Reacting to the controversial approval of the Biogen (BIIB) Alzheimer’s drug, a leading advocacy group is urging the Biden administration to request resignations from or remove three top Food and Drug Administration officials, including acting agency commissioner Janet Woodcock.
The approval “showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency,” Public Citizen wrote in a June 16 letter to Department of Health and Human Services Secretary Xavier Becerra.
“The primary beneficiaries of the agency’s action are Biogen and its shareholders, who undoubtedly are ecstatic about their soon-to-be-reaped windfall profits from sales of the company’s exorbitantly priced but ineffective drug. The damage caused by the FDA’s reckless approval to the agency’s credibility as a science-based regulatory agency and to public health… cannot be overstated.”
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