FDA chief calls for investigation into Biogen Alzheimer's drug approval process
The FDA approved Biogen's Aduhelm in early June
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The acting commissioner of the Food and Drug Administration (FDA), Janet Woodcock, is calling for an investigation into communications between Biogen representatives and doctors within the agency ahead of the decision to approve the company's controversial Alzheimer's drug.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| BIIB | BIOGEN INC. | 202.46 | +0.47 | +0.23% |
The FDA OK'd Aduhelm in early June using Accelerated Approval, which allows for drugs targeted at serious conditions that fill an unmet medical need to be approved "based on a surrogate endpoint." The decision ultimately resulted in the resignation of three members of an FDA expert panel who had advised against approving the drug. Since then, the reception of the drug, which marked the first Alzheimer's treatment approved in nearly 20 years, has been mixed.
Woodcock said while it's "inevitable" that some FDA decisions will lead to controversy and that she has "tremendous confidence in the integrity of the staff and leadership" involved in the approval process, a review would help assuage some of the public's concerns.
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"There continue to be concerns raised, however, regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process," Woodcock said in a letter posted online Friday. "To the extent these concerns could undermind the public's confidence in FDA's decision, I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures."
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Woodcock closed the letter by pledging her "personal commitment" that the agency would cooperate with any investigation.
Her surprising move comes one day after the agency approved new prescribing measures likely to limit the use of the drug, which is intended for use in patients with early or mild Alzheimer's.