How Bioethics and Reproductive Justice Ought to Inform Glucagon-Like Peptide-1 Receptor Agonists, Research, and Pregnancy.
Pondugula N, Merriam AA
Bioethics researchers argue that pregnant people are systematically excluded from GLP-1 receptor agonist studies, creating evidence gaps that prevent understanding of safety and efficacy during pregnancy. Theoretical framework analysis applying reproductive justice principles to GLP-1RA research methodology. This highlights a regulatory and commercial challenge facing all GLP-1RA manufacturers as pregnancy safety data remains limited across the drug class.
Strategic Signal
FDA pregnancy labeling requirements for GLP-1RAs remain unchanged without actual clinical data. This theoretical framework could influence future trial design discussions at advisory committee meetings, but regulatory agencies prioritize clinical evidence over ethical positioning papers. The practical impact on Novo Nordisk and Eli Lilly's pregnancy research strategies depends on whether bioethics committees at major academic centers adopt these frameworks when reviewing protocols.