Document Type
Article
Abstract
This essay argues the exclusion of pregnant people from drug and biologic clinical trials is paternalistic, unjust, and counterproductive because the failure to include pregnant people in experimental trials can enhance risks to maternal and fetal health. Bioethicists, legal scholars, and other researchers have pleaded for reform in this context for decades. This article describes pregnancy medical drug use and the genesis and evolution of federal regulations and policies that operate to exclude pregnant people from clinical trials. It argues that the implementation of legal reforms that ensure the inclusion of pregnant people in clinical trials is imperative given Covid, the likelihood of enhanced pregnancy drug use surveillance and policing post-Dobbs, and the potential implications of the challenge to the FDA’s approval of mifepristone. It proposes three categories of reforms: regulatory reforms to the current clinical trials participation rules that pertain to pregnant people, statutory mandates and incentives aimed at enhancing the inclusion of pregnant people in clinical trials, and legal reforms to mitigate research liability concerns.
Recommended Citation
Jennifer D. Oliva, Reforming Clinical Trial Pregnancy Exclusions, 15 ConlLawNOW 87 (2024)