though no one knows whats going on. Theres more no more Public Access information i wonder if you do, eat on the process of negotiation or the substance of what should be in a new nafta negotiation . Well, no pain antenna, let me discuss it generically. [laughing] i dont know what the issue, the nafta negotiation, but every time theres an International Trade treaty, pharmaceutical questions. There were attempts by the manufacturers of the brandname drugs to tell other countries, even developing countries, if they couldnt sell a generic and less they followed the hatchwaxman act timetable, which of course we never envisioned in hatchwaxman. We certainly didnt envision a developing country producing the brandname drug and having it on the market where nobody could afford it, and then say after enough time went by they could then get a generic approved, even though in the United States a generic was already on the market. I argued with our trade representatives and all these negotiations that thats an untenable position for us to take. Its wrong because it hurts the ability of poor people in these developing countries to get the drugs they need, and can afford. They cant afford the brand and theres no market because of the high price of the brand drugs so we need to get the generics out as quick as possible. I dont know the specific issue, but generically im sure it is related to that very question. Thank you very much. That was a great conversation. Good. Thank you. [applause] [inaudible conversations] thank you, dr. Kesselheim and representative waxman. Everyone is invited to enjoy a nice long 30 minute break. Our program will be on Health Status underwriting at essential Health Benefits in the nongroup market. Concurrent session three be on implications for hospitals one for upstairs in 116. Thank you. [inaudible conversations] we believe this. You can find the speakers that we just saw online, that will be up at cspan. Org. Check out the video library. They will be taken like to the white house for the Daily Briefing today. Thats scheduled to start at 2 30 p. M. Eastern pic expecting questions from reporters about the partial release yesterday of the kennedy assassination papers as well as other issues and the White House Briefing will have live over on cspan. Also life on cspan Supreme Court Justice Ruth Bader ginsburg making remarks on social justice. Thats at 4 00 eastern and you can watch that live online at cspan. Org or using the free span radio. Tomorrow Hillary Clinton amazon ceo jeff bases and Billie Jeanne king will be attending the human rights campaigns annual dinner in washington, d. C. Cspans live coverage begins at 7 p. M. Eastern and begin to can watch online or listen live with the radio app. This weekend on American History tv on cspan3, saturday night at 8 p. M. Eastern on lectures in history, university of california san diego professor louise alvarez on the 1943 los angeles suit suit riots and other suits were used to challenge conventional gender and racial identities. Mexicanamerican suit suitors in particular were viewed as public enemy, if not number one, then number two or one be right behind japaneseamericans. They were seen as unamerican. Sunday at 6 p. M. On american artifacts, savings with us at project explores the Green Hill Plantation. This site Green Hill Plantation has the original slave owner here was very active in the slave trade, as one of the things he decided to put in his yard is a slave Auction Block and auctioneer stand. You can definitely feel the power of this place. I think the Auction Block steny what is right now is a huge part of why the site is a powerful. This would have been really the last place men, women, and children wouldve been with their families. After this place they would have been scattered all across the United States into this is really kind of kind of ground zero. At eight an interview with historian william see you on the stonemasons who built the outer walls of the white house. A swag over the front door, which is carved with the lilies and flowers and ribbons and acorns, everything you could think of. Very lush over the front door. Wobbly the finest example of carbon in america of 100 years. American history tv all weekend every weekend only on cspan3. House Speaker Paul Ryan signed off on the 36 billion aid package for hurricane, while fire and flood aid that was passed by congress. He tweeted we are committed to helping communities hit hardest by the seasons hurricanes signed and sent another a package to the white house. Work begins next week on tax reform. Heres a look at whats ahead on capital with wall street journal textiles reporter Richard Rubin. Richard rubin, how does the republican budget proposals specifically set up the next steps for tax reform in congress . It does two things. One, it sets up with no as reconciliation. Thats a fasttrack procedure that lets a bill moves through the Senate Without any democratic votes. It can get on the floor with a straight up or down vote. Republicans have the majority him and it can also get off the floor with a straight up or down vote. Thats unlike most legislation which has a 60 vote threshold innocent were republicans would need some democratic assistance. The budget by the house and senate agreeing on this clears path for that to happen. The second thing it does is it sets the budgetary rounder for the tax the periods of the tax bill can increase deficits by as much as 1. 5 trillion over the next decade and thats the outer limit that the taxwriting committees are going to attempt to hit as the craft this bill. Host when of your headlight on the passive house bill on wall street says the move starts a sixday camp dont release the closely guarded details of the text later tell us a bit about what the timeline looks like for the tax bill in the house anyway. Guest you want to at cspan on 24 7 in november because its going to be really busy and really curious. The ways and Means Committee in the house is going to release the text of the built on november 1 and then start the committee markup, the nimitz and postnovember six. The Senate Finance committee will wait and at some point maybe that week or early the following week. It will be on house floor probably the week of november 13 and dent on the senate floor, Senate Finance committee and the senate floor shortly after that. The goal, members, visioned both houses to get the house and senate to pass something by thanksgiving. They will go eat some turkey come come back and try to reconcile the differences between what of it house passes and whatever the senate passes. We expect those to be somewhat different trend what it was a close shave getting the budget resolution that has the 20 republicans against the measure. A number from new york integers with concerns about state and local Tax Deductions. What specifically dont you like about the possibility of that being included in the tax reform package . Guest data like anything about repeal being included in the tax bill. Heres why. If youre from a hightech state, new york, new jersey, california though none of those never sowed against the budget, you are able to deduct your state and local taxes, your income taxes or sales taxes and your property taxes from the federal tax bill. Thats a a benefit for residens of the states and even the other things that are likely to be in the bill but your standard deduction can lower rate will not offset that loss for a lot of people particularly in those states and the statistics. Republicans from new york and interview guide to make a point. They did. They were not able to take down the budget but they made it clear. That Republican Leaders if they want to solve a problem, problems in for the spill reaches the floor they will try and reach some sort of accommodation, some sort of deal that may not get all in an immersive voted note today on the budget from the states but they are going to have at least may be a way to a few of them. The way is to focus on property taxes and acknowledge people from high income areas where income Tax Deductions are a bigger concern mages never be able to vote for the house textile. Host thats been an argument for democrats in the house as well. The Democratic Leader Nancy Pelosi after the boat issuing a letter to all the members saying our caucus has to be fully mobilized. Whats the number one argument against the tax reform package . Guest the number one argument is that a real benefit to billionaires in the industry refer to this repeatedly. This plant plan even though wee seen details info yet its too tilted to the people at the top of the income scale. It cut tax rates to the topic thats the Corporate Tax the company cuts taxes and other business. For democrats thats not acceptable way to detect the second argument is is a definite argument, this would be increase budget deficit and put pressure on spending programs, medicare, medicaid and social security. Even if those are not specifically on the table as part of a tax bill that they create a desire republicans and argument to cut those programs later down the line. Host lets look at the senate. You tweeted about john cornyn saying the goal is to get a tax bill through the senate before thanksgiving, reconciled with the house after that. You also write about there are obstacles in every direction. Are there more obstacles and the senate than in the house . Guest i think well find out in november. The senate map is tougher. They are 50 to vote and the to hold 50. That means they can only let to members go get you can imagine the usual set of numbers on the senate side that might have some difficulty, senator corker startup budget deficits as conservator senator paul wants to make sure a large tax cuts. Senator flake obviously is generally with republicans on the policy issues but is got his differences with his party right now. Senator mccain, senator collins, you can imagine at some level they can only lose two of those members. Thats going to be the challenge for republicans in putting this package together on the senate side. Host has the widest been taking an active role so far . Sector Steve Mnuchin and gary cohn, have they been participating weekly or regularly with members of congress . Guest that was happening more over the summer into september. For the last few weeks there been engaged for letting the committees, the house ways and Means Committee and the Senate Finance Committee Really do a lot of the detailed work to get the bill where it needs to be in order to pass, to get to the committee and on the floor. We did have a situation with the president weighed in on potential changes to 401 k plans. That something members are sensitive if you are hearing from the president , having him get involved, which hes got political clout among Republican Base but also jumping in and declaring red lines and what can change and what has to change is something that can attend for a multidimensional process. Particularly the president and his twitter account and the public is unhealthy something that bears watching as november rolls forward to lots of tax debated. Reporting on all of it is Richard Rubin who is attacked post reporter with the wall street journal. Hes on twitter at Richard Rubin d. C. Thanks for joining us. Guest yep. Thanks. Picture of the White House Council of economic advisers appear before the joint Economic Committee to give that Trump Administration is perspective on the need for tax reform reforme of the broader policy objectives. This is one hour 20in minutes. Good morning, everybody. The most informative but and he can separate Economic Growth in the United States. What is holding back Economic Growth in america has been a central interest to this committee from the onset of my term as chairman. All hearing, are hearing some produce useful information and insights. Im tal