A sign identifies a Biogen facility in Cambridge, Massachusetts, March 9, 2020.
Brian Snyder | Reuters
Biogen shares fell Friday after the chief of the Food and Drug Administration called for an investigation into the company’s recent approval of the company’s Alzheimer’s drug Aduhelm.
In a letter dated and published on Friday, Acting FDA Commissioner Dr. Janet Woodcock asked the independent inspector general’s office to investigate interactions between the US agency and Biogen agents prior to the drug’s approval on June 7th.
“I believe it is critical that the disputed events be reviewed by an independent body such as the Office of the Inspector General to determine whether any interactions between Biogen and the FDA investigators were inconsistent with FDA policies and procedures.” wrote.
Biogen shares fell more than 3% after the announcement.
Biogen’s stock rose last month after the FDA approved the biotech company’s drug, the first drug approved by U.S. regulators to slow cognitive decline in people with Alzheimer’s, and the first new drug against the disease for nearly two decades.
This decision was a departure from the recommendations of the agency’s independent panel of external experts, which unexpectedly refused to approve the drug last fall, citing inconclusive data. At least three members of the committee resigned in protest after the agency’s approval.
Federal agencies have faced heavy pressure from friends and family of Alzheimer’s patients to ask for the drug scientifically known as aducanumab to be expedited. STAT News and other media outlets reported that FDA officials used a government abbreviation to get approval to bring the drug to market earlier.
This is a developing story. Please check again for updates.