October 19, 2020
Stephen M. Hahn, M.D.
Commissioner of Food and Drugs
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Letter in Support – Not to Withdraw “17P” Treatments from the Market
Dear Commissioner Hahn:
On behalf of the undersigned organizations, we write to express our support to maintain the availability of synthetic hormone 17-hydroxyprogesterone caproate, also known as “17P” treatments on the market.
Preterm birth is the leading cause of infant death, and prematurity can result in life-long health issues for babies. Also, a history of spontaneous preterm birth is a significant risk factor for recurrent preterm birth, which can profoundly impact a pregnant person’s quality of life and psychological well-being. Following the proposal, that all approved treatment options be withdrawn, the Food and Drug Administration (FDA) must protect patient access to synthetic hormone 17-hydroxyprogesterone caproate, also known as “17P”, the only approved treatment to reduce the risk of preterm birth in women with a history of spontaneous preterm birth. It would not be in the best interests of patients or the healthcare providers who care for them to deprive pregnant people access—especially as there are no other approved treatment options—without considering alternative methods to better understand which patients benefit the most from 17P.
In this country, where institutional racism contributes to health disparities, including preterm birth and infant mortality, the preterm birth rate among Black women remains nearly 50 percent higher than the rate among all other women. Most recently, COVID-19 has also disproportionately impacted Black women – the very population most likely to experience preterm birth.
The synthetic hormone “17P” is the only FDA-approved treatment to help prevent early delivery in women who are at elevated risk because of a history of spontaneous preterm birth. It is currently available to eligible women through the branded prescription, Makena, and five generic 17P prescription products. This medicine has been approved by FDA for decades, and obstetricians have been prescribing some form of the drug as standard treatment since approximately 2003, when a National Institutes of Health clinical trial showed that 17P was effective in preventing preterm delivery in women with a history of preterm labor. The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) continue to recognize the role of 17P for prevention of recurrent preterm birth.
Recently, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) proposed that Makena be withdrawn from the market because the required postmarket study failed to verify a clinical benefit, and that the available evidence does not show Makena is effective for its approved use.
We, the undersigned organizations, are dedicated to improving the health of the women we serve. We are deeply concerned about the possible permanent withdrawal of the only FDA-approved treatment to help prevent early delivery in women who are at elevated risk because of a history of spontaneous preterm birth. Our primary concern is that these life-saving products remain available to all eligible pregnant people, so that no person experiencing pre-term birth, is left without any access to a safe treatment option. A decision to withdraw approved 17P products may deepen profound existing maternal and infant health inequities in the U.S. We urge you to not withdraw 17P treatments so that all pregnant people will continue to be empowered with access to a safe treatment option for preterm birth.
Black Women’s Health Imperative
American Society for Reproductive Medicine
In Our Own Voice
National Black Nurses Association
New Voices for Reproductive Justice
Perinatal Health Equity Foundation
SisterSong – The National Women of Color Reproductive Justice Collective
Southern Birth Justice Network
SPARK Reproductive Justice Now! Inc.