Preterm Birth and 17OHP — Why the FDA Should Not Withdraw Approval

This perspective article argues against the FDA’s proposed withdrawal of approval for 17 alpha hydroxyprogesterone caproate (17OHP), a drug used to prevent recurrent preterm birth in high risk women. The authors highlight the 2003 NICHD sponsored study showing a 34% reduction in preterm birth among Black women, a group disproportionately affected by this condition. They critique the subsequent PROLONG study, which failed to replicate these benefits but enrolled a predominantly White, low risk cohort, undermining its generalizability. The article emphasizes the ethical and clinical implications of withdrawing 17OHP, particularly for vulnerable populations with limited treatment alternatives, and calls for cautious reconsideration given the drug’s safety and potential lifesaving impact.

This perspective article argues against the FDA’s proposed withdrawal of approval for 17 alpha hydroxyprogesterone caproate (17OHP), a drug used to prevent recurrent preterm birth in high risk women. The authors highlight the 2003 NICHD sponsored study showing a 34% reduction in preterm birth among Black women, a group disproportionately affected by this condition. They critique the subsequent PROLONG study, which failed to replicate these benefits but enrolled a predominantly White, low risk cohort, undermining its generalizability. The article emphasizes the ethical and clinical implications of withdrawing 17OHP, particularly for vulnerable populations with limited treatment alternatives, and calls for cautious reconsideration given the drug’s safety and potential lifesaving impact.