Pediatric Cancer Study Requirements Added To FDA User Fee Bill
User fee legislation headed for a US House vote this week would require pediatric studies of certain molecularly targeted cancer drugs; the requirement, which could apply to some orphan drugs, would not take effect for three years.
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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.
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.
Advisory committee says planned waivers for molecularly targeted studies should take into account comparative adult efficacy and toxicity data for multiple drugs in the same class, as well as differences in product attributes, such as route of administration and dosing schedule; unmet clinical need should have less influence on decision to grant waivers, panelists said.