Evaluation of Drug Labels Following the 2015 Pregnancy and Lactation Labeling Rule

Key Points Question What is the current state of US Food and Drug Administration labeling of medications in relation to pregnancy and lactation? Findings In this cross-sectional study of 290 newly approved medications from January 2010 to December 2019, all products submitted after June 20, 2015, were in compliance with the Pregnancy and Lactation Labeling Rule (PLLR); however, of those submitted between 2010 and 2015, 32.6% were not in PLLR format by the designated date of June 30, 2019. Human data on pregnancy and lactation were available in less than 20% of new product labeling. Meaning This study found that with the implementation of PLLR in the last decade, new therapeutic products are in compliance with the new rule; however, more than one-third of labels remain out of PLLR compliance.
This cross-sectional study identifies the drugs that have adhered to the new US Food and Drug Administration Pregnancy and Lactation Labeling Rule, sheds light on the continued need for implementation of pregnancy, lactation, and reproduction into clinical studies, and evaluates how many new therapeutic products have human and animal data specific to pregnancy and lactation.
Importance The US Food and Drug Administration (FDA) Pregnancy and Lactation Labeling Rule (PLLR), implemented in 2015, includes information on pregnancy, lactation, and women and men with reproductive potential. Objectives To identify the drugs that have adhered to the new PLLR format; to shed light on the continued need for implementation of pregnancy, lactation, and reproduction into clinical studies; and to evaluate how many new therapeutic products have human and animal data specific to pregnancy and lactation. Design, Setting, and Participants This cross-sectional study of 290 new therapeutic drugs reviewed labeling data for newly FDA-approved therapeutic products from January 2010 to December 2019. Therapeutic products submitted on or after June 30, 2015, were required to be in PLLR format; those approved from June 30, 2007, to June 29, 2015, had until June 30, 2019, to be in PLLR format. Approval data and subsequent labeling revision were evaluated for pregnancy and lactation data (human and animal), pregnancy registry, black-box warnings, and inclusion of PLLR labeling format. Exposures Date of new drug approval by FDA. Main Outcomes and Measures Compliance with PLLR; presence of animal or human data; presence of pregnancy registries; and presence of information regarding female and male reproductive potential. Results A total of 290 new molecular entities or therapeutic products were approved by the FDA between 2010 and 2019 in 19 categories. Black-box warnings occurred in 89 drugs (30.7%; 95% CI, 25.4%-36.3%), with 3 (3.4%; 95% CI, 0.7%-9.5%) involving pregnancy. All products submitted after June 30, 2015, were in PLLR format; however, of the 138 submitted between 2010 and that date, 45 (32.6%; 95% CI, 24.9%-41.1%) were not in PLLR format by June 30, 2019. During the 10 years of data analyzed, significantly more were in PLLR format (P for trend