'Right-To-Try' Has US FDA Support: Scaled-Back House Bill Retains Agency Oversight
Commissioner Gottlieb’s recent remarks on pending federal 'Right-to-Try' legislation were his most positive to date; he pushed back on earlier versions that would have removed FDA from process.
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Gottlieb: Lack Of Compromise On Right-To-Try Bill Is 'Interesting Lesson In Politics' For Stakeholders
In interview with the Pink Sheet, former US FDA commissioner Scott Gottlieb said that opposition to the modified House version of the right-to-try legislation ultimately led to the less favorable Senate bill becoming law.
Protocol-driven approach could generate reliable data about investigational drug's efficacy and safety in patients who do not qualify for clinical trials, PhRMA's Moscicki says; Johns Hopkins' Sharfstein cautions this could turn expanded access programs into burdensome studies that take away from primary purpose of providing access to investigational therapies.
US House passage sends legislation back to Senate, where it may not garner widespread support.