CareTalk Podcast – Who Will Lead the FDA?

The FDA has been without a permanent leader for 8 months and counting. In this episode, John and David nominate the candidates they’d like to see fill the seat.

David Williams:

Welcome to CareTalk, America’s home for incisive debate about healthcare business and policy. I’m David Williams, president of Health Business Group.

John Driscoll:

And I’m John Driscoll, the CEO of CareCentrix. David, what questions do we have to answer this week for our audience?

David Williams:

Well, John, this is a funny one because you’d think that the FDA, the Food and Drug Administration, would have a leader at this point but it’s eight plus months into the Biden presidency, but nobody has been nominated to run the Food and Drug Administration. What do you think of that?

John Driscoll:

You’re picking on Biden unnecessarily. I mean, come on, they only regulate all of food, all of drugs, all of devices, and it’s not like we’re in the middle of like a massive pandemic or anything. I mean, the whole approval of drugs and therapeutics, everything to do with this pandemic, runs through the FDA, the Food and Drug Administration, as does our food supply, which has been stressed at a lot of different levels. Yeah, no, it’s a little bit of a surprise, but whether you’re talking about therapeutics, the drugs, the monoclonal antibodies and others that can help people who get sick get better fast, the vaccines themselves, the devices that deliver the vaccines — oh yeah — and testing. The testing that we’re not doing, that we didn’t approve, that the CDC bungled, all of those tests also run through the FDA, let alone all of these incredibly important, really truly life changing oncology drugs, the new biologics, CRISPR, tobacco. I mean, just the remit of the Food and Drug Administration is huge. No, it’s really odd that they don’t have a leader.

David Williams:

You know, John, as you’re saying all the things that are regulated by the FDA, it’s something like $3 trillion worth of the economy, it’s like- it’s.

John Driscoll:

Oh, I think it’s more. I think it’s more. It’s all food, all drugs, all devices, and it’s going to grow.

David Williams:

Well, I’m just quoting from them, but that’s fine. But their budget is only $6 billion, it’s actually less than 1% of the budget of the defense department, and interestingly, just over half of it is funded by the federal government, but 45% or so is actually paid by industry user fees. So it’s very different, I mean, imagine if the-

John Driscoll:

If defense contractors had to pay to subsidize the staff at the Pentagon I [crosstalk 00:02:29] they’d be very happy to do that.

David Williams:

I wasn’t going to go that way, John, but yeah, so it’s an interesting budget.

John Driscoll:

But think about it, David, that actually does make some sense. I mean, tobacco, which we know harms kids and adults and everyone, but is a personal choice. There should be user fees for those costs that they create to regulate it in a safer way. The device companies, the J&Js and the large manufacturers, are making a lot of money off of these medical devices once they get into the market, to have to pay some element of an access fee to support the really critical research for safety and efficacy that the FDA does across all medical devices, makes a ton of sense. I think that this massive industry, certainly with their massive margins, has the ability to invest a little bit and support the appropriate regulation and management of their development process. I mean, I don’t think you should be sticking the average taxpayer with those costs when the different companies are the winners. I mean, where are you going with that one?

David Williams:

John, it’s about $10 per person that the FDA costs us, not very much. I think that the background on the funding is that it was put in place so that the FDA would be able to hire more reviewers that would speed up the reviews. I think it’s neither here nor there on that one, but why is it that the FDA doesn’t have a head? They’ve got actually an acting Commissioner, Janet Woodcock, who’s been at FDA for a long time and a lot of people thought that she was going to be the nominee, but that’s not happening.

John Driscoll:

Well, I think the most important thing, David, is not to focus on the personnel, it’s really to realize that this is effectively war time, from a pandemic perspective, and we’ve got a critical general that’s not clearly in charge. And anyone who’s acting, Janet Woodcock a long time FDA executive, she’s very highly regarded. There’s clearly some ambiguity about whether she’s going to get the job, because otherwise you’d logically nominate her, but it’s not like we don’t have other candidates, but that job is a critical one and I think there should be more public pressure to actually fill that job. I mean, one of the things that the United States government doesn’t do well is provide quick and easy access to approvals for anything other than the absolute top jobs. And I don’t know whether it’s the politics of the White House or the politics in the Senate, but for whatever reason, we don’t even have an announced nominee, and again, we’re in the middle of war, a public health war, and we need that seat filled.

David Williams:

John, let’s give one tangible and [inaudible 00:05:30] example of why you need somebody running the FDA right now. So on this topic of vaccine boosters, there’s a lot of confusion and different opinions within the government. Typically, FDA would be really leading the way on that, but instead, you’ve got the CDC and the NIH stepping into that. NIH knows more about the basic science, but they don’t know as much about drug development, but because Tony Fauci is there, NIH has been prominent. CDC does the public health side of things, and FDA would usually be more prominent here and with an acting person, you can’t do it as well. And in fact, two of the leaders in the vaccines role are actually retiring from FDA because I think they feel they’re being pushed around by the White House. So this is a challenge and it’s partly of the White House’s own making.

John Driscoll:

You get really into this beltway back-and-forth, and who cares about what, and this agreement … As we go through COVID, there will be more and more information and I think the healthy debate about who gets a booster and when, what data is used, I actually think that the White House pushing the FDA or the CDC, the CDC pushing back, is actually a healthy sign of a democracy of not just the will of the people, but of an open reflection of ideas and data, so that we get the public health decision. I don’t blame the acting for the back-and-forth on that decision, and I think people make retirement decisions for any number of reasons, but there’s no question that we need a clear head of the FDA in place as soon as possible because there’s an entire organization of, I don’t know how … How many people work in the FDA now?

David Williams:

18,000, John.

John Driscoll:

18,000. And they cover so many different areas. There’s really important stuff going on with CRISPR, and oncology research, cancer research, regulatory decisions on e-cigarettes that are coming right now, and without a leader, you can’t organize that group to make a clear decision. The back-and-forth on the boosters, I think we have to give some room for the scientists to disagree, to disagree about the data and argue it out so that we have some transparency around decisions, not have some sort of faux oracle, like you, telling people what the decision is and not explaining the process-

David Williams:

The [faux-racle 00:08:01], John.

John Driscoll:

… and the process is, by nature, going to have some back-and-forth, but that’s separate and above the question that this is a critical part of government. It has been since the passing of the bill in 1906. I mean, we-

David Williams:

You remember it well, John.

John Driscoll:

It was a great year, I miss Teddy Roosevelt. But the beginning of the Republican progressive movement, which showed that government could be a partner to industry, regulate it, and keep food and drugs safe, it’s one of the foundational reasons why our drugs and devices are some of the most successful and broadly used in the work world. And to not have a leader of that, it’s not just going to be a political problem about who gets appointed and what decision- It changes the speed and effectiveness of government to partner with healthcare, the healthcare industry, frankly, to drive and manage innovation in a way that’s in the best interest of the American public. It’s embarrassing, honestly, that a president that really wants to reinforce the fact that government can work, has not made a final appointment in a part of the government that really does work pretty effectively.

David Williams:

So John, it’s really important for all the people that are career officials at FDA and scientists there to have strong leadership, it’s important for morale. I know you hate the inside the beltway stuff, but I actually grew up inside the beltway, as you know, and the son of the FDA Commissioner at the time, Frank Young, was actually the co-captain of the wrestling team with my brother. And we saw actually a lot of tension between people who were working with-

John Driscoll:

This is way off piece, where are we going here?

David Williams:

So the thing is, there was tension between the politically appointed leadership of FDA and other government agencies under Reagan administration and certainly now, with the people that were the career folks, and we saw that in our high school is my point. So I think we need actually a strong leader because the government employees are really being beaten down. Everybody forgot, I guess, the government shutdown that was needlessly caused during the Trump administration, I think there may be another one that’s coming, and we need somebody that’s going to be strong. So John, you do a lot of criticism of me here and you say they need a strong leader, so clearly you’re not nominating me for the FDA, and if nominated, I would not serve in any case, just to make that clear, but who do you have in mind?

John Driscoll:

Well, let’s come up with our own short list. Vivek Murphy, the current Surgeon General, has deep experience as a clinician and he was the Surgeon General in the prior administration. You could immediately probably put him in and appoint him, he’s got obviously the support of the White House. He’d clearly have the White House’s support and having the White House’s support would be great. Another logical one would be Scott Gottlieb, who’s got a great book out on the pandemic and what we should do differently. He was a Trump appointee, it would be very hard for the Republicans to oppose him. And again, I think you could ask for any of these people, Peggy Hamburg, Margaret Hamburg, who served on the Obama administration, well regarded both sides of the aisle. Great bench scientist, who’s involved in HIV research, would work well probably with Dr. Fauci, Who’s deeply involved there. I think any of those three, someone who’s in Washington in place, someone who might be able to be convinced to return to Washington, in the case of Dr. Scott Gottlieb, or probably still lives in Washington, Dr. Peggy Hamburg.

John Driscoll:

Any of them would be great, but I think what you want is someone who has experience in the job, is a noted clinical leader, and can immediately not learn on the job. We are, again, at war, it’s a public health war, and we need a leader who is not going to have to figure out their way to the bathroom for the first six months of the job, but has experience in DC, has deep clinical background, and has the respect of not just clinical side, but the political side. Because I think that ultimately solving this pandemic and coming up with public health solutions is going to be as much of a political solution, to align the different voices around a sensible public health policy, as it is a clinical job. So I would go to the usual suspects, the people who’ve done the job, or the people who are already in the mix, in Washington in a senior leadership position.

David Williams:

John, I know we’re supposed to disagree on the show, I more or less agree with you. I’ll add one more name to the list, Joshua Sharfstein, who was the deputy previously at FDA, and now he’s in Maryland as the Head of the Health and Human Services there. So that would be another one that could be good, assuming you’re not available, John, because I know you’re too modest for the role.

John Driscoll:

Josh would not be-

David Williams:

John, you worked at FDA. You did. Weren’t you like an intern there? Like a coffee boy?

John Driscoll:

I was an entrepreneur in residence for the Obama administration helping advise on some new innovation tracks for the Device Bureau. And my brief experience with the FDA as a part-time appointee during the Obama administration just gave me a sense of the absolute pristine clinical and analytical talents of that department, but every department needs to be led and I just hope they can pick- You can even nominate somebody else, David, if you’d like, but Josh Sharfstein would be great because he’s very involved in the public health response in Maryland, which has actually done a pretty good job, and again, having been the deputy in the FDA, would actually know the complexity and the breadth and the reach of this incredible department.

David Williams:

All right, John, well, I’ll say in closing here, let’s hope that FDA gets a permanent commissioner appointed soon, nominated soon, and that actually the government does not shut down and is able to continue along because clearly we need the government to do its job if we are going to try to keep the pandemic … Under control? Bring it down? Manage it? I don’t know.

John Driscoll:

And if the White House Office of Personnel needs ideas for nominations, they should call you, David.

David Williams:

Okay, I’ll let them know. I’m not sure I want my phone number publicized, it’d be ringing off the hook, so to speak. In any case, this is David Williams, President of Health Business Group, unlisted phone number.

John Driscoll:

And I’m John Driscoll, the CEO CareCentrix. Thanks for listening, and please subscribe.