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Learning Curve

The FDA: Science in Action

Friday, June 5, 2020

On this episode of “Learning Curve”, Caputo sits down with FDA Commissioner Dr. Stephen Hahn to talk about the race to a vaccine, developing therapeutics, and why the FDA is “science in action.”

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Transcript

Michael Caputo:

Hello and welcome back to "Learning Curve," I'm Michael Caputo, Assistant Secretary of Public Affairs at the United States Department of Health and Human Services. Yes, even when I wake up in the morning I come to work I still pinch myself, I don't know how I got here, well I know how I got here. But it's really an honor to serve and one of the great honors of serving as Assistant Secretary of public affairs at Health and Human Services, as opposed to any of the other government departments; is you know you as a public affairs guy you know how to get people on the news you know how to write a press release. You might not know a lot about your client in this case my client is the United States Health Department. And the people who were you know upset about me getting this job said I don’t know anything about the American health system. It's true I didn't know a lot. I joke I say everything I learned about health care I learned from the Obamacare website.

And my doctor, but that's where I started and what's really a pleasure for me is that I get to learn from brilliant people, people who, who all of us sat on the edge of our couches and watched and waited for every word they would say as these coronavirus task force press conferences happened. I actually after the President called me and brought me in as Assistant Secretary here, I get to learn from those people on television that you see. And the one thing I always noticed is that I would meet people on television like you do and I didn't know exactly what they did but also they would bring up things that I wanted to know more about but the rest of the world moved on, the reporters moved on to the palace intrigue questions and things that really didn't matter to me and my family. My family wanted to know how to stay healthy during the coronavirus pandemic. My family wanted to learn about when my children were never going to go back to, if they ever do go back to school. My kids are 5 and 7 and 18. My 18 year old is graduating from high school this weekend in the Buffalo New York area.

And they're doing it in their cars. I had no idea why until I got here. And I got to learn from those brilliant people in the country and in many ways in the world and I'm going to bring each one of those people to you to talk to you. And I think it's important for you to understand that these people serve you, they serve you every single day. And, and you're, we are as a people as a country, really completely advantaged by this. And one person in particular I want to bring to you to introduce you to is Dr Stephen Hahn who is the commissioner of the Food and Drug Administration here, which is part of the Department of Health and Human Services. Thanks a lot for joining me Dr. Hahn.

Dr. SH:

Michael, thank you very much it's really a great pleasure to be here with you and congratulations on your position, it's well deserved.

MC:

Thank you so much, you know you have such an integral role in the response to the coronavirus. You know our country is never going to recover without a vaccine, without therapeutics. The world will never recover without vaccines and therapeutics, without cures. You know there's no way for us ever to go back to normal without them and that's, that's your bull's eye isn't it?

SH:

It's absolutely the bull's eye. So the agency, 18,000 strong scientists, doctors, nurses, pharmacists; this is the expertise this is what we do. Our client as you say, our patient if you will, because I'm a doctor is the American public, it's the American people and we're here to serve them night and day. We use science and we use data to make decisions about medical products, whether it's personal protective equipment, vaccines, drugs, biologics any of that is what we do in terms of serving the American people. And our job is to get innovation from the great American producers of medical products to come through the door to develop their medical products in a way that's safe and effective and then get them out to providers and patients.

MC:

And you kind of parachuted in here just like I did, didn't you? I mean you're not from Washington, you're not even I mean, you're a public health professional human doing it all your life you're from from Houston, Texas aren't you?

SH:

That's right. I was sworn in on December 17th and what a great honor to be the Commissioner of Food and Drugs. But I've been a cancer doctor all my career for 30 plus years, was Chief Medical executive in Houston. Really looked forward to this job because throughout my career I came to depend upon the FDA to make sure I had the right tools to take care my patients and I completely trust and did trust in the past the FDA. So dream job. You know and of course coming in

MC:

Dream job, nightmare scenario.

Stephen Hahn

Right, I was I was learning about FDA because one of the things you do when you start in a new organization is you want to learn. What does FDA do? How do they do it? What's the culture like? And then coronavirus came. So at the same time I'm learning, I had to lead the agency to move forward doing this unprecedented public health crisis.

MC:

I've, you know, of course none of us had ever seen anything like this, certainly not in our lifetimes and certainly not even probably in our parents' lifetimes.1917 was the last pandemic of this kind of size and scope. But you're actually surrounded by brilliant people in your agency. You see I met some of them like Dr. Peter Marks and others, who I just, I'm in awe of these people. How smart they are and how they apply it every single day for every single American citizen.

SH:

Unbelievable talent at the agency, as I said 18,000 strong but these people have expertise

that really serves the American people in an incredible way. Dr. Marks, Dr. Woodcock, Dr Cavazzoni, Dr. Shurin, really every day they come to work and they help us in our mission which is to prevent protect and promote the public health. And, and within, embedded within Food and Drug are experts on every imaginable product, every imaginable situation. I don't want to forget food right? We have a primary responsibility with respect to food safety and security and that group, again unbelievable expertise. So it's, I'm so fortunate to be surrounded by folks like that, they have really served the American people well during this during this epidemic.

MC:

I just met Dr. Woodcock too and she's actually involved in Operation Warp Speed which is the President's, cross governmental, public-private partnership organization that's, that's moving toward resolutely toward developing a vaccine, developing therapeutics, developing the diagnostics. Dr. Woodcock has been at the agency almost her entire career; the, the institutional memory that these people bring. I mean, what's interesting to me is, you know Dr. Marks for example, is completely absolutely kind of fanatically devoted to his regulatory role. To the point where, it, he eats lives and breathes it. You know how many of us, I mean I was never like that in anything I did. I guess my Army Drill Sergeant wished I was. But these people, I mean there, there, it's, it's their life.

Dr. Hahn:

7:26 It's striking the commitment at the agency to the public health mission is amazing and they will work night and day for it. And you bring up Dr. Marks and Dr. Woodcock, Dr. Woodcock's been there for thirty plus years. She is a perfect person to be involved in operation "warp speed" because she is probably the world's expert on drug development; something that we need right now. And she understands all of the aspects of that and brings the regulatory side. So the way I like to think about this, always thought about FDA was that NIH was about basic science, research, bringing things to the table, FDA is science in action.

MC:

Right.

SH:

There's a pragmatic component to that, there's a development component to that but there's also bringing that basic science in to help us develop medical products. Amazing place, these folks have remarkable experience

MC:

Tell us about the development of a vaccine, it's supposed to take a minimum of 12 to 18 months and the President, I remember when he called me, in Buffalo and asked me to take this job he was already talking about how the timeline just, not acceptable, business as usual, forget it with Donald Trump, right. What does, you know the people that are really concerned about this, obviously we need a vaccine, they're worried that hurrying it up is going to you know they're going to be foregoing safety precautions. That's not true is it?

SH:

That is not true. It is, the safety of a vaccine, because you're giving it to people who don't have the disease that's of primary importance. Of course the effectiveness is important as well. But I want to step back a minute because you're right. The President called on the agency and the President has his own sense of what time is, is needed. He recognized the importance of this, he acted early, really important on behalf of the American people. I don't think we would have done as well as we've done if he hadn't done that. In fact, I don't think, I know that's the case. And he asked us to eliminate red tape but he never asked us to cut corners on safety and effectiveness. So we've looked at ourselves very critically and will continue to do that. What can we do to lean in with producers to help them develop these products in the best way possible to get to the right answers? And so what I can promise American people is that we're looking very closely at this development pathway to expedite it. But we want to make sure that we get the answers regarding safety in particular, there to help us make the absolute best decision. Because I know people are scared, they're scared of the disease but they're also from a recent survey scared about the vaccine. Our job, our sacred responsibility to the American people is to make sure that we do the absolute best with respect to gathering the information that can show that, that a vaccine is safe.

MC:

And it's, it's also, the name operation Warp Speed I actually was asked to name the organization and and I came up with all these ideas like from you know Greek mythology and all the things you do when you're naming common naming companies and products all my career as a marketing professional. And I finally threw my hands up and I turn to Dr. Marks and I said, "so what do you call it you know when you were talking about you guys would talk about this for over a month what do you call it?" And he kind of like grinned and looked at the ground and said, "well you're just going to laugh. And I said come on, tell me and he says we call it operation Warp Speed," he said. Of course I do like Star Trek but not all scientists like to Star Trek Mr. Caputo. I said, "that's it, it's operation Warp Speed." But it's not about speeding up the safety precautions.

SH:

Right.

MC:

There's so much red tape and so many developmental overlaps and things and redundancies in the development of a vaccine, that you can eliminate, you can collapse those things and pay complete and absolute attention to safety and never forgo safety right?

SH:

Absolutely and I want to get too wonky here but I want to explain.

MC:

Do you like Star Trek?

SH:

I do, actually, So, so typically when you develop any therapeutic or a vaccine it's phase one which is safety. It's a small trial, get some information on safety and then you need to Phase 2 or you get more safety data then you just really big Phase 3 trial and it's sequential one after the other. It takes years. If you can start off with a big enough safety trial to get that preliminary information or that really robust information early you can follow those people for months before you get to the Phase 3 trial. You already have a pretty big robust safety profile. And that allows you to make decisions more quickly on the back end. And so what we're all thinking here is that if this works during the pandemic, this is going to work in the future. This is our pathway moving forward to expedite medical product development. And so,

MC:

I didn't even think about that

SH:

We're not just looking at Covid-19, we're looking at, let's, let's make this a permanent change at the

FDA. if in fact we can show that it works and I'm confident we can. But we can't,

MC:

That's a huge cultural shift.

SH:

It's a huge cultural shift and guess what, our team is there. Because we have no interest at FDA at blocking innovation in medical product development. We want that for the American people and there's so much great science and research and medicine in this country that just needs to get out there for the people.

MC:

The issue we have here, I think, I really wonder is it true that you're either going to get the virus or you're going to get the vaccine?

SH:

No, I don't think that that's true. I mean there is this concept of herd immunity which you know if we vaccinated enough people we could get to the point

MC:

So describe herd immunity, I've heard 90 percent, I've heard 70 percent, it's like

SH:

Yeah I don't think the numbers as important as the concept, which is that, we could have for example, allow the virus to spread. You have enough people who develop immunity, that's the concept of herd immunity. And

MC:

And pre-vaccines and pre-therapeutics that's how the human race dealt with it.

SH:

Exactly, because what happens is enough people are immune, that the virus sort of dies out and you know you had that immunity from the largest group of people. Now the problem with that concept is that our most vulnerable were those that had underlying illnesses cancer etc as well as the elderly, And so one of the risks associated with that is causing increased death in those groups so we had to really carefully consider that. But with the vaccine, you can give a vaccine to a large number of people, 70 percent immunity you're getting pretty darn close to herd immunity. Or you can target those who are the most vulnerable who need it the most because they're the most at risk for the disease. So these are things are going to have to think about moving forward.

MC:

So we were not allowed to talk about Operation Warp Speed details. In fact, it's kind of interesting you know that the White House you know listening to your people and others from HHS and the Department of Defense stood this organization up, operation Warp Speed and they said, 'OK, do a little bit of press at the beginning and then lock the door' because we don't want people chatting with reporters we want people looking at you know scientific data and developing a vaccine. The reporters hate that, I can tell you, they call me constantly and say 'I really want to interview this person that person.' But you know anybody who has the operation Warp Speed business card which by the way if there's not enough time for them to get business cards by the time the ink dries we're gonna have a vaccine.

SH: Right.

MC: These people are all from different government organizations we have Dr. Moncef Slaoui who comes from the outside, but General Gustave Perna who is in charge of logistics here, straight out of central casting both of those guys.

SH:

They are, all-star team

MC:

Absolutely. But you're, you're kind of in and out of it, you come in for the important points where they need your advice and counsel but you actually get to see, you're frontward facing on this,you get to see them at work, what's it like?

SH:

Well first off, All-Star team, really great and you're right they are out of central casting but they are all focused on getting the job done. There's a goal the President has given us on behalf of the American people, laser focused on that goal, getting rid of the obstacles. It's science, right? And ultimately the science will win out here and well will either meet that goal or we won't; I'm confident that we will. But I see the team in action, I see the discussions and I see that they're approaching this in the right way and they're doing the right things to position us to win. And I'm really enthusiastic about it. Now, one thing it be careful about is that we're Regulators, we have to make an independent decision so we're not involved, I, Peter aren't involved in the decision making but we are providing the technical assistance because what you don't want are studies to be designed that don't answer the questions that we need to actually answer the questions about is it safe in effective?

MC:

What actually happens in the industry right? They'll come to you, an independent company will come to you with a product or a or a therapeutic or something and they will not have addressed some questions beforehand they've got to go back out,

SH:

That's right.

MC:

And then they come back and it's the timeline, slack.

SH:

It's the timeline issue that's right, which is why we really encourage people to come in early and do pre-submission discussions so we can just lay it out for them and provide as much transparency as possible.

MC:

So those pre-submission discussions are what's going on at operation Warp Speed?

SH:

Absolutely and they're happening across the industry as well and all the medical products. Think about this, this is just a great story that needs to be told. So we worried that we would have a shortage of ventilators. We didn't, the President made sure we had enough for the states but all these great new manufacturers of very novel ventilated technology called us. We said 'OK, we'll work with you.' I remember receiving a call from a company in the Northeast; literally within a month from concept to start production they were sort of in our door in a rolling way, 'hey we have this concept.' That just shows you that with the right in engagement and with the right innovation which we have in this country we can do anything.

MC:

We can and our FDA, people complain about regulators, etc. and especially people on the conservative side, where I sit. But it's because of the FDA that we have one of the most robust you know pharma industries in the world isn't it?

SH:

It is, and you know what we one thing we don't want to do is create a situation where we reduce competition, where we reduce innovation. We need to make sure that we reduce the barriers and the President is, has been way out in front of this topic. And it was one of the 3 things that I wanted to do at the FDA is do everything possible to stimulate innovation and bring medical products safely and effectively in a quality way and as quickly as possible. And I, Covid-19, none of us wanted it to happen but it's really accelerated that process at the agency.

MC:

So even though it was something that snuck up on you, snuck up on all of us, right, and it wasn't something that was like you know you talked about or were asked about in your hearings, coronavirus and some ways is it providing medical data, medical information that is advancing the technologies.

SH:

That's exactly right. I mean if we come out of this with 5 new ventilators, with amazing new technology that can be simply, easily, relatively inexpensively made. I mean nobody wanted it to happen but we need to be able to turn positive things out of this for the country.

MC:

What were you looking forward to the most when you decided you would go ahead and you know, stand up for a Senate hearing on becoming the new head of the FDA? What was, what really attracted, you were sitting pretty comfortable in Houston, let's face it comparatively Washington is no fun.

SH:

Right.

MC:

It isn't, you know that you're like that you know like Mr. Smith comes to Washington.

SH:

(laughs) I have to tell you you're right about Washington D.C. in general. The, the thing that I was looking forward to was working with these incredible professionals. I had interacted as a cancer researcher in clinical trials for years with the FDA. I knew of the expertise and just to be able to jump in there and help with this. I laid out 3 priorities for the agency which still exist today, one is reducing barriers to innovation. Number 2, updating and modernizing data and real world evidence so that we can get to answers more quickly and in a robust way. And the 3rd one is incorporating the patient voice, hearing from the patient. What's important to the American consumer and the American patient? And every one of those priorities became really important in Covid-19. So we're going to push forward on all of those but every one of them

MC:

Now it's on steroids

SH:

Now it's on steroids and the agency has been so great about responding to those things.

MC:

I'm actually stunned at how, how they responded, not just the FDA but all the regulatory agencies who just basically said, 'OK, we're all in this together', it's a mission lockstep everybody's moving and they're not cutting corners they're just working harder.

SH:

Yeah rolling up your sleeves and I think we talk about America back to work. At the agency we've coined it 'come back to the offices' because we've been working pretty much around the clock since this started and actually right now you know we want our groups to be able to take a little bit of time for themselves so that we can be prepared for the Summer and the Fall should there be an acceleration of the work we need to do. But no relaxing, on the going forward with reducing barriers to innovation none whatsoever.

MC:

So we see people protesting now, not wearing masks or wearing masks and taking them off. We see the summer starting to unfold people are going to be exposed more, some people are going to do it smart some people are going to not going to be so smart about it. There's a lot more exposure to each other now, now that people are coming out for good or for bad. Do you think we're going to see a recurrence or a spike in the virus in the Fall? I mean we all know that flu comes back when it gets cold right? Are we going to see it and how would we deal with it what's the FDA's role in it if it happens?

SH:

So Michael one thing I learned as a physician, as a cancer physician I have no crystal ball. I don't , I admit my imperfection,

MC:

We're not on your crystal ball, doctor.

SH:

Thank you, I think we have to prepare for the possibility that it will come back and you're absolutely right, you know we people are outside now but there's a lot of sun and you know sun kills this virus we know this, UV light does, the warm weather probably suppresses it as well. People are outside, there's more social distancing. I do worry about the protests in the lack of masks that concerns me. But I think what we've seen so far with the opening is really positive. We've seen no relationship in the data so far between opening and outbreaks. Now we see, so, so

MC:

Is that true? There's nothing?

SH:

That's true. I mean you know we review the data at the White House task force and there is not a relationship there that we can discern. And so, so I guess my point about that is that I think there is a possibility it'll come back in the Fall. What FDA is doing to be prepared is looking at the issues that I just discussed.

MC:

Right.

SH:

What are we going to keep that's permanent in terms of reducing barriers? What is our decision making look like particularly around this concept of emergency use authorization? Because that's our vehicle for making decisions quickly and then how are we going to spin that into permanent approvals of these products? How do we lay the groundwork and most importantly for a regulator is how are we going to be transparent and how are we going to engage the developers? We're not their enemy, we're totally aligned with all the developers and getting something that's safe and effective out, they want the same thing but how do we get there together and how do we make sure that we're really transparent about it? We're laser focused on this, what do we learn from the last 2 months?

MC:

And it's going to, the learning is just going to continue

SH:

Continue.

MC:

Absolutely. I have to ask you, I'm a big live music fan and there are a lot of sports fans out there. You know, I've seen the Grateful Dead so many times I'm ashamed to say it on the air, actually not ashamed just a little worried. When am I going to be able to go see a Grateful Dead show again? When are people going to be able to go see the Mets play or let's say the Astros.

SH:

The Astros. Well my favorite football team the 49ers, I love the Eagles as well but yeah I've said on the radio the other day that it's a real problem for us if we don't have NFL football in the Fall. I know that's not the same as lives but there is a there is a part of all of us whether it's music or sports or concerts you know we need that and as a free people we want that. I'm hopeful that we'll see that toward the end of summer.

MC:

So what does it mean, masks?

SH:

It means masks

MC:

Does it mean taking people's temperatures on their way in to see if they have a fever it?

SH:

It may mean all of those things. I think, Michael, one thing we learn from this it's really important and the press is impatient about this

MC:

They truly are.

SH:

But the American people understand it and that is, we're learning as we're going. The American people don't want us to just stay with one strategy and don't change it based upon more information. They want us to learn as we go and then adapt, that's what we're going to do as we open up we're going to learn more about what works and doesn't and I think we're learning some good lessons now that's positive. And then that's going to allow us to make the recommendations moving forward. Camps, colleges, sporting events, concerts etc. So I'm hopeful it won't be the same, won't be the same because of this and one last point about this. If there's one thing that we can do no matter how we open up and what we do and that is protecting our most vulnerable. So you may be safe when you go out whether you wear a mask or not you may be safe whether you catch it or not because of your age, whatever. But when you go home to Grandmom we need to you need to wear a mask because you don't you need to make sure you're not giving it even if you're asymptomatic to her.

MC:

Right.

SH:

Or to Grandad, and so that, that's what really got to focus on, our primary responsibility is to protect others.

MC:

And protecting others, will those elderly people be the 1st to get the vaccine?

SH:

Well, so,

MC:

Among the 1st

SH:

That's worth thinking about. The vulnerable should be the 1st to receive the vaccine now it all depends on the safety profile and the effectiveness of the vaccine but you're thinking about it exactly the right way. That's the public health priority for opening, that should be the public health priority for vaccination and therapeutics.

MC: SH:

What were, what's your favorite part about your job right now, what's the most memorable thing that you have every day in your life? I mean you go to the White House every day. Have you ever been to the White House before you took this job.

SH:

As a kid when I toured, you know once, once.

MC:

Just so you know everybody if you taken a tour of the White House as a kid you may, too also be the FDA Commissioner, go to the White House every day.

SH:

That's funny. I have a couple of favorite things. One is when I get to talk about science and when I get to talk about the regulatory interface with science and really helping develop products within the agency and I talk to a great Center Directors, love that. When I have the conversations at the White House task force with the Vice President and the doctors on the task force and others, love that, because we're really looking at data trying to figure out what's best for the American people. And then I absolutely love interacting with the President. President is smart, he's got incredible intuition, he asks really good questions and yes, he's demanding as the Commander- In-Chief should be.

So those are my favorite parts

MC:

But he listens, right?

SH:

Oh my gosh.

MC:

I've known him for some years, he listens.

SH:

He asks questions and he incorporates what you say and I've said this in multiple press settings there's no question about that. And I remember when he asked me to speak on the podium about you know therapeutics and I got up there I'm thinking, I'm a cancer doctor I can speak to this issue and that was like hey, can see we're talking about a possible treatment but we're talking about providing hope but we don't want to provide false hope. And I think the President embraced that, the President really understood that and I give him a ton of credit.

MC:

Now he's got, he surrounded by doctors. I mean he's surrounded like you, there's doctor Fauci, doctor Birx, doctor Redfield, the doctors the list of doctors goes on and on and on. I's got to be like a battle of ideas in that task force. How invigorating is that?

SH:

It's incredibly invigorating, because you know what, in medicine really good doctors get together and talk about things and they know that they by themselves don't have all the answers. And so to be able to sit down with doctors Birx, Fauci, Redfield etcetera to actually have these conversations and really incorporate information from other people it gets you to the right place.

MC:

It does.

SH:

It does.

MC:

It does, and the President takes his own counsel in the end

SH:

He does as well he should

MC:

As he should and he forms that by listening to some of the most brilliant people on the planet. I mean to me it's, the American people need to understand I really believe this Doc, I really do. I know you and the rest of your colleagues you're going to solve this pandemic. I'm, I mean, I was optimistic when I got here I was a little cynical when I was sitting on the couch at home like everybody else locked in my house but I got optimistic within a couple of days when I got here. Now I'm 100 percent certain, completely certain because I know all you guys now and I know that you're single minded about you're going to solve that. I know the President's going to fix the economy, I know, you know

I know Larry Kudlow for 30 plus years. I know these people are going to fix it, they know what's up they know everything about the President created the strongest economy in history in the United States, certainly in modern times, he will do it again. But who is going to solve the despair that comes from this? I mean villages are falling apart, people, I know two families that are close to me in the last week their sons committed suicide. And I'm convinced it that has something to do with being locked in the house too long. My daughter is graduating on Saturday from high school and they're all in mourning because of a kid, that last weekend just couldn't take it anymore whatever he was suffering.

Who's going to fix the despair?

SH:

You know what we're going to see, first of all we're gonna have great leadership from the President and the Administration, but we're going to see the American people. You can see this across the country in the American people always do this they always rise to the occasion. This is who we are and what we're about and what folks are telling us is, it's time to move on. Let's figure out the smart way of doing this, we're already seeing it. And it's going to be figured out with great support from the scientists and doctors but by the American people and we're going to get to the point where, where we're going to be able to be out there and do it safely. So I have complete confidence that that's the case and it is tragic Michael, I mean it breaks my heart to be honest with you. And there has been a cost to what we've done, and I'm not talking economically really, I mean although it is,

MC:

The secretary talks about health versus health there are so many health problems that are created by the solution.

SH:

That's exactly right and so we don't look at that side of the equation very often and thanks to the Secretary we're hearing more and more about that and I echo that. You know depression, suicide overdoses, I mean all the sort of tragedies of human life are just accentuated by you know the isolation that we're all feeling. We have to find a way to open up safely, we are finding a way to open up safely and we're seeing that across the country and I think the data supporting that, we've got to get beyond this current period. What happened in Minneapolis was tragic, but we must get beyond this and we cannot put our most vulnerable at risk. And I know we'll do it, 100 percent confident in that.

MC:

I agree because I know you and I know others. Dr Stephen Hahn who is the commissioner of the FDA, the Food and Drug Administration, one last question. What do you miss the most about Houston?

SH:

I miss my patients, I miss my colleagues and I miss my friends. Texas is a great state. I have. it's home now. And I miss it very much and I know one day I'll get back.

MC:

You will and they always say if you want to friend in Washington buy a dog. It's the truth but the great thing is we all have Zoom right. You can always go home, just for a minute. Dr Stephen Hahn of the Food and Drug Administration thanks a lot for talking for a little while here on Learning Curve. I'm Michel Caputo, Assistant Secretary of Public Affairs that's a long way around the barn of saying I'm the guy that talks the most at Health and Human Services thanks for listening we'll catch you next week here on Learning Curve.