FDA Commissioner Marty Makary’s missteps led to his ouster

CONTENTS

Out of Step with the Science and Time

WASHINGTON, D.C. — According to a new report in the Wall Street Journal, “President Trump has signed off on a plan to fire Food and Drug Administration Commissioner Marty Makary, according to people familiar with the matter, following a tumultuous period for the regulator that included clashes over vaping, abortion and drug policy.”

Top members of the administration have become “increasingly convinced” Makary’s tenure has run its course and undermined the President’s agenda for U.S. biotech and healthcare leadership in the world.

The Consumer Choice Center‘s media director, Stephen Kent, reacted to the WSJ report, saying:

“Makary has been in open opposition to the White House since at least August 2025, when he rehired Dr. Vinay Prasad as director of the Center for Biologics Evaluation and Research. Prasad was at the center of a string of biotech delays, denials and regulatory confusion, and the result of that has been significantly less investment in cutting-edge cures by U.S. pharmaceutical firms.”

Denies and Delays

President Trump has recently been angry with Makary for not moving quickly to approve flavored vapes and other nicotine alternatives, which have received the broad support of Robert F. Kennedy Jr. as part of the administration’s harm-reduction efforts to offer a safer alternative to combustible cigarette smokers.  

“After the bribery scandal involving Makary’s hand-picked leader for the Center for Drug Evaluation and Research, Dr. George Tidmarsh, the clock has been ticking for Marty Makary at FDA. Makary’s FDA imported the slow-moving culture of the European Union and their ‘precautionary principle’, which has amounted to hundreds of millions lost in the biotech sector as approval processes for drugs slowed down by 14% from 2024. Real patients die waiting for new treatments to come to market, and it looks like Trump has had enough. Join the club,” said Kent.

A New Drug War No One Asked For

Commissioner Makary was also instrumental in the panic policy surrounding the kratom alkaloid 7-OH, which he urged to immediately schedule as a class one narcotic back in July of 2025, a re-scheduling that would impact millions of Americans.

“What’s more, his rash decision to call on the DEA to list 7-Hydroxymitragynine (7-OH) as a Schedule One controlled substance, without any public input or scientific basis, was highly suspect. When millions of American patients use a substance as an alternative to opioids and for pain relief, they deserve a regulatory framework rather than a new prohibitionist policy,” added Yaël Ossowski, deputy director of the Consumer Choice Center.

“Makary’s exit signals a lot about the future of health policy in Washington, and the next leader should aim to implement President Trump’s agenda rather than their own,” concluded Ossowski.

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