Expanded Access Amendment Could Blunt 'Right To Try' Legislation In US
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.
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House passes bill reauthorizing FDA user fee programs via voice vote and makes many other policy changes, but in the process touts the bill's potential to push drug prices lower.
'Clean' bill includes expanded access language from Senate, generic review revisions from House as legislators hope for enactment this month.
CBER Director Peter Marks says center will mobilize necessary resources to make sure these provisions are implemented; Marks also offered comments in opposition to 'right-to-try' legislation.