OBJECTIVES

: With implementation of FDA’s Pregnancy and Lactation Labeling Rule (PLLR) in June 2015, product labels are required to provide human data on safety of product use during pregnancy or lactation. This study examines trends in post-marketing commitments (PMCs) for new molecular entities and biologic therapies to implement pregnancy and lactation studies pre-and post PLLR implementation.

METHODS

: We searched FDA website to identify approvals of all new molecular entities and biologic therapies from 2013-2017. Approval letters were reviewed to identify PMCs for pregnancy and lactation studies. This study was limited to new molecular entities and biologic therapies; vaccines and devices were not included.

RESULTS

Of 319 new drugs approved in the last 5 years, 28 (8.8%) PMCs for pregnancy registries and 3 (0.9%) PMCs for lactation studies were identified. The percentage of drugs with a pregnancy registry PMC pre-and post PLLR implementation was 7.0% in 2013, 10% in 2014, 8.9% in 2015, 9.0% in 2016, and 8.8% in 2017. After PLLR implementation, all 3 drugs in 2017 and 1 of 2 in 2016 that required a prospective pregnancy registry also required a retrospective pregnancy study. Regarding lactation study PMCs, only 1 was required post implementation in 2017 versus 2 pre-implementation (1 each in 2013 and 2014).

CONCLUSIONS

: In the 5-year period pre-and post PLLR implementation, there was little variation in the percentage of drugs that required a PMC for pregnancy and lactation studies. It is possible that FDA was issuing pregnancy and lactation PMCs in the 2 years prior to implementation in anticipation of PLLR. A noticeable change in the 2 years after PLLR implementation was the additional requirement for both prospective and retrospective pregnancy monitoring studies.