Public Citizen Presses FDA to Make Panel Considering Makena Withdrawal Balanced

Consumer advocacy group Public Citizen has asked the FDA to ensure that an expert panel set to consider pulling Covis Pharma’s premature birth drug Makena (hydroxyprogesterone) is fair and balanced.

The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee has been tasked with reviewing a potential withdrawal of Makena’s accelerated approval — after a confirmatory trial showed the drug wasn’t effective at reducing the risk of preterm birth.

Public Citizen alleged that the company is seeking to “essentially stack the jury in its favor by significantly expanding the advisory committee roster for the hearing with individuals whom the company believes will be sympathetic to its view that Makena should remain on the market.”

Covis Pharma has not responded to Public Citizen’s allegations.