President Trump has reportedly approved a plan to fire Food and Drug Administration Commissioner Marty Makary, following a series of high-profile clashes over the regulation of vaping products, abortion medication, and broader drug policy that have drawn complaints from the pharmaceutical industry.
"Does the government have the ability to basically bully companies? Yes, and I think we’re seeing that," said Dan Troy, the FDA’s former chief counsel, commenting on the administration's broader strategy of pressuring industries without formal rulemaking.
The internal conflict follows several contentious decisions, including Makary's reversal on authorizing flavored vapes from manufacturer Glas after initial refusal, and the FDA's review of the abortion pill mifepristone, which a U.S. Court of Appeals cited in a ruling to restrict access. The administration has also pursued a voluntary "phase out" of synthetic food dyes, a move public health experts criticize for lacking regulatory teeth.
Makary's potential exit injects significant uncertainty into the pharmaceutical, biotech, and tobacco sectors, which face a volatile regulatory environment. A new commissioner could radically alter approval timelines and enforcement priorities, leaving companies to navigate a landscape where policy is dictated more by press conference than by the Federal Register, a shift that could easily be undone by a future administration.
A Pattern of Regulation by Announcement
The potential ouster of Makary is the culmination of a tumultuous period at the FDA, an agency that has increasingly favored policy-making through informal announcements rather than the time-consuming process of federal rulemaking. This approach was evident when Health and Human Services Secretary Robert F. Kennedy Jr. and Makary unveiled a plan to "phase out" synthetic food dyes, which was later revealed to be a voluntary understanding with foodmakers, not a formal ban.
"If FDA has changed its position, then FDA should document why and pursue a ban," said Susan Mayne, a Yale University public health expert and former director of the FDA’s food program.
This strategy has been applied to other areas, including new restrictions on COVID-19 vaccines, which were announced in medical journal articles and bypassed the agency's traditional outside expert panels. While the approach allows for speed, critics argue it lacks scientific basis and legal standing, making the policies themselves fragile. "Anything that this administration does that they don’t embody in law can easily be undone by a future administration,” Troy noted.
Vaping and Abortion Flashpoints
Two issues in particular appear to have brought Makary's standing with the White House to a breaking point: vaping and abortion. Trump was reportedly frustrated with Makary for not moving faster to approve flavored nicotine products. In February, Makary refused to authorize blueberry and mango vape flavors from Los Angeles-based manufacturer Glas, citing concerns about youth vaping, only to reverse the decision after pressure from Trump.
Even more politically charged has been the agency's handling of the abortion pill mifepristone. The Trump administration's FDA announced a review of the drug's safety based on a report widely criticized as "junk science." This move was later used by the 5th U.S. Circuit Court of Appeals to justify suspending regulations that allowed the pill to be mailed. The FDA, as a defendant in the case, did not defend the regulation on its merits or appeal the decision, leading the court to note the agency had "essentially acknowledged … procedural deficits." The decision suggests politics, not science, are driving the timeline.
This article is for informational purposes only and does not constitute investment advice.
