Graduate Research Assistant University of Minnesota, United States
Background: The objective of this study was to characterize trends in pregnancy and lactation (P&L) related post-marketing requirements (PMRs) and post-marketing commitments (PMCs) for new molecular entities (NME) approved by the USFDA between 2000-2021. Methods: Approval letters of original NME New Drug Application (NDA) were obtained from drugs@fda and NDAs with P&L based PMRs/PMCs were identified and extracted. Information collected included: PMR/PMC timeline and attributes of requested study(ies) [type, design elements, and outcomes] when available. Results: Fifty-three NDAs included 78 PMRs/PMCs related to P&L. Thirty-nine NDAs had pregnancy related PMRs/PMCs, 3 had lactation related PMRs, and 11 had both. Most of the PMRs/PMCs were in neurology (N=25) and psychiatry (N=13).
Fifty-five PMRs and 9 PMCs (total = 64) were issued to assess safety of the NME in pregnant women and/or fetuses, neonates and infants. Sixty-three PMRs/PMCs requested observational studies and 30 requested controlled studies in pregnant women. Thirty-eight specified collecting safety data in infants in the first year of life, and 9 assess the NME’s safety in pregnant women only. All pregnancy related PMRs were issued after 2008 and most PMCs (N=8) were issued before 2008. One PMC requested a pharmacokinetic study in pregnant women.
All lactation related PMRs (N=14) requested measurement of drug concertation in breast milk with 1 requiring measurement of maternal blood in addition to breast milk. Twelve lactation related PMRs were issued after 2017, other two were issued in 2009 and 2010. Conclusion: A substantial increase in P&L related PMRs/PMCs was observed following the enactment of FDA Amendments Act in 2007 and P&L Labeling Rule in 2015. Clinical Pharmacology is expected to play a significant role in fulfilling these PMRs/PMCs.
