P337: FDA Post-Marketing Pregnancy Study Requirements: Evaluating Study Reporting and Label Integration
Poster Presenter
Jami Peters
Associate Director
Gilead Sciences United States
Objectives
To build on the 2022 review of pregnancy and lactation postmarketing studies required by the FDA by assessing whether results from completed observational pregnancy studies were communicated publicly, and to examine differences in study findings.
Method
We reviewed FDA’s post-marketing requirement (PMR) website to identify completed observational pregnancy studies, cross-checking ongoing ones via ClinicalTrials.gov, HMA-EMA RWD, and PubMed. We assessed US labeling for incorporated results, and a second reviewer performed quality control.
Results
As of October 2025, among the 50 observational pregnancy studies, 14 were marked as fulfilled or submitted on the FDA PMR site, 18 were listed as ongoing, delayed, pending, or released, and 18 no longer appeared on the site—likely due to fulfillment, release, or updates in data management.
An additional 6 studies that were removed from the FDA site were found to be completed on Clinicaltrial.gov or HMA-EMA RWD. Nineteen of the 20 completed studies involved primary data collection (17 registries, 2 cohorts); 6 registries participated in the Organization of Teratology Information Specialists (OTIS) network. Several studies were listed as fulfilled or removed from the FDA PMR site that did not meet their enrollment targets, according to Clinicaltrial.gov or HMA-EMA RWD.
Among 14 studies with reported results, 7 products included findings in US labeling under Section 8.1 Use in Specific Populations - Pregnancy. There were 4 studies that enrolled patients, but we could not locate study results. Five labels noted methodological limitations such as small sample sizes, lack of internal comparators, and confounding.
Conclusion
Challenges such as low enrollment and methodological limitations affected the studies’ robustness. Several studies did not report results publicly, and among those that did, half included their findings in US labeling. It may be possible for FDA to support greater transparency through study registration, protocol and report sharing, and inclusion of contextualized results in safety communications.
