FDA (Image: AP)

FDA ex­perts vote to yank the agen­cy's 2011 OK of con­tro­ver­sial preterm birth drug af­ter a tri­al fail­ure

Should AM­AG con­tin­ue to be al­lowed to sell their ther­a­py for pre­vent­ing preterm births even though their long-run­ning con­fir­ma­to­ry study flopped — bad­ly?

That was the ques­tion an FDA ex­pert pan­el had to an­swer on Tues­day as they heard from peo­ple and ex­perts on both sides of the thorny is­sue. And a slight ma­jor­i­ty cast their votes in fa­vor of urg­ing the agency to yank the ac­cel­er­at­ed OK, by a vote of 9 to the 7 who thought the drug should be kept on the mar­ket — but on­ly with a new study to pro­vide a de­fin­i­tive an­swer to the clin­i­cal ben­e­fit, if any, of Mak­e­na.

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