Full Senate Approves Pediatric Exclusivity Bill
The Senate last Thursday approved by voice vote a bill expanding the 1997 FDA Modernization Act's pediatric exclusivity rule, the AP/Billings Gazette reports. The existing law is set to expire at the end of this year (Abrams, AP/Billings Gazette, 10/19). The Best Pharmaceuticals for Children Act (S 838), sponsored by Sens. Christopher Dodd (D-Conn.) and Mike DeWine (R-Ohio), would grant drug companies that conduct clinical research on a drug's effectiveness in children a six-month patent extension on that drug (California Healthline, 8/1). The bill would also expand the law to include newborns, establish an Office of Pediatric Therapeutics at the FDA and set up a "privately funded foundation" to research other drugs "commonly used by children." The bill's sponsors said the lack of clinical trials for children has "subjected [them] to higher risks of underdosing, overdosing or dangerous side effects." DeWine said, "Kids are not just miniature adults. You can't just cut a pill in half" (AP/Billings Gazette, 10/19).