In their ongoing effort to continue improvements to the safety and effectiveness of medications for children, Representatives Edward J. Markey (D-Mass.), Anna G. Eshoo (D-Calif.) and Mike Rogers (R-Mich.) today introduced H.R. 4274, legislation to reauthorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Because of these laws, in the past five years alone at least 130 medications have been studied for use in children. The legislation has been successfully expanding the number of treatment options for children since Congress first recognized the need to ensure that drugs were being studied in children and passed BPCA in 1997. However, a lack of parity still exists between the number of drugs studied for adults and children. The bipartisan reauthorization of BPCA and PREA makes significant improvements to the laws to increase the number of studied medications available for children that would help reduce incidences of wrong dosage or age and size-appropriate treatment.
"What medications are good for the goose are not necessarily good for the gosling. Reauthorizing the laws that promote the study of pediatric drugs will ensure that children's medical needs are not relegated to the kids table and that children receive equal attention in the development of medications," said Rep. Markey.
"As an original champion for the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, I'm proud that these laws have dramatically improved the number of drugs that have been studied and approved for children," said Rep. Eshoo. "Government and private industry have worked together to fill an important void. The laws have provided greater transparency and accountability in the programs, while improving communication between FDA and companies. I'm proud of how far we've come and look forward to a day when we know how all medicines will affect children."
"These two successful laws have led to 180 new drugs being studies in children, and more than 400 drug labels have been updated with critical pediatric information, leading to more information about pediatric drug safety, effectiveness, dosing and formulations," said Rep. Rogers. "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."
The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act:
Provides FDA the necessary enforcement tools to ensure that companies complete their required pediatric studies under PREA on time.
Increases transparency of the status of pediatric clinical trials required under PREA.
Ensures the timely submission of a company's "Pediatric Study Plan", a blueprint for how a company plans to study their drug in children.
Ensures that neonatologists are involved in the process of reviewing and planning pediatric clinical trials.
"We applaud Representatives Mike Rogers, Anna Eshoo, and Ed Markey for their leadership in authoring the BPCA and PREA Reauthorization Act of 2012. 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 makes 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," said Robert W. Block, MD, FAAP, president, American Academy of Pediatrics. "Children are not just small adults. Drugs work differently in children than in adults and must be studied specifically for their use. 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."
"Permanent reauthorization of BPCA and PREA would provide biopharmaceutical companies with the certainty that they need in order to plan and conduct pediatric studies," said John Castellani, PhRMA's CEO. "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 thank Representative Rogers, Representative Eshoo and Representative Markey for their support for permanent reauthorization, 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 incontinued 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."