(B-297) Public Reporting of U.S. Food and Drug Administration Post-Marketing Requirement and Commitment (PMR/PMCs) on Drug Safety

Background: The U.S. Food and Drug Administration (FDA) frequently requires pharmaceutical manufacturers to complete Post-Marketing Requirement (PMR) and/or Post-Marketing Commitment (PMC) to further evaluate the post-approval safety of medical products. The PMRs include studies and clinical trials that sponsors are required to conduct under statutes or regulations, while PMCs include studies or trials that sponsors voluntarily agree to conduct without regulatory requirements. However, little is known regarding how commonly these studies are publicly reported.

Objectives: To evaluate the public reporting of PMR/PMCs for drug safety in the United States.

Methods: We performed a cross-sectional analysis of the FDA’s PMR/PMC database. We searched the database on January 8, 2024, and included fulfilled PMR/PMCs for drugs approved from January 2015 through December 2019. We further restricted our analysis to PMRs/PMCs conducted in adult populations and those specifically evaluating the safety of a drug product. Because there is no unique identifier associated with PMR/PMC, we manually searched PubMed, ClinicalTrials.gov, the European post‐authorisation study (EU PAS) register for final reports or publications of each PMR/PMC.

Results: We identified a total of 110 PMC/PMRs from the database. After removing duplicates, we included 96 potentially eligible PMR/PMCs. We excluded 65 studies that involved medical devices, animal studies, cell-based research, and pediatric populations, and 15 studies with a purpose other than safety. We ultimately included 16 PMC/PMRs. Our manual review of publications for these 16 studies found full-text articles for 4 studies (25%).

Conclusions: The results of most completed PASS studies we examined were not publicly available. Such information would be of high potential value to many parties, including clinicians and patients seeking to understand the safety, and overall value, of U.S. pharmacologic products with important yet unanswered safety questions.