HealthyWomen Statement on Proposal to Withdrawal Only FDA-Approved Treatment Option for Preterm Birth

HealthyWomen urges the U.S. Food and Drug Administration (FDA) to maintain patient access to Makena (hydroxyprogesterone caproate or 17P), an important therapy health care providers say can help protect the health of mothers and babies from preterm birth, following an FDA announcement proposing it and all generic forms of 17P be withdrawn from the market.

Preterm birth is an urgent public health crisis in our country with approximately one in 10 babies born prematurely in the U.S. each year. A history of preterm birth is a significant risk factor for recurrent preterm birth, and a woman’s quality of life and overall well-being can be profoundly impacted by early delivery.

While prematurity can be traumatic for any women and child, it is an issue that affects women of color and their babies much more frequently – the preterm birth rate among U.S. Black women remains nearly 50 percent higher than the rate among all other women. Currently, Makena and its five generic equivalents are the only FDA-approved treatments available for pregnant women at risk for recurrent preterm birth.

The health and well-being of a newborn begins with the health of the mother. 17P in all of its forms has played a significant role in protecting the health of mothers and their babies for nearly a decade. Proposing to withdraw 17P from the market would leave the women’s reproductive healthcare community without an ACOG guidance recommended standard of care.

Nearly one year ago, the clinicians on an FDA advisory panel, five of the six who practiced obstetrics, voted in favor of maintaining market access to 17P, while additional data to further support efficacy is generated. Despite this, access to 17P is now threatened as the FDA Center for Drug Evaluation and Research (CDER) has signaled its support to remove all forms from the market, despite the strong safety profile of the drug. The process through which the agency has reviewed and proposed to withdraw 17P has lacked transparency, communication and input from providers and patients who have experience using 17P.

Earlier this year, HealthyWomen joined leading consumer, women’s health, and maternal health organizations and thought-leading healthcare providers to raise serious concerns about this regulatory decision. However, since then, the agency has made no attempts to communicate with the providers or patient advocates who recommend continued use of this therapy while additional data is collected. We urge the FDA to accept any hearing request so that the available evidence and significant concerns of patients and the providers who treat them can be discussed in a public forum.

During a global pandemic, when pregnant women and the providers who serve them continue to face a unique set of challenges, Makena and all its generic forms should not be withdrawn and pregnant women should continue to have access to treatment options that have potential to better their health and the health of their babies.