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

 
• By Sue Sutter

Following accelerated approval of Biogen’s Alzheimer’s drug aducanumab in the US, we look back at 10 of the 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 • Source: Photo illustration/Alamy, Shutterstock images

The US Food and Drug Administration’s decision to grant conditional approval to Biogen Pharma and Eisai Co., Ltd.’s Alzheimer’s drug aducanumab has been met with mixed responses. 

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

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