This is a rush transcript. Copy may not be in its final form.<\/p>\n
AMY<\/span> GOODMAN<\/span>:<\/strong> Following a growing pressure campaign from powerful Republicans, anti-abortion groups and other allies of President Trump, Food and Drug Administration Commissioner Dr. Martin Makary resigned Tuesday. He had served in the position since April of 2025. President Trump spoke to reporters at the White House ahead of his departure for China and said he preferred not to say if Makary had been fired or resigned.<\/p>\n PRESIDENT<\/span> DONALD<\/span> TRUMP<\/span>:<\/strong> Everybody wants that job. It\u2019s a very important job. Marty is a terrific guy, but he\u2019s going to go on, and he\u2019s going to lead a good life.<\/p>\n<\/blockquote>\n REPORTER<\/span>:<\/strong> Should Americans be concerned that\u201d \u2014<\/p>\n<\/blockquote>\n PRESIDENT<\/span> DONALD<\/span> TRUMP<\/span>:<\/strong> He was having \u2014\u00a0he was having some difficulty. You know, he\u2019s a great doctor, and he was having some difficulty.<\/p>\n<\/blockquote>\n AMY<\/span> GOODMAN<\/span>:<\/strong> The Wall Street Journal<\/em> reported<\/a> Dr. Makary was pushed out in part because he tried to block FDA<\/span> approval of fruit-flavored vapes, angering President Trump, who saw approval as important to his MAGA<\/span> base. Dr. Makary also drew ire from anti-abortion groups for not moving quickly enough to restrict access to the abortion drug mifepristone.<\/p>\n The agency was already in turmoil before Dr. Makary became commissioner. HHS<\/span> Secretary Robert Kennedy Jr. had already fired 3,500 workers from the FDA<\/span>, roughly 20% of its workforce.<\/p>\n FDA\u2019s deputy commissioner for food, Kyle Diamantis, will take on the role in an acting capacity as FDA<\/span> commissioner. Diamantis was previously an attorney in Miami who represented Abbott Laboratories, a manufacturer of baby formula. He\u2019s also a personal friend of Donald Trump Jr. He does not have a background in medicine.<\/p>\n For more, we\u2019re joined by two guests. Dr. Robert Steinbrook is Health Research Group director at Public Citizen. And Dr. Aaron Kesselheim is a professor of medicine at Harvard Medical School.<\/p>\n Dr. Kesselheim, let\u2019s begin with you. I want you to respond to Makary leaving, but start off by talking about the significance of the Food and Drug Administration.<\/p>\n DR. AARON<\/span> KESSELHEIM<\/span>:<\/strong> Well, first off, thanks for having me.<\/p>\n I think the Food and Drug Administration is one of the most important public health agencies in the United States, if not the world. The oversight of the Food and Drug Administration extends to about a quarter of the economy, including prescription drugs, medical devices, a lot of food oversight. It has some things to say about cosmetics and nutritional supplements. There are some reports that, on average, the average person touches about 12 to 15 FDA<\/span>-regulated products over the course of a day. So, this agency is incredibly important in ensuring that the medicines that we take are tested and the food that we eat is inspected, and it is vital to the health of the country.<\/p>\n And, you know, unfortunately, in the last 18 months, we have seen it increasingly engulfed by chaos and, you know, undertaken a lot of questionable decisions under Dr. Makary\u2019s oversight.<\/p>\n AMY<\/span> GOODMAN<\/span>:<\/strong> Dr. Steinbrook, if you can also talk about how much the FDA<\/span> regulates, is in charge of food and drugs in this country, and then your criticism of Makary, but then the criticism of the reasons he was pushed out?<\/p>\n DR. ROBERT<\/span> STEINBROOK<\/span>:<\/strong> Glad to be with you.<\/p>\n I agree with everything which was just said about the FDA<\/span>. It\u2019s vitally important. And it\u2019s important for all of us in this country, and others throughout the world who look to the FDA<\/span> for leadership, to have an effective, strong FDA<\/span> which is grounded in science and which is grounded in public health.<\/p>\n Dr. Makary was in a very difficult position, and perhaps it was impossible, though he didn\u2019t help his case at all. He was trying to be too many things to too many people. He was flip-flopping. He had some good ideas, but before he was finished with one good idea, he would have another idea. Some of his initiatives \u2014 for example, cracking down on direct consumer advertising, misleading consumer advertising, that\u2019s a good idea. But on the other hand, being in a position to try to please everybody, anti-abortion activists, drug companies, people who wanted more access to certain tobacco products or alternatives to tobacco, in some ways, it\u2019s a no-win situation. And perhaps another person could have handled it better than he did, but the writing has been on the wall for some time. There was just pure chaos and not great leadership of this very important organization.<\/p>\n AMY<\/span> GOODMAN<\/span>:<\/strong> So, talk about the whole issue of the fruit-flavored vaping, his concern about kids getting addicted. And who was putting pressure on him to approve this?<\/p>\n DR. ROBERT<\/span> STEINBROOK<\/span>:<\/strong> Well, the reporting has suggested that there was pressure from the White House and perhaps elsewhere within the Department of Health and Human Services for the approval of these vapes. And Dr. Makary\u2019s stance seems to be well reasoned. Whether this was, in fact, the straw that broke the camel\u2019s back or not, it\u2019s hard to say, because there were many other issues where he seemed to have been able to offend people on all sides of the political spectrum \u2014\u00a0on the one hand, wanted more evidence about vaccines and their safety and effectiveness; on the other hand, wanted to greenlight drugs with less evidence about their safety and effectiveness. He was just all over the place.<\/p>\n AMY<\/span> GOODMAN<\/span>:<\/strong> And, Dr. Kesselheim, the whole controversy created under the Trump administration over mifepristone, the abortion pill? Abortion medication is now the major way people are able to have abortions in this country, and abortions are up since Roe v. Wade<\/em> was overturned. But talk about his position.<\/p>\n DR. AARON<\/span> KESSELHEIM<\/span>:<\/strong> Well, I mean, I think that part of \u2014\u00a0I think that part of the problem, as Dr. Steinbrook pointed out, was this controversy about mifepristone, which is a drug that has been around for many decades and has been used very safely. There were some preexisting restrictions on it from the FDA<\/span> that had been lifted in concordance with the evidence a few years ago. And the question was whether \u2014 you know, what the circumstances were of those being \u2014\u00a0of those restrictions being lifted, and whether or not they would be reimposed.<\/p>\n And, you know, I think this is another situation where Dr. Makary did not show a lot of firm leadership from his position in putting science first and making sure that the FDA<\/span> operated clearly and made clear statements about the, you know, appropriate use and safety of that drug where he could have. And, you know, I think that that is one of the circumstances that led to this situation, where, because he did not lead by putting the science first and, you know, by going through clear, transparent channels about what was going to happen, it ended up that nobody was happy with what he did.<\/p>\n AMY<\/span> GOODMAN<\/span>:<\/strong> So, Dr. Steinbrook, you now have \u2014\u00a0the U.S. now has no confirmed FDA<\/span> commissioner, no confirmed CDC<\/span> director \u2014\u00a0that\u2019s the Centers for Disease Control and Prevention \u2014\u00a0no Senate-approved surgeon general. Can you talk about the significance of this and, overall, how you would characterize Robert Kennedy\u2019s tenure?<\/p>\n DR. ROBERT<\/span> STEINBROOK<\/span>:<\/strong> Well, we shouldn\u2019t be in this situation 18 months into the \u2014\u00a0or, just about 18 months into the second Trump administration. If we start with the CDC<\/span>, Robert F. Kennedy Jr. has effectively been his own CDC<\/span> director from the get-go. There have been people back and forth and various acting directors, but he\u2019s basically been calling the shots, as best we can see from the outside.<\/p>\n And that\u2019s led to very bad public health consequences in terms of vaccines and recommendations for vaccines and the whole staff and effectiveness of the agency. We\u2019ve seen some of these issues come up with the recent cruise ship issue with hantavirus, and the whole CDC<\/span> office, which was looking into cruise ships and safety and things of that sort, having been disbanded earlier.<\/p>\n AMY<\/span> GOODMAN<\/span>:<\/strong> What \u2014\u00a0no, go into that \u2014<\/p>\n DR. ROBERT<\/span> STEINBROOK<\/span>:<\/strong> The surgeon general \u2014<\/p>\n AMY<\/span> GOODMAN<\/span>:<\/strong> \u2014\u00a0for a minute. I just would like to stop there, since this is right now such an important story, what\u2019s happened with the cruise ship with hantavirus and the people who\u2019ve been brought to places like Nebraska, who are in isolation. Explain the role of the FDA<\/span>, HHS<\/span>, you know, basically, Robert Kennedy\u2019s running of the health sector and the government.<\/p>\n DR. ROBERT<\/span> STEINBROOK<\/span>:<\/strong> Well, without going into all the details of the hantavirus outbreak, it\u2019s an example of why we need a strong public health agency which collaborates internationally. The CDC<\/span> would be traditionally working with the World Health Organization to understand what was going on with a disease outbreak, even though this was not primarily a U.S.-based outbreak, to offer advice on control of the outbreak and to provide effective treatment for people who needed treatment.<\/p>\n And the massive staff cuts, the loss of expertise, the lack of people in charge who are standing up for public health, from Robert F. Kennedy Jr. on down, is apparent when things happen that we need to be prepared to respond. And that\u2019s why we need effective agencies which have science-based leadership. That\u2019s really the issue here. It\u2019s the overall effect of organizations which were strong and robust, and when you pick them apart for particular theories and the idiosyncrasies of the Health and Human Services secretary, you destroy things which take years, if not decades, to rebuild.<\/p>\n AMY<\/span> GOODMAN<\/span>:<\/strong> This is former, now, FDA<\/span> Commissioner Marty Makary during an interview on CNBC<\/span> in February discussing efforts to change how most prescription drugs are available, making them over-the-counter for consumers.<\/p>\n DR. MARTY<\/span> MAKARY<\/span>:<\/strong> In my opinion, everything should be over-the-counter, not requiring a prescription, unless it\u2019s unsafe, unless you need laboratory tests to monitor how it\u2019s being received by your body, or if it could be used for some nefarious purpose or it\u2019s addictive. If it doesn\u2019t meet those criteria, why shouldn\u2019t a drug be over-the-counter? So, we should be asking, \u201cWhy not?\u201d instead of, \u201cOh, you want to move over-the-counter, you got to go through our long, tedious process.\u201d<\/p>\n<\/blockquote>\n AMY<\/span> GOODMAN<\/span>:<\/strong> So, that\u2019s Dr. Marty Makary, the former FDA<\/span> commissioner. Dr. Aaron Kesselheim, your response to what he\u2019s proposing?<\/p>\n DR. AARON<\/span> KESSELHEIM<\/span>:<\/strong> Well, as with some of the stuff that he did as commissioner, there is a grain of truth in what he said. There are certain drugs that we have decades of experience with safe use of them and for which making them over-the-counter would help broaden their availability to patients and might help reduce their price and, you know, subject them to some competition that might help reduce their price. So, there is a grain of truth to that.<\/p>\n But I think that the way he says it is very broadly stated in a way that doesn\u2019t appear to be, you know, designed to be put sort of in the context of what the evidence is. Certainly, if there is good evidence around drugs that they can be used safely with fair \u2014 with fair labeling that people can understand, it is reasonable to consider how those drugs should be made over-the-counter. And the FDA<\/span> has a process for that, and maybe that process needs to be reviewed and examined to ensure that it\u2019s operating efficiently and maximally effectively. But I think to, you know, say in a public way that, basically, all drugs, by default, should be over-the-counter \u2014\u00a0oh, by the way, except for all these exceptions \u2014 is a challenging way to put it, because, you know, it does kind of give the impression that the role of the FDA<\/span> is not a significant one in ensuring that these drugs are safely vetted and can be used appropriately.<\/p>\n So, I don\u2019t know. I think that, in general, this is a good example of him having a germ of a good idea, that, by the way, didn\u2019t go anywhere because he then moved on to some other, you know, crusade that he was talking about, but that was ultimately done in by his lack of attention to science-based leadership and to the established legal and regulatory processes that the FDA<\/span> has.<\/p>\n AMY<\/span> GOODMAN<\/span>:<\/strong> So, Dr. Robert Steinbrook, the acting FDA<\/span> commissioner is now Kyle Diamantis, one of Donald Trump Jr.’s, President Trump’s son\u2019s, hunting buddies. Can you talk about the significance of a Florida attorney with no prior federal government experience now heading the FDA<\/span>? What is Public Citizen calling for?<\/p>\n DR. ROBERT<\/span> STEINBROOK<\/span>:<\/strong> Well, it\u2019s a very unfortunate precedent. We have a science-based agency with a nonscientist in charge \u2014\u00a0we don\u2019t know how long he will be in charge \u2014\u00a0answerable to Robert F. Kennedy Jr., who, as we\u2019ve said before, we don\u2019t believe is qualified to be the HHS<\/span> commissioner \u2014\u00a0director, should never have been confirmed, with all the whims of the White House and political pressure.<\/p>\n Now, it is possible that Kyle Diamantis will have less drama in terms of the day-to-day management of the agency and will allow some of the career scientists and nonpolitical appointees who are still left to do their jobs, but there are so many people out there, again, who may or may not agree with Robert F. Kennedy Jr. on this and that, who are far better qualified even to be in an acting position at the FDA<\/span> and to give the American people a sense of confidence that the FDA<\/span> is able to do its job.<\/p>\n AMY<\/span> GOODMAN<\/span>:<\/strong> And I\u2019ll give you the last word, Dr. Kesselheim, around the issue of vaccines, where they stand today.<\/p>\n DR. AARON<\/span> KESSELHEIM<\/span>:<\/strong> Unfortunately, we\u2019re in a position where the head of our public health agencies are doing the best that they can to undermine the public confidence in the safety and effectiveness of vaccines, to undermine their \u2014 the standard review of new vaccines to ensure that high-quality, safe and effective vaccines are able to be available to patients. And this is a major public health crisis. The active undermining of vaccines\u2019 availability and use by patients is a major health crisis, because, you know, we know that vaccines work in the circumstances that they are recommended, and as we move away from that, we will just see increases in deadly infectious diseases that might have otherwise been in control. And that\u2019s a major public health tragedy that is unfolding and will take years to recover from. So, you know, I think that it is highly irresponsible, what our current public health leaders are doing to try to undermine vaccines.<\/p>\n AMY<\/span> GOODMAN<\/span>:<\/strong> Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School, and Dr. Robert Steinbrook, Health Research Group director at Public Citizen, teaches medicine at Yale Medical School.<\/p>\n Coming up, \u201cThe fight against AI data centers isn\u2019t just about tech \u2014 it\u2019s about democracy.\u201d We\u2019ll speak with Astra Taylor.<\/p>\n [break]<\/p>\n AMY<\/span> GOODMAN<\/span>:<\/strong> \u201cSow \u2019Em on the Mountains,\u201d performed by Nora Brown and Stephanie Coleman in our Democracy Now!<\/em> studio.<\/p>\n<\/div>\n The original content of this program is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 United States License<\/a>. Please attribute legal copies of this work to democracynow.org. Some of the work(s) that this program incorporates, however, may be separately licensed. For further information or additional permissions, contact us.<\/p>\n\n
\n
\n
\n