tv Public Affairs Events CSPAN November 23, 2016 8:19pm-9:17pm EST
it's not just about innovation, it's about working and being responsible industry within the system at à la jing role to play in saving lives and addressed to mrs. but also what we can do in health care and make this a more sustainable. >> let's flip this around for second in the world where secretary had been elected and our solutions better or worse plex that's a terrible way to ask that question. let me ask more directly. if donald trump's election last tuesday help or hurt american patients ultimately quick story, any thoughts? >> i think we can take a step back. very helpful to have this dialogue at this point in time that i think was his campaign good or bad for sector? at some point you have to start at the top and look back at
president-elect trump's record and in terms of his campaign proposals they had not been particularly well detailed and there was not a meaningful focus on by medical and biotech issues. that's one and if we look at some of the stickers on science and if we look at climate change issue as an example is the science that's true for some of his supporters. >> he doesn't believe in climate change. >> i think from a scientific level as other should flag the globalization to. there is a lot of concern globally and i also think some of the focus on the case to. part of it was is taking half a
step back on that but i feel like in terms of her capital funding particular for some smaller companies i work with any of these major changes aca is hugely deceptive. it has tremendous uncertainty and i worry about some of the proposals in that context and what that will mean for financing and keeping the industry going in a robust way. the jury is out for me. i won't say it won't be terror world is coming to an end by any means. it will be important to see what comes forward through this transition team in terms of who his top political appointees will be, what proposals will come out and we also need to watch what happens in congress. i do think i have a number of
concerns but i'm not willing to say at this point it will be a positive. >> let's get to the transition stuff in a moment that it's a big box to impact second-tier point pointed answer to be what that means for the industry and whether that's good or bad and are feeling the navy could be bad. any reaction to it door at just the? >> i think it's actually good that the president-elect is not taking a hard position on some of these issues. he doesn't have anything to actually pull back from. we can shape the future and let me be specific about that. i don't think anyone thought either side would not want to see us address the critical problem of the price of rugs. i think it's a matter of what you would do about that. price controls demonizes the industry in my opinion and would not be a very positive thing and what the ultimately negatively
impact patients. but there are other possible solutions and ways of doing this. i think if you look at the people who are devising president-elect trump and i would say specifically newt gingrich, it was spoken and afraid of ways of what we can do in an innovative way including with alzheimer's creating an opportunity for bonds that would be able to fund an offset costs. i think this administration could be open to innovative ideas. andrew whoa is an economist at m.i.t. and a fellow at the milken institute and his work on the concept which essentially is mortgage for medicine. i think going forward we don't have to view the solution to the problem of price of drugs by simply looking at price controls but rather look at innovative other ways illuminate the burden
on the patient reconfigure our system. i'm optimistic that we have an open space here that we as a community ought to contribute to and help this administration defined as the solutions. >> one more perspective and keep you are out there working with clinical trials and seeing some of the research being done. what is your perspective on what has happened in the past week? >> there are causes for concern space on what we have heard in the campaign about evidence-based decision-making and what the particular foci should be that this is not a time for trenching and on those concerns as opposed to really finding the right people to sit down and talk with and coming out of transition. newt gingrich is a great example and beginning to educate the administration about the
potential opportunities for the administration to do things that will be recognized by the american populace as contributing in recognizing things that will have an effect on their health and health care. an example would be drug pricing and looked at from a different perspective. that is that the way that pharma makes money is by selling the drugs that the fda approves and selling those drugs to make money means that to cover the cost. understanding the mechanisms and the medicine approaches we can better understand the mechanisms of disease and leads to smaller trials and more success of those trials and therefore less obligation to cover costs. that approach you'd be able to
say let's get back to the basics and figure out the mechanisms of the disease for these winds which would drive down the cost per drug companies to buy will have an impact on health care and drug costs. price right now is a major driver of health care and the cost curve in this country. everyone agrees it's not sustainable so here's a way to approach a direct way. i think that's the kind of message i would try to establish. >> one of the most encouraging parts about this election is that president-elect trump is a businessman and most people running a large business the way he has want a lot of information before they make decisions. i reflect on andy's comment. he didn't take an ideological position may be a positive
thing. it may signal that he's open to all ideas and if he sets up a way of working with the industry with patience and with academics and the financial services industries all of the people and the e. as system i think we will undoubtedly come up with better solutions. i don't think it doesn't care about affordable care or isn't in principle a goal that you continue to have 20 million people with insurance. what do things there i think is where they need to be a lot more work and detailed. >> is a businessman trump is at a lot of experience in different businesses in retail. i'm not sure about trump drugs. if i can paraphrase what i'm hearing on this question the sector overall has likely benefited from the election.
before we get to policies that can be rolled out i think the operative question right now is what happens next in the transition? who is going to be put into place and what does the new administration need to do? we have some folks on stage who have experienced getting a transition through and we can start with you. again this is not hypothetical. from team based on what my sources have told me they could use a little bit of advice on how to figure out the transition next. what comes now before the president-elect and his team especially around help care? >> but if already seen a lot of analysis. the transition team is rapidly being assembled. >> i'm sorry i'm a terrible moderator. you have the experience because you went through this years ago. >> i was on president obama's transition team so i had experience at every level. the first is continuing to have
core members on board and they will have two main tasks. the first and this is what we are seeing right now is to identify and begin to set candidates at the highest level. the cabinet secretaries, a prime example and that will depend on the right type of experience managing large organizations having policy credibility being able to work with others. you have to be part of the team. a very difficult process. even working through that there is an intense interest in starting policies. the president trumbull not too's too's -- want to start the first day in office saying what are my priorities right now starting at that point. he wants to be ready to hit the ground and pass some of them
right away. a prime example is president obama during his transition team that's only drafted and negotiated a recovery and reinvestment act, are a -- r to do was ready to be signed by congress for the authorization of the health insurance program. if the clinical function of his transition team working closely with congress to think about what are we going to be able to say that we have accomplished for the american people? i think president -- when i was on the transition team we met with groups from all different parts of the sector who came in with their ideas to fill the role of the director.
i think this is the time now to start to seek these types of appointments be going to map to icon to people. i think this is the time to start that conversation. >> are we talking about 20 groups? >> are like 50 or 60. that's the core transition team. advisers helped even more so -- and i think that's true because of the change in administration and the change of the political parties. we want to make sure that whatever else needs to be added or retooled you still want to care about that. sad this is a super self this question but when you meet with those groups how do you decide who is worth scheduling a meeting with? are we talking about only national associations, and street-level?
>> i think these are groups that we would expect. the major physician groups the major trade associations. i don't know that they would even be surprised in terms of who we met with. i will stop there. >> one of the things that is absolutely typical about a transition is the instability and the anxiety and its stability about policy and anxiety and also about personnel. i actually am going to insert a commercial here because i think at this particular moment as far as we are concerned one of the most important things i think that could occur right now immediately is the passage of the 21st century insurance
skill or the up perspective of the next commissioner needs to navigate quick. >> i strongly believe this skill set is around leadership and organizational management it isn't important the head the these agencies for this shameless clinician's it is nice to have but most critically important to provide of leadership of team building and is now basketball and integrated without leadership who can teach and manage that and i
think they have to look deep into these organizations because the next administration will be hallmark by reform they want a different way to do business. the next leadership summit. >> let's talk about 21st century. i am assuming they know what this is but there is a big question if it will be be solved with a lame-duck congress or teeth pushed off again. so ratio of pans who thinks the 21st century jurors will get through congress this year? very few people. of.
>> and they did know of quite a bit to lobby round the 21st century so can you tell us what you are hearing? >> last week was a long time ago that i was fairly optimistic from both parties nobody is against by a medical research so futile give frank opposition to the topic and congress would like to have the wind at its back so there is some
>> i would lead agree with the biomedical research i'll think it is but they're not you have opponents but if there is a bigger agenda at play if you want to end the year as a tax cut all of these things is bigger than it was anticipated so poor that could just be issues. >> id did hear what has given the past week there is an appetit -- an appetite and now is all round the repeal but i know you have been informed perspective
and of we want to see legislation go but what you think that would do for the community that is not currently being done quick. >> i think the most important piece of that legislation is the additional funding for the moonshot and the funding that is different is different from what is going on right now but the biles pharmaceutical products are components to that legislation that they're going on now. is important that congress says that these need to be focused on in this is one of
the favorite things he did such great work as a way to have a buyout market is. so it became an issue that suddenly america was all about by barker's. so the new could argue the legislative language of that bill or whether you could argue that congress then save signal to the fda that it is important that both of those all are equal and those are important messages in the bill as well as important changes that could lead fans of development of that product to get them
developed maury efficiently -- more efficiently to go back to how the clinical trials are too big or too long and one of the things that we have focused on in negotiating the prescription drug user fee access also focuses 21st century chairs to say that we have slimmed down the review process they're practically reviewing uh drugs between six and eight months across the board and that is pretty good. but where we haven't is the amount of time that it takes to develop drugs we have to be innovative of how we design clinical trials and how we looked at the data from clinical trials of the
multiple multiple sources of data and that exist? how can we take advantage of real-world evidence? when we do clinical trials? when we look at drug safety as well as the effectiveness ? all of these are crucially important to get the drugs developed faster. we cannot slowdown the fda review process much more but we sure can slim down drug development 21st century cheers put our heads together to figure out how to slim down drug development. so we can get the effective products to the market quickly and everybody will
and then to continue for word not to do any retrenching. that also help in terms of the obama finishing is legacy so there is some tension that that is just like a lame duck session. >> looking at the process and those that have to be addressed with these legislation and political i think right now if the bill does not get past there is
retribution marco over to 1/2 years. >> just think how young we were when we started. [laughter] >> i was not. and then to have bipartisan support and brought an amazing cross section of the community and there are more telling halls. and that all goes away. we start all over again. and when that happens there is so many editing is on the table a betty that opposes this politically and then
they will be held accountable for that. >> i and agree but i do think there's a lot of anger on capitol hill right now. of milan democrats flu resoundingly supported of those on the senate side. the question that i have is if that anchor of the election but across the board and the country. to break apart that alliance over the course of that to years in that you will see this political pullback but
i don't disagree with you that there will be consequences i know what to say that. [laughter] but there acre with the public if that drives away a positive thing that congress can't altogether the last couple of years. >> i think in with those priorities. and to be in issue. and indicates with even more things to be added.
administration may not recognize the power that it has to bring those federal agencies to gather. look at the way the moonshot was developed with 10 years of project in cancer research. and elements of the ways that we work to serve as barriers. in the task force pulled together 20 federal agencies to make cancer research move faster so to figure out things cooperative lead that they are not by now.
so if we expand the notion to the administration to say you have a chair and hip-hop that those arty agencies that fight for their budget every year. to convince congress and they are doing. and the way that they do that to say we're doing something unique. so there is a very strong force in the industry shinkin do things and they have done wonderful job for that job and for that group.
and then to motivate these agencies to work together. and we are in danger of missing that. >> so to paraphrase. >> interagency collaboration coming together more as a team of rivals? >> what do you think? >> those comments really touched on the theme of that this election was defined of making america a great and there is a drive to focus just on focusing on our problems as a country. i would not want this industry shin to mrs. it is health care industry is global and there is the need of campaign initiatives to
drive those global health care concerns and also stimulating new innovations could they approve over 30 years? and we are starting to see the application of the 2 million people so now we cannot handle that so i hope that as a big public health concern to reach across to other partners to identify ways of these issues. >> >> focusing on trade have they hedged against that?
is there in is what. >> they are headquartered in the u.k. but you see from poolside the of the atlantic but thorax cooler heads will prevail. but these problems that exist today existed before election and how we get there with a fresh set of eyes to incentivize the marketplace had to egad better regulatory alignment that that would be very appealing to the next demonstration. >> whether we are risk of in missing? >> and the she just quoted
price said previously but. [laughter] >> should i move to the right? [laughter] this mechanized spirit negative collaboration. >> but some of that with the transition team you want to point to ready to go with your first day in office. that this is what we will push john and to pass the budget resolution. and my fear is that if they did not have established policy there is sound
flexibility that we don't take the time to go through the process. so those juniors has all of the collaboration's that is what they really need and what are the people in their priorities can we be scheerer that we are taking the race steps wet clothes and my concerns at this point in time. >> regarding trade the most politically important issue one i am worried about with regard to transition with the administration to focus
on education. anything we hope for anything we are looking for to figure out the creativity is based on the next-generation over the next few years. we have got to focus on that long-term said the education system because without that all eight years from now we will not big country that we want or to generate that creativity is the use to. what i don't want to see that dismissed of the biomedical research and don't want us to miss those young minds to identify and
nurture and we can change the world. >> if it is harder for immigration do you see that as a challenge? >> absolutely. >> but to be focused on human capital with gdp for any nation. there are only three ways you can produce human capital you grow it, you import or you nurture and we should make that a theme how will we developed a human capital of this nation in the 21st century? >> as the administration
focuses on only those things to make the assumption almost everything that happened before they got there was wrong and have to be changed and fixed so equally on those that are working well so they are eager to make the difference to make a change. so to enhance those things that are working well. with the fda is an agency and the people that we represent there are many things that work well. not everything is bad.
and for those that are regulated to be uncertain about what will happen in so if the market thinks suddenly everything will change unpredictably for the sake of change it is not good thing for those with those innovative products. i health been thinking about what to do next and what to do first, there is not an assumption of what exists now house to be changed or fixed. . .
and raised from time to time that have an impact on the pharmaceutical sector because this is the sector that is influenced by the occasional remark. so, for example, the drug prices caused literally the bottom to fall out of the market. it was momentary in the sense that it's not a good thing to have that kind of fluctuation. but i think that there was a sort of overall negative view by some people so the cost of
having to justify its existence i don't think that is necessarily the best thing but in general i don't think that it was a bad administration. i think there were moments that were less than thrilling. spank the fda has been caught up in the challenges and the drug was approved in the political pressure. from your perspective as a former commissioner of them is the agency insulated enough from the political pressures? >> first, let me say that in my experience at the time i was
there it wasn't one decision was made on ththat was made on the l basis. they were all made on the science base and that the issue you have to come to grips with is the agency in the administration interest in policy and the drug or the device o were something should e approved or not approved those are always based on science. how that goes forward into the public realm is shaped by the policy. let me give you a very specific example. shouldn't be allowed to be put into the milk supply and the answer from a scientific point of view is absolutely yes
because it is no different between the milk that comes from a cow that's been cloned as opposed to why old or something. given the way we process milk in this country, if you put milk from a cloned cows into the milk supply, you wouldn't be able to track and trace it and immediately all of our cheese exports were shut off. so the agency and the commissioner has to be a part of the policy aspects of government while leading an agency that has to make decisions based on science and where there is a conflict then the secretary delegates that and they make a decision. they may say wait a minute
that's contrary to what we said. i don't deny that but on the other hand it's not in the best interest from the policy point of view and i can track the decision you make because it reinforces the decision i made it when we put an age limit on what we thought was appropriate for someone 12 or 14 years of age. >> i understand all the things you have to balance. i guess i just want to come back to this for a second. from your vantage point it looked like it did in to back up the decision. did i give you new concerns about how they made the decisions and set a precedent that could be dangerous?
>> to be candid and honest, i wasn't immersed in the decision and i don't know that i know enough about the discussions and conversations to comment on that. and i'm not dodging the question but there is a space where the leadership looks at issues, judges the science and then determines what is in the best interest of the vot public. >> there are a number of initiatives we talked about the push towards more precision. do we know that any of those are paying off and i realize it is early in the going but given thathat there is effort going io these initiatives. you said it yourself, the
procession medicine initiative recognized how to address the problems. it's set by how those initiatives are instructed and intended to do. in the case of the tenor of where the industry has been the last six months which hasn't been very kind to the industry and doesn't recognize in many ways the industry and its value to society there are certain tales where the administration has not wanted the industry to be involved. whether it is the healthcare over the country and the lack of acknowledgment the industry can play a role in improving patient care and helping to drive the better improvements.
it can be harnessed to do good budo thatalso good but also is improving the patient care post approval. so i do think that it is too early to tell. i love the tone set by the administration relative to how we work together as an ecosystem and hope this continues into the future. >> i would argue that those initiatives are working and this calls into question the role of the administration in the case and that's facing big challeng challenges. i think the well enunciated challenge service quickly and demonstrates the success because it brings into the endeavor
individuals and holds disciplines that didn't think of themselves as being able to contribute in the precision that says the really need to involve engineers and physicists and scientists if we are going to be able to woo the health care challenges in an effective way to. it wasn't achievable. we were having a hard time getting their rackets into the sky forget about a man to the moon. we are sequencing dna which on a good day you could get 40, 50, 100. what happened was people from other fields and disciplines said i can do something here.
we can actually make some progress. i would argue that the initiatives had already done that and these are challenges that will span the administration ten years and so forth. we know that there are challenges to say an administration can bring forward and those are working. >> so enough peopl >> so enough people can come along for the ride. let's end with one question we can shoot down the line. that is who is the one person you are going to be watching in 2017 with impact it could be bernie sanders or someone
outside of legislation. of the one person, i think everyone is thinking about their answers. [laughter] starts with her. she doesn't have to think about her answer. >> why don't we start with you. >> i don't have to answer the questions. [laughter] i am very curious about the overshadow. i want to know who the next chair will be because they could have a fair amount over what is happening and then paul ryan macro because there is a of plug and play could he be the guy on the ground and that is bigger than the sector all across
healthcare. that's my answer but i shouldn't have to give one because i'm the moderator. >> i would keep my eye and ear to the ground for newt gingrich. he is an advisor to mr. trump and over his congressional career and his private consulting business he has remained extremely interested in the regulation that fda does. the ti time between the director and the commissioner. >> do you know who either one of those will be? >> i will tell you afterwards. [laughter]
>> i would say the new secreta secretary. >> any predictions on that? is to make those are all good. i'm going to watch for barack obama. he has shown enormous interest and capacity to capture the current challenges we have and to be able to say and do things about them. we will see what happens. >> he'd talked about doing this before. thank you all so much. [applause]
the discussion also includes childhood obesity. ucla and harvard university hosted this policy conference in los angeles in october. i salute the effort around the issues and i think there are some amazing works that will come of this. is it possible to put my slides up? my hat goes off to senator harkin who has been an incredible hero for the decades of work in public service and it's been a pleasure for me to interact in that context and i
very much look forward to hearing your comments later on tonight. it is important that we get the food right. policies affect us and in innumerable ways and there's all sorts of pieces of data that suggests this but i like to show one thing from an article that came out with look and see how food is implicated in this particular list. you can see in almost every case it is a major player. it is because in many parts of the world people are using inefficient stoves to prepare their food leaving enough of respiratory illness. so, it can be an important player so there's a lot of good work to be