(Reuters) -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 company Alzheimer’s disease drug last month.
Shares of the drugmaker fell 3.5% after the agency’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 Food and Drug Administration (FDA) approved the drug, Aduhelm, despite strong objection from its own expert advisory panel for Alzheimer’s disease patients, resulting in the resignation of three of the 11 members of its panel.
“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. (https://bit.ly/3jY9wV3bit.ly)
“We believe this review and assessment will help ensure continued confidence in the integrity of FDA’s regulatory processes and decision-making.”
The drug was approved in spite of the fact that one of its two large-scale clinical trials failed to show a benefit to patients.
The FDA authorized the drug 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.
Memos released by the FDA last month showed a clear struggle within the agency ahead of its controversial decision to approve Aduhelm.
After months of internal deliberations, agency officials cleared the drug using its accelerated approval pathway, which required a study to confirm that the drug works as intended.
(Reporting by Manas Mishra in Bengaluru; Editing by Arun Koyyur)
