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Under PDUFA VII Pregnancy Safety Commitments, FDA will develop a framework describing how different types of post-market studies might optimally be used to assess pregnancy safety. The framework considers factors such as, but not limited to, purpose of study, types of post-market studies, anticipated exposure in females of reproductive potential (FRP) and pregnant women, potential toxicity of the drug and proposed risk mitigation, benefits of the drug, and magnitude and type of risk to be detected. To inform the development of this framework, it is important to understand how different types of post-market studies have been used by FDA and identify knowledge gaps.
This study examined the sources and characteristics of quantitative human pregnancy safety data contained in the “Human Data” subsection of Section 8.1 for products with “Pregnancy and Lactation Labeling Rule” (PLLR)-converted drug labeling during the period June 30, 2015, to December 31, 2021. As part of PDUFA VII Pregnancy Safety Commitments, this study aimed to conduct a review of the types of post-market human pregnancy data that have been included in pregnancy labeling. The study found that quantitative data included in the pregnancy subsection 8.1 was not limited to any particular type of study design. The Sentinel Distributed Database was used to assess the utilization during pregnancy of the products with PLLR-converted drug labeling changes related to pregnancy from January 1, 2008, to September 30, 2023. This analysis showed that study types incorporated in labeling did not always correlate with prevalence in use of products during pregnancy.
These results contributed to the completion of PDUFA-related commitments. Please see the Products for the Development of the Pregnancy Safety Study Framework & Use in Pregnancy Study for additional information on Sentinel’s contributions to the PDUFA VII Pregnancy Safety Commitments.