Makary's Exit Raises New Questions About FDA Stability And Direction
By Katie Anderson, Chief Editor, Pharmaceutical Online
After serving as Commissioner of the U.S. Food and Drug Administration for a little over a year, Dr. Marty Makary resigned on May 12, 2026. Allegedly, pressure to approve fruit-flavored e-cigarettes was the straw that broke the commissioner’s back. It was reported by the New York Times that Makary strongly opposed the approval of flavored e-cigarettes for their appeal to youth, but the Trump administration strongly pushed for their greenlight.
Discord In the Administration
The e-cigarette disagreement was not the only source of contention between Makary, Health Secretary Robert F. Kennedy Jr. and The White House. The administration disagreed with the FDA’s approval of Pfizer’s updated mRNA COVID-19 vaccine (Comirnaty) for adults over 65 and those susceptible to severe COVID-19 reactions. Makary also supported the approval of a second generic version of mifepristone and didn’t complete the safety review of mifepristone requested by Kennedy.
However, it should not go without mentioning that Makary took office when the regulator was already going through turmoil. After President Trump took office in January 2025, several FDA officials resigned or were fired, followed by mass DOGE layoffs.
Advancements in Pharmaceuticals
Despite staff setbacks, Makary accomplished major milestones toward his goals of faster drug approval and more regulatory transparency. The FDA published complete response letters for new drug applications and biologics license applications to increase transparency and allow sponsors to learn from peer companies.
Makary also launched the PreCheck Program to streamline drug review and created the Commissioner’s National Priority Voucher Program to speed review of drugs that address national health priorities. Since the launch of the CNPV program in June 2025, seven drugs have been approved, with the most recent being Partner Therapeutics’ Bizengri for cholangiocarcinoma.
These advances as well as some of Makary’s transparency on deaths linked to COVID vaccines, lightening of restrictions for compounding pharmacies to use unapproved peptides, and the phasing out of damaging synthetic food dyes from the U.S. food supply have kept him in the good graces of the Trump Administration. Speaking of Makary’s resignation on social platform Truth Social, President Trump said, "I want to thank Dr. Marty Makary for having done a great job at the FDA. So much was accomplished under his leadership. He was a hard worker, who was respected by all, and will go on to have an outstanding career in Medicine."
The Future of FDA Leadership
In another statement, President Trump announced that Kyle Diamantas will take over for Makary in the short term. Diamantas is a former corporate lawyer who served as deputy commissioner of food for the FDA. Kennedy is already reportedly screening candidates for commissioner.
With all this upheaval, we must wonder what the future of Makary’s Precheck, CNPV and CRL policies will be. Will these programs see continued support and vigor, and will the fast track of important medicines continue? Or will we lose the momentum and more motivated, qualified drug leaders because of a need to support candy flavored lung irritant?