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Funded by the FDA, TRIM aims to provide comprehensive evidence on prenatal exposure to teratogenic drugs and develop a new decision tool to evaluate and prioritize teratogenic medications for risk mitigation programs.

Specific aims

Preventing prenatal exposure to teratogenic drugs is one of the most prominent targets for the FDA’s risk mitigation efforts. Our recent work shows that more than one in 100 pregnancies have prenatal exposure to drugs with definite teratogenic risk and about one in 20 pregnancies are exposed to medications with potential teratogenic risk. Funded by the FDA, this project aims to provide FDA with comprehensive evidence on prenatal exposure to teratogenic drugs to evaluate the current public health impact and need for enhanced risk mitigation and to develop a decision tool to prioritize teratogenic drugs for risk mitigation.

Our specific aims include: 

(1) Quantify the overall prevalence of prenatal exposure to teratogenic medications and rank drugs based on their relative contribution to prenatal exposure as well as in the context of their overall utilization among persons of child-bearing potential.

(2) Develop TRIM, a decision-making tool that considers multiple explicit criteria to prioritize drugs for REMS implementation based on FDA’s decision framework.

(3) Use TRIM to rank the top 12 teratogenic drugs without REMS that contribute to prenatal exposure and all 12 drugs with current or previous REMS.

Special features

TRIM incorporates input from 30 clinical and scientific experts to develop an innovative, evidence-based decision tool that uses quantifiable criteria to allow prioritization of drugs for further risk mitigation. TRIM’s utility will not be limited to future drug approvals, but also applicable to re-evaluation of drugs that are currently approved without REMS and those that require REMS. Its innovative methods and its focus on evidence critical for regulatory and clinical decision-making to minimize fetal harm support Regulatory Science and Innovation, to enhance the Safe Use of Medications, and to improve child and maternal health.