Rep. Anna G. Eshoo (D-Palo Alto) issued the following statement today after the House voted in favor of the Prescription Drug User Fee Act, which includes Eshoo's reauthorization of the Best Pharmaceutical for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Eshoo's 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.
"I'm thrilled for the children of our country that the House of Representatives voted to approve the reauthorization of my BPCA and PREA legislation today," Rep. Eshoo said. "This will help doctors prescribe the most effective treatment, protect children from harmful drug side effects, and give parents peace of mind when it comes to their children's health. The bill provides children the same safeguards that adults already have--detailed prescription labeling for proper dosage, and the clinical testing to back it up."
The Prescription Drug User Fee Act passed the House with overwhelming support and will now be merged with the Senate version in conference.
Eshoo's bill to reauthorize the Best Pharmaceutical for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) was recently voted out of the House Energy and Commerce Committee with unanimous support as part of the Prescription Drug User Fee Act. 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.
More information on the BPCA and PREA Reauthorization Act of 2012, including a summary, a list of supporters, Rep. Eshoo's prepared remarks on the bill for the Committee markup, and additional letters of support, can be found here.