((A-265)) (A-265) Assessing Study Feasibility Using Trends in the FDA PMR/PMC Database: 2020-2024

Background: The United States Food and Drug Administration (FDA) is the agency responsible for protecting public health through regulation of veterinary drugs, vaccines, and other biological products. Following the approval of new drugs onto the market, certain post-marketing requirements (PMR) must be met by the drug’s sponsor under one or more statutes of regulations. For drugs that have a specific indication where the number of potential users is small, conducting a large post-marketing study such as a randomized controlled trial may not be feasible due to inadequate enrollment to reach certain statistical parameters.

Objectives: To ascertain any attributable factors that make certain indications or drug classes more likely to have good cause for noncompliance, and enhance our ability to assess the potential feasibility of a required study.

Methods: Data were accessed using the FDA’s downloadable database file for Postmarketing Requirements (PMR) and Commitments and analyzed in Microsoft Excel. The characteristics of PMRs that were released or terminated were evaluated against those that were submitted to identify potential drug classes and indications that trend more highly with termination or release, compared to submitted PMRs. Additional information on individual drugs, such as orphan and/or priority review status was accessed using the Drugs@FDA database. Drug labels were reviewed to ascertain drug class and indications. Following that, the studies that were "pending" were evaluated to identify potential candidates for release from their PMRs.

Results: For drugs approved on or after January 1, 2020, on average, 14% of PMRs/PMCs were delayed, 8% were fulfilled, 17% were ongoing, 49% were pending, 4% were released, 8% were submitted, and 0% were terminated. Each newly approved drug had an average of 4 PMRs/PMCs. Out of 1077 listed requirements or commitments for 288 drugs, only 46 were released and related to 19 different drugs. Of the 19 drugs where at least one requirement or commitment was released, 6 (32%) were due to discontinued marketing of the product.

Conclusions: The bulk of required postmarketing studies are either pending or delayed. Roughly 1/3 of studies that were released were due to discontinued marketing of the drug. Several may be eligible for waivers or from release from their requirements.