Anna Eshoo: “I rise in support of H.R. 3580, the Food and Drug Administration Amendments Act. This bill will make an enormous…”

“I rise in support of H.R. 3580, the Food and Drug Administration Amendments Act. This bill will make an enormous difference in the safety and effectiveness of drugs and medical devices used to treat adults and children. I'm pleased that the bill adopts much of my legislation (H.R. 2589, Improving Pharmaceuticals for Children Act) to renew the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Together, BPCA and PREA represent two halves of a comprehensive effort to make sure that prescription drugs are appropriately tested and labeled for children. According to the American Academy of Pediatrics, about 25 percent of drugs administered to children have been appropriately tested and labeled for use in kids. Pediatricians often have to prescribe drugs for 'off-label' use, because the drug has not been studied in appropriate FDA-approved pediatric clinical trials. Children are not small adults; they have specific medical needs that have to be considered when drugs are used. Children have died or suffered serious side effects after taking drugs that were shown safe for use in adults but had different results in children. The bill helps improve drug safety for children in two ways. First, under BPCA, the bill provides an incentive, an extra 6 months of marketing exclusivity, for a drug if the innovator company agrees to undertake comprehensive pediatric studies requested by the FDA.”