Details
The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to inform the development of a framework to guide the selection of optimal study designs for post-approval pregnancy safety studies. FDA committed to developing this framework under the latest reauthorization of the Prescription Drug User Fee Act (PDUFA VII). The goal of this Sentinel study was to characterize the utilization of a selected group of products during pregnancy and explore product characteristics that may be used to estimate exposure during pregnancy.
A total of 249 products associated with studies in the analysis of post-approval pregnancy safety were identified. Out of the 249 products, all products (n=44) with relatively high exposure (≥2,500) during pregnancies that ended in live births throughout the query period were selected. An additional convenience sample (n=28) of products with relatively low exposure (<2,500) during pregnancies was selected. A total of 72 products were included in the study. Overall, drug utilization in pregnant individuals was low, but the pattern of drug utilization was not solely explained by the number of years on the market. Other factors, such as those related to patient and product characteristics and treatment considerations, should be further explored as potential predictors of drug use during pregnancy.
FDA used results from this study to help identify potential products for the four demonstration projects led by the Center for Drug Evaluation and Research. The demonstration projects are being conducted to meet FDA’s PDUFA VII commitments and will ultimately inform development of the framework to guide optimal study design for post approval pregnancy safety studies.