Preterm Birth Drug Makena Ignites Argument Over Health Equity

A controversial preterm birth drug is reigniting a debate among doctors on whether keeping fast-tracked drugs on the market without a clear clinical benefit worsens racial health disparities.

The Food and Drug Administration is expected in the coming months to decide whether to withdraw Covis Pharma’s Makena, which the FDA approved through its accelerated pathway in 2011. If it’s removed from the market, it would mark the first withdrawal of an accelerated drug approval in more than 10 years.

Makena was designed to reduce the risk of preterm birth among patients who previously had an unexplained delivery before 37 weeks ...