Biogen Faces FDA Probe of Alzheimer’s Drug Approval; Stock Falls
- FDA’s acting chief seeks HHS inspector general investigation
- Company, agency staff said to have met often before approval
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The head of the U.S. Food and Drug Administration said she is seeking a federal investigation of the approval of the Biogen Inc. Alzheimer’s disease drug Aduhelm, a highly unusual step that will increase scrutiny of a heavily criticized clearance.
In a letter posted on Twitter, Janet Woodcock, the agency’s acting commissioner, said she was requesting an independent review of whether any interactions between Biogen and FDA staff were inconsistent with the agency’s policies and procedures. The inspector general for the Department of Health and Human Services would undertake the probe.