Groups Hail Advance On Drugs And Devices For Pregnant, Lactating Women

December 7, 2016

A long sought after task force on research into new medicines for pregnant and breastfeeding women will be provided for in the 21st Century Cures Act, passed by the House of Representatives on November 30 and by the Senate today, says the Coalition to Advance Maternal Therapeutics (CAMT).

Each year, nearly four million women in the United States give birth and more than three million breastfeed their infants. Nearly all of these women will take a medication, yet not enough is known about the effect of most drugs on a woman, her pregnancy, or her breastfeeding infant, or the ways in which pregnancy and lactation may alter the uptake, metabolism and effect of medication. As more women with chronic diseases such as diabetes, hypertension, depression and asthma are becoming pregnant and breastfeeding, safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed.

This provision in the 21st Century Cures Act will establish an interagency task force to identify and address gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies and the collaboration on and coordination of such activities. Within two years, the task force would develop a report to Congress with specific recommendations for addressing the issues identified.

The inclusion of this provision was the result of tireless efforts by strong bipartisan champions. CAMT is deeply grateful to Senator Patty Murray (D-WA) and Representatives Jaime Herrera Beutler (R-WA) and Kathy Castor (D-FL) for their leadership and perseverance.

CAMT was founded in 2014 with the goal of advancing research into drugs and devices used by women during pregnancy and lactation. The CAMT steering committee consists of the Society for Maternal-Fetal Medicine, the March of Dimes, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics.