NEW YORK — Robert Califf, the new head of the Food and Drug Administration, admitted Thursday that the agency’s controversial approval of the Alzheimer’s drug Aduhelm has diminished its standing with experts.
“It’s pretty clear that the controversy around this has temporarily impacted the trust in the FDA by people who pay attention to these things,” Califf said during STAT’s Breakthrough Science Summit. He added, however, that he doesn’t feel the broader public has lost trust in the FDA.
Califf largely declined to explain how he plans to deal with the continued fallout of the Aduhelm approval or how he plans to win back trust among critics of the decision. Both Congress and a federal watchdog are investigating the approval after a STAT investigation found that regulators closely collaborated with Biogen to approve the drug, despite the fact that it failed its Phase 3 trial.
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