Biogen Alzheimer's drug: Former FDA adviser calls for wider probe into approval
New Delhi: A federal probe of the U.S. Food and Drug Administration's approval of a controversial new Alzheimer's disease drug should look into why that decision was made without clear evidence of patient benefit, a former adviser to the agency said on Tuesday.
Acting FDA Commissioner Janet Woodcock earlier this month asked the Office of the Inspector General at the Department of Health and Human Services to investigate whether FDA representatives' interactions with drugmaker Biogen Inc were inconsistent with agency policies.
"I happen to think that there's a lot more to investigate than just that," said Dr. Aaron Kesselheim of Harvard-affiliated Brigham and Women's Hospital, who resigned as a member of the FDA advisory panel that reviewed and voted against approval of Biogen's drug prior to the FDA green light.
Speaking at a live event presented jointly by The Forum at the Harvard T.H. Chan School of Public Health and Reuters, he said more information is needed on FDA's role in Biogen's evaluation of clinical trial data, as well as why the agency decided to base its approval on a "surrogate" biomarker rather than the drug's impact on cognitive function.
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