The latest turmoil within Commissioner Marty Makary’s Food and Drug Administration, an alleged bribery scandal involving a high-level official, is no anomaly. The Sunday resignation of the Center for Drug Evaluation and Research’s Dr. George Tidmarsh, handpicked by Makary, reveals a pattern of obstructionism and chaos, as well as an antipathy toward green-lighting new therapies, within the nation’s top drug safety agency.
Aurinia Pharmaceuticals sued Tidmarsh for an exchange it claimed was a pay-to-play offer, as well as for disparaging its FDA-approved drug, voclosporin, in posts made on LinkedIn. The result was a $350 million loss of market value, all tied to a personal grudge between Tidmarsh and a former colleague.
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Makary’s house is badly out of order, and as the Wall Street Journal noted in a recent editorial, taking accountability doesn’t seem to be in the cards. The agency has been under fire for months over its sharp decline in drug approvals and delays, which has served as a wet blanket of sorts for a biomedical industry already dealing with high levels of uncertainty around President Donald Trump’s tariffs and executive orders on drug pricing.
A report from RBC Capital Markets outlined that on-time drug approvals are down at least 14% from 2024, and delays have more than tripled. For patients dealing with novel illnesses that lack proven cures, new treatments are about the only glimmer of hope. That might be why the Wall Street Journal was so forceful in its rebuke of Vinay Prasad, director of the Center for Biologics Evaluation and Research, and Makary for their role in not clearing an experimental treatment from Replimune, or RP1, an immunotherapy for metastatic melanoma.
Melanoma is expected to claim thousands of lives by year’s end. The RP1 trials demonstrated a total disappearance of tumors in one of six patients and reductions in virtually all. Of course, that has not spurred any urgency from Prasad or Makary, who have been busy podcasting about their gripes with newspapers that dare to point out the obvious: that Makary runs the FDA and can’t credibly blame anyone else.
Prasad and the now-ousted Tidmarsh are aligned in their disinterest in a robust, accelerated approval pipeline for new treatments. Tidmarsh was hired by the FDA the same month it revamped its denial process under the guise of “radical transparency.”
Radical predictability would be better, not just for the drug developers investing millions of dollars in breakthroughs, but also for the patients whose lives hang in the balance in the interim. Whether it’s the RP1 saga or the FDA’s hand-wringing over a new cell therapy to treat Duchenne muscular dystrophy, the goal posts are perpetually moving.
That is because the “Make America Healthy Again” movement, which helped usher in Trump and Robert F. Kennedy Jr. to head the Health and Human Services Department, is a coalition of pharmaceutical skeptics and naturalists who see speedy approvals as inherently problematic. That makes what happened with Tidmarsh even more unsurprising.
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For all the hostility toward the European Union found within the Trump administration, it keeps bringing in people who reflect the thinking behind Europe’s “precautionary principle,” a risk-averse posture that’s crippled the EU on tech innovation and risks doing the same to U.S. medical breakthroughs. That exact mode of thought is the FDA’s current operating system.
If that mindset calcifies under Makary’s leadership, the United States risks forfeiting its status as the world’s premier engine for medical innovation. It might have happened already.
Stephen Kent is the media director for the Consumer Choice Center. Follow him @stephenkentX.