Rep. Anna G. Eshoo (D-Palo Alto) issued the following statement today after the President signed into law the Prescription Drug User Fee Act. The new law includes Eshoo's reauthorization of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Eshoo's reauthorization bill, referred to as the BPCA and PREA Reauthorization Act of 2012, incents pharmaceutical companies to conduct more clinical trials to study the effects of medications on children, and encourages more pediatric labeling to ensure proper dosage.
"Today, with President Obama's signature, children across our country have won," Rep. Eshoo said. "The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act have played exemplary roles in the health and safety of America's children and will continue to for years to come."
Eshoo's bill to reauthorize BPCA and PREA was recently voted out of the House and Senate with overwhelming support as part of the Prescription Drug User Fee Act. In May, the House Energy and Commerce Committee approved the bill with unanimous support. Eshoo has championed these programs for nearly a decade and was the original sponsor of the legislation.
Congress first recognized the need to ensure that drugs were being studied in children in 1997 when it passed Eshoo's legislation, BPCA, a bill to incent the study of off-label uses in pediatric populations by offering companies an additional six months of patent life on their product. In 2003, Congress passed another one of Eshoo's bills, PREA, to study on-label indications in children, when safe and appropriate.