Developing and refining methods to assess medical product utilization, safety, and effectiveness during pregnancy is a focus of FDA’s Sentinel System. The Sentinel Common Data Model (SCDM) includes a Mother-Infant Linkage (MIL) table that enables routine evaluation of the effects of medical product exposures during pregnancy on infant outcomes. Descriptions of efforts led by the Center for Drug Evaluation and Research are shown below. Please visit the links to learn more about each area of activity.
In this report, we examined syphilis testing and treatment in pregnant women in the Sentinel Distributed Database (SDD) and we described demographic, health, and treatment characteristics of these individuals. The companion infant population analysis can be found here.
The study period includes data from January 1, 2010 through December 31, 2023. We distributed this request to five Sentinel Data Partners on September 17, 2024.
The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.
In this report, we examined syphilis testing and treatment in the first 30 days of life in infants linked to pregnant women with a diagnosis of syphilis in the Sentinel Distributed Database (SDD). The companion pregnant women population analysis can be found here.
The study period includes data from January 1, 2010 through December 31, 2023. We distributed this request to four Sentinel Data Partners on August 1, 2024.
The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.
This report lists the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes and algorithms used to define syphilis diagnosis in this request.
For additional information about the algorithm and how it was defined relative to the cohort and exposure(s) of interest in the analysis, refer to the analysis webpage here.
In this request, we aimed to characterize pregnancy-related markers within Sentinel’s pregnancy algorithm. This analysis had two primary objectives:
- To explore the feasibility of identifying isolated (orphan) pregnancy markers observed in varying time periods prior to, between or after pregnancy episodes identified by Sentinel’s pregnancy algorithm.
- To characterize pregnancy marker codes within pregnancy episodes that are not prioritized by the Sentinel pregnancy algorithm for determining pregnancy duration and start date.
The study period includes data from October 1, 2015 to March 31, 2023. We ran this analysis against the Merative™ MarketScan® Research Databases on February 13, 2025.
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. This new law includes the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products. FDA committed to the “Enhancement and modernization of the FDA drug safety system.” The enhancement and modernization include the development of a consistent and transparent approach to help decide when and what postapproval pregnancy safety studies might optimally be used to obtain timely evidence of safety for regulatory decision making.
In the September 2023 Public Workshop, FDA presented a preliminary framework addressing how to select viable and optimal study approaches in various scenarios. As a follow-up, the Sentinel System will conduct three demonstration projects to inform this pregnancy framework and address gaps in knowledge about performance characteristics of different study approaches. Through the use of existing pregnancy registry data and electronic healthcare data, project one compares signal detection study approaches when the exposure to medication in pregnancy is relatively common, project two compares signal evaluation study approaches when the exposure to medication in pregnancy is relatively common, and project three compares signal detection approaches when the exposure to medication in pregnancy is relatively low. The projects collectively have four aims: 1) protocol development, 2) data acquisition, 3) analysis execution, and 4) dissemination.
Cases of congenital syphilis have risen 10-fold in the US between 2012-2022. Lack of screening and adequate treatment for syphilis during pregnancy, often due to a lack of timely prenatal care, are the most cited reasons for transmission to the neonate.
This poster assesses syphilis screening and treatment during pregnancy among publicly and commercially insured pregnant patients in the US. It was presented at the 2024 ISPE Annual Meeting.