(305) Prevalence of Selected Health Conditions among Individuals with Childbearing Potential to Inform the Development of the Pregnancy Safety Study Framework

Background: As part of the FDA User Fee Reauthorization Act of 2022, FDA has been developing the pregnancy safety study framework to address gaps in knowledge about the appropriate use of different study types. The framework can leverage the predicted magnitude of product exposure during pregnancy and study goal (signal identification or evaluation) to help identify the most appropriate study type to assess safety.

Objectives: To estimate the prevalence of key conditions in individuals with child-bearing potential (ICBP) to generate an informed estimation of potential product magnitude of exposure during pregnancy upon approval.

Methods: The prevalence of 29 different psychiatric, pulmonary, neurologic, cardiovascular, metabolic, and renal conditions in women aged 10 to 54 was calculated using Merative™ MarketScan® Research Databases from October 1, 2015, to December 31, 2022. Chronic Condition Data Warehouse (CCW) algorithms were used to build the condition specific numerators and beneficiaries enrollment information during the query period was used to build the denominator. The disease specific prevalence was also presented by age group and year.

Results: A total of 24,607,370 ICBP met all cohort entry criteria. The most prevalent health condition was anxiety disorder (N=3,402,869, 14%), followed by depression (N=2,662,403, 11%), obesity (N=2,326,897, 9%), hypertension (N=2,037,886, 8%), and hyperlipidemia (N= 1,815,086, 7%). The prevalence of anxiety disorders (11-13%) and depression (8-11%) was similar in all age groups, except for ICBP aged 10-14 years (7% and 5%, respectively). In general, cardiovascular, metabolic, and renal conditions were more prevalent among older ICBP (prevalence in aged 50-54 vs. 20-24, obesity: 14% and 5%; hypertension: 23% and 1%, respectively). As expected, dementia related neurologic conditions (Alzheimer's disease, N=644, 0.003%; Parkinson's disease and secondary Parkinsonism, N=2,725, 0.011%; non-Alzheimer's dementia, N=10,613, 0.043%) were rare among ICBP, and the prevalence was highest in the 50-54 age group. Index year-stratified analysis showed that the prevalence of some psychiatric and metabolic conditions increased over time (prevalence in 2016 vs. 2022, anxiety disorder: 6% vs. 14%; attention deficit hyperactivity disorders: 2% vs. 4%; obesity: 4% vs. 8%, respectively).

Conclusions: Our analysis successfully captured the prevalence of a range of health conditions in ICBP. Further analyses evaluating additional conditions are underway. These findings are expected to be useful to predict magnitude of product exposure during pregnancy at the moment of approval, which in turn will help the FDA in the development of pregnancy safety frameworks.