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ACOG Statement on the FDA Withdrawal of 17-OHPC

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Washington, D.C. — Christopher M. Zahn, MD, FACOG, chief of Clinical Practice and Health Equity and Quality, for the American College of Obstetricians and Gynecologists (ACOG), issued the following statement:

“After a years-long process to determine the efficacy of the only previously approved treatment option to prevent recurrent, spontaneous preterm birth, the U.S. Food and Drug Administration (FDA) made a final decision Thursday to withdraw approval of Makena (17-OHPC) and its generics. 

“We have understood for some time that this was a possible outcome. The unfortunate result is that patients now have no FDA-approved treatment option available to them and obstetricians-gynecologists are left with limited options to prevent a condition that affects roughly 10 percent of U.S. births and is the leading cause of neonatal morality.

“To assist obstetrician-gynecologists in their decision-making regarding the administration and prescribing of the remaining supply of 17-OHPC and other immediate concerns regarding generics and compounding, ACOG has issued a set of Frequently Asked Questions.

“We understand that people who are currently prescribed 17-OHPC for prevention of preterm birth have concerns about whether they will be able to continue the course of treatment. ACOG recommends that patients discuss their concerns with their health care professionals, but they should know that the FDA Center for Drug Evaluation and Research does not identify any potential harm from discontinuation of the treatment regimen prior to 37 weeks. Patients should also understand that while compounded HPC may remain available, compounded products do not undergo FDA premarket review for safety, effectiveness, or quality.

“ACOG has also released a Practice Advisory for its physician members as an update to its standing clinical guidance, ‘Prediction and Prevention of Spontaneous Preterm Birth.’ Vaginal progesterone may be considered as a treatment option for patients with a history of preterm birth, singleton gestation and a shortened cervix. However, vaginal progesterone has not been proven effective in the absence of a shortened cervix and should not be considered as an alternative to 17-OHPC.

“Preterm birth remains a significant public health issue. As we know, there are notable racial and ethnic disparities in the preterm birth rate, with Black women being at greater risk for preterm birth and experiencing significantly higher and disproportionate rates of preterm birth compared to every other racial group. 

“Additional research addressing the challenges of preterm birth prevention and identifying effective interventions is urgently needed now more than ever.

“ACOG will continue to monitor the evidence as it evolves and advocate for prevention strategies for preterm birth that are effective and accessible to all patients.”