{"id":19121,"date":"2021-04-26T18:08:31","date_gmt":"2021-04-26T18:08:31","guid":{"rendered":"https:\/\/nclnet.org\/?p=19121"},"modified":"2021-04-26T18:08:31","modified_gmt":"2021-04-26T18:08:31","slug":"giving_voice_pretermbirth","status":"publish","type":"post","link":"https:\/\/nclnet.org\/giving_voice_pretermbirth\/","title":{"rendered":"Giving a voice to women facing preterm birth"},"content":{"rendered":"

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By Sally Greenberg, NCL Executive Director<\/strong><\/p>\n

Born out of our historical focus on reducing health inequities in the United States, and a nearly year-long movement to\u00a0preserve access to approved therapies that fight premature birth<\/a>, NCL supported the launch of the Preterm Birth Prevention Alliance (PBPA)<\/a>, which brings together a coalition of 15 patient advocacy organizations who share concerns about the grave state of preterm birth in the United States and its disproportionate impact on Black, Indigenous, and women of color.<\/p>\n

For the past decade, hydroxyprogesterone caproate, commonly called \u201c17P,\u201d has been the only available FDA-approved treatment option to reduce the risk of recurrent preterm birth. Patients and the healthcare providers who serve them currently have access to one branded and five generic versions of the prescription product. However, in 2020, the FDA proposed withdrawing all forms of 17P, based on conflicting efficacy data from two studies composed of vastly different populations \u2014 one inclusive of women in the U.S. most vulnerable to preterm birth<\/a> and one not<\/a>. Both studies showed that this class of treatment is safe for both mother and baby.<\/p>\n

Despite multiple formal requests to consider additional data and alternate ways to study the efficacy of this class of drugs before effectively depriving women of access, FDA made its recommendation without engaging the most important stakeholders\u2014patients who are at the highest risk and their providers. And even after a recently published meta-analysis<\/a> showed that 17P injections reduced the risk of preterm birth before 34 weeks in high-risk women with singleton pregnancies, FDA persisted in its recommendation.<\/p>\n

The Alliance was formed to stand up for the needs of moms and babies of every race and ethnicity and urge regulators to hear directly from women facing prematurity and their providers about their real-world experiences \u2014 in a public hearing \u2014 before making a decision on withdrawal.<\/strong><\/p>\n

We believe that evidence of efficacy for Black, Indigenous, and women of color in the United States \u2014 who are at highest risk of adverse outcomes \u2014 should be more determinative than a lack of demonstrated treatment efficacy on primarily white women from other countries. And we believe that more inclusive studies and data are needed, across more racially and ethnically diverse patient populations, to better understand the causes and impact of disparate outcomes in preterm birth.<\/p>\n

Alliance partners currently include:<\/p>\n