FDA Acting Commissioner Dr. Woodcock proposed a review of the FDA-Biogen executive's meetings in addition to a probe of the Aduhelm approval process.
On July 9, the FDA called for a government probe into the process that led to the approval of a new Alzheimer's disease drug that has sparked outrage among politicians and the medical community, reports the New York Times. The Acting FDA Commissioner Dr. Janet Woodcock ordered the Office of the Inspector General to look into communications between the U.S. agency and Biogen personnel.
In a letter issued on July 9, Woodcock said she believes it is essential that the events at issue be examined by an impartial entity such as the Office of the Inspector General. The review could establish if any contacts between Biogen and FDA review personnel were inconsistent with FDA policies and procedures, she mentioned.
Following the announcement, Biogen's stock dropped by more than 3 percent. Biogen's stock rose in June when the FDA approved the Biotech company's treatment.
The FDA's independent panel of outside experts had rejected the medication, citing weak data, and this decision represented a change from their advice. Following the agency's decision, at least three members of the panel have resigned in protest.
According to STAT News and other media sites, FDA officials reportedly took a regulatory shortcut to get clearance to get the medicines on the market faster.
Biogen's drug targets beta-amyloid, a "sticky" material in the brain that experts believe contributes to the fatal disease. Biogen halted the development of the medicine in March 2019 after an independent investigation determined that it was unlikely to function. After a few months, the company announced that the drug would be submitted for regulatory approval.
The New York Times reports that the agency's request for a probe into its own staff's decision-making process for a single medicine approval is unprecedented. On July 9, the FDA narrowed its recommendations for who should receive the drug. The agency's updated rules suggest it should only be recommended to persons with modest cognitive difficulties after prescribing it for all Alzheimer's patients.