CHANGES IN THE NUMBER OF PREGNANCY AND LACTATION POST-MARKETING REQUIREMENTS/COMMITMENTS ISSUED BY THE FDA AFTER THE RELEASE OF THE DRAFT POSTAPPROVAL PREGNANCY SAFETY STUDIES GUIDELINES IN 2019
Author(s)
Yassaman Vafai, PhD1, Sara Angleman, PhD2, Jessica Gleason, PhD3, Payal Pozin, MPH4, Ivana Sestak, PhD5.
1Thermo Fisher Scientific, Barcelona, Spain, 2Thermo Fisher Scientific, Sundbyberg, Sweden, 3Thermo Fisher Scientific, Bethesda, MD, USA, 4Thermo Fisher Scientific, New York, NY, USA, 5Thermo Fisher Scientific, Milan, Italy.
1Thermo Fisher Scientific, Barcelona, Spain, 2Thermo Fisher Scientific, Sundbyberg, Sweden, 3Thermo Fisher Scientific, Bethesda, MD, USA, 4Thermo Fisher Scientific, New York, NY, USA, 5Thermo Fisher Scientific, Milan, Italy.
OBJECTIVES: In the absence of clinical trials, post-marketing pregnancy and lactation studies, often required by regulators, generate real-world evidence on medicinal safety during pregnancy. This study assesses the impact of the 2019 Food and Drug Administration (FDA) draft guidelines for Postapproval Pregnancy Safety Studies on the number and type of preg/lac post-marketing requirements/commitments (PMR/Cs) issued by the FDA.
METHODS: FDA PMR/Cs Database was searched for preg/lac PMR/Cs between January 2015 to June 2026. PMR/Cs were classified into relevant categories (registry, descriptive pregnancy safety study [DPSS], complementary [i.e., administrative claims and/or EMR data], lactation studies, and other/unknown) and geographic region. Number of PMR/Cs was assessed by category, year, and geography.
RESULTS: Of ~2600 PMR/Cs issued between 2015 and 2026, 260 (10%) were preg/lac PMR/Cs related. Before 2019, 46 PMR/Cs were issued for preg/lac studies with 3 lactation studies; from 2019 onward, 214 preg/lac including 48 lactation studies. The average annual number of preg/lac PMR/Cs increased from 12 (2015-2018) to 27 (2019-2026), while lactation PMR/Cs increased from 2 (2015-2018) to 6 (2019-2026) per year. Pregnancy registries were the most requested study type (N=77 [29.6%]), followed by complementary studies (N=68 [26.2%]) and DPSS (N=61 [23.5%]). Geographic region was unspecified in most PMR/Cs (n=164 [63.1%]). When a geographic region was specified (n=96), global was most frequent (n=66 [68.7%]) followed by the US (n=23 [23.9%]). Most DPSS specified a global reach (n=56/61 [91.8%]) whereas pregnancy registries were rarely required for conduct outside of the US (n=12/77 [15.6%]).
CONCLUSIONS: The number and type of FDA issued preg/lac PMR/Cs doubled for pregnancy and tripled for lactation studies since the release of draft 2019 guidelines, with no decrease in number. These trends suggest regulatory emphasis on monitoring adverse maternal and infant outcomes, to guide clinical recommendations and enhance safety of pregnant women and infants.
METHODS: FDA PMR/Cs Database was searched for preg/lac PMR/Cs between January 2015 to June 2026. PMR/Cs were classified into relevant categories (registry, descriptive pregnancy safety study [DPSS], complementary [i.e., administrative claims and/or EMR data], lactation studies, and other/unknown) and geographic region. Number of PMR/Cs was assessed by category, year, and geography.
RESULTS: Of ~2600 PMR/Cs issued between 2015 and 2026, 260 (10%) were preg/lac PMR/Cs related. Before 2019, 46 PMR/Cs were issued for preg/lac studies with 3 lactation studies; from 2019 onward, 214 preg/lac including 48 lactation studies. The average annual number of preg/lac PMR/Cs increased from 12 (2015-2018) to 27 (2019-2026), while lactation PMR/Cs increased from 2 (2015-2018) to 6 (2019-2026) per year. Pregnancy registries were the most requested study type (N=77 [29.6%]), followed by complementary studies (N=68 [26.2%]) and DPSS (N=61 [23.5%]). Geographic region was unspecified in most PMR/Cs (n=164 [63.1%]). When a geographic region was specified (n=96), global was most frequent (n=66 [68.7%]) followed by the US (n=23 [23.9%]). Most DPSS specified a global reach (n=56/61 [91.8%]) whereas pregnancy registries were rarely required for conduct outside of the US (n=12/77 [15.6%]).
CONCLUSIONS: The number and type of FDA issued preg/lac PMR/Cs doubled for pregnancy and tripled for lactation studies since the release of draft 2019 guidelines, with no decrease in number. These trends suggest regulatory emphasis on monitoring adverse maternal and infant outcomes, to guide clinical recommendations and enhance safety of pregnant women and infants.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EPH53
Topic
Epidemiology & Public Health, Health Policy & Regulatory, Real World Data & Information Systems
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
No Additional Disease & Conditions/Specialized Treatment Areas