Rep. Anna G. Eshoo issued the following statement today after the House Energy and Commerce Committee unanimously voted to send her legislation to reauthorize the Best Pharmaceutical for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) to the House floor for consideration. Eshoo's bill, referred to as the BPCA and PREA Reauthorization Act of 2012, would make prescription drugs significantly safer for children and was voted out of Committee as part of the Prescription Drug User Fee Act.
"I'm thrilled by the Committee's vote today," Rep. Eshoo said. "Doctors should not have to play a guessing game when it comes to prescribing medication to children. That's why I've been working for more than a decade to make progress in pediatric drug labeling. Kids deserve access to the same safe medicines adults have, and today we're one step closer to that goal."
Twenty-three nationwide medical associations support Eshoo's legislation, including a number of Bay Area community stakeholders.
"As pediatricians, our primary focus in the care of children has always been prevention. Unfortunately, we must accept the fact that children do get sick," said Dr. Janet Chaikind, Pediatrics Medical Director for San Mateo Medical Center. "Children deserve medications and treatments specifically designed, studied, and safety tested for their unique needs. Both the BCPA and the PREA Reauthorization Act of 2012 support our ability to provide the best and safest treatment for children when medications are needed. This type of legislation is essential for the future health and safety of our children."
"We thank and wholeheartedly support Representatives Eshoo, Markey, and Rogers in their efforts to reauthorize this critical legislation," said Christopher G. Dawes, President and CEO of Lucile Packard Children's Hospital at Stanford. "The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act have played an extraordinary role in the health and safety of America's children. On behalf of pediatric caregivers everywhere, we urge the continuance of these important laws."
"The March of Dimes applauds Representative Anna Eshoo for her long-time leadership in creating and now updating two essential laws that improve the safety of prescription drugs for all children," said David K. Stevenson, MD, Principal Investigator, March of Dimes Prematurity Research Center at Stanford University. "The Best Pharmaceuticals for Children and Pediatric Research Equity Acts are fundamental to ensuring that all medications are tested properly before they are given to children. Parents of babies in the NICU and hospitalized children should have the peace of mind of knowing that the drugs being administered have been tested thoroughly to show that they are safe and being given in the best form and dosage. BPCA and PREA will help guarantee that the appropriate research is done on prescription drugs to ensure both safety and efficacy in pediatric care."
Eshoo's bill to reauthorize the Best Pharmaceutical for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) was voted out of the House Energy and Commerce Committee with overwhelming support as part of the Prescription Drug User Fee Act. The reauthorization of BPCA (Best Pharmaceutical for Children Act) and PREA (Pediatric Research Equity Act) requires and incents companies to conduct more pediatric clinical testing. 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.