FDA seeks to investigate discussions with Biogen ahead of Alzheimer’s drug approval

July 9 (Reuters) – The United States Food and Drug Administration on Friday called for an independent federal investigation into its representatives’ interactions with Biogen Inc (BIIB.O) that led to the approval of the disease drug ‘Alzheimer’s disease last month.

The drugmaker’s shares fell 3% after the agency’s acting commissioner Janet Woodcock asked the Office of the Inspector General of the Department of Health and Human Services to verify whether the talks were inconsistent with the policies of the regulator.

“We have received the letter and are reviewing it for appropriate action,” Tesia Williams, spokesperson for the HHS Inspector General’s office, said in an email to Reuters.

The Inspector General is an internal oversight office tasked with eradicating waste, fraud and abuse. It performs audits and evaluations to help track the effectiveness of HHS department programs and employs federal officers who conduct criminal investigations.

The Inspector General’s findings are likely to lead to recommendations for the management of the FDA. They could also result in disciplinary action for some staff. If criminal behavior is suspected, the Inspector General has the potential to refer the case to the Ministry of Justice for possible prosecution.

Biogen has said it will cooperate with any investigation in connection with a possible review.

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

“Concerns continue to be raised … regarding contacts between representatives of Biogen and the 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 reviewing the drug.

Aduhelm was approved despite the failure of one of its two large-scale clinical trials to show any benefit to patients.

The decision was based on evidence that it can reduce brain plaques, a likely contributor to Alzheimer’s disease, rather than evidence that it slows the progression of the deadly disease that causes you to lose your mind.

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

“Dr Woodcock’s letter appears to be more of a maneuver to ease the pressure on the FDA and it focuses on the nature of the interactions / discussions, not the essence of the approval decision,” he said. declared.

Notes released by the FDA last month showed a clear struggle within the agency before its controversial decision to approve Aduhelm.

After months of internal deliberation, agency officials cleared the drug using its fast-track approval path, which required a study to confirm that the drug is working as intended.

Reporting by Manas Mishra, additional reporting by Sarah Lynch and Dania Nadeem; Editing by Arun Koyyur and Maju Samuel

Our Standards: Thomson Reuters Trust Principles.

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