Pregnant and lactating trial participants pose little legal risk to sponsors: report

The legal risk of excluding pregnant and lactating people from clinical trials outweighs the liability of including them, a Congress-commissioned report from the National Academies of Science, Engineering and Medicine (NASEM) has found. 

The report was originally published in early April. In a May 8 blog post, Mintz associate attorney Madison Castle and attorney Kate Stewart outlined its findings and recommendations for U.S. regulators and researchers. 

“Overall, the report concluded that legal liability for including pregnant and lactating persons in research is very limited, but that perceptions of potential liability and a lack of expert guidance for including this population safely have created real barriers to their inclusion,” Castle and Stewart wrote. “Study sponsors and institutions conducting research should continue to monitor developments in this area, including guidance from [the] FDA.” 

The study follows Congress’ creation of a special task force, called PRGLAC, to identify knowledge gaps about the safety and efficacy of therapies in pregnant and lactating people. A 2018 report from PRGLAC highlighted that trial sponsors often use liability concerns as justification for not enrolling pregnant or lactating individuals or removing subjects who become pregnant. High-profile cases where drugs harmed the fetuses of pregnant people may make sponsors hesitant to include them, Castle told Law360 in an interview about the NASEM findings.

As a result, pregnant and lactating people remain in the dark about what drugs are safe for them, despite the fact that 70% of pregnant and at least half of lactating individuals take medications, according to the NASEM report. 

“Although pregnancy and lactation are physiologically unique, pregnant and lactating women and their clinicians must usually rely on data derived from clinical studies in nonpregnant and non-lactating adult, as well as from any preclinical studies in pregnant and lactating animals,” the report reads.

But NASEM’s analysis of past court decisions found little precedent that sponsors would be in legal trouble if the drugs they tested turned out to be harmful to these populations. In fact, not including them posed a bigger risk: There were no claims of damages due to research involving lactating or pregnant individuals since 1962, but there were “many cases involving liability claims related to pregnant women’s use of on-market drugs,” according to the report. It also noted that while the analysis is limited by the small number of trials involving pregnant and lactating people, the results lend to the conclusion that including them in trials from the start might have avoided later problems.

NASEM concluded the report with nine recommendations, including suggestions for the FDA, Office for Human Research Protections and Congress. For the FDA, it proposed revising guidance so pregnant and lactating people are included in clinical trials no later than the end of phase 3 if the products are anticipated to be used by them once they’re approved. They should also be included in diversity action plans.

Meanwhile, the OHRP should issue new guidance to researchers, institutional review boards and data and safety monitoring boards that updates the definitions of “minimal risk” and “additional safeguards” to clarify how these terms apply to pregnant and lactating people, according to the NASEM report. Congress should also pass legislation regarding pregnant and lactating people that mirrors the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, the report reads.

Finally, NASEM suggested the creation of an inter-agency task force to establish guidelines for post-marketing pregnancy and lactation safety studies. That includes a central repository for collecting such data and standards around electronic health records for trial subjects that link their health with that of their offspring.