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FDA chief calls for probe of talks between agency and Biogen before Alzheimer’s drug was approved

Janet Woodcock, the acting commissioner of U.S. Food and Drug Administration, said on Friday she is calling for an investigation into links between FDA staff and pharmaceutical company Biogen prior to the agency’s approval of a controversial Alzheimer’s drug

“Given the ongoing interest and questions, today I requested that [the Office of Inspector General at the U.S. Department of Health & Human Services] conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm,” Woodcock wrote on Twitter. 

Aduhelm, the brand name of the Biogen drug, was approved a month ago by the FDA, making it the first new drug for Alzheimer’s disease in nearly 20 years cleared for commercial use by government health officials. 

The approval came despite warnings from independent advisers that the controversial treatment hasn’t been shown to help slow the brain-destroying disease. Three of FDA’s outside advisers resigned over the decision, while one prominent Harvard University expert called it the “worst drug approval decision in recent U.S. history.”

“There continue to be concerns raised, however, regarding contacts between representatives of Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process,” Woodcock wrote in a letter addressed to Christi Grimm, the acting inspector at the Department of Health’s Office of Inspector General. 

A Biogen spokesperson said they would cooperate with any investigation. “We will, of course, cooperate with any inquiry in connection with a possible review of the regulatory process,” the company said in a statement to CBS MoneyWatch.





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