After the Food and Drug Administration drew controversy for approving Biogens’s dementia drug Aduhelm, the acting FDA commissioner Janet Woodcock has called for an independent probe into potentially inappropriate contacts between the agency’s staff and the pharma firm, The Wall Street Journal reports.
Woodcock’s letter published on Friday shows she asked Health and Human Services Inspector General Christi Grimm to look into the allegations of misconduct- initially brought to light in a report by the health news site Stat last month – between the FDA and Biogen.
The late June report pointed to off-the-record, closed-door meetings between Biogen personnel and the head of the FDA’s neuroscience division, Billy Dunn, after which a previously denied approval for Aduhelm in 2019 by the federal regulators was overturned.
The highly controversial decision of FDA last month to approve Aduhelm prompted three of the FDA’s own scientific advisers to resign in protest, arguing that the drug had not been shown to be effective and had potentially dangerous side effects. The report also notes that none of the 11 experts tasked to review the medication voted for approval, with 10 directly in opposition and one abstaining.
FDA scaled back on Thursday its approval for Aduhelm, narrowing uses only to patients with mild forms of dementia while initially made no distinction between different stages of Alzheimer’s in approving the drug.
Woodcock acknowledged the concerns about impropriety between representatives from Biogen and the FDA during the review process, including some that may have occurred outside of the formal correspondence process, must be investigated by an independent body.
According to Stat, Inspector general’s investigation that advocacy groups, former federal health officials, and members of Congress previously called for is among the most serious types of civil investigations that can be conducted into a federal agency. According to them, it is rare for the OIG to investigate the FDA, and even more exceptional for it to investigate an individual drug approval decision.
Woodcock’s letter does not guarantee the OIG will mount an investigation since it operates independently from any federal agency, and if the office chooses to investigate the Aduhelm approval, it will publish its findings in a public report. Biogen said in a statement it would cooperate with any federal inquiry into the approval of Aduhelm.
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