Reuters, July 9 – The FDA called for an independent government investigation of its representatives’ interactions with Biogen Inc (BIIB.O) that led to the approval of the company’s Alzheimer’s disease medicine last month. The drugmaker’s stock dropped 3% after acting commissioner Janet Woodcock requested the Department of Health and Human Services’ Office of Inspector General to look into whether the talks were in violation of the regulator’s standards. The inspector general’s office is entrusted with uncovering waste, fraud, and abuse within the organization. It hires federal agents who undertake criminal investigations and conducts audits and reviews to help track the efficacy of HHS Department initiatives. The inspector general’s findings are likely to result in FDA management recommendations. Some employees may face disciplinary action as a result of them. If criminal behavior is suspected, the inspector general has the authority to report the case to the Justice Department for possible prosecution. Biogen stated that it will cooperate with any investigation into a potential review. The FDA approved Aduhelm on June 7 amid considerable opposition from the FDA’s expert advisory panel, which resulted in the resignation of three of the panel’s 11 members. In a statement released on Twitter, Woodcock stated, “There continue to be concerns raised… regarding contacts between personnel from Biogen and FDA during the review process.” (https://bit.ly/3jY9wV3bit.ly) Woodcock, on the other hand, expressed “extreme trust” in the integrity of the professionals involved in the drug review. Despite the fact that one of Aduhelm’s two large-scale clinical trials failed to show a benefit to patients, the drug was approved. The decision was made largely on evidence that it can reduce brain plaques, which are a known component to Alzheimer’s disease, rather than proof that it slows the illness’s progression. The latest revelation, according to Stifel analyst Paul Matteis, is unlikely to have an influence on Aduhelm’s standing as an approved medicine. “Dr. Woodcock’s letter appears to be more of a ploy to relieve pressure on FDA, since it focuses on the nature of interactions/discussions rather than the basis of the final decision,” he noted. Memos disclosed by the FDA last month revealed a clear internal fight ahead of the controversial approval of Aduhelm. Agency regulators cleared the medicine under its fast approval procedure, which required a study to confirm that the drug works as planned, after months of internal deliberation. find out more Manas Mishra contributed reporting, with Sarah Lynch contributing additional reporting; Arun Koyyur and Maju Samuel edited the piece. The Thomson Reuters Trust Principles are our standards./n
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