Alliance for Patient Access / IfPA’s Patient Access Policy Blog / FDA Opens Door to Pregnant Women in Clinical Trials

FDA Opens Door to Pregnant Women in Clinical Trials

Nearly 4 million babies are born each year in the United States.  Yet physicians can have remarkably limited data about treating mothers’ health conditions during pregnancy.

New draft guidance from the Food and Drug Administration could change that.

The draft guidance addresses how drug manufacturers can safely and ethically include pregnant women in clinical trials. The document speaks both to enrolling pregnant women and to maintaining participants who become pregnant during a study.

Researchers have historically strayed from investigating drug effects on both groups. As a result, there is a lack of understanding about drug safety, dosing, side effects and interactions for this population. Yet millions of pregnant moms need safe and effective treatments for conditions ranging from epilepsy to diabetes to kidney disease.

Not knowing proper dosing and efficacy of medicines can put doctors in a precarious position when they recommend a course of care. And in some instances, not addressing a condition could expose the women or their baby to more risk than taking a medication off-label. Sometimes pregnant women and their doctors are forced to make daunting, calculated decisions.

The FDA’s draft guidance addresses ethical concerns and research-related risks as well as other considerations. Of note, it remains silent on lactating women, who often face similar questions about drug safety while breastfeeding.

While long-standing efforts to protect women and their unborn babies continue, the FDA’s guidance signals that it’s time for an updated approach. Insight gained from enrolling and collecting clinical trials data about pregnant women will help doctors make more informed prescribing decisions. It might also ease some pregnant women’s distress about determining which course of care is best for them and their baby.

The FDA accepts comments or suggestions about the draft guidance until June 8.

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