{"id":12686,"date":"2026-05-09T13:12:05","date_gmt":"2026-05-09T13:12:05","guid":{"rendered":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/2026\/05\/09\/the-fda-is-a-complete-mess-trump-makes-fate-of-agency-chief-unclear-as-public-trust-plummits-the-guardian\/"},"modified":"2026-05-09T13:12:05","modified_gmt":"2026-05-09T13:12:05","slug":"the-fda-is-a-complete-mess-trump-makes-fate-of-agency-chief-unclear-as-public-trust-plummits-the-guardian","status":"publish","type":"post","link":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/2026\/05\/09\/the-fda-is-a-complete-mess-trump-makes-fate-of-agency-chief-unclear-as-public-trust-plummits-the-guardian\/","title":{"rendered":"\u2018The FDA is a complete mess\u2019: Trump makes fate of agency chief unclear as public trust plummits – The Guardian"},"content":{"rendered":"
\n

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<\/a> on Friday, after a series of high-profile agency decisions put the FDA head in the crosshairs of the White House and Republican lawmakers.<\/p>\n

Makary\u2019s 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\u2019s new priority review vouchers and \u201cdata-free<\/a>\u201d regulatory decisions.<\/p>\n

Trump\u2019s plan to fire Makary is not yet final and may still change, the Journal reported. Makary, \u201can embattled, paranoid leader\u201d, is \u201cone more high-profile misstep\u201d away from losing his job, Bloomberg News reported<\/a> on Monday. He is on \u201cthin ice\u201d with the White House because he is \u201cnot the best fit\u201d to manage staff and navigate bureaucracy, according<\/a> to Notus.<\/p>\n

Trump \u201cupbraided<\/a>\u201d 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<\/a> agency scientists to halt the approval, according to the Wall Street Journal. The new flavours, reportedly part of Trump\u2019s plan to appeal to younger voters, were approved on Tuesday. The news release<\/a> does not include any comments from Makary, which is unusual, and attributes moves like these to \u201cPresident Trump\u2019s leadership\u201d.<\/p>\n

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Vaping is a divisive issue<\/a> 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 \u2013 or even the appearance of it \u2013 in regulatory decisions, experts say.<\/p>\n

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.<\/p>\n

\u201cPublic trust is built up not over months, but over decades. On the other hand, you can destroy it in mere months,\u201d Lurie said. \u201cIn 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.\u201d<\/p>\n

There has been sharp backlash from the public to new restrictions on vaccines and how they are brought to market \u2013 and leaders are aware of the unpopular decisions, Lurie said. \u201cVaccines have really gotten their attention. They do understand that they\u2019ve gone too far for the American people on vaccines.\u201d<\/p>\n

FDA officials reportedly stopped the publication of research on the safety of shingles and Covid vaccines, reporting revealed<\/a> this week. The research on the safety of Covid vaccines<\/a> 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 \u201cthe benefits of vaccination outweigh the risks\u201d, according<\/a> to Stat News.<\/p>\n

\u201cI think we\u2019re going to start seeing a big pattern of this,\u201d Rasmussen said of top-level interference with research publication. \u201cIt just seems like this is the tip of the iceberg, and the FDA is just a complete mess.\u201d<\/p>\n

The FDA may serve as a testing ground for leaders to override experts and staff since most people don\u2019t pay attention to the inner workings of the FDA, Rasmussen said.<\/p>\n

\u201cThey see what they can get away with administratively, and see what people notice,\u201d she said. While the FDA is \u201cincredibly boring\u201d to many members of the public, it\u2019s also \u201creally powerful from a regulatory perspective\u201d, Rasmussen said. \u201cSo you could do something totally boring that nobody pays attention to and, boom, millions of people don\u2019t have access to a drug or vaccine that they need.\u201d<\/p>\n

Makary is causing \u201cpolitical headaches\u201d for the White House, especially around decisions like the rejection of a melanoma treatment from the drugmaker Replimune, according to a column<\/a> in the Wall Street Journal.<\/p>\n

\u201cI think that article in the Wall Street Journal is the ninth article they\u2019ve posted in that opinion section, begging for Replimune\u2019s approval,\u201d Makary told CNBC on Tuesday. \u201cI don\u2019t work for Replimune, I work for the American people, and I stand by the scientists at the FDA.\u201d<\/p>\n

Senator Ron Johnson, a Republican from Wisconsin, said in March that he was investigating<\/a> the FDA for rejections of rare disease treatments.<\/p>\n

The FDA\u2019s \u201cmismanagement and bungled drug reviews\u201d had \u201cchilled investments in life-saving, innovative cures\u201d, 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.<\/p>\n

It\u2019s \u201cvery important that we have a vibrant, efficient FDA,\u201d and \u201cI intend to take that up with Dr Makary,\u201d LaHood told Robert F Kennedy Jr, secretary of the US Department of Health and Human Services.<\/p>\n

Kennedy defended the record of the FDA and Makary in particular, taking a swipe at the very lawmakers in the hearing.<\/p>\n

\u201cEverybody 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\u2019s trying to do change over there,\u201d Kennedy said.<\/p>\n

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<\/a> 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.<\/p>\n

A string of hirings, firings, rehirings, and refirings, as well as the appointment of inexperienced officials had created a \u201cmassive upheaval that has been an ongoing feature of daily work at FDA ever since the new administration began\u201d, Lurie said. \u201cIt\u2019s just endless chaos.\u201d<\/p>\n

There have been several directors of the FDA\u2019s 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<\/a> \u2013 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.<\/p>\n

\u201cThat 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,\u201d Lurie said. The current acting CDER director, Tracy Beth H\u00f8eg, is a sports medicine physician with \u201cno expertise<\/a>\u201d, critics say.<\/p>\n

Turmoil has also rocked the FDA\u2019s 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<\/a> the agency again at the end of April. Makary reportedly<\/a> 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.<\/p>\n

Prasad overruled center scientists when he decided to limit Covid vaccines and again<\/a> when the agency refused to consider<\/a> Moderna\u2019s new flu vaccine, a decision that was quickly reversed after public outcry.<\/p>\n

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<\/a> published in the New England Journal of Medicine on Wednesday.<\/p>\n

Prasad also tangled<\/a> publicly with uniQure, the company creating a gene therapy for Huntington\u2019s disease, soon before he was ousted for a second time.<\/p>\n

A new program called the commissioner\u2019s priority voucher, a program to make one-day regulatory decisions, has also drawn criticism and questions.<\/p>\n

\u201cIt\u2019s just a matter of time before the wrong thing gets approved or before the right thing doesn\u2019t get approved, and people die as a result,\u201d Rasmussen said. \u201cThere 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.\u201d<\/p>\n

The agency\u2019s decisions were supposed to be based on science alone, balancing between safety and effectiveness, Lurie said. Especially with promises to speed up the reviews, \u201cthat\u2019s just completely contrary to the way the agency is operated,\u201d Lurie said. \u201cThat increases the likelihood of making a mistake.\u201d<\/p>\n

Makary, previously a professor and surgeon at Johns Hopkins, came to prominence by critiquing Covid boosters. As FDA head, he\u2019s seen as a respectable white coat in the White House, but Makary has also promoted dangerous conspiracy theories. HIV \u201cvery well may have come from a lab\u201d, Makary said<\/a> on a far-right podcast in November. \u201cWhere did Lyme disease come from? I can tell you with a high degree of probability it came from lab 257 on Plum Island,\u201d 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.)<\/p>\n

Makary was a featured speaker at the first HHS conference on women\u2019s 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. \u201cLuckily, he did not need a c-section,\u201d he said, though \u201csometimes you need \u2019em.\u201d And, he said, his son \u201cis not getting antibiotics unless he\u2019s on his deathbed or suffering\u201d.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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\u2019s tenure at the FDA […]<\/p>\n","protected":false},"author":1,"featured_media":12687,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-12686","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/wp-json\/wp\/v2\/posts\/12686","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/wp-json\/wp\/v2\/comments?post=12686"}],"version-history":[{"count":0,"href":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/wp-json\/wp\/v2\/posts\/12686\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/wp-json\/wp\/v2\/media\/12687"}],"wp:attachment":[{"href":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/wp-json\/wp\/v2\/media?parent=12686"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/wp-json\/wp\/v2\/categories?post=12686"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/wpinitiate.com\/echo-test\/demo973e36f5\/wp-json\/wp\/v2\/tags?post=12686"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}