For drugs granted accelerated approval, the treatment is approved based on limited data, based on surrogate measures that aims to predict meaningful clinical benefits for the patients. The FDA has received critique for the follow-up of the compliance of such studies, and as a result the Food and Drug Omnibus Reform Act (FDORA), signed December 29, 2022, introduced a drug reform addressing the criticised issues in the Accelerated Approval pathway.

FDORA amends FDA’s accelerated approval process for drugs and biologics by:

  • Allowing FDA to require the sponsor to have confirmatory clinical trials underway before accelerated approval is awarded.
  • Requiring sponsors of products granted accelerated approval to submit progress reports for post-approval studies to FDA every six months. Information from the progress reports must be publicly available on the FDA website.
  • Giving FDA the option to use expedited procedures to withdraw approval if the confirmatory trail fails to verify the product’s clinical benefit.
  • Requiring FDA to post the rationale for any decision not to require a post-approval study in connection with an accelerated approval.
  • Ordering the establishment of an intra-agency Accelerated Approval Council with senior official members from various FDA centers and divisions, including the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), to “ensure the consistent and appropriate use of accelerated approval” across the agency by engaging directly with product review teams which may include providing training and developing guidance. The Council must meet at least three times a year and publish an annual report detailing its activities.

Using surrogate endpoints can create uncertainties in translation into clinically meaningful outcomes for patients. Therefore, confirmatory results are critical to substantiate the earlier access and this reform authorizes FDA to require the post-approval conditions to be met.

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