Stewart Kameen Provides Insight on OIG Decision to Review FDA Approval Pathway Process

August 10, 2021
Pink Sheet

Bass, Berry & Sims attorney Stewart Kameen provided insight on the announcement by the U.S. Health and Human Services (HHS) Office of Inspector General (OIG) to assess the Food and Drug Administration’s (FDA) accelerated approval pathway. This process was recently used by the FDA to review and approve Biogen’s Alzheimer’s drug treatment Aduhelm and was the only example cited in the OIG announcement about the review.

Stewart said the description of the review suggests that the focus is going to be on Aduhelm as a “case study, as it were, for the process.” A review will usually result in a report with recommendations for corrective actions, whereas an investigation could result in administrative, civil and criminal penalties.

Stewart is a former senior counsel in the Office of Counsel to the Inspector General-Industry Guidance Branch at HHS OIG.

The full article, “Beyond Aduhelm: OIG Review Will Put FDA’s Entire Accelerated Approval Program Under Microscope,” was published August 4 by Pink Sheet and is available online (subscription required).