fbpx The FDA Struggle to Withdraw Makena Problems With the Accelerated Approval Process | Harvard Kennedy School

Additional Authors:

  • Glenn Cohen


December 8, 2022, Paper: "Hydroxyprogesterone caproate (Makena) is an injectable drug for the prevention of preterm birth, ie, birth prior to 37 weeks of gestation. About 1 in 10 US infants is born preterm,1 a condition that is increasing in the US and is responsible for about 75% of perinatal mortality and about half of neonatal morbidity.1,2 The US Food and Drug Administration (FDA) approved Makena through its accelerated approval pathway in 2011. In this Viewpoint, we discuss the controversy surrounding the current efforts of the FDA to withdraw Makena from the market and the implications for the broader accelerated approval pathway."