NCL leads advocates in urging FDA to protect patient access to critical therapy for preterm birth

The National Consumers League and 14 leading health organizations and individual providers have collaborated in sending a letter to the Food and Drug Administration (FDA) as the agency considers whether to withdraw the only FDA-approved therapy that reduces the risk of preterm birth in women with a history of preterm birth.

Why did we and our fellow advocates decide to send this letter in the midst of the COVID-19 pandemic? Several important reasons.

First, preventing preterm birth is always a vital cause—during or without a pandemic. The leading cause of infant death in the United States, premature birth has devastating effects on families and is very costly to our health care system. For babies who do survive, short and long-term complications can accompany preterm birth. For mothers, a history of spontaneous preterm birth is a leading risk factor for recurrent preterm birth, yet providers have only one therapeutic option – hydroxyprogesterone caproate or “17P,” in one branded and five generic forms – to prevent recurrent preterm birth for these at-risk mothers.

Taking away these options—especially in the midst of a pandemic—would be concerning for pregnant women who are at high-risk for preterm birth, including those that reduce their risk of being admitted to the hospital for early delivery.

Secondly, as recent events surrounding both COVID-19 and continued fundamental rights injustices have reminded us, a profound and systemic inequity exists in the United States where institutional racism contributes to health disparities—including preterm birth and infant mortality. COVID-19 has disproportionally impacted African American women, the same population that is most likely to experience preterm birth. The preterm birth rate among U.S. black women is 49 percent higher than the rate among all other women, according to the March of Dimes.

Thirdly, 17P is the only FDA-approved therapy that reduces the risk of preterm birth and has been used for nearly a decade. We are concerned that removing access to the only FDA-approved therapy may deepen maternal and infant health inequities that exist within the U.S.

It is also troubling that if providers cannot access FDA-approved forms of 17P, this may expose pregnant women to compounded medications, which have no labeling to provide guidance on administration, contraindications, or potential side effects.

Removing 17P products in the absence of suitable alternatives would leave patients and providers significantly disadvantaged in the fight against prematurity. While we recognize the FDA is encountering tremendous challenges in addressing the COVID-19 pandemic, it is important to underscore the public health need for continued access to approved treatment options, and we trust that the agency will consider the patient impact as they evaluate this issue.

To add your voice to the letter to FDA, urging the agency to preserve patient access to the only FDA-approved therapy to reduce the risk of preterm birth, you can sign on here.