(A-278) Predicting FDA-Mandated Pregnancy Registries for Future Drug Approvals: Insights from the Thermo Fisher Scientific Drug & Trial Intelligence Dashboard

Background: Pregnancy exposure registries are critical for monitoring drug safety in pregnant populations, but identifying which newly approved drugs will require such registries remains uncertain. Anticipating these regulatory requirements can help pharmaceutical companies, researchers, and policymakers allocate resources efficiently and plan post-marketing safety studies proactively.

Objectives: To identify therapeutic indications most likely to have newly approved drugs (2025–2027) with an FDA-mandated pregnancy exposure registry, using historical regulatory trends.

Methods: We analyzed data from the Thermo Fisher Scientific proprietary Drug & Trial Intelligence Dashboard, comprising 52,405 clinical trials of 16,086 unique drugs. We applied filters to select Phase 3 or pre-launch innovator products expected to be approved within the next three years, focusing on trials conducted in the United States. Each drug was manually assigned a likelihood category for a pregnancy registry requirement by two independent raters (1 = high likelihood, 2 = possible, 3 = unlikely) based on historical precedents for similar drugs or indications.

Results: The final dataset included 1,830 clinical trials of 1,239 unique drugs. The top therapeutic indications with the highest number of products likely to require a pregnancy registry were:
- Osteoarthritis – 9 products
- Metabolic Dysfunction-Associated Steatohepatitis (MASH/NASH) – 8 products
- Myasthenia Gravis – 6 products
- Secondary Progressive Multiple Sclerosis (SPMS) – 6 products
- Chronic Obstructive Pulmonary Disease – 6 products
- Chronic Kidney Disease – 6 products
- Obesity - 6 products
- Ulcerative Colitis – 5 products
- Myocardial Infarction – 5 products
- Plaque Psoriasis (Psoriasis Vulgaris) - 5 products
- Systemic Lupus Erythematosus - 5 products

Conclusions: Our findings provide a data-driven approach to anticipating pregnancy registry requirements, enabling stakeholders to prepare for post-market safety studies efficiently. Notably, the presence of multiple products within the same therapeutic indication suggests the opportunity to develop disease-based pregnancy registries instead of single-product registries. Disease-based registries enhance efficiency by capturing broader patient populations, reducing redundancy, and improving statistical power for safety assessments. Limitations of the results presented here include the manual assignment of likelihood categories and the inherent uncertainty in FDA decision-making. While this analysis offers valuable insights, actual regulatory outcomes may vary.