January 3, 2023
Life Sciences
  • The House Oversight and Energy and Commerce committees released a report revealing that the Food and Drug Administration’s (FDA) approval for Alzheimer’s drug Aduhelm was “rife with irregularities.” According to the 18-month investigation, officials didn’t follow the agency’s own guidance and improperly collaborated with drugmaker Biogen – engaging in at least 115 “atypical” meetings, calls, and substantive email exchanges over a 12-month period. The committees recommended corrective steps to regulatory reviews, such as ensuring that all substantive FDA interactions with drug companies are properly documented and establishing a protocol for joint FDA-drug sponsor briefing documents for advisory committees. (Articles here, here, here, and here; Report here)