The Mysteries of Pregnancy: The Role of Law in Solving the Problem of Unknown But Knowable Maternal-Fetal Medication Risk

Abstract

The treatment of medical conditions during pregnancy is one of the least developed areas of clinical pharmacology. The resultant uncertainty has a direct impact on patient care, leading to inappropriate treatment but also to under treatment, with aphorisms like “better safe than sorry” and the cultural norm of purity in pregnancy guiding decision making in the absence of evidence. This article reviews existing statutory, regulatory, and common law levers to elicit private-sector drug research – including the research required to monetize a patent, to secure permission to sell a prescription drug and to do so without incurring excessive tort liability, to market an approved drug for a heretofore unapproved use, and to make certain promotional claims about a drug – and explains why none generates adequate research into the safety and efficacy of drugs when used during pregnancy.

Two oft-mentioned policy responses to an underproduction of medical research – (1) eliminating (or muting the effect of) the “liability barrier” facing pharmaceutical companies and (2) offering an extended period of protection from generic competition as a “voluntary incentive” to private-sector research – are, on balance, undesirable approaches to increasing our understanding of maternal-fetal medication risk. Instead, the federal government should continue and expand its own research efforts in this area, including through innovative public-private partnerships like the FDA’s recently-announced Medication Exposure in Pregnancy Risk Evaluation Program. In addition, Congress should empower the FDA to require manufacturers to sponsor maternal-fetal medication research, authority the agency already has in the pediatric arena. Finally, the FDA should make full use of its existing authority to require postmarketing surveillance (including the establishment of pregnancy registries) as a condition of drug approval and to require manufacturers to conduct postmarketing clinical trials and studies evaluating the safety of their drugs in pregnant women.

Keywords: pharmaceutical, research, pregnancy