October 20, 2022
Life Sciences
  • An FDA advisory panel recommended to pull Makena, a pre-term birth prevention drug, off the market. The panel said that the drug has not shown to be effective and exposes women to “serious risk.” The decision came after years of tension between the company, the FDA, and medical associations and highlights the controversy around the FDA’s accelerated approval program. The House and the Senate have proposed reforms to the program, but punted action when they debated a must-pass FDA bill last month. The issue could resurface during a post-election lame-duck session. (Articles here, here, here, and here)