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Testimony Before the FDA’s Hearing on CDER’s Proposal to Withdraw Approval of Makena (Hydroxyprogesterone Caproate)

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View complete testimony as PDF

View PowerPoint slides as PDF

In testimony before the Food and Drug Administration’s (FDA’s) hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena (hydroxyprogesterone caproate), Public Citizen argued that the agency must remove Makena from the market because it is not effective for preventing preterm birth or related fetal and neonatal health problems and death.

See Public Citizen’s other work on hydroxyprogesterone caproate (Makena).