Policy Analyst US Food and Drug Administration, Maryland, United States
Background: US FDA can establish postmarketing requirements or commitments (PMRs/Cs) to address knowledge gaps after drug approval. At the time of approval, data are often unavailable to inform drug use in lactating and pregnant patients1. Herein, our aim was to evaluate clinical pharmacology-related PMRs/Cs established to evaluate drug disposition in pregnancy and lactation. Methods: PMRs/Cs related to drug disposition in lactation and pregnancy were identified using an internal database and approval letters. PMRs/Cs established to original new molecular entities (NMEs) at the time of approval between 2009 and 2021 were included. We also evaluated fulfilled PMRs/Cs for how they informed prescription information (PI). Results: 507 NMEs were approved between 2009 and 2021, of these 21 drugs had pregnancy-related PMRs/Cs (20 PMRs and 1 PMC) and 1 drug had a pregnancy-related PMC. The majority of PMRs/Cs (16/22) were established after 2018. 4 PMRs/Cs were fulfilled (as of April 2022) and were lactation-related with revisions to the PI. While original PI cautions or restricts use of these 4 drugs, for 3 drugs, PI revisions resulted in new instructions for use and for 1 drug, PI revisions supported existing instructions for use. Conclusion: Although still limited, there was an increase in lactation-related PMRs/Cs established in the last 5 years and only 1 PMR related to drug disposition in pregnancy in the last 13 years. This increase in lactation-related PMRs/C may be the outcome of a renewed focus on the topic, including a 2017 FDA public workshop1. Fulfilled PMRs/Cs have informed PI recommendations for lactating patients.
1. Wang, J et al. “Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary.” Clinical pharmacology and therapeutics vol. 101,6 (2017): 736-744. doi:10.1002/cpt.676
