ACTION ALERT RE: Proposed Withdrawal of 17P/Makena/Progesterone
We are posting to make you aware of a troubling development involving the FDA and pregnant women at high risk for preterm birth, and where your help is urgently needed.
Recently the FDA proposed withdrawal of 17P (including the branded Makena, all five generic versions, and compounding of the product) the only FDA-approved treatment to reduce the chances of recurrent preterm birth. We were shocked to learn that the FDA would leave vulnerable women and the healthcare providers who care for them without a treatment option, especially considering both the profound consequences of preterm birth on mothers, babies and families, and the many times the mothers our organization works with have had success using 17P.
Removing the safe option of 17P without a comparable or better alternative, particularly during a worldwide pandemic, seems an ill-advised and unnecessary action. The American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine also continue to recommend the use of 17P for indicated high-risk patients.
We have issued a statement to the FDA (see below) expressing our deep concerns about the proposed withdrawal of all forms of 17P and encouraging the agency to maintain access to 17P while additional data is gathered. Your trusted voice can help make a difference on this important issue.
We encourage you to submit your own personal statement to the FDA at this link; look for the COMMENT button the left side of the page.
We urge you to submit your statement by November 2, 2020 to make the greatest possible difference, encourage the FDA to reconsider their recommended withdrawal of 17P approval and by granting a hearing on this critical issue. Please send a copy of your letter to us or contact us here.
Thank you so much for your amazing help to support the women served by Sidelines.
October 19, 2020
Patrizia Cavazzoni, M.D.
Acting Director, Center for Drug Evaluation and Research
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Dear Dr. Cavazzoni,
We urge you to encourage the manufacturer to conduct additional studies on 17P and grant a hearing on this very important issue. Further, we echo the urging of other leading organizations, including the National Consumers League, to reconsider your recommended withdrawal of the approval, which would negatively impact the continued availability and access to 17P for the prevention of the devastating effects of preterm birth.
Sidelines is a 501(c)(3) non-profit organization providing support for women and their families experiencing complicated pregnancies and premature births. We also encourage mothers to investigate and take advantage of scientifically well-founded therapies targeted at reducing preterm birth, irrespective of the circumstances surrounding delivery (e.g., singleton births, multiple births, recurrent and first-time preterm delivery).
The leading cause of infant death in the United States is premature birth. Those who survive can have life long complications that will impact their families in many ways. The situation is even worse for mothers of color. Sidelines’ goal for the past 29 years has been to educate and advocate for our high-risk mothers; that includes access to as many prevention and treatment options as are available. Our greatest surprise and disappointment working in pregnancy support for almost three decades, has been the lack of advancement in treatments and technologies to prevent preterm delivery.
It was with great anticipation and celebration that we learned of the accelerated approval of alpha-hydroxyprogesterone caproate (17P) for the indication of the prevention of recurrent preterm birth. It is our understanding that the study used to make the decision to withdraw this approval was comprised of mostly Eastern European mothers having significantly fewer risk factors and much lower rates of preterm birth. This fact ignores the well-documented disparity in pregnancy outcomes in US women of color. Removing the safe option of 17P without a comparable or better alternative, particularly during a worldwide pandemic, seems an ill-advised, irresponsible, and unnecessary action. Although the women we support would be considered anecdotal, we have thousands of families that support the use of 17P in pregnancy who previously had preterm deliveries.
Candace Hurley and Tracy Hoogenboom
Sidelines National Support Network