Report highlights flaws in FDA rapid approval of Alzheimer drug

A new report from the U.S. Department of Health and Human Services’ Office of the Inspector General (OIG) highlights flaws in the U.S. Food and Drug Administration’s (FDA) Accelerated Approval Pathway, a program that allows for earlier approval of drugs that treat serious conditions.

Bloomberg was the first to cover the news, with the OIG focusing on specific examples of drugs approved for use that are later shown to have problems related to efficacy and safety, including Biogen’s Alzheimer's medication, Aduhelm; Sarepta Therapeutics' muscular dystrophy treatment, Exondys 51; and Covis Pharma's birth control, Makena.

According to the OIG, each drug’s approval was linked to process issues and record-keeping at the FDA. For example, the OIG said the FDA reported only 13 meetings with Biogen related to the approval of their therapy, while Congress has a record of more than 40 interactions, which may signal there were concerns over the use of the medication.

However, that remains unclear, as the FDA failed to properly document meetings and many summary filings were incomplete. The OIG notes the Biogen drug was later removed from the market due to safety concerns, although it's uncertain if the FDA had identified some of these concerns in advance of approval.

Accelerated approval is designed to improve patient access to novel treatments, but the OIG raises concerns that proper regulatory oversight may not be in place.

Read the full coverage from Bloomberg at the link below.