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HealthyWomen Assertion on Proposal to Withdrawal Solely FDA-Permitted Remedy Possibility for Preterm Start

HealthyWomen urges the U.S. Food and Drug Administration (FDA) to maintain patient access to Makena (Hydroxyprogesterone Caproate, or 17P). This may help protect maternal and baby health from premature birth, and all generic forms of 17P will be withdrawn from the market, according to an important announcement from the FDA.

Premature birth is an urgent public health crisis in our country, with approximately one in ten babies born in the United States each year. A history of preterm birth is a significant risk factor for recurring preterm birth, and a woman’s quality of life and general well-being can be significantly affected by early delivery.

While prematurity can be traumatic to any woman and child, it affects women of color and their babies much more often – the premature birth rate in black women in the United States remains nearly 50 percent higher than any other woman. Currently, Makena and its five generic equivalents are the only FDA-approved treatments for pregnant women who are at risk of 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 an important role in protecting the health of mothers and their babies for nearly a decade. The proposal to take 17P off the market would leave the reproductive health care community of women without a standard of care recommended by ACOG.

Almost a year ago, clinicians on an FDA advisory panel, five of the six who practiced obstetrics, voted to maintain market access to 17P while additional data was generated to further support efficacy. Even so, access to 17P is now threatened as the FDA Center for Drug Evaluation and Research (CDER) has signaled its support to withdraw all forms from the market despite the drug’s strong safety profile. The process through which the agency reviewed and proposed withdrawing 17P lacked transparency, communication and input from providers and patients with experience with 17P.

Earlier this year, HealthyWomen joined leading consumer, womens and maternal health organizations and leading healthcare providers to raise serious concerns about this regulatory decision. However, since then the agency has made no attempts to communicate with providers or patient advocates recommending continued use of this therapy while additional data is being collected. We urge the FDA to accept all hearing requests so that the available evidence and key concerns from patients and the providers treating them can be discussed in a public forum.

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

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