1. Pink Sheet

Expanded Access Amendment Could Blunt 'Right To Try' Legislation In US

 
• By Michael Cipriano

Senate's user fee legislation would now require FDA and NIH to hold a public meeting about how to broaden clinical trial enrollment; amendment offers a more subtle approach to increase access to experimental treatments than does 'right-to-try legislation.

A bipartisan amendment to user fee legislation offers a softer approach to addressing "right to try" concerns related to experimental pharmaceuticals that could defuse the issue during the current session of Congress.

The Senate Committee on Health, Education, Labor and Pensions – which approved the FDA Reauthorization Act by a 21-2 margin following a May 11 markup – agreed by a unanimous voice vote to tack on an

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