The Food and Drug Administration operates a complex apparatus to deal with everything from food labels to life-saving medical equipment. It’s been at the center of the federal pandemic response, trying to speed up medical testing and possible therapies without opening the market to every snake oil purveyor. For an assessment, Federal Drive with Tom Temin spoke to former FDA Commissioner Dr. Margaret Hamburg.
Tom Temin: Dr. Hamburg, good to have you back.
Dr. Hamburg: I’m delighted to be with you. Wish it was better circumstances though.
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Tom Temin: I wish it was, yes. And I guess there was no crisis quite of this nature during your six year tenure. But in general, how did you find, let’s start here, the communications apparatus. How efficient was it between FDA, other elements of HHS that you had to deal with, and maybe other elements of the government like FEMA.
Dr. Hamburg: Well, at the FDA, during my tenure, we had no crises like this one. I think this is a unique moment in time for most of us, unless you happened to live back in 1918 when the other great global pandemic, the so called Spanish flu, occurred. But we on a routine basis and during crises, did work very well with our counterparts in government as well as with other critical sectors and with other nations. By the very nature of the FDAs work, our broad scope cutting across food safety and nutrition issues, medical products, tobacco products, dietary supplements, animal food and feed, things that emit radiation, so many areas of responsibility for the FDA that it really required working together and having good communication. And that was even more so during a crisis. And certainly the comparables are are not really there in terms of my experience. But we did have, just as I started my tenure at the FDA, the threat of a global flu pandemic with H1N1 and had to mobilize very quickly and had to do that, you know, really, as the Obama administration was still standing up in terms of appointments and activities. And then later we had the Ebola outbreak in Western Africa that we responded to very aggressively and, of course, had some care and cases in this country. And then the Zika outbreak as well, so that gave me a flavor of what it must be like to head the FDA during this global pandemic. But it is, of course, very different.
Tom Temin: And also during those years, and I guess, culminating toward the end of the Obama administration, there was pretty much bipartisan support, if I recall correctly, for reforming some of the apparatus in the regulatory regime under which the FDA operated, and now we’ve got sort of an accelerated deceleration, if you will, of a lot of regulations and rules. What’s your assessment of what’s the right balance there? And do you think they’re following it at this point?
Dr. Hamburg: Well, when I was at the FDA, we worked very hard at trying to modernize and streamline the regulatory pathways at the agency to really speed promising new medical products to the people who needed them. And I think that that was important work that laid the groundwork for activities of the current administration, and especially in response to this crisis. But of course, there have been other issues that have emerged. Also, while I was FDA commissioner, one of the things I was concerned about was the fact that FDA now had to operate in a much more globalized world, the products that we regulated were coming in whole or in part from many other countries in the world and through complex supply chains, and that, you know, we really couldn’t monitor everything that was coming in for quality. And so we really needed to work with regulatory authorities around the world to help strengthen their capacity for oversight of products. We had to do more inspections overseas, and we really needed if we wanted to really deliver on the promise of science in terms of new products and also food safety and nutrition, work together to align our standards and approaches. And that work to be honest wasn’t as well attended to in subsequent years as I would have hoped. But I think that connection and spirit of coordination and collaboration with other regulatory authorities is very, very important. Now, as we’re responding to this global pandemic and trying to make sure that in this country and around the world we’re able to move as swiftly and effectively as possible to translate the incredible science that’s going on to develop new diagnostics, new drugs, new vaccines into real world products that will make a difference.
Tom Temin: And I think maybe the biggest case currently is the well, couple of things, there’s a coronavirus accelerated development program that has been launched by FDA to try to speed up development of therapies. And they also had a reform effort to speed up the approval of diagnostics and testing procedures such that they could bypass the usual rules and eventually report back to the FDA when time permitted because of the hurry here. Do you feel that some of that stripping away of what is normal regulation should stay off the vine once this is all past? Or how do you know how much to put back once things get back to normal, if they ever do?
Dr. Hamburg: Well, whether it’s a crisis or routine needs, no one is helped by innovation that isn’t actually studied, tested and proved. If a medical product a drug, a vaccine, a diagnostic doesn’t actually do what it’s intended to do, it doesn’t serve patients. So it is important to always have scientific rigor in the development of these new products and in the assessment approval and ultimately availability of these products. So even in a crisis when it sometimes feels because of the urgency of the problem and the desire to get something to people in in desperate need something that can help to abate this devastating disease, it sometimes feels like something must be better than nothing. But that actually isn’t the case for those patients who are sick. And for those patients who will follow, we really do need to do good science. And that’s why it’s important, even in a crisis, to be working together with industry and the product developers with the research community with other regulatory authorities, as I mentioned, and all of the elements of government to make sure that we’re standing up the studies that need to be done as quickly and innovative as possible so that we can get answers quickly. And I’ve seen that happen. When I was at the FDA during the Ebola outbreak and during Zika, we moved very quickly both to make diagnostics available and for each one and one as well, but also to put the studies in place so that we could end up with some products that we actually had evaluated fully and knew whether they worked or not. We actually now have a licensed Ebola vaccine, so I think it’s it is important in the emergency use authorization, criteria enable FDA to move more swiftly and move products out into use without the same elements of review that would occur under normal circumstances. But there always should be good science brought to that practice and and rigor in that as well.
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Tom Temin: So in other words, the statement, well you’ve got nothing to lose try this, is not really a great blanket statement to make about all of these possible cures that are out there.
Dr. Hamburg: No. That’s absolutely right, because drugs do have side effects. A drug can make you worse, even if you’re very sick. And using an unproven drug may actually prevent you from getting other therapies or medical interventions that might benefit you more. So we need to assess the relative risks and benefits as we make decisions for patients, for healthcare more broadly and for public health even as we are responding to a crisis and even as we are learning about those products and certainly a vaccine. You want to know that it’s gonna provide protection because it will give a false sense of security to people who are vaccinated. If the vaccine in fact doesn’t work. And also you’re giving vaccines to people who are already healthy. They’re concerned about possibly becoming infected but they are healthy. And so if it has safety risk, including the possibility of making your disease worse if you get infected, which has occurred with certain classes of vaccines in the past, that is not good for anyone.
Tom Temin: Alright, so looking at FDA and understanding that there’s a million variables really that they’ve been dealing with here simultaneously, would you venture a mild assessment of performance to date in the coronavirus?
Dr. Hamburg: Well, let me begin by saying that FDA is absolutely an extraordinary agency, unique in terms of its critical role in promoting and protecting the health of the American people and beyond and has some of the most outstanding professionals that I’ve ever worked with in my life. I know that they are stretched to near breaking at the moment in terms of all of the demands on them in terms of their expertise and juggling a million high priority issues all at the same time. And the truth is that FDA is always, I think, been underappreciated in terms of its critical and unique role and contributions and as a result, already starting from a position of being under resourced in terms of the dollars it needs and the people it needs to do its important work. So I, you know, just have such respect, and I applaud the work that they are doing. I do think that, you know, frankly, all of our government response has suffered from being slow to recognize the magnitude and urgency of this unfolding novel coronavirus outbreak. And because of not really having from the very beginning identified leadership at the top and response team and that represents all the critical components of government, really. A whole of government response with the clear strategy and a plan on understanding of who’s responsible for which components and activities and making sure that people are held accountable and also you need that kind of centralized leadership also make sure that other critical partners and stakeholders could be part of the process so that the business sector, for example, can have a way of connecting into the response so that we have a mechanism to make sure that were engaging with international partners adequately to make sure that the needs that are emerging at the state and local level are identified and the federal government, with all of its resources again, both people resources and expertise and also dollar resources, can help to ensure that we have an integrated, comprehensive, and effective response.
Tom Temin: And final question, you’ve had some subsequent experience in the CBRN field, chemical, biological, radiological and nuclear threats area. And this feels a little bit like that, doesn’t it?
Dr. Hamburg: Well, over the years, even though I come from a background in medicine, science and public health, I got very interested in issues of of terrorism, issues of conflict involving weapons of mass destruction and the link between naturally occurring pandemic threats such as the one that, sadly, we’re experiencing now, and one that could be triggered by the deliberate use of a biological agent to do harm, so called biological terrorism. And there are many, many parallels and I think that one of the things that this unfolding pandemic certainly demonstrates is that Mother Nature can be a pretty good terrorist. And it demonstrates that health is absolutely central, not only to our own health and well being in that of our communities, but also the health of our health care system, the health of our economy, the very fabric of our society, our national and international security, the ability of our economy to grow and thrive. And of course, it’s also critical to the trust of the public in critical institutions, including government and political leaders.
Tom Temin: Dr. Margaret Hamburg is former commissioner of the FDA. She’s now the foreign secretary at the National Academy of Medicine. Thanks so much for joining me.
Dr. Hamburg: Thank you for having me.