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.”
Shalala joins a chorus of advocates and academics demanding answers on the close relationship between Billy Dunn, head of the FDA’s neuroscience division, and Biogen executives in the run-up to the approval of the drug, called Aduhelm. Public Citizen, the progressive advocacy group founded by Ralph Nader, cited the STAT reporting in a renewed call for an OIG investigation, as did Yale University public health professor Gregg Gonsalves. [Continue reading…]