Trump Plans to Fire FDA Commissioner Marty Makary Amid Controversy
President Donald Trump has signed off on a plan to fire Marty Makary, the commissioner of the US Food and Drug Administration (FDA), according to a Wall Street Journal report on Friday. The decision comes after a series of high-profile agency decisions that have put Makary in the crosshairs of the White House and Republican lawmakers.
Makary's tenure at the FDA has been marked by several controversial decisions on drugs and vaccines, alongside plummeting staff morale due to layoffs and the appointment of divisive officials. Recent political clashes include issues related to abortion, drugs, and vaping, but decisions to pull back publications on the safety of shingles and Covid vaccines have also rocked public health. Concerns have also been raised about the transition from two clinical trials to one, the introduction of priority review vouchers, and what some call 'data-free' regulatory decisions.
The plan to fire Makary is not yet final and may still change, the Journal reported. Makary, described as 'an embattled, paranoid leader,' is 'one more high-profile misstep' away from losing his job, according to Bloomberg News. He is on 'thin ice' with the White House because he is 'not the best fit' to manage staff and navigate bureaucracy, as reported by Notus.
Trump reportedly 'upbraided' Makary and made a series of calls over the weekend to pressure him into approving fruit-flavored vapes for the first time, after Makary overrode agency scientists to halt the approval. The new flavors, part of Trump's plan to appeal to younger voters, were approved on Tuesday. The news release does not include any comments from Makary, which is unusual, and attributes such moves to 'President Trump's leadership.'
Vaping remains a divisive public health issue, as it can serve as a smoking cessation aid but also carries its own health risks. However, experts say the greater risk is political interference—or even the appearance of it—in regulatory decisions.
The FDA was previously known for its stability and predictability, especially given the multi-year drug development process, said Peter Lurie, executive director of the Center for Science in the Public Interest and a former FDA associate commissioner. 'Public trust is built up not over months, but over decades. On the other hand, you can destroy it in mere months,' Lurie said. 'In a very short period of time, they have managed to undermine years of trust that the agency has built up with the public and industry because of their unpredictable practices and the general chaos.'
There has been sharp backlash from the public to new restrictions on vaccines and how they are brought to market, and leaders are aware of these unpopular decisions, Lurie added. 'Vaccines have really gotten their attention. They do understand that they’ve gone too far for the American people on vaccines.'
FDA officials reportedly stopped the publication of research on the safety of shingles and Covid vaccines, as revealed this week. The research on Covid vaccine safety was withdrawn by the authors after being accepted by the journal Vaccine, according to Angela Rasmussen, co-editor of the journal and a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada. Vinay Prasad, the top US vaccines regulator, decided to pull the study, which showed that 'the benefits of vaccination outweigh the risks,' according to Stat News.
'I think we’re going to start seeing a big pattern of this,' Rasmussen said of top-level interference with research publication. 'It just seems like this is the tip of the iceberg, and the FDA is just a complete mess.'
The FDA may serve as a testing ground for leaders to override experts and staff since most people do not pay attention to its inner workings, Rasmussen said. 'They see what they can get away with administratively, and see what people notice.' While the FDA is 'incredibly boring' to many members of the public, it is also 'really powerful from a regulatory perspective,' she added. 'So you could do something totally boring that nobody pays attention to and, boom, millions of people don’t have access to a drug or vaccine that they need.'
Makary is causing 'political headaches' for the White House, especially around decisions like the rejection of a melanoma treatment from drugmaker Replimune, according to a Wall Street Journal column. Makary responded to CNBC on Tuesday, saying, 'I think that article in the Wall Street Journal is the ninth article they’ve posted in that opinion section, begging for Replimune’s approval. I don’t work for Replimune, I work for the American people, and I stand by the scientists at the FDA.'
Senator Ron Johnson, a Republican from Wisconsin, said in March that he was investigating the FDA for rejections of rare disease treatments. Darin LaHood, a Republican representative from Illinois, stated at a House Ways and Means Committee budget hearing last month that the FDA's 'mismanagement and bungled drug reviews' had 'chilled investments in life-saving, innovative cures,' opening the door to international competitors like China.
'It’s very important that we have a vibrant, efficient FDA,' LaHood told Robert F. Kennedy Jr., secretary of the US Department of Health and Human Services. Kennedy defended the FDA and Makary in particular, taking a swipe at lawmakers in the hearing. 'Everybody goes after him because the industry is so powerful. They own Congress, they own the media, and they can beat up Marty Makary because he’s trying to do change over there,' Kennedy said.
Abortion has been another key flashpoint at the FDA. For months, Republicans in Congress have demanded action on mifepristone, one of two medications frequently used for abortion, pointing to Makary as a stumbling block in their attempts to restrict access. Senator Josh Hawley, a Republican from Missouri, introduced a bill in March to remove FDA approval of mifepristone for abortion entirely.
A string of hirings, firings, rehirings, and refirings, along with the appointment of inexperienced officials, has created a 'massive upheaval that has been an ongoing feature of daily work at FDA ever since the new administration began,' Lurie said. 'It’s just endless chaos.'
There have been several directors of the FDA’s Center for Drug Evaluation and Research (CDER). Despite criticizing the role of industry at the agency, leaders first chose George Tidmarsh, a biotech industry veteran, to lead CDER. Tidmarsh was soon ousted and sued by a company alleging he used his position to affect their business. Richard Pazdur, a respected cancer drug regulator, accepted the role and then quit after a month. 'That was probably about the only personnel decision that made people within the agency happy, but its rapid reversal had the end effect of depressing morale still further,' Lurie said. The current acting CDER director, Tracy Beth Høeg, is a sports medicine physician with 'no expertise,' critics say.
Turmoil has also rocked the FDA’s Center for Biologics Evaluation and Research (CBER). Vinay Prasad, until recently the head of CBER, is known for clashing with the industry. He was fired and then rehired last year, departing the agency again at the end of April. Makary reportedly went to bat for Prasad, and the two worked closely to create a new vaccine approval framework, including for Covid shots, which they announced in a journal article instead of through usual agency processes.
Prasad overruled center scientists when he decided to limit Covid vaccines and again when the agency refused to consider Moderna’s new flu vaccine, a decision quickly reversed after public outcry. That flu vaccine, based on messenger RNA (mRNA) technology, works better than other flu shot options for people over 50, according to new research published in the New England Journal of Medicine on Wednesday.
Prasad also tangled publicly with uniQure, the company creating a gene therapy for Huntington’s disease, soon before he was ousted for a second time. A new program called the commissioner’s priority voucher, which aims for one-day regulatory decisions, has also drawn criticism and questions.
'It’s just a matter of time before the wrong thing gets approved or before the right thing doesn’t get approved, and people die as a result,' Rasmussen said. 'There is nothing we should be doing to the regulatory process that speeds it up at the expense of being able to actually evaluate and regulate drugs.'
The agency’s decisions were supposed to be based on science alone, balancing safety and effectiveness, Lurie said. Especially with promises to speed up reviews, 'that’s just completely contrary to the way the agency is operated,' he added. 'That increases the likelihood of making a mistake.'
Makary, previously a professor and surgeon at Johns Hopkins, came to prominence by critiquing Covid boosters. As FDA head, he is seen as a respectable white coat in the White House, but he has also promoted dangerous conspiracy theories. 'HIV very well may have come from a lab,' Makary said on a far-right podcast in November. 'Where did Lyme disease come from? I can tell you with a high degree of probability it came from lab 257 on Plum Island,' he added, referring to a theory that the bacteria was created in a secret military lab, though the bacteria that causes Lyme disease circulated long before then.
Makary was a featured speaker at the first HHS conference on women’s health in March. He focused on potential links between disruptions to the microbiome and long-term health, criticizing diverse potential causes such as C-sections and antibiotics. Makary invoked his own young son at home, saying, 'Luckily, he did not need a C-section,' though 'sometimes you need ’em.' He added that his son 'is not getting antibiotics unless he’s on his deathbed or suffering.'
