A joint investigation released Thursday by House Democrats identified unusual collaboration between Food and Drug Administration officials and Alzheimer’s drugmaker Biogen, highlighting potential problems in the agency’s approval of the controversial drug Aduhelm.
The House Energy and Commerce and Oversight and Reform committees concluded their findings “raise serious concerns” about the drug’s approval process.
“The number of patients and families impacted by Alzheimer’s disease will continue to increase, and it is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust,” Oversight and Reform Chair Carolyn B. Maloney, D-N.Y., said in a statement, calling the report a “wake-up call” for the FDA.
