FDA seeks probe into Biogen discussions

The U.S. drug regulator on Friday called for an independent federal probe into the interactions between its representatives and Biogen Inc. that led to the approval of the firm’s Alzheimer’s disease drug last month.

The drugmaker’s shares fell three per cent after the Food and Drug Administration’s acting commissioner, Janet Woodcock, asked the Office of the Inspector General at the Department of Health and Human Services to probe if the talks were inconsistent with the regulator’s policies.

The inspector general is an internal watchdog office tasked with rooting out waste, fraud and abuse. It conducts audits and evaluations to help track the effectiveness of HHS Department programs and employs federal agents who conduct criminal investigations.

The inspector general’s findings are likely to lead to recommendations for FDA management. They could potentially also lead to discipline for some staffers. If criminal behaviour is suspected, the inspector general can potentially refer the matter for possible prosecution to the Justice Department.

Biogen said it will co-operate with any inquiry in connection to a possible review.

The drug, Aduhelm, was approved by the FDA on June 7 despite strong objection from its expert advisory panel, resulting in the resignation of three of the 11 members.

“There continue to be concerns raised … regarding contacts between representatives from Biogen and FDA during the review process,” Woodcock said in a letter posted on Twitter.

Woodcock, however, said she had “tremendous confidence” in the integrity of the staff involved in the review of the drug.

Aduhelm was approved despite one of its two largescale clinical trials failing to show a benefit to patients.

The move was based on evidence that it can reduce brain plaques, a likely contributor to Alzheimer’s disease, rather than proof that it slows progression of the lethal mind-wasting disease.

Stifel analyst Paul Matteis said the latest development was unlikely to impact Aduhelm’s status as an approved drug.

“Dr. Woodcock’s letter appears to be more of a manoeuvre to alleviate pressure on FDA and it centres around the nature of interactions/discussions, not the actual essence of the approval decision,” he said.