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tv   Outgoing FDA Commissioner Gottlieb at Brookings Institution  CSPAN  March 24, 2019 10:57am-12:07pm EDT

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a campaign kickoff rally in front of -- kiersten gillibrand holt a campaign kickoff rally. live coverage begins at 12:30. >> food and drug administration commissioner scott gottlieb talks about his tenure in the future of the fda. he is stepping down from the position in less than two weeks. the brookings institution hosted the event. david: good afternoon, i am david wessel. director of the center here at i am thedirector of the center here at brookings. this is for health policy. i want to welcome everybody here, i want to welcome scott gottlieb. his biography is so long that i had to write it down. it is hard to believe he is only 46 years old.
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he has done the following things. he has been a financial analyst, a think tank fellow, a venture capitalist. he has done three separate stints at the fda. first as an assistant and then as a deputy commissioner for medical and scientific affairs and then since 2017, he has been the commissioner. as most people are aware, he is a cancer survivor. sometime along the way, he managed to have three kids. he did it very efficiently because two of them are twins. >> my wife did it efficiently. david: what intrigued me is, i was looking at what people said when he was appointed. one of the more mild comments is he is a shill for pharmaceutical corporations for much of his career.
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i think he impressed everybody, even people who don't agree with him about the integrity that he has shown as commissioner. his ability to manage a large bureaucracy and the fact that he has gotten so much done in such a short time, scott was telling me short time is relative. he has served longer in the trump administration than any except for the 20 top people. i probably got that wrong but you get the point. the entire cabinet is turned over and he was still in the fda. we are glad to have him here. scott has shown another thing, you can be a good regulator and very active on social media. i expect that he will be live tweeting his own remarks for the next hour if you don't like listening. he only has 40,000 followers. i hope we can build your audience. i appreciate you coming on short
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notice. she was at the national journal and fda week. she has been writing about health policy. we are lucky to have her. she will interview scott for 35 or 40 minutes or so. then we will take questions. the floor is yours. anna: obviously, the one place i wanted to start, i think tobacco is on a lot of people's minds as you are living. it is a pretty hot topic. one of the questions i had, they said that in front of senators last week. from that, they had pointed questions on nicotine, mental and e-cigarettes. on nicotine, he said absolutely, he is committed to reducing nicotine levels. when do you think we will see a proposed rule on that? it has been a while since he talked about it.
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ofwe put that out in march 2018. we solicited comments and we were going through drafting. i expect the rulemaking would be out later this summer. when i say out, out of the hss.y to that is the timeframe we have right now. this was the proposed rule. this would be the proposed rule to regulate nicotine levels. the idea here was to transfer quickly off of tobacco products. anna: when you say out of the fda, you're talking to hhs. scott: to hhs. this is a big rule. it will go through careful review by hhs. the to that, historically, even if you look back during the
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obama administration, even the rule that we have right now, this is the role that has been undergoing as love. we will have that as well. this is a longer rulemaking process. they should be out of the fda right now. right now, the timetable the are looking at is late this summer. anna: do you think that within a year from now, we will see a final product as well on nicotine products and cigarettes? scott: it would be a notice of proposed rulemaking. you have to get that out of the fda, building in some time for that to slip. last time we were committed to , get this out in january. we got it out in march instead. he had to allow sometime to buffer in these. if you get that to the department, it would be hard to predict how long it would be under review. it would be out for a 90 day.
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it is a long rulemaking process. the average rule from proposed to final is three years. that is historically if you look at the average fda will. if you look at more complex rules that are novel, it is longer than that. the rulemaking process is long for a reason. we make good of ministry records. i think it has been sustained in court a number of times now. the fda develops their careful rules about its process. there are thing is complex legal issues around banning menthol and cigarettes. you sounded less sure that that was something that was going to move forward. can you explain what some of those legal issues are? >> i don't want to prejudge the rulemaking process. what i would say is that we are
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committed to removing flavors from combustible tobacco. if you saw some of the things that we put out last week, that's not too bad flavors including mental and cigars. cigarillos as well. the youth use those. cigars are the fastest-growing category of tobacco use among african-american teens. we don't believe flavors, including menthol should be in , tobacco products. attract youthe to to tobacco products, historically. you do see overuse of flavored tobacco products by use. that is long-term, whether it is menthol or other flavors. we are going through a rulemaking process to seek to ban the-- seek to flavors in non-grandfathered cigars. that is moving through. >> are you confident that menthol will be dead and cigarettes? scott: i think the long-term
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trajectory is to remove flavors from combustible tobacco for public health reasons. they are building consensus around that. if you saw the issue of mental more broadly and you look at this issue five years ago, there was more of a split opinion around that. i think the overwhelming consensus both politically and from a public consensus is there is no role for flavors in combustible tobacco. they affirmatively banned characterizing flavors and cigarettes. it was regardless of if they take the action. menthol they did not codify , it. they left that to the fda to take that decision. >> the other tobacco issue that has been a big deal is youth vaping you just took some action in that area to restrict sales. , i wonder when you look back on
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what you have done on tobacco, do you think if you had not moved the date for the reviews for e-cigarettes that the space vaping may not have gone up as much as it did? scott: all of the provisions of this rule were put into effect. the manufacturing inspections, deliver requirements. i think it is hard to draw a direct line between. it is very hard between us deferring the application deadlines and what ultimately occurred six months later. the epidemic was clearly getting underway at the time that we made that decision. we were unaware of it. we do not have the tobacco survey. we started to see the anecdotal reports of a juul epidemic early in 2018 and january of 2018. you can see the press start to report that. it was first revealed to be over august of 2018.
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my senate director came to me and we knew we had it underway. within two weeks i was giving a speech. i was demanding action from the manufacturers. we followed it up in november with an announcement about what we do. in hindsight, if we had not known what was going to ensue in 2018 we made the decision in 2017 to put forth that cover has -- that comprehensive vision, would we have done the same thing? absolutely not. we pivoted very quickly. i don't think the decision stoked that fire. i would have liked to know if that was underway. remember, the vision we put forward was to regulate the use of tobacco control act. the product standard to regulate nicotine combustibles. at the same time, we recognize there were other opportunities for currently addicted adult smokers who want to get -- don't to do it through vehicles.
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with medicinal nicotine products being the least risky. we have issued guidance to try to open up those opportunities and attract nicotine delivery systems. not safe but less dangerous than combusting tobacco. the way we saw it was we were seeking to regulate nicotine in combustible cigarettes, we can't foreclose the opportunity to i have currently addicted adult smokers who want to inhale nicotine to get it in vehicles that are less risky. i think the vision still holds. i think we believe e-cigarettes could be a useful tool for addicted adult smokers. it can't come at the expense of all this use. where it is predominantly happening is the pod-based systems. depending on what we see in the
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2019 year, it is very clear that we can be in a position where we have to take action that is against the flavored products but an entire category of products. we are looking at developing a guidance document that would define clearly what a pod-based and cartridge-based system is. anna: do you have a political support to move forward on sales restrictions and anything further? scott: the secretary is extremely supportive. and there is broad political support across the administration. if you saw the announcement last week, the secretary put out a very supportive statement. he has been extremely supportive of this. they had a fact sheet put out by the white house that affirmed that we were doing. we had the deputy press tutorial retweet my from sunday talking about the action, we have a statement from the president's chief of staff affirming that we would take action to address youth use. that it would not be tolerated and there would be additional
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regulations. so i don't know what you could ask for for a more affirmative statement from the ministration than what we saw in the last week. from the top-down, you had affirmative statements from the administration and you had, in my press rollout material, very clear statements say that the white house support the policy and the president was mentioned as well. obviously, you are building that it your press material, you have gotten clearance from the highest levels. anna: one more question on tobacco, you mentioned juul. out tria took a stake in them and you seemed concerned. scott: it happened last week. we asked the companies to submit involuntary plans for how to propose to address the crisis, we gave them 60 days to submit plans before we announced but we're going to do in november and followed that up by implementing that plan.
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we went further than what we announced in november by moving in the dates of the applications for 2003 1. -- 2021. i was concerned at the time that, in their view, and they sent me a 15-16 page letter, saying that they felt that the youth addiction crisis was being driven by the pods in particular and especially the flavored products and they said they agreed to withdraw their pod-based products and said they would not put flavored products in the market other than menthol and tobacco so they either have an authorized use. i asked him plainly if they thought the crisis has been abated, and i forget their exact language but that is the essence of what they said. it concerned me that the company that affirmed what we believe,
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that the pod-based products driving the youth use and went so far as to take the product off the market public limited, the time i put out a supportive message about that, we acknowledged they were taking that voluntary action and then made a substantial investment and also guaranteed they would spend the market share of leading product leading pod-based flavored products being used by children. so i wanted to see if they had new data that was driving at decision. anna: how did it go? scott: it was a difficult meeting, as far as they have gone. i have had at my time less than 10 meetings with manufactures. i cannot member a meeting i had with a single manufacturer that was not with a tobacco company. if you remember when we announced the plan, who publicly said we would meet with the manufactures of tobacco products to give them a chance to come in
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and present their view. in part, we met with individual companies because they did not have an association we felt it was important to give them a chance to express their views. we have heard from them a number of times now. i continue to have some concerns that some of the activities they are taking in the market are not necessarily consistent with what they are telling us, but certainly not consistent with what we think the broader public health objectives should be and what i view as the existential threat this category. i am having debates about whether or not flavored products should be sold in convenience stores. the real debate is whether or not any of these products should be sold in convenience stores. i think we're losing the forest in the trees not understanding the real risk. it is a category risk. i don't want to see it come down to this risk, because i believe there is a role for these
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products for currently addicted adult smokers. we do see evidence that some adults are fully transitioning to these products, but it cannot come at the expense of growth in youth use. anna: what was the outcome of the meeting, will you talk again? are they supposed to present you with more data? scott: i don't think there was a specific outcome. the objective was to try and understand their decision-making from a public health standpoint and whether anything has changed interview. i did not hear anything from that discussion that leads me to believe that they have seen something different in the market. and that there was anything from a public health standpoint driving a position. i assume it is just a business decision they made to withdraw a product that did half -- did not have good market penetration.
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then to go make an investment in a similar product that good market penetration. but i don't know exactly what the decisions were was not guided by anything i heard. >> does that change how you look going forward at the category? you kind of hinted at that. scott: i don't think it changes the category. the tobacco survey for this year, which we are in the field doing, currently conducting it, i got the results early, and i suspect the fda will get the results earlier. they will accrue that data first. i think if you see an increase in youth use, high school use, of 20-40%, i don't know the exact number is, but i think the fda is going to have to very carefully contemplate their actions. maybe it is the entire category where you take them off the market and required them to have
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authorized applications before they come back on the market. regardless of your view on whether or not these products could help currently addicted adult smokers transition off of cigarettes, youth use is so widespread, so rampant, that whatever redeeming public health value they could potentially have, it is offset by youth use. remember, the statute requires fda to overweight tobacco use amongst kids, it explicitly says that when you're looking at making a judgment about public health utility of a tobacco product, that could potentially be a modified risk product, you have to overweight youth initiation as a component of how you assess the overall potential benefits of the product. we explicitly have to look at youth use. it does not take a lot of complicated math. if you see e-cigarette use go up 40% next year, which is not out of the question.
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you will see cigarette use go up among kids because at that level of e-cigarette use, you'll start to see cigarette use creep back up. we saw that last year, not significantly, but we saw it. you will be at levels of overall tobacco use amongst children of 40-45%, simply intolerable. i looked at data in 1950 and we have not seen that level of tobacco use among kids. nicotine is addictive and it does affect the development of a child. and we do have evidence that those children are now going to migrate onto combustible tobacco. so all of the dramatic gains we have made in reducing smoking rates in this country, particularly among young people will be reversed as a result of , these products. anna: i want to switch gears and talk about some difficult situations you have faced as commissioner. one of the most recently was the shutdown.
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how is the agency bouncing back? is there anything that is still kind of backed up? is there anything you are digging out of because the shutdown? scott: in my view, this is the biggest operational challenge we face in modern times and by observance of the last three decades. we faced operational challenges but they were in a discrete area of activity across the board. i think the agency has recovered from the shutdown very admirably, very effectively. but the long-term impacts, we have not seen immediate impacts on hiring or an immediate decrease in departures. i think a long-term impacts are going to be judged by what impact it does to the reduction of government service overall. people who might have stayed on for another couple of years and might have retired. there will take some time to figure out and look back at data.
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when you look at over six months or so, we have not seen that impact yet. certainly, the budget being passed and the budget being a very good budget, we had substantial increases in budget authority, maybe the biggest in modern times. that helped, we will be able to hit most if not all of our targets for the year. the place where we are going to see some slippage is in the overall inspection numbers for the year. they will be down an amount that is not fully commensurate with the periods in which we were shutdown. we were able to get a lot of the inspections back up. they will be down some portion. you have a 2-3 week decline in inspection. whether it is between 5% and 10% down from where we would have been, it is probably the case that inspections would be up overall this year, and you are going to come down from a number that would have been up.
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it is not going to look like a big drop, but that will be one place where you see some impact, as you just can't physically make up for that lost time. anna: and that is across the board? this is food and drug? scott: we got a high risk inspections back up, so to some of the routine inspections where would be down. routine inspections that are not covered by user fees. the generic drug inspections paid for by user fees continued so would be routine drug and , device inspections and it would not have been a big period of time. this was over christmas. we would not be getting inspections the week of christmas or between christmas and new year's, or even the week after. so that would typically be a slow time for the agency. the impact was mitigated by that. you're really looking at three weeks where things were not fulltilt. anna: obviously, inspections are topics that we have written about. [laughter]
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one thing i wanted to ask you specifically is the arb's recall that has still been going on. there has been a lot of focus, particularly in the last few days on the growing pressures on the government relying on the industry heavily for a self policing role. drug manufacturing that happens as well with south martin, the chinese company that started this recall. they were inspected in 2017 and found that there were impurities in their products but they were not figuring out what those impurities were. come to find out down the line that some of their products do have carcinogens or possible carcinogens. you think they rely too heavily on the industry to tell them what is going on? scott: i don't think that is an accurate conclusion.
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to craft that narrative and thesis we would have to look at other examples. we are going to be promulgating the first real modernization of this in a long time. looking specifically at the requirements we put on api manufacturers. that is where the vulnerabilities have been, also with shortages. with the situation, we, over the last couple of years, have grown up pharmaceutical quality with a lot of organic chemists. we have dozens of organic chemists who basically review manufacturing changes to look for manufacturing changes that could create steps where impurities get introduced through changes in organic chemistry. that looks like what happened here. there was a change in the manufacturing process that was published. a lot of the manufacturers adopted this.
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not all of them. in that change in manufacturing process you are literally trying to close a ring. if you go back to organic chemistry, using certain solvents and in doing that this impurity was being created. it was a low level so it was hard to detect. this was a theory. for some who watched the api over and over again with the same solvent, the impurity built up over time. it is a long way of saying, if you did not know to look for this, this would have been hard to detect. the impurities that were found during the inspection were not related to the impurities that caused this. which was tragic and deeply concerning that people were exposed. it should not have happened. the way to fully police this, because when you don't know what you are looking for, which is what happened here, nobody knew that this specific process change could produce this specific byproduct until it
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actually happened. the only way to mitigate that is to do what we are doing. this is why we have done it to , employ people who have expertise in looking at chemical reactions in organic chemistry, and being able to impute how changes in chemical reactions can introduce certain risks. that is why we have built the pharmaceutical quality and we made a decision to make organic chemists in this way. we will do a number of things, but it will impose more requirements on manufacturers for reporting process changes so so we have a full information for when these things are put into place so we can do that proper evaluation. i don't think this was the case where we did not know the process change was made. it was patented and published. i think this was a case that we did not know this particular impurity could be introduced in the changes that happened. anna: could the fda have done anything better on the recall?
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scott: i think after it was detected, i think the world regulatory agencies, we collaborated closely with world regulators, they worked very quickly to test other products to develop a standardized test for testing impurities. they made it available. i think that the direct response was admirable and efficient. you are going to see rolling recalls. i don't know if we are fully through, we are probably through most of it but there is additional testing of additional products in additional lots where you find some that had the impurity introduced in it. i think it is important, not to dismiss the risk. the absolute risk is exceedingly low. this is an impurity that is found naturally in other food products.
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you would have had to have been taking maximum doses of the contaminated product over a maximum period of time to have measurable risks. you remember the math we published probably better than i do. it was a pretty low instance of what was your absolute risk of cancer if you had been fully exposed. it was very low. that is not to dismiss it, but it is important to put that into perspective. patients who have concerns around these products. anna: another abbreviation is cbd. i know that is something you have been working on that will not be done before you leave. or will it? scott: i don't think that will be done before the next guy leaves too. it is a long process. the issue for us is, the farm a
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bill has passed, farmers who grow hemp and want to extract cbd as a commodity cbd oil, legitimate food companies want to put cbd into the food supply. but because it did not previously exist in the food supply, and it exists as a drug, under the statute it is either a drug or subject to clinical experimentation. i think that is the statutory language. i might be a little bit off. it cannot just be put into the food supply. the law only allows the fda to contemplate putting a drug that was not previously in a food supply into the food supply as opposed to a rulemaking process. we have never done this before. i just told you that the normal rule takes two to three years. that is a common rule. you think of a more complex rule like this, where we have not done it before, it would take longer. one of the things we will do is,
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we are putting together a work group and we are going to announce it within a week. we will have a public meeting around this issue for public comment. the workgroup will be charged with doing, it will be a high-level work group chaired by amy abernathy, the workgroup will look to look to what some potential legislative pathways might be to create a framework for allowing cbd into the food supply. we think some in congress intended for that with a farm bill. there is precedent for congress legislating on a one-off basis around specific substances. i believe it did with human growth hormone. precedent for drugs that are sold in pharmaceuticals also existing as products at or putting food in dietary supplements, like fish oil. you need to come up with a frame work that defines concentration levels where you would create a cut off. that would be up to the agency. congress would give direction to
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the agency to do that. cbd in high concentration isn't risk-free. in low concentrations it is probably safe. i don't want to make a declaration. it is also a question of if it is providing therapeutic benefits. people seem to believe that it has some value. this is a process that the agency would have to work in the most efficient way to get to a pathway. it would be through legislation. that would probably be a legislation specifically addressing cbd. anna: do you know when the working group would want to try to get that proposal to congress? scott: we are getting started right now. we have been briefing staff on the hill. what i said just now, we brief staff on our thinking. every meeting i go into on capitol hill i get asked about this. i think we would work doing an efficient process. we would have recommendations
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this summer. there is a question of dea has scheduled cbdde derived from hemp. i think the prevailing view is that the plain language is a statute. i don't know if they have done it yet. that is another step that would have to take place. they would have to formally deschedule cbd derived from hemp. there is a question of how you differentiate cbd derived from hemp as opposed to cbd derived from marijuana. anna: what things do you want to see get done? scott: i think i wanted to see through. i won't be able to see through the legislative initiative i work through. otc reform, the bill that would fashion a modern framework of diagnostics. those are on a longer time horizon. it will not happen within my timeframe. hopefully it will happen within the next few months and we won't sit out there for another cycle
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to be put on to. otc is ready. i think it would be a very productive modernization of the pathway for getting otc pharmaceuticals to the market and open up innovation on products that can be sold over-the-counter, and open new categories. not just different formulations that could be low-cost for consumers, but new category of products as well. anna: you have talked about the market not taking off the way the u.s. would have wanted. one of the things that was talked about last week with senators being concerned about evergreening and the patent. can the fda do anything? what should the government be looking at? scott: i would point to some of the commercial obstacles and biosimilars and the incumbent biologicals have large royalties associated with them. the manufacturers are smart.
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they amp up the royalties on biosimilar entry. if you are a health plan and adopt it, you lose the rebates. to offset that, you have to be able to move enough market share for the biosimilar to offset that launch revenue from the rebate. that is hard to do in this market because they have a difficult time converting patients over to the biosimilars. that is not just a difference of interchangeability, it it is a question of biosimilars being used in curative therapy. as the market develops, as doctors gain more biosimilars as they are developed against there be where there will be more clinical comfort. i think this market will evolve and be robust. it has been slow to develop, but it has not surprise me that it has been slow to develop. i think some of the early expectations, you can look back
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at the debate around biosimilars around 2003-2005, people were a little bit bold in their predictions. back, it was slow for generic drugs to penetrate the market come as well. i think the biggest impediment is a commercial impediment. the health plan should look beyond the long run and recognize that they put a biosimilar formulator and they might use a quarter when they lose the rebate. if they convert their population over a two-year period, they will save a lot of competition. i think they need to take the long view. the captive health plan seemed to do that. you look at intermountain health and kaiser. they have done a better job introducing these products. they have more control over utilization. they have done a better job of capturing the savings than some of the private health plans. the whole notion is to manage utilization.
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if they can't do this, i am not sure what they are doing. anna: when is your last day? scott: it looks like i will stay to testify before congress on april 3. i'll probably make friday, april 5 my last day. anna: that is on the budget? scott: i will testify on the budget before the house and senate. no one else wanted to do it. [laughter] anna: there was a tweet that you did on january 3 that you heard from friends contacted by in online news preparing his story speculating that i am leaving, i want to be clear i am not leaving, then two months later we heard a different story. what happened? >> that was an article saying i will announce my resignation within a week and i would certainly not do that. this is in a difficult decision. i have been going through a week of speculation. he can't possibly leave for personal reasons because you miss your family. there really was not more intrigue to the story than what
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was there. if you asked me back in january what my goals were, it would be to stay to the two-year mark. that got increasingly difficult. i did not think i could stay until august. i was at the point where i would come home friday night, get home at 10:00, spend part of saturday with my kids. spent all day sunday reviewing documents and working and be back sunday night. this is two years. two years of doing that with young kids. i did not think it would be as hard as it got. if i had to do it over again, i probably would have moved my family down here, rather than try to commute between westport, connecticut and washington, d.c. i cannot do it over again. it got difficult. it is hard to walk a way from this job. it is the best job i will ever have. we felt good at it. we were doing great.
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there is a great team left behind. there is a lot a policy laid out. a lot of policy will rollout. i feel good about the inflection point right now, and stepping away. we will continue to finalize certain things. there are other things that will roll out that are meaningful. the other policies on a good trajectory or longer-term enough that i was never going to be able to bring them over the finish line in a reasonable amount of time. anna: do you think under this current administration that the fda will have a permanent fda commissioner? scott: i hope so. i a have made no secret i am a big fan of ned sharpless. i think he is going to do an outstanding job. i think he has a great aptitude for the agency. he will be embraced by the professional stand. i have met with him a few times.
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i feel very confident about his leadership with the agency. it is up to the secretary and ultimately the president what they do with that slot. anna: is anything fun on the horizon? scott: i got the week off after i leave the job. next week is my girls' spring break. i outsourced my vacation plan for them, so they picked disney world. i am one of the few people who could say i am going to disney world. [laughter] but i really am going to disney world. i will see what comes next. i cannot look for a job while i am in this job. anna: i want to keep time for audience questions, so we can move on to that. wherever you see anyone. >> hello, thank you for sharing your thoughts. i work at the austrian embassy.
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my question is with relation and international trade. there is a possibility that in eu and u.s. trade talks, food products will be included, which might entail a certain degree of regulatory convergence. do you have any thoughts on the type of difficulties that might be encountered? scott: i think the broader challenge when you look at harmonization across the eu and u.s. on food policy, the eu has adopted a precautionary principle when it comes to some of the technologies we readily embrace here. we think they provide public health value. whether you are looking at genetically modified animals or crops. from a policy standpoint, people talk about harmonization across the portfolio. i think we have more ability to harmonize on medical products than we do on regulation on the food side because of the positions that we have adopted. we see opportunities to create
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more harmonization around things like inspections on food products and produce. we have entered into recognition with some european regulatory authorities where we can borrow from their work, and they can do it with us as well. we are currently in discussion with the u.k., we have done it with new zealand. countries that we formalize with on produce inspections. [indiscernible] >> you are without a doubt the most prolific communicator out of all the commissioners the fda has had. it is hard to imagine any successor keeping up with the complexity of the agency's
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portfolio, and the expectations that in some sense you have created among stakeholders as a transparency. do you think now is a good time for policymakers to start thinking about a three-person commission format for the agency? do you think it is a good time to think about fda as an independent agency, given the complexity of the relationship between fda and hhs? you have written about fda from a management perspective. has your thinking had issues as a result of the past few years? scott: i think fda's manageable. if you ask me what the single biggest difference is between agencies are, it is the complexity and scope of the portfolio, which has grown enormously over a period of time. if you look at new authorities we have, i still think it is manageable with the right structure and the right team. i feel like we have managed the agency and been able to pay attention across the entire
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breath of the portfolio and make policy within every aspect of the agency. but, when you come into that position, you need to make a conscious effort to staff yourself in a way that you can maintain involvement with all of the agency. the first thing i did when i got there was to move the recording -- reporting of the senate directors to me directly. previously, they reported through deputy commissioners. having that direct contact with all them on a weekly basis was important. not only to maintain policy, but maintain a perspective on what is going on and help the senators solve that problem. as far as an independent agency, i will reserve my judgment for about two and a half weeks. then, i will opine on that. the agency, i think, the portfolio of the fda is so unique in many respects that it is hard for folks who have never worked there that don't work
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there to fully understand the breadth of the issues at fda. whether it is hhs or the white house. you are dealing with complex scientific regulatory matters. there is a very unique aspect to the work that fda does. >> hi, noelle callahan. i want to thank you for your leadership and for ending some nicotine testing experiment on monkeys and sending monkeys to sanctuaries. i am curious as to what motivated you to make those historic announcements? scott: what happened to the monkeys under our -- in our possession and our trust was tragic in that experiment. it was hard to justify what happened to the monkeys relative to what our expected gains were.
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we made the decision to shut it down and reserve capital to move them to a sanctuary. we paid for their safekeeping in that sanctuary. i think when animals are entrusted to our care, and when we are conducting experiments under our stewardship, or directing the conduct of experiments, it needs to be done with great care. there is an overwhelming public health purpose to the experimentation. we have looked for opportunities to use modern technologies to better predict toxicologies as a way to supplant the use of animals in studies. with respect to the dog study we are doing, what we are seeking to do there is provide a -- develop a model with how dogs metabolize drugs. if we could have a rigorous model that predicts the metabolism of drugs in dogs, we wouldn't need to use dogs in future studies.
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we can supplant that model for all future studies we might involve dogs and save literally hundreds, if not, thousands of dogs in future studies. that study in particular is taking great care to make sure there will not be a lot of intrusion. they are going to get blood drawn, that is it. they are going to be -- the circumstances of the studies themselves, i think we will provide good care. these dogs are in the hands of our center for veterinary medicine, they will put them up for adoption. there is a lot of work going on in fda. if we can get legal clearance, these dogs could be fully adopted by fda staff. there is a real desire. they are beagles. we have to make a legal determination of whether we can adopt federal property. we are going through that process right now. we are spending legal time on my question. i feel very good about that too.
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if we can develop what we hope to develop in that context, that can have a lasting legacy of reducing, if not, eliminating the need to subject dogs to experimentation in the future. >> i am a rare disease patient advocate. i wanted to ask you about the implementation of the 21st century cures act. if i had an existing fda approved medication that can be repurposed and so it needed approval for a new indication from the fda to be used on label, is there a difference between going through the grind now versus a couple of years ago? scott: i think so. there has been a lot of -- when it comes to rare diseases, there has been a lot of innovations that we have introduced for
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medical trials. we're looking at enriched trial designs. we are looking at non-placebo trials. part of what the money that we got in the 2019 budget that we asked congress for was $20 million to develop natural history models that we can use in lieu of placebo arms in rare disease trials. we have allocated a lot of resources. we have made that a real focus. we have propagated master protocols to make it easy to conduct studies and rare diseases where you could allow the same patient population. if you have a small patient population you don't have to , constantly re-create new protocols. you can have a master protocol. we have patients that are able to enroll in multiple clinical trials and test multiple different drugs in different clinical trial settings. there has been a lot of innovations in clinical trials. it has facilitated much more efficient processes. whether it will impact one specific disease or not is hard to judge.
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i think overall, it has had a tangible impact. it is evidenced by a record number of approvals. 59 novel drug approvals. a majority of which were targeted to rare diseases. >> paul blair, with americans for tax reform. you mentioned europe's standard of review. i want to talk what you said, the redeeming public health value, this connie gorey of -- this category of pods based products, talking about e-cigarettes, may have for smokers. it could be fully offset. given the fact that more than 35 million adults still smoke cigarettes. what is the regulatory standard for review at the fda, or beyond your tenure as commissioner for improving current products, or making determinations on how it
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will be approved moving forward? given the fact that there are still guidelines on how a manufacturer is supposed to keep a product on the market beyond 2021. thank you. scott: there is guidance for now. there will be additional guidance coming out shortly that will lay out more of the rules of the road. we have received pmta applications from sponsors. i think there is a demonstration where you can adjudicate the pmta process. i have said publicly before we , haven't received a single application from e-cigarette manufacturers. i don't know what they are waiting for it. i don't know why they are not further along on the pmta process. we are at the point of filing applications -- these products have been at the market for a long amount of time now. the fda is open for business and is giving feedback to a lot of sponsors. including some e-cigarette manufacturers around the
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application process. it is on them, the manufacturers, to file pmta applications. if they had gotten underway a couple of years ago, they would be finished by now. demonstrating that it is a modified risk. making a claim is a different standard and higher hurdle. the pmta standard could officially be met. i don't want to prejudge the outcome of this process, but could potentially be met by certain e-cigarettes that are marketed a certain way or flavored in a certain way where you can demonstrate that you will help certain smokers transition from tobacco. position them in a way you are not going to allow for initiation. there are ways to do that. with heightened age verification and other measures that some of these manufacturers could be taking. some are taking them, but some are not.
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>> hi, joe, we consult for the pharmaceutical and the consumer and health care industry. this is a question about nicotine and reynolds american on their noncombustible nicotine products. i want to ask a question about the comprehensive framework that i think has not gotten a lot of attention. that is the public's misperceptions about nicotine. still referenced in the webpage about the plan. two related questions. any comments about the public's misperceptions -- and does the fda have plans to address this? scott: this is a challenge because there is a perception that nicotine is what causes cancer by some people, and nicotine is a very harmful substance in and of itself. while nicotine is not a benign substance, it is not what causes the diseases associated with
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tobacco. it is the product of the combustion. we have been clear on that. we don't want to discourage currently addicted adult smokers transitioning to other nicotine delivery vehicles have nicotine's illegal substance will be the ones who enjoyed nicotine. they will be adults who enjoy nicotine and have potential value from it. we have been clear on that. we believe nicotine exists. what we did in that summer of 2017 announcement -- we wanted to put nicotine at the center of our regulatory efforts and talk about tobacco regulation as regulation of nicotine is existing among risks with the combustible products being most harmful. medicinal products being the least harmful. what i think changed our policymaking was the explosion in the use of nicotine by children.
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and, i think that the comments from the e-cigarette community have been overly dismissive of that risk. i think the positions they have taken have created an existential threat to the entire category. they have been insufficient in the terms of their earnestness and seriousness of the problem. their idea that kids are only using it on the weekends, so it is not a big deal. we are capturing an exploding epidemic right now. of course, the new users we are capturing, aren't going to use it every single day. when you look at the nature of any epidemic and the evolution of an epidemic, people become occasional users before before they become regular users. adele floyd epidemic -- the o pioid epidemic started with people becoming medically
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addicted to products they used recreationally. they started to snort pills and ingest pills and migrated to heroin. you're going to see occasional use by children before you see regular use. we have enough evidence to know that's going to happen. that is where our concerns have been raised around nicotine. it is not necessarily around nicotine with adults. we recognize it is not a completely benign substance, but certainly not what causes the death and diseases associated with tobacco use. >> i've got allison, with npr. >> you have made a big push to streamline of approval for and biosimilars. i have been hearing about the 12-year market exclusivity for
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products. do you think it is too long and should be reduced? scott: i have not looked at that question too closely in a while. i think that trying to define what the right period of time is for exclusivity and to increase or attract efficient investment to have the robust innovation that we have is a very difficult science. all i know is what i see. which is that we have very robust investment in the pharmaceutical sector. we are at a time of great opportunity in medical science. whatever we did, we did the right thing in terms of getting tremendous opportunity for patients. and so, we got a lot of things right. there is still problems of affordability with patients having difficult times accessing medicines. but i think a lot of the problems, the market failures are not related to the patent. over time, they have actually come down.
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outside of the context, you have a sort of guarantee of data exclusivity. patent terms have gone down. as you probably know, when you look at the biologics, most of the exclusivity goes beyond 12 years. 12 years is not the floor for a lot of those products. the ceiling is sort of a floor. but i think the challenges are, we don't always have the product competition that we expect. when we have the product competition we expect, we don't have the pricing mechanisms in the marketplace that allows that competition to actually deliver savings. in partly, you don't have a competitive system in the part b context. when you actually do have price competition, the discounts come in in the form of rebates that don't occur to the patient. those are the three failures. lack of product competition. we talk about that at fda.
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lack of competition with generic drugs. then, lack of price competition in certain areas of the market when you have multiple products that could be competing against each other. when you finally have product competition and price competition, the discounting of the back end rebates that don't benefit the consumer out of product medicine. those are the three failures. that is where i would focus my time. that is where i am focusing my time. >> i think we have time for one more. scott: how are you? >> want to grab the microphone? >> phyllis greenberg. we have worked for years together. you have been terrific on women's health issues. as you know, the director of the office retired in january and made her announcement in october. there is still a vacancy for the director. will you be able to -- in the time that you have left, pick someone to head that office?
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i am concerned about that. scott: i don't know in the next two weeks that we will be able to name a permanent director of that office. we have a very good leadership with the acting director who is there, who is outstanding, who came over from an of medical policy and was a reviewer -- she is a physician. i met with her about a week ago. she has a lot of interesting ideas in terms of what she wants to try to advance to promote women's health. she will work closely with amy abernathy and the commissioner deputy who is engaged in these issues. i feel very good about where that office is right now. the leadership of the office, obviously on an acting basis. the relationship of the office, and also under the guidance of the principal deputy commissioner. >> i am told we can do one more. >> the man in the back there.
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>> we were really pleased last october when you put out the rfi for sesame allergen and the potential for labeling it. i was just wondering, could you comment on the status of that possible regulatory action -- labeling it as the ninth major allergen? scott: without prejudging the outcome, i think we are concerned about both the incidence of allergies and the severities of the allergies with sesame. it certainly appears in the information that we have now that it meets this objective criteria of the h allergen. both in terms of the instance of it, and how severe some of the reactions are. i think that there are sufficient concern that the fda will continue to move forward with the process. it is obviously a rulemaking
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process. it will take some time to declare that a ninth allergen. i have been concerned about it. i had a lot of discussions with the center about it. we have obviously received a lot of input from patient groups. capitol hill, as well. i am confident that it will continue to go forward. i don't want to prejudge the outcome other than to say it seems to meet the threshold of where the eighth allergen sits. if not, in some respects, succeeded in terms of the severity. >> thank you. >> before you go, there is a demand on twitter for you to explain if there is any significance to your socks? [laughter] i don't recognize any complex molecules there. scott: there are skeletons. i liked them so i bought a bunch of pairs of them. >> skeletons? >> these were the socks, i was in the rose garden when they announced the drug pricing blueprints, and new york times took a picture and published it. on their editorial page. they objectified me.
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[laughter] >> please join me in thanking scott gottlieb. and, anna. [applause] if there are papers and coffee cups at your seat, it would be nice if you took them to the back of the room in the wastebaskets. [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit] [captions copyright national cable satellite corp. 2019] >> today democratic presidential candidate senator kiersten a campaignholds kickoff rally in front of trump international hotel in new york city. live coverage at 12:30 p.m. eastern on c-span, online and our free radio lab. democratic national committee
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chair, perez talks about campaign 2020, the emerging candidates, the party convention in milwaukee, the debates, and more. newsmakers, today, 6:00 p.m. eastern on c-span. congress returns to session this .eek speaker pelosi has announced terminatingse -- his national emergency declaration on border security. that vote is scheduled for tuesday. see it live here on c-span. when the senate is back in session on monday they will continue debate on judicial nominations. on tuesday senators will take up a resolution of support for the green new deal. when the senate is back in session live coverage on c-span 2. >> news agencies are reporting that attorney general william barr and deputy attorney general
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rod rosenstein are at the justice department reviewing the contents of the mueller report and working on a summary for congress that could be released later today. the mueller report was also the topic of sunday news programs and reaction first from the chairman of the house judiciary committee. >> we will try to negotiate and will try everything else first. if we have to we will issue subpoenas to get that information. >> you will take that although it to the supreme court if you have to? >> absolutely. we are hearing that the president may want to claim executive privilege on some of this. the fact is, he has no right on any evidence of wrongdoing. the was made very clear by decision of the supreme court in the nixon case where they ordered tapes revealed even though those tapes were personal
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conversations with the president and some of his advisers. executive privilege cannot be used to shield wrongdoing. >> how long are you going to give the justice department to turn it over? >> i can't give a specific answer. >> can you give a general -- >> it will not be months. >> you heard my interview with gerald nadler. he intends to keep investigating not only other issues but also to keep investigating collusion, obstruction of justice, all of the issues the special counsel was looking at. estimatesall we had all they have. they really don't have a policy agenda. it have an agenda against the president to win 2020. they think they can go into the judiciary committee and have a limited budget limited staff and go up against an investigation that lasted 22 months, unlimited power, unlimited subpoena power, and they think they can find something more than what they did, i think they are mistaken
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and the american people will see through that. >> i hope it's made public. bill barr says he's going to make as much public as he can in consultation with ron rosenstein and bob mueller and we will read the report. it's been an amazing 2.5 years and i think the american people appreciate that and i know the central charge of the special counsel investigation and there has been zero evidence of any type of collusion between the trump campaign manager russia to influence the election. people have done things wrong, they will be held accountable for that. that's the way it's supposed to work in this country but on the central issue, no evidence whatsoever. >> you told the san francisco chronicle is no bombshell there's no impeachment. does no new indictments qualify as no new bombshell? >> not necessarily. they can't indict the president. that's their policy. there could be overwhelming evidence on the issue and i don't know that that is the case
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but if there were overwhelming evidence of criminality on the president part congress would need to consider remedy if indictments were foreclosed. it is too early to make those judgments. we need to see the report and i think we will have a factual basis to discuss what this means for the american people. what steps this congress needs to take to protect the country. but in the absence of those facts those judgments are impossible to make. >> i think the mueller investigation went on too long and i think bob mueller made a mistake when he brought together the team of investigators and lawyers and selected so many partisan democrats who had been longtime democratic donors. i think that was unfortunate. by doing that it undermined the credibility and impartiality of the special counsel's office. --t being said
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>> would you go as far as the president has in calling it witchhunt? >> i will leave that language to the president. i will say i'm concerned that it may have become a fishing exposition. we will see what's in the report but i do think it is striking that at least the early indications are there are no further indictments which means that not a single person was indicted for colluding with the russians to influence the 2016 election. if that is right, that there are no indictments for collusion with the russians, that is good news for the american people. those were serious charges when they were raised and if the special counsel concluded there is not evidence that that occurred, that would be good news. >> canadian prime minister justin trudeau answers questions from members of the house of commons during his regular question punto session. members criticized the prime
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minister for his alleged role in a criminal investigation against canadian engineering company s and c lack:. also accused of pressuring his former justice minister to give the company a favorable deal. >> the honorable leader of the opposition. >> mr. speaker, canadians were shocked and appalled when the prime minister shot down the questions from the corruption scandal. serious questions remain unanswered and key players in this affair have yet to testify. my question is for the chair of the standard committee on ethics . can he inform this house


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