U.S. Rep. Mike Rogers, MI-08, introduced bipartisan legislation today with Representatives Anna Eshoo (D-CA) and Ed Markey (D-MA) that creates a permanent structure for strengthening testing of pediatric drugs and improving their safety.
"It is difficult to study and test prescription drugs for children, placing them at risk of being exposed to ineffective or harmful treatments," said Rogers, a senior member of the House Energy & Commerce Committee. "Studying drugs in children is a risky, expensive, and scientifically challenging task."
Congress recognized this problem and in 1997 passed the Best Pharmaceuticals for Children Act (BPCA) to encourage companies 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. Rogers's legislation makes both successful programs permanent.
"These two successful laws have led to 180 new drugs being studies 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 said. "Drug manufacturers, physicians, patients, and the FDA all recognize that BPCA and PREA have worked incredibly well to increase the study of prescription drugs in children. Making both programs permanent provides a more certain regulatory environment for drug makers in pediatric drug research."
Rogers' legislation, the BPCA and PREA Reauthorization Act of 2012 (H.R. H.R. 4274), 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.
Additional praise for the BPCA and PREA Reauthorization Act of 2012
"We applaud Representatives Mike Rogers, Anna Eshoo, and Ed Markey for their leadership in authoring the BPCA and PREA Reauthorization Act of 2012," said Dr. Robert Block, President of the American Academy of Pediatrics. "This bipartisan legislation is critical because it both renews BPCA and PREA, two pediatric drug testing laws that have improved the health and well-being of millions of children, and it mkes several important policy improvements called for by the Academy and the Institute of Medicine (IOM) in its recent Safe and Effective Medicines for Children report.
"Children are not just small adults. Drugs work differently in children than in adults and must be studied specifically for their use," Block continued. "Because of BPCA and PREA, 427 drug labels have been revised with important pediatric information. While there has been significant success, more progress is needed, and these laws must be reauthorized and strengthened by improving the timing and quality of pediatric research as well as ensuring that required studies are completed by their due date. Your legislation does just that."
"BPCA and PREA have been extraordinarily successful in improving medical care for children by driving research to create innovative medicines for use in pediatric patients," PhRMA CEO John Castellani said. "As we look to the future, permanent reauthorization of BPCA and PREA will provide biopharmaceutical companies with the certainty that they need in order to plan and conduct pediatric studies. Because these studies can take several years, it is important for companies to know that the pediatric-research programs will continue throughout the span of the trial. We commend Representative Rogers, Representative Eshoo and Representative Markey for their bipartisan leadership in the permanent reauthorization of these important programs. We support H.R. 4274, which will provide a more predictable regulatory path and will help to stimulate increased pediatric research."
"We are pleased that Representatives Rogers, Eshoo and Markey have introduced legislation to reauthorize BPCA and PREA that will continue to incentivize the development of lifesaving therapies for children," said Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO). "Together BPCA and PREA have been remarkably successful in generating pediatric drug information for physicians and parents, contributing to improved health outcomes for children. Making BPCA and PREA permanent will result in continued investment in pediatric research infrastructure and ensure that new drugs and biologics will be used safely and appropriately in pediatric patients."
"BPCA and PREA have greatly improved pediatric labeling of HIV medications. This is especially important for children living with HIV, because underdosing can lead to drug resistance, and overdosing can lead to toxicity," said Dr. Laura Guay, Vice President of Research for the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). "The bipartisan legislation introduced today strengthens these important laws to ensure that children are prioritized in the drug development process, and have access to life-saving medicines labeled especially for their unique health needs."