First Biogen, now the FDA: Congressional Democrats request agency records over Aduhelm's approval

Months after two high-ranking Democrats demanded Biogen answer for concerns shrouding its controversial Alzheimer’s drug Aduhelm, the lawmakers are now turning their aim toward the FDA.

In a letter sent to the agency’s interim commissioner Janet Woodcock, M.D., the chairs of two leading House committees—Rep. Carolyn Maloney, D-New York, and Rep. Frank Pallone Jr., D-New Jersey—demanded the FDA produce additional data and documentation supporting its accelerated approval for the drug.