Dear Dr. Cavazzoni:

As OBGYNs treating women at risk of preterm birth, we rely on evidence-based practices to provide every patient with the best possible advice and care. With the continued high rates of prematurity in the United States that disproportionately affect mothers and infants of color, health care professionals must clearly understand the clinical risks and benefits of all available treatment options across diverse patient populations. Yet, representative data for women with a history of preterm birth remains scarce.

As physicians, we strive to practice evidence-based medicine, however the evidence is only applicable for the populations that have been studied.  Unfortunately, in the case of hydroxyprogesterone-caproate (17P), that population has been largely homogenous. While the majority of participants in the original approval trial—which found 17P to have a clear clinical benefit—were African American (59 percent) and other women of color in the United States, the subsequent confirmatory trial—from which FDA drew its recommendation to remove 17P from the market—offered contradictory evidence based on a population of overwhelmingly white women living outside of the U.S.

Using data from the PROLONG trial to determine the fate of 17P, without further investigation across more racially and ethnically diverse populations, would be doing a disservice to patients of color in the United States. We risk unintentionally exacerbating the racial and ethnic health inequities that contribute to our nation’s high preterm birth rates.  

We urge the FDA to allow for further study within the US health care system to understand which, if any, populations may benefit most from 17P, and engage the manufacturers of 17P to help the clinical community better understand its impact on diverse patient populations.

In the meantime, we hope this product will be allowed to remain on the market until additional evidence can be gathered. Thank you for your consideration.

Sincerely,

[Your name here]