Paediatric drug laws: BPCA and PREA
Two US laws, one a carrot and one a stick, that get new drugs studied in children: BPCA gives six extra months of exclusivity for doing requested paediatric studies, and PREA requires paediatric assessments, though until 2020 cancer drugs mostly escaped it.
Overview
United States, federal statutes. The Best Pharmaceuticals for Children Act (BPCA) was enacted on 4 January 2002 (Public Law 107-109), continuing the paediatric exclusivity incentive first created by the 1997 Modernization Act. The Pediatric Research Equity Act (PREA) followed on 3 December 2003 (Public Law 108-155). Both were made permanent by FDASIA in 2012. Primary text: the FDA's BPCA and PREA pages link the statutes and the current guidance.
What they changed: under BPCA a sponsor that completes studies the FDA asks for in a written request earns six months added to every existing exclusivity and patent protection on the active ingredient, an incentive worth hundreds of millions of dollars for a blockbuster; the National Institutes of Health also fund studies of off-patent drugs. Under PREA a new drug, indication, dosage form or route must include a paediatric assessment unless waived or deferred, with a paediatric study plan due at the end of phase 2.
Why oncology was different: PREA applied only to the adult indication being sought, so a lung cancer drug had no paediatric obligation because children do not get lung cancer, and orphan indications were exempt outright. The result was that targeted drugs reached children a decade after adults, if at all. The RACE for Children Act of 2017 closed that gap for applications from August 2020 by tying the obligation to the drug's molecular target rather than the adult cancer, and the European Paediatric Regulation is the counterpart on the other side of the Atlantic.
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