Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug

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WASHINGTON — Former health secretary Donna Shalala called for a federal investigation into the Food and Drug Administration’s polarizing approval of a Biogen treatment for Alzheimer’s disease, citing STAT’s revelation Tuesday that regulators were far more closely aligned with the company than previously disclosed.

“When you see a report like this, you have to investigate it,” said Shalala, a former member of Congress who led the Department of Health and Human Services under President Clinton. “You cannot hesitate and you can’t do it with your general counsel. You’ve got to send in the Office of Inspector General. I mean, you shouldn’t hesitate for one second.”

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