Pediatric modifications pending

Senior Senate Democrats are planning moves to scale back incentives to develop pediatric indications for pharmaceuticals when Congress resumes work in September. Last week, the Senate Health, Education, Labor and Pensions (HELP) Committee passed The Best Pharmaceuticals for Children Act (S. 838), which would reauthorize provisions of the FDA Modernization Act that provide drug manufacturers with an additional six months of market exclusivity in exchange for conducting pediatric clinical trials (see BioCentury Extra, Wednesday Aug. 1). Unless reauthorized, the pediatric incentives will expire on Jan. 1. ...