FDA Commissioner Makary Pushes Back on Drug Rejection Criticism
CNBC reported Tuesday that FDA Commissioner Marty Makary is pushing back hard against a growing wave of criticism directed at the agency’s recent drug rejection decisions.
Makary Addresses the Replimune Controversy
The highest-profile flashpoint has been the FDA’s rejection of a melanoma drug candidate developed by Replimune. The decision drew sharp public criticism, including repeated opinion pieces from The Wall Street Journal pressing the agency to reconsider. Makary told CNBC’s David Faber that the newspaper had run roughly nine such opinion pieces on the matter. He made clear he does not answer to the drugmaker. Speaking to Faber, he said his obligation is to the American public, not to any pharmaceutical company, and expressed full confidence in the FDA’s scientific staff.
Replimune representatives have disputed the FDA’s handling of their application, characterizing the agency’s treatment of the company as unfair. Makary rejected that framing entirely.
Background: Pressure Mounts on the Agency
The interview came as criticism of the FDA under Makary’s leadership reached a new intensity. A Bloomberg News investigation this week described an atmosphere of instability and anxiety inside the agency. Separately, a Wall Street Journal opinion piece raised the pointed question of whether any official in the current administration has generated more political difficulty for President Donald Trump than Makary himself.
The FDA commissioner has faced scrutiny not only from industry stakeholders but also from observers who question whether the agency’s review processes have become more adversarial toward drug developers under his watch.
Makary Defends the Review Process
Makary argued that three separate independent review teams reached the same conclusions on the Replimune application. He insisted no improper or politically motivated dealings had influenced any decision. He also warned that FDA commissioners who override agency scientists have historically created serious problems. He pointed to two past episodes as cautionary examples. One was the approval of Aduhelm, a controversial Alzheimer’s treatment. The other was the clearance of a Covid-19 booster vaccine for young, healthy individuals. Both decisions, he suggested, illustrated the dangers of political interference in scientific review.
What Comes Next for the FDA
The public back-and-forth between Makary and his critics shows little sign of cooling. With the Replimune situation still unresolved and broader questions about agency morale circulating, pressure on the FDA chief is likely to persist through the coming weeks. Markets and biotech investors are watching closely, as the agency’s posture toward drug approvals carries significant financial consequences across the pharmaceutical sector.
Read Next: Fed Holds Rates Steady as Trade War Uncertainty Clouds Outlook
