FDORA 2022 accelerated approval reforms
A December 2022 US law that lets the FDA insist the confirmatory trial for an accelerated approval is already running before the drug is approved, and gives it a quicker way to withdraw a drug when confirmation fails.
Overview
United States, federal statute. The Food and Drug Omnibus Reform Act (FDORA) was enacted on 29 December 2022 as part of the Consolidated Appropriations Act, 2023 (Public Law 117-328). Its accelerated approval title amended section 506(c) of the Federal Food, Drug, and Cosmetic Act. Primary text: the Congress.gov record of H.R.2617.
What it changed: the FDA may now require that confirmatory studies be underway before it grants an accelerated approval, may set enrolment targets and milestones, receives progress reports every 180 days, and has an expedited procedure for withdrawing an indication when the confirmatory trial fails or is not conducted with due diligence. It also created an Accelerated Approval Council inside the agency. The reforms followed a decade in which several oncology indications sat on accelerated approval for years without confirmation, the 'dangling' approvals reviewed by the Oncologic Drugs Advisory Committee in April 2021, and the Aduhelm controversy in Alzheimer's disease.
The arguments: sponsors warn that requiring a confirmatory trial to be enrolling at approval is hard when the approved drug then becomes standard of care and patients decline randomisation; the FDA's Oncology Center of Excellence answers that a randomised confirmatory trial started before approval is exactly what protects patients from years of uncertainty, and Project Confirm publishes the status of every oncology accelerated approval. Other FDORA titles addressed clinical trial diversity action plans, decentralised trials and cosmetics regulation.
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