US FDA User Fee Legislation: Is Sen. Burr’s ‘Clean’ Bill A Lifeline – Or A Wrench In The Works?
Sen. Richard Burr introduces a reauthorization bill without any policy changes, even ones he previously endorsed, saying it’s the clearest path forward now.
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Nearly four years after introduction and a half-dozen legislative attempts, proposal to establish academic centers of excellence – hoped to help usher in a renaissance in US pharmaceutical manufacturing – secures passage in omnibus spending bill. New law also supports emerging technologies, building on the FDA’s Critical Path Initiative.
Nancy Goodman, founder of Kids v Cancer, got two bills through Congress via PDUFA riders but struck out with Give Kids a Chance Act, which did not make it into the omnibus government funding legislation. She hopes to prevail next year.
The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.