Is “Accelerated Approval” the way to go? This debate was amplified in part by the agency’s controversial approval in June 2021 of the Alzheimer’s disease drug aducanumab (Aduhelm), whose high price and unclear benefits highlighted key challenges associated with the accelerated-approval process and reignited criticisms of the program.

The program was created in 1992, largely in response to the HIV/AIDS epidemic. This pathway is now used primarily for oncology products. Sponsors sometimes miss deadlines for confirmatory trials, or such trials don’t show evidence of benefit. Despite these problems, there are few constraints on the prices that companies can set for products granted accelerated approval. The FDA has started responding to some of the criticisms of the program; for example, between December 2020 and May 2022, it withdrew the approvals of 14 cancer indications for drugs after manufacturers failed to complete follow-on trials. The Accelerated Approval Integrity Act of 2022 would provide the FDA with more authority. The bill would require manufacturers to work with the FDA before a product is approved to design required confirmatory studies, and it would authorize the FDA to require that these trials be underway before approval. It would also expand the set of conditions under which the FDA may use expedited procedures to withdraw products from the market to include cases in which “the sponsor fails to achieve agreed upon enrollment targets, milestones, or timely study completion.”1

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Disclaimers

  • The material in these reviews is from various public open access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred

References

  1. Sachs, R. E., Donahue, J. M., & Dusetzina, S. B. (2022, July 6). Accelerated Approval — Taking the FDA’s Concerns Seriously. New England Journal of Medicine. https://www.nejm.org/doi/pdf/10.1056/NEJMp2204487