Today the House of Representatives overwhelmingly 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. The Senate is expected to pass the bill next week, sending it to the president's desk for his signature.
Rogers, a senior member of the House Energy and Commerce Committee, introduced the bill (H.R. 4274) with Representatives Anna Eshoo (D-CA) and Ed Markey (D-MA). The bill would reauthorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) and was passed by the House as part of conference agreement for the Food and Drug Administration Reform Act of 2012 (H.R. 5651).
"It is difficult to study and test prescription drugs for children, placing them at risk of being exposed to ineffective or harmful treatments," Rogers said. "However, many children depend upon a sizeable number of the same life-saving measures used regularly by adults. Permanent reauthorization of BPCA and PREA will help the FDA, drug manufacturers, and physicians provide safer treatments for children of all ages."
BPCA and PREA have led to 180 new drugs being studied in kids, and more than 400 labels have been updated with critical pediatric information, leading to more information about pediatric drug safety, effectiveness, dosing, and formulations.
Congress originally passed BPCA in 1997 to provide incentives for researchers to conduct more clinical trials of certain drugs in children. Congress also passed 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.
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.