Safer meds for moms and babies: Bill aims to include pregnant and lactating people in more clinical trials

Pregnant and lactating individuals have long been withheld from clinical trials due to fear of the unknown effects of a particular medication, vaccine or other intervention. In reality, in a clinical trial, the same could be true for a nonpregnant individual, but they are offered informed consent to proceed with the trial.

Why is the same not true for pregnant and lactating individuals? The pregnant or lactating person is responsible for making decisions for both themselves and the developing fetus or young child—they should have the option to obtain informed consent to proceed in a clinical trial if they desire.  

Close to four million individuals give birth annually in the United States, with 90% of those pregnant individuals taking at least one medication, including prenatal vitamins. More than 50% of pregnant patients will need at least one medication during the postpartum period. It is interesting, then, that over 69% of clinical trials currently exclude pregnant and lactating individuals.

For example, they were excluded from the clinical trials during the COVID-19 vaccine development phase, resulting in a delay in interpretation of safety and efficacy of the vaccines in pregnant and lactating people. This exclusion can also create hesitation of use when the benefits may outweigh any known or perceived risks due to the lack of studies and documented outcomes. Without the data, these individuals may choose to not lactate, which may carry its own set of comorbidities or concerns.

This resonated with Jodi Benett, DO, an OB-GYN in New Jersey.

“We need to support the inclusion of pregnant and lactating individuals in clinical trials to ensure adequate safety profiles and protect them through research and not from research,” she says.

Dr. Benett carries a unique perspective on this topic—not just from the obstetrical lens, but also as the government affairs committee chair for the American College of Osteopathic Obstetricians and Gynecologists (ACOOG).

They have advocated for the Advancing Safe Medications for Moms and Babies Act of 2023 (HR 1117) at the United States House of Representatives. This legislation will aim to advance health equity through promotion of clinical trials that will be inclusive of and accessible to pregnant and lactating individuals. 

The legislation would establish a committee to coordinate federal efforts to advance the inclusion of pregnant and lactating individuals in research with a particular focus on implementing recommendations established by the Task Force on Research Specific to Pregnant and Lactating Women.

The legislation would also direct the National Institutes of Health to establish a research prioritization process for new and existing medications prescribed to pregnant and lactating individuals, and establish a federal clearinghouse of clinical trials that enroll this population. Federal regulations would also be updated to allow for the removal of pregnant individuals as a vulnerable research population.

“The lack of research on medications and vaccines could increase morbidity and mortality if patients are hesitant to take medication or receive a vaccine while pregnant,” said Dr. Benett. “Pregnancy is a state of being, not a disease state. It is important that if this legislation passes, that we not only pass on information to the patient but also to health care providers so we can continue to advance the options for this population in regards to medication and vaccines.”

Part of what Dr. Benett hopes this legislation accomplishes (should it pass) is an expansion of grassroots educational efforts and dissemination of information regarding clinical trials that will aim to improve and advance health care for pregnant and lactating individuals.  

There are sources that do outline currently available research on certain medications and vaccinations in pregnancy and lactation, but we know it is not enough. Allowing these individuals to participate freely in clinical trials will help advance this topic and allow for increased visibility on medication and vaccine safety in this population.

At this time, there is no companion bill in the Senate. The House bill is currently sponsored by Rep. Lauren Underwood, D.-Ill., and Rep. Brian Fitzpatrick, R.-Pa. You can find out if your representative is a co-sponsor here.

The AOA and the ACOOG support this legislation, as noted in this letter of support.  

For those who would like to notify their legislators of this bill and encourage co-sponsorship, be sure to visit the Osteopathic Advocacy Network to send your lawmakers a pre-written, editable email here. Your voice will help build momentum for this bipartisan bill by encouraging your lawmakers to support this important issue.

I am grateful to work with Dr. Bennett, the AOA and ACOOG to promote this commonsense legislation to help support the underrepresented population of pregnant and lactating individuals in clinical trials and research.

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