The Food and Drug Administration's acting commissioner has called for a watchdog probe of her agency's dealings with the drugmaker Biogen prior to last month's accelerated approval of a new Alzheimer's therapy from the company.
The decision to greenlight Aduhelm has drawn widespread scrutiny, and came over the objections of independent advisers to the FDA and other experts who said there was little evidence of its effectiveness. STAT reported that FDA officials worked with Biogen executives to help get the drug, which has an annual cost of $56,000, on the market.
The review by the Department of Health and Human Services inspector general will establish “whether any interactions that occurred between Biogen and FDA review staff are inconsistent with FDA policies and procedures,” acting commissioner Janet Woodcock wrote in a letter made public Friday. It would also assuage concerns about any kind of inappropriate relationship between the agency and a company it regulates, Woodcock wrote.
Backstory: The decision to approve Aduhelm stirred heated debate among public health experts and private insurers. Critics, including some within FDA, have argued that the late-stage clinical trial data did not demonstrate that the therapy was effective. On Thursday, the FDA reversed its initial decision on how to label Aduhelm. Instead of an approved usage for all patients with Alzheimer’s, it is now indicated only for those in the earliest stages of the disease.
What’s next: Public Citizen has also called for an independent investigation of the FDA’s collaboration with Biogen. Last month, two congressional committees also launched their own investigation into the decision to approve the drug.
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July 10, 2021 at 01:11AM
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FDA chief calls for probe of relationship between agency and Biogen - POLITICO
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