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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