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# Include Pregnant, Lactating Women in Trials: Report
- URL: https://www.fdaweb.com/include-pregnant-lactating-women-in-trials-report/
- Published: 2024-04-10T12:00:00.000Z
- Updated: 2026-09-14T14:27:56.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5156752

A new report from the National Academies of Sciences, Engineering, and Medicine calls on FDA, HHS, the National Institutes of Health, and Congress to act to improve the inclusion of pregnant and lactating women in clinical trials. The [document](https://www.nationalacademies.org/news/2024/04/urgent-action-needed-from-nih-fda-congress-and-hhs-to-improve-inclusion-of-pregnant-and-lactating-women-in-clinical-trials-says-new-report?ref=fdaweb.com) says such women are often excluded from clinical trials due to concerns about legal liability.

But, it says, “the lack of evidence available to pregnant and lactating women and their clinicians with which to make decisions about using a drug or vaccine poses greater potential for harm than including them in research.”

FDA should develop clearer guidance on using these populations in clinical trials, the report says, while Congress should create incentives to encourage their inclusion, and the National Institutes of Health should develop a plan to prioritize research with these populations across its institutes and centers.

A case law analysis commissioned by the committee that wrote the report found no claims of liability for injuries resulting from pregnant or lactating women participating in clinical trials since 1962, when FDA began requiring trials to evaluate the safety and efficacy of drugs before they could be marketed, the report says.

“Clearer guidance from FDA, detailing expected study designs, safeguards, and product-specific monitoring, would equip investigators and research sponsors with crucial information for safely executing these trials and mitigate potential legal liability,” the report says. It recommends FDA revise its guidance to state that studies providing explicit support for drug safety, efficacy, and dosage in pregnant and lactating women should be initiated no later than the end of Phase 3 of a clinical trial. It says the guidance should be clear that the requirement to include pregnant and lactating women in a trial is dependent upon available clinical and preclinical safety and efficacy data.