Drugs

OIG Faults 3 of 24 FDA Accelerated Approvals

The HHS Office of Inspector General (OIG) says its review of a sample of 24 drugs approved via the FDA Accelerated Approval pathway identified concerns with three of the approvals. The OIG report says that because accelerated approval does not require that a drug demonstrate a clinical benefit before it is approved, there is a risk that an accelerated approval drug will not ultimately provide a clinical benefit for patients, necessitating safeguards and transparency in agency decision-making.

The three drugs for which the OIG raises concerns are aducanumab (Biogen’s Aduhelm), eteplirsen (Sarepta’s Exondys 51), and hydroxyprogesterone caproate (Covis Pharma’s Makena).

For two of the three approvals (Aduhelm and Exdonys 51), OIG says, FDA evaluated analyses not included in the sponsor’s original analysis plans, deviating from recommended practices. All three of the drugs were approved despite concerns from agency medical reviewers and/or advisory committees, it says. And for Aduhelm, some meetings with Biogen appeared to be missing from the administrative file and other meetings were not fully documented.

“Additionally,” the report says, “two of the three drugs that raised concerns (Aduhelm and Makena) are now off the market and completion of the confirmatory trial for the third drug is delayed.”

The OIG recommends that FDA strengthen guardrails in certain circumstances to ensure appropriate and consistent use of the accelerated approval pathway. It says the agency should:

define specific factors that would require FDA’s accelerated approval council (agency executive leadership from several Centers) to advise on certain drug applications; and
take steps to ensure that appropriate documentation of meetings with sponsors is included in drug approval administrative files.

OIG reports that FDA concurred with the second recommendation but did not concur with the first.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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