The Office of the Inspector General at the Department of Health and Human Services raised concerns on Wednesday regarding what it characterized as lapses in the FDA’s judgement in granting accelerated approval to certain medications.

In a 32-page report, the Office of the Inspector General (OIG) flagged three drugs in particular—Biogen’s Alzheimer’s disease antibody Aduhelm (aducanumab), Sarepta’s Duchenne muscular dystrophy therapy Exondys (eteplirsen) and Covis Pharma’s Makena (hydroxyprogesterone caproate)—for which it said the accelerated approval process “deviated” from the appropriate pathway “in ways that raised concerns.”

The OIG identified three main avenues by which the FDA improperly granted accelerated approvals. For all three drugs, for instance, the regulator pushed through with accelerated approval “despite concerns from its own reviewers and/or advisory committees,” the report read. In addition, the FDA’s review for two of the three problematic drugs—Aduhelm and Exondys—involved data and analyses not included in the companies’ original plans.

Finally, for Aduhelm exclusively, the OIG’s investigation found that some meetings with the sponsoring drug companies were “missing” or otherwise “mentioned but not fully documented” in the regulator’s administrative files. “Although these meetings were documented as having happened, the lack of details regarding the meetings makes it difficult to determine whether the meetings contributed significantly to FDA’s decision making,” according to the report.

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