'Right to Try' Has White House Support: Add-On To PDUFA Looks Tough To Stop
The 'Right to Try' movement is gaining momentum at the federal level with support from both the Trump Administration and Republicans in Congress to enact legislation that would direct FDA not to interfere with existing state laws and allow terminally ill patients to access unapproved treatments.
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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.
Heading into the user fee reauthorization cycle, it seems inevitable that some form of federal 'right to try' legislation will tag-along for the ride. The recently departed head of the Office of New Drugs is among those who thinks the innocuous-sounding bill is a very bad idea.
In meeting with PhRMA, president says FDA approval must be faster and that a commissioner pick is coming.