Former HHS Secretary Calls for Investigation into FDA’s Aduhelm Approval

Former Secretary of Health and Human Services (HHS) Donna Shalala has called for an investigation into the widely criticized Aduhelm approval by the Food and Drug Administration (FDA). She notes that the Office of Inspector General (OIG) is independent of the HHS secretary and could lead to congressional action. Criticism of Biogen’s Aduhelm drug is building after STAT reported an off-the-record meeting between the company and the FDA prior to the controversial drug’s approval.

“OIG, should it find wrongdoing, can recommend a host of disciplinary actions, including monetary penalties and firing, though it is up to the HHS Secretary whether to follow those recommendations. The OIG can also refer criminal cases to the Department of Justice, although neither Public Citizen nor Shalala have alleged any criminal wrongdoing by the FDA.” Read more here.

(Source: Damian Garde and Nicholas Florko, STAT News, 6/30/21)