The FDA will make its case this week to do something it hasn’t in over a decade — order a drug it expedited to the market to be pulled. A panel of independent expert advisers on obstetric and reproductive drugs will decide whether to recommend that Makena, an injection marketed as lowering the risk of preterm birth, remain available for at least some patients. Lauren Gardner talks with Daniel Payne about why the years-long effort to yank the drug’s approval offers a case study of the agency’s accelerated approval program.

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