The House Committee on Energy & Commerce has unanimously passed a bipartisan bill written by U.S. Rep. Mike Rogers, MI-08, that would create a permanent structure for strengthening the testing of pediatric drugs and improving their safety.
Rogers, a senior member of the Energy & Commerce panel, introduced the bill (H.R. 4274) with Representatives Anna Eshoo (D-CA) and Ed Markey (D-MA). The committee passed it today as part of the Food and Drug Administration Reform Act.
"Studying and testing pediatric prescription drugs is an expensive and scientifically challenging task, which too often places children at risk of exposure to ineffective or harmful treatments," Rogers said. "Creating a more certain regulatory environment for drug manufacturers, physicians, patients, and the FDA in pediatric drug research will help to overcome the inherent challenges in developing new medicines for children."
Congress first addressed this challenge in 1997 when it passed the Best Pharmaceuticals for Children Act (BPCA) to encourage researchers to conduct more clinical trials of certain drugs in children. Congress also passed the Pediatric Research Equity Act (PREA) in 2003 to give the FDA authority to require pediatric testing as part of the new drug review and approval process. These laws are scheduled to expire this year, and Rogers' legislation makes both successful programs permanent.
These two laws have led to 180 new drugs being studied in children, and more than 400 labels have been updated with critical pediatric information, leading to more information about pediatric drug safety, effectiveness, dosing and formulations.
Rogers' legislation would also enact new reforms to strengthen both BPCA and PREA. These include new tools for the FDA to ensure pediatric studies are completed on time, increased transparency about the status of ongoing pediatric studies, and a greater focus on the safety of drugs for infant children. The bill has been endorsed by numerous organizations, including physician, patient, and industry groups. It is expected to be considered by the full House of Representatives in the coming weeks.