FDA Commissioner Marty Makary defended recent drug rejections, saying he works for the public and stands by agency scientists under mounting criticism.
U.S. Food and Drug Administration Commissioner Marty Makary defended the agency’s recent drug approval decisions in a CNBC interview aired Tuesday, pushing back against criticism that has intensified around several high-profile rejections.
The pressure has focused in part on the FDA’s rejection of a melanoma drug candidate from Replimune, a decision that has drawn public objections from the company and sharp commentary from outside the agency. Replimune representatives have said the FDA treated the company unfairly.
Makary rejected the idea that the agency should bend to pressure from companies or commentators. Referring to a Wall Street Journal opinion piece that criticized him and cited the Replimune decision, Makary told CNBC’s David Faber, “I don’t work for Replimune, I work for the American people, and I stand by the scientists at the FDA.”
The commissioner said three independent teams reached the same conclusion on the matter, and he said the agency has not made “corrupt sweetheart deals.” His comments came after Bloomberg News reported on “paranoia, turmoil and backlash” at the FDA during his tenure, and after the Journal opinion piece questioned whether any administration official had created more problems for President Donald Trump than Makary.
Makary framed the issue as a question of whether political leaders should overrule scientific reviewers inside the FDA. He said he stands behind the agency’s review teams and argued that commissioners stepping over staff scientists has gone badly in the past.
He pointed to the FDA’s approval of the Alzheimer’s disease drug Aduhelm and its clearance of a Covid-19 vaccine booster for young, healthy children as examples of decisions he views as cautionary.
The interview leaves the dispute unresolved: Makary is defending the agency’s process and scientists, while Replimune has maintained that it was unfairly treated. The next test for the FDA will be whether the commissioner’s public defense eases criticism or deepens scrutiny of how the agency is handling contested drug reviews.
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