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.
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.
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