HHS extends Aduhelm investigation into the accelerated approval pathway, wading into a brewing controversy
The government investigation into how the FDA approved Aduhelm appears to point well beyond the agency’s ties with Biogen in the leadup to its approval of their controversial Alzheimer’s drug Aduhelm.
The HHS Office of Inspector General posted a notice Wednesday that officials will review the accelerated approval pathway, the regulatory mechanism the agency used to approve the drug in the face of conflicting data over whether it could actually slow Alzheimer’s patients’ mental decline. Now the Aduhelm OK is just one branch of an investigation called for last month by acting FDA commissioner Janet Woodcock.
Read the Full Article!
Tags
bioethics health law policy pharmaceuticals public health rachel sachs regulation