How To Get A Bill Through Congress: Pediatric Cancer Treatment Advocate Scores 2 Wins, 1 Loss
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.
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Sen. Richard Burr introduces a reauthorization bill without any policy changes, even ones he previously endorsed, saying it’s the clearest path forward now.
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.
Unless reauthorized by Congress, the rare pediatric disease program will begin to expire in September; renewal could bring bigger changes across the three PRV programs, including an FDA-requested clarification of biologic products eligible for vouchers and reforms suggested by sponsors and other stakeholders in a recent GAO report.