Since pregnant and lactating women have historically been excluded from drug development trials, safety studies need to be conducted postapproval. This study evaluated FDA's Post Marketing Requirements for pregnancy and lactation studies from 2007 to 2020, and identified trends and potential future opportunities. The number of studies required to be conducted in the postmarketing setting was compared with the number of new drugs approved during the same time period. We excluded drugs that were approved for use in men, children, or postmenopausal women. Since 2007, there has been an increase in pregnancy and lactation studies required to be conducted postapproval. However, only 16% of drugs that may be used in females of reproductive potential were issued a postmarketing requirement for a pregnancy and/or lactation study. The most common type of required pregnancy safety study was a pregnancy registry (37%), followed by a descriptive pregnancy safety study (27%), and a retrospective cohort study (26%). In conclusion, there is a need for more comprehensive data collection in pregnant and lactating individuals to better inform prescribers and patients about the safety of medication use during pregnancy and lactation so that they can make a fully informed decision about medication use.
Keywords: FDA; pharmacoepidemiology; postmarketing study requirement; pregnancy safety study.
Published 2022. This article is a U.S. Government work and is in the public domain in the USA.