People often assume that medical treatments prescribed by doctors and covered by insurance are safe and effective. After all, there’s a whole government agency – the Food and Drug Administration – to ensure that very thing. But most medical drugs and devices available in the U.S. were approved by the FDA through an expedited pathway that sped up the review or required less clinical trial evidence. In this episode of the podcast, we speak with a former FDA attorney about the debate over whether the FDA should prioritize safety and effectiveness or swift access to medical innovation. We hear from a mother whose daughter urgently needed an individualized treatment only available in Italy, as well as the Right to Try advocate who assisted her. And an ER doctor explains why it’s a problem that many drugs commonly prescribed to women were only been tested on men before being approved.