{"id":11906,"date":"2025-05-07T18:00:00","date_gmt":"2025-05-07T22:00:00","guid":{"rendered":"https:\/\/cov19longhaulfoundation.org\/?p=11906"},"modified":"2025-05-07T08:12:45","modified_gmt":"2025-05-07T12:12:45","slug":"conversation-with-fda-commissioner-dr-marty-makary","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=11906","title":{"rendered":"Conversation with FDA Commissioner Dr. Marty Makary."},"content":{"rendered":"\n

In our wide-ranging Q&A, Dr. Makary outlines his vision, addresses low morale, asserts his independence, explains his stance on Novavax, and says “no” to an agency reorganization.<\/a><\/h3>\n\n\n\n

<\/a>Jeremy Faust, MD<\/p>\n\n\n\n

Over the weekend, I reached out to FDA Commissioner Dr. Marty Makary to get comments for an Inside Medicine article in which current and former FDA staffers describe some concerns about recent events at the agency. That piece will be published soon. Dr. Makary\u2014who preceded me as editor-in-chief of MedPage Today\u2014kindly agreed to an exclusive conversation (which took place via two phone calls and follow-up emails) to address the issues raised and related topics, to provide his impressions of the early days of his tenure, and to share his vision for the agency. Some of his comments will appear in the second piece, but the entirety of Dr. Makary\u2019s on-the-record remarks appear below.<\/em><\/p>\n\n\n\n

Among other things, Dr. Makary breaks some news here by stating, for the first time, that there will be no significant reorganization at the FDA, like those proposed<\/a> for other HHS agencies.<\/em><\/p>\n\n\n\n

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JF: How were your first few weeks as FDA commissioner?<\/strong><\/p>\n\n\n\n

MM: I had a lot of emotions doing my last operation at Hopkins the day before my Senate confirmation hearing, but I\u2019m glad I\u2019m here. The agency has many challenges ahead. We need to ask big questions, such as: Why does it take over 10 years for a new medication to come to market? Why is medical AI held up in old regulatory processes? Why are foreign drug manufacturers held to a much lower inspection standard than U.S. facilities? And why have we ignored ultra-processed foods, and thousands of chemicals in the U.S. food supply that are banned in Europe?<\/p>\n\n\n\n

My belief is that the FDA can modernize if we challenge deeply held assumptions and traditional ways of doing things. To do so, we have to uphold two fundamental guiding principles\u2014gold standard science and common sense.<\/p>\n\n\n\n

JF: Is there one thing that you didn\u2019t expect about the job that surprised you?<\/strong><\/p>\n\n\n\n

MM: Ha, well, working within the government is interesting, for sure. I didn\u2019t expect to learn that one guy was changing the ink cartridge on the fax machine each day. I think healthcare is single-handedly keeping the fax machine industry alive. There are also warehouses of paper files that have not been digitized. There is tons of opportunity to modernize\u2014something many Americans want.<\/p>\n\n\n\n

JF: What would you like people to understand about your goals and agenda?<\/strong><\/p>\n\n\n\n

MM: Things that I believe most Americans find sensible\u2014reducing animal testing, advancing AI, removing industry members from FDA advisory committees, and taking action to remove synthetic dyes from our food supply. In my opinion, the FDA should partner with industry and make the approval process more user-friendly, efficient, and faster, but the scientific review process needs to be independent of industry. It\u2019s one step towards rebuilding public trust. Last week, we also took action to remove eight petroleum-based food dyes from the U.S. food supply. I expect more announcements in the coming weeks.<\/p>\n\n\n\n

When people ask me \u201cwhat\u2019s my agenda,\u201d I tell them I\u2019m focused on cures and meaningful treatments, healthier food for children, facilitating innovation, and promoting public safety. There is literally nothing political about any of these priorities. I have tremendous confidence in the many scientists, inspectors, and staff at the FDA to help accomplish these goals and am excited to work with them. My goal is to get to know as many of them as I can.<\/p>\n\n\n\n

JF: I\u2019m hearing that morale is low in the rank and file and it seems widespread. What is your message?<\/strong><\/p>\n\n\n\n

MM: There are many past and present narratives, some with political spin. The only narrative that is definitely not true is that morale was great before. Over many years, the different centers at the FDA became siloed fiefdoms that sparred with each other and duplicated resources. What also killed morale three years ago was when the FDA\u2019s two most respected vaccine scientists, Drs. Gruber and Krause left the agency over disagreements with leadership over vaccine policy. We are now rebuilding the culture to create more teamwork, collegiality, and shared services across the agency.<\/p>\n\n\n\n

JF: Are there things that your boss, RFK Jr., said during his April 11 remarks to the FDA staff that you\u2019d like to disagree with or take exception to?<\/strong><\/p>\n\n\n\n

MM: He was absolutely correct, and courageous, in detailing how government regulatory agencies through history have gone through times when they were captured by industries they were supposed to oversee. Just take a look at the approval of OxyContin for chronic pain based on a 14-day study. The regulator then went on to work for Purdue Pharma. In my view, that was<\/em> industry capture, where there was undue influence.<\/p>\n\n\n\n

JF: FDA scientists tell me they are now strapped for resources after the RIFs. They anticipate missing PDUFA<\/a> [Prescription Drug User Fee Act] deadlines, and they\u2019ll have to start declining meetings. These are new problems, and some of it because support staff that the scientists rely on to do their jobs are suddenly not around. If the RIFs have not negatively affected FDA\u2019s core mission activities, as you\u2019ve said in some interviews, why are rank-and-file scientists telling me otherwise?<\/strong><\/p>\n\n\n\n

MM: The FDA had 9,500 employees in 2007. Last year it was nearly 19,000. Has the 100% increase in employees increased approval times, innovation, AI, food safety, or agency morale? No it hasn\u2019t. In fact, it\u2019s increased regulatory creep. The agency has also become bloated with duplicate services because of the siloed culture. We had hundreds of employees with \u201cstrategy\u201d or \u201cstrategic\u201d in their job title, many CIO\u2019s, and several travel offices. Some of the biggest areas of waste were in the duplicative IT systems. Each center created their own clunky adverse event reporting system. There were also hundreds of communications staff.<\/p>\n\n\n\n

Look, even I was told by my comms staff that I could not do a media interview because of the recent reductions. I kept asking, and they said \u201cSorry, we don\u2019t have anyone to set it up.\u201d Then I find out there are still forty active folks in my comms office (it was cut from over a hundred). So, there are some overstatements.<\/p>\n\n\n\n

To be clear, no scientists or inspectors were laid off.<\/p>\n\n\n\n

On the question of productivity, my center leaders have assured me that the FDA will reach its PDUFA targets. By the way, they are actually not deadlines as the media has reported, they are targets. Scientists have at times said that individual targets will or won\u2019t be met due to the complexity of certain product applications. I\u2019d rather have a sound decision a few days after the target date than have another Vioxx that potentially killed 38,000 Americans. It\u2019s been a long-standing practice that some fraction of product decisions are made after the PDUFA target date, and usually days after. But I realize that PDUFA money comes from meeting a certain percentage of target dates. My center leaders say they are confident they will be met and I trust them.<\/p>\n\n\n\n

JF: What would you say to keep scientists around? Because I\u2019m hearing that many good people are looking for work elsewhere and you might lose highly productive people.<\/strong><\/p>\n\n\n\n

MM: I recognize that I inherited the agency at a difficult moment for a lot of people here. I was not involved in the recent cuts, but understand their goal to get back to 2019 staffing levels. By percentage, the total cuts of HHS under this administration have been less than the cuts to HHS under President Clinton. Now that I\u2019m here, and it\u2019s only been a few weeks, I\u2019m trying to do an assessment of what people need to do their job well. I am trying to do an assessment and fix any unforeseen consequences of cuts. I am taking a detailed inventory. If my center heads say they are running thin here or there, we take care of it. We\u2019ve made some progress, like getting the library resources back up and running.<\/p>\n\n\n\n

JF: Insiders and outsiders are saying that they see the Novavax approval as a bellwether for your ability to run the FDA independently. Here\u2019s what you said on Twitter<\/a> in 2021:<\/strong><\/p>\n\n\n\n

Do you still believe that? Do you think Novavax is less safe or less effective than the Covid vaccines that the FDA has fully approved?<\/strong><\/p>\n\n\n\n

MM: I am responsible for 100% of decisions made at the FDA. No one above me has been or will be making decisions on products. Secretary Kennedy may have strong recommendations, which he has a right to, but I make my decisions based on the two guiding principles of gold standard science and common sense. When Secretary Kennedy offers a suggestion to me, he always adds, \u201cYou decide for yourself.\u201d So, yes, there is independence.<\/p>\n\n\n\n

On the Novavax question, my views evolve with data. I have been a fan of traditional vaccine platforms for Covid, especially in 2021, when it provided another pathway for people uncomfortable with mRNA to get vaccinated. But the big Novavax 2020-2021 study excluded people with natural immunity to Covid. Today, there is broad population immunity, and the big question is does it provide a benefit? Without a study on the new formulation and product, we can\u2019t give an honest evidence-based answer to that question. These are new vaccine products, not the tried-and-true flu shot that has been around for 80 years. If we had a study showing that Covid boosters help keep people out of the hospital today, it could significantly increase the low Covid vaccine uptake rate that we have today. Look, 85% of healthcare workers declined the latest Covid booster vaccine last fall. Should we accept that and just keep pounding on parents to get their healthy 12-year-old daughter a 7th<\/sup> Covid jab this fall? Or should we make evidence-based recommendations based on a meaningful study showing a clinical benefit today?<\/p>\n\n\n\n

JF: You\u2019re arguing that in the post-immune era (that is, when everyone has some immunity to SARS-CoV-2, by way of vaccines, infections, or both), we need new data. But what\u2019s the difference between this and the mRNA vaccines, which <\/strong>do<\/strong><\/em> have full FDA approval?<\/strong><\/p>\n\n\n\n

MM: I think it\u2019s time to get back to gold standard science. The Wall Street Journal<\/em> headline<\/a> on this topic was accurate\u2014that the FDA asking the vaccine maker to do a clinical study for a new vaccine product could cost \u201ctens of millions of dollars.\u201d But my job is upholding gold standard science and rebuilding public trust, not to save pharma companies tens of millions of dollars.<\/p>\n\n\n\n

JF: Will there be a significant reorganization at FDA? If so, what might that look like in terms of center\/division realignment versus elimination of activities and staff?<\/strong><\/p>\n\n\n\n

MM: No. There will not be a reorganization. Yes, we are consolidating travel offices, IT, and some other things that make sense for efficiency, but nothing else is planned. A proposal for a reorganization came from some staff, but I rejected that proposal. I said that we will work within the existing structure. We are going to focus on making the FDA a great place to work. Reviewing applications is hard work. Our staff deserve a great place to work.<\/p>\n\n\n\n

JF: And nothing ever came from DOGE on this?<\/strong><\/p>\n\n\n\n

MM: No, but we maintain a very collaborative relationship with DOGE. There\u2019s a lot of work that needs to be done to modernize the agency. We have a big agenda. It\u2019s time to turn our attention to it.<\/p>\n","protected":false},"excerpt":{"rendered":"

In our wide-ranging Q&A, Dr. Makary outlines his vision, addresses low morale, asserts his independence, explains his stance on Novavax, and says “no” to an agency reorganization. Jeremy Faust, MD […]<\/p>\n","protected":false},"author":2,"featured_media":11985,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[761,445,608],"tags":[],"class_list":["post-11906","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-concerns","category-policies-politics","category-vaccine-safety"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11906","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=11906"}],"version-history":[{"count":3,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11906\/revisions"}],"predecessor-version":[{"id":11984,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11906\/revisions\/11984"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/11985"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11906"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=11906"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=11906"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}