Post-approval Activities Providing Data on the Safety of Medication Use During Pregnancy and Lactation-A TransCelerate Perspective.

Abstract

Pregnant and lactating women are frequently excluded from clinical trials, leading to a significant global unmet need for safety data regarding medication use in this population. Post-approval safety activities on pregnancy and lactation are currently the main sources of information for product labeling to guide clinical practice. However, generating this information can take years, and the data often remains insufficient for healthcare providers and patients to make informed decisions. Given the differences in regulatory guidance on this issue and the evolving perspectives on the most appropriate types of post-approval activities on pregnancy and lactation, TransCelerate BioPharma conducted a survey of its member pharmaceutical companies to evaluate common post-approval practices over the past 11 years. All survey participants reported engaging in post-approval activities on pregnancy, citing pregnancy registries as the most common type of activity, followed by database studies and enhanced pharmacovigilance. These activities resulted in outcomes, including updates to the prescribing information, however these materialized after many years. Conversely, fewer post-approval activities on lactation were conducted, with limited impact on outcomes reported to date. These results emphasize the need for a comprehensive, multi-faceted approach using a wide array of data sources for effective and timely post-approval surveillance to characterize medication use during pregnancy and lactation.