National Consumers League

Leading advocates urge FDA to protect access to treatment that reduces the risk of recurrent preterm birth

June 30, 2020

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—Led by the National Consumers League (NCL), 15 leading consumer, women’s health, and maternal health organizations and thought leading healthcare providers joined efforts to urge the Food and Drug Administration (FDA) to maintain and protect patient access to the only approved therapy to reduce the risk of preterm birth in women with a history of preterm birth.

Preterm birth is the leading cause of infant mortality in the U.S, and a history of spontaneous preterm birth is a significant risk factor for recurrent preterm birth. Currently, “17P,” or hydroxyprogesterone caproate – which is offered through one branded and five generic products – is the only FDA-approved therapy that reduces the risk of preterm birth and has been used for nearly a decade.

Leading advocates who signed onto the letter include the American Society for Reproductive Medicine; Association of Women’s Health, Obstetric & Neonatal Nurses; Black Mamas Matter Alliance; Black Women’s Health Imperative; Expecting Health; HealthyWomen; Jewish Women International; March of Dimes; National Birth Equity Collaborative; National Coalition for Infant Health; National Medical Association; and the PA Foundation.

Together, they encouraged “careful, deliberate consideration of the potential impact on patients… and the public health consequences if FDA approval of 17P is withdrawn.”

The letter expressed concern “that removing access to the only approved therapy could serve to deepen health inequities.” In the U.S., women of color are more likely to give birth early, and the preterm birth rate among black women is nearly 50 percent higher than the rate among all other women, according to the March of Dimes.

The letter notes additional concerns about exposing pregnant women to compounded medications, which have no labeling to provide guidance on administration, contraindications, or potential side effects. Compounded products are not FDA-approved and can carry potential quality and safety concerns due to the lack of uniformity and absence of regulatory oversight.

The signers stressed the need for “the agency to consider alternative ways to further evaluate and define the patient populations that most benefit from 17P, without depriving women of access.”

The full text of the letter can be viewed here (pdf).

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America's pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.