'Right To Try' And PDUFA VI: Patient Advocates, Industry Fight Senate Add-On
Given that 'right to try' is intended to be a patient-centered proposal, patient organizations are a strong voice in opposition, working behind the scenes to revise – or entirely exclude – the legislation as part of the user fee package. But the bill also has powerful advocates among Senate Republicans and in the Trump Administration.
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Proponent says companies ready to use new expanded access pathway that US FDA will have essentially no involvement in.
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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.
Trump On Right-to-Try: Gottlieb's 'Heading It Up'?
Curious comment by president could place US FDA Commissioner in tough spot balancing his boss' priorities with his and staff's concerns about pending right-to-try legislation.