A top official at the U.S. drug regulator on Friday called for a federal probe into the interactions between the agency's representatives and Biogen Inc that led to the approval of the company's Alzheimer's disease drug last month.
Janet Woodcock, acting commissioner of the Food and Drug Administration (FDA), in a letter posted on Twitter, asked the Office of the Inspector General at the Department of Health and Human Services to probe if any interactions between FDA staff and Biogen were inconsistent with the agency's policies.
The FDA has drawn sharp criticism for its broad approval of the drug last month without proof of clear benefit against the disease.
Stat News first reported that Woodcock had called for a probe.