US FDA Could Require Pediatric Cancer Drug Combo Studies Under Amended User Fee Bill
House Energy & Commerce Committee adds Give Kids a Chance Act to user fee reauthorization package during markup. Bill was modified to exclude provision giving the FDA authority to require preclinical studies.
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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.
After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?
Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.
Draft legislative text would allow some biologics and biosimilars to rely on published literature or other information and avoid some clinical studies, but the wide FDA discretion also included could raise more questions.