A Comparison of FDA and EMA Pregnancy and Lactation Labeling

Abstract

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have robust collaboration and dialogue around the need for data and the inclusion of pregnant and lactating individuals in clinical trials. Despite this collaboration, the two agencies have their own standards for the format and content of labeling for these populations. To understand these differences, the pregnancy and lactation labeling sections for 31 approved drugs were compared, and trends were assessed for use of language concordance and discordance related to use during pregnancy and lactation between the 2 agencies. Further analysis evaluated the presence of human data included in the labeling. The EMA and the FDA had high discordance between pregnancy and lactation labeling language, in 68% and 71% of labeling, respectively, and only 10% of pregnancy labeling and 16% of lactation labeling include human data. Concordance in labeling language is not the norm but occurs when there is a sizeable body of human data, animal data suggesting a particular safety issue, drug mechanism of action information, or disease‐specific considerations. This study highlights the need for more human data to inform prescribing decisions in these populations. The results also suggest that there is an opportunity for alignment in labeling across regions.

PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Metabolism in Pregnant Subjects and Fetuses

“…Female physiology evolves during pregnancy, and understanding the impact of these changes on the PK of an active pharmaceutical ingredient (API) is critical to ensure its safety and efficacy for both the pregnant woman and the fetus. However, clinical trials rarely include pregnant women for ethical reasons [ 1 , 2 ], and most drugs administered during pregnancy have not been formally tested in a safe clinical environment [ 3 ]. New methods to investigate API behavior in pregnant populations have been developed, such as in vitro systems or preclinical studies [ 4 , 5 ], but the predictability of these tests is limited, and other approaches are mandatory.…”

Responding to the Call to Action: Framework to Accelerate Clinical Data Generation for Antiretroviral Use in Pregnant Individuals with HIV

“…cautious interpretation of federal guidance for “not greater than minimal” risk) [ 4 ]. Moreover, regulatory authorities do not require clinical pregnancy data for marketing approval, mandating only non-clinical data and descriptions of restricted use in specific populations, such as pregnant individuals, in drug labelling [ 5 ]. This cautious approach has resulted in the de-prioritization of data generation in pregnant individuals before marketing approval of antiretroviral agents; consequently, most HIV drug labels include no clinical data regarding use in pregnancy or during lactation.…”

Haptens in preparations marketed as dedicated for pregnant women: Analysis of product composition

“…Pregnant and lactating women have been excluded from most clinical trials, hence limited human data as regards safety during pregnancy and breastfeeding. 6 Studies of treatment patterns have shown that patients are inclined to reducing the usage of topical products to avoid presumed damage to the foetus which leads to an increase in the severity of F I G U R E 1 Analysis of leave-on and rinse-off cosmetics for pregnant women based on haptens from the European Baseline Series, Cosmetic and Fragrance series by Chemotechnique, 2023. A total of 160 products have been analysed.…”