Every drug marketed in the US goes through an FDA review process for approval. Priority review (PR) means the FDA’s plans to take action on the application within 6 months (compared to 10 months under standard review).
With the 1992 Prescription Drug User Act, the FDA agreed to improve drug review time through a two-tiered system of standard and priority review.1
PR is the FDA’s attempt at nurturing the innovation ecosystem and ensuring patients’ timely access to life-saving treatments.
PR directs attention and resources to evaluating applications for drugs that would yield improvements in the safety or effectiveness of the treatment, when compared to standard therapies. Significant improvement can be demonstrated by: increased effectiveness in treatment, prevention, or diagnosis, elimination or substantial reduction of a treatment-limiting reaction, enhancement of patient compliance or evidence of safety and effectiveness in a new subpopulation. FDA decides on the review designation for every application but PR can be requested. FDA informs the applicant of a PR within 60 days of receiving the Biologic License Application, New Drug Application or efficacy supplement. Designation of a drug as “priority” does not change standards for approval, the quality of evidence necessary or affect the length of the clinical trial period.1
In a Government Accountability Office report on FDA expedited pathways, they found that of the 637 new drugs applications submitted from fiscal year (FY) 2014 through FY 2018 only 32% had a PR designation.2
The FDA has shortened its review times from more than 3 years in 1983 to less than 1 year in 2017. However, PR does not alter the timing for a drug's development, which remains at approximately 8 years.3
Priority Review. U.S. Food and Drug Administration. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review.
FDA Approval. Washington, D.C.: Government Accountability Office; 2020. https://www.gao.gov/assets/gao-20-244.pdf.
Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983-2018 [published correction appears in JAMA. 2020 Feb 11;323(6):573]. JAMA. 2020;323(2):164-176. doi:10.1001/jama.2019.20288