Public Citizen decries preterm birth drug

Makena, a drug used to prevent premature birth, is one of the earliest and best-known examples of price-gouging in pharma. Now, however, an even bigger question looms about the decades-old drug. Does it even work?

The latest evidence says no. This past spring, a confirmatory study testing the drug’s efficacy flopped — finding that Makena was no better than placebo in preventing preterm birth. The drug’s up for regulatory review on Oct. 29.

Now, the consumer advocacy group Public Citizen is urging the FDA to immediately withdraw the drug. It also argues that the FDA made a mistake back in 2011 when it allowed Makena to follow the accelerated approval pathway, because data from its Phase 3 study was “seriously flawed” as well.