Becker's Healthcare January 15, 2025
A new report from HHS’ Office of Inspector General raises concerns about the FDA’s accelerated approval process for drugs with weak supporting evidence, Bloomberg reported Jan. 14.
The report highlights issues with the approvals of Biogen’s Alzheimer treatment, Aduhelm; Serepta Therapeutics’ Duchenne muscular dystrophy therapy, Exondys 51; and Covis Pharma’s preterm birth prevention treatment, Makena.
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with...
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