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 Biogen, but congressional investigations revealed at least 40. Some meeting summaries were also found to be incomplete, according to Bloomberg.
While Adulhelm and Makena were withdrawn from the market due to safety concerns, Exondys 51 remains available despite doubts about its clinical benefits.
The accelerated approval pathway, which aims to provide faster access to drugs addressing unmet medical needs, has been criticized for allowing drugs to remain on the market without conclusive evidence of improved patient outcomes, Bloomberg reported.
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