FDA Head Seeks IG Probe Of Biogen Alzheimer's Drug Talks

Law360 (July 9, 2021, 6:59 PM EDT) -- The acting head of the Food and Drug Administration said Friday that she had asked for an investigation into conversations between members of her agency and Biogen representatives prior to the FDA's approval of the company's Alzheimer's treatment aducanumab.

Following Thursday's announcement that the FDA would rein in the recommended patient population for aducanumab, also known by the brand name Aduhelm, acting Commissioner Janet Woodcock sent a letter to the U.S. Department of Health and Human Services' Office of Inspector General seeking an independent review and assessment of all interactions between the Biogen reps and her office.

She asked the watchdog...

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