US FDA’s Most Controversial Drug Approval Decisions, From A To Z

05 Jun 2021

With action imminent on Biogen’s Alzheimer’s drug aducanumab, the Pink Sheet looks back at 10 of FDA’s most controversial drug approval decisions, from Addyi to Zohydro.

FDA approval controversies (photo illustration) — During a controversial review, sometimes all sides have pitchforks out at the US FDA. (Pitchforks not shown.) • Source: Photo illustration/Alamy, Shutterstock images

The US Food and Drug Administration’s imminent action on Biogen Pharma and Eisai Co., Ltd.’s Alzheimer’s drug aducanumab is bound to be controversial, regardless of whether the agency approves the biologics license application or issues a complete response letter.

Questions about the robustness of the efficacy data, internal FDA disagreement on the application’s merits, harsh advisory committee criticism of...