HHS OIG highlights flaws in three accelerated approvals

An HHS Office of Inspector General report about FDA’s use of the accelerated approval pathway found procedural anomalies in the agency’s approvals of three drugs, but didn’t uncover malfeasance or systemic problems.

The OIG recommended that FDA institute better record-keeping for interactions with drug sponsors, and set criteria that would increase the number of accelerated applications considered by the agency’s accelerated approval council. FDA accepted the former recommendation and rebuffed the latter...