‘The FDA is a complete mess’: Trump makes fate of agency chief unclear as public trust plummits

Donald Trump has signed off on a plan to fire Marty Makary, the commissioner of the US Food and Drug Administration (FDA), the Wall Street Journal reported on Friday, after a series of high-profile agency decisions put the FDA head 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 amid plummeting staff morale over layoffs and the appointments of divisive officials. Recent political clashes include abortion, drugs and vaping, but decisions to pull back publications on the safety of shingles and Covid vaccines, among other immunization decisions, have also rocked public health. There have also been concerns about the transition from two clinical trials to one, the commissioner’s new priority review vouchers and “data-free” regulatory decisions.

Trump’s plan to fire Makary is not yet final and may still change, the Journal reported. Makary, “an embattled, paranoid leader”, is “one more high-profile misstep” away from losing his job, Bloomberg News reported on Monday. He is on “thin ice” with the White House because he is “not the best fit” to manage staff and navigate bureaucracy, according to Notus.

Trump “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, according to the Wall Street Journal. The new flavours, reportedly 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 moves like these to “President Trump’s leadership”.

Vaping is a divisive issue in public health, since it can be used as a smoking cessation aid but it also carries its own health risks. But the greater risk is political interference – or even the appearance of it – in regulatory decisions, experts say.

The FDA was previously known for its stability and predictability, especially because the drug development process is a multi-year 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 the unpopular decisions, Lurie said. “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, reporting revealed this week. The research on the safety of Covid vaccines was withdrawn by the authors after being accepted by the journal Vaccine, 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 don’t pay attention to the inner workings of the FDA, Rasmussen said.

“They see what they can get away with administratively, and see what people notice,” she said. While the FDA is “incredibly boring” to many members of the public, it’s also “really powerful from a regulatory perspective”, Rasmussen said. “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 the drugmaker Replimune, according to a column in the Wall Street Journal.

“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,” Makary told CNBC on Tuesday. “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.

The FDA’s “mismanagement and bungled drug reviews” had “chilled investments in life-saving, innovative cures”, opening the door to international competitors like China, Darin LaHood, a Republican representative from Illinois, said at the House ways and means committee budget hearing last month.

It’s “very important that we have a vibrant, efficient FDA,” and “I intend to take that up with Dr Makary,” LaHood told Robert F Kennedy Jr, secretary of the US Department of Health and Human Services.

Kennedy defended the record of the FDA and Makary in particular, taking a swipe at the very 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 to the medication. 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, as well as the appointment of inexperienced officials had 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, and he was fired and then rehired last year; he departed 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 the 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 that was quickly reversed after public outcry.

That flu vaccine, which is based on messenger RNA (mRNA) technology, works better than other flu shot options for people over the age of 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, a program to make 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 between safety and effectiveness, Lurie said. Especially with promises to speed up the reviews, “that’s just completely contrary to the way the agency is operated,” Lurie said. “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’s seen as a respectable white coat in the White House, but Makary 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. (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 such diverse potential causes as c-sections and antibiotics. Makary invoked his own young son at home. “Luckily, he did not need a c-section,” he said, though “sometimes you need ’em.” And, he said, his son “is not getting antibiotics unless he’s on his deathbed or suffering”.