Watchdog to Review FDA's Approval Process for Biogen's Alzheimer's Drug

The Department of Health and Human Services' Office of Inspector General (HHS OIG) has announced it will review the Food and Drug Administration's (FDA) process for approving Biogen's Alzheimer's drug, Aduhelm. This decision comes after the FDA's approval of Aduhelm sparked unprecedented controversy over regulatory standards and the drug's efficacy.

The HHS OIG will specifically examine the accelerated approval pathway used by the FDA, which allows for quicker approvals of drugs treating serious conditions with unmet medical needs. This pathway was utilized for Aduhelm's approval two months ago, despite initial doubts about the drug's effectiveness based on two clinical trials. Biogen reanalyzed the data, finding a modest slowing of cognitive decline in one trial's high-dose participants, while the other trial showed no benefit.

Acting FDA Commissioner Janet Woodcock requested the OIG review, following concerns over the FDA's proactive role in assisting Biogen through the approval process, including drafting a roadmap for approval. This has raised questions about the FDA's independence and objectivity, especially after an FDA advisory panel nearly unanimously recommended against the drug's approval.

The review will also look into the FDA's interactions with external parties and the decision-making process for the accelerated approval pathway, without assessing the scientific appropriateness of the drugs reviewed. The HHS OIG aims to ensure the integrity of the FDA's drug approval process and address stakeholders' concerns regarding Aduhelm's approval.

Aduhelm's approval has significant financial and health implications, with a wholesale list price of $56,000, far exceeding the cost-effective threshold. The FDA initially issued a broad label for the drug but later narrowed it to patients with mild cognitive impairment or mild Alzheimer's. The ongoing debate over Aduhelm's effectiveness has led Medicare to consider national coverage decisions, leaving many patients and insurers in uncertainty.

The FDA has defended its approval of Aduhelm, stating it fits within the accelerated approval pathway and reflects current scientific knowledge. However, the HHS OIG's review, expected to be completed by 2023, seeks to provide clarity and ensure the integrity of the FDA's approval process.