21 U.S.C. § 356–2 — Accelerated approval Council

(1) In general: Within 1 year after December 29, 2022, the FDA Secretary must set up a Council inside the Food and Drug Administration. Its job is to make sure the FDA uses "accelerated approval" the same way across the agency, as described in section 356(c). (2) Membership: The Council is made up of senior FDA leaders, or someone each one picks to represent them. Members include: (A) the Director of the Center for Drug Evaluation and Research; (B) the Director of the Center for Biologics Evaluation and Research; (C) the Director of the Oncology Center of Excellence; (D) the Director of the Office of New Drugs; (E) the Director of the Office of Orphan Products Development; (F) the Director of the Office of Tissues and Advanced Therapies; (G) the Director of the Office of Medical Policy; and (H) at least 3 directors from review divisions or offices that oversee accelerated-approval products, including at least one from the Office of Neuroscience. (3) Duties of the Council: (A) Meetings: The Council must meet at least 3 times a year to discuss accelerated approval, including how different disciplines can work together on product review. (B) Policy development: The Council works directly with product review teams to keep accelerated approval use consistent. This can include (i) writing guidance and best practices for review teams, including on how sponsors and the FDA should communicate and how products under accelerated approval get reviewed; (ii) training review teams; and (iii) advising review divisions on best practices for developing, reviewing, and withdrawing accelerated-approval products. (4) Publication of a report: Within 1 year after December 29, 2022, and every year after that, the Council must publish a report on its activities on the FDA's public website.