The American Academy of Pediatrics (AAP) and the Elizabeth Glaser Pediatrics AIDS Foundation (EGPAF) today praised the introduction of the BPCA and PREA Reauthorization Act of 2012 (H.R. 4274) in the U.S. House of Representatives.
Introduced by Representatives Mike Rogers (R-MI), Anna Eshoo (D-CA) and Edward Markey (D-MA), the legislation reauthorizes and strengthens two essential laws to improve drug labeling for children, the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).
Until BPCA and PREA were passed in 1997 and 2003 respectively, most medicines used to treat children had been tested for safety and efficacy only in adults. Under PREA, drug companies have been required to study adult drug indications in children, and the incentive under BPCA has been a successful mechanism to encourage drug companies to conduct pediatric studies requested by the U.S. Food and Drug Administration (FDA)-especially for off-label drug uses-in return for an additional six months of marketing exclusivity. Unless reauthorized, BPCA and PREA expire on Oct. 1, 2012.
"Children are not just small adults. Drugs work differently in children than in adults and must be studied specifically for use in children," said AAP President Robert W. Block, MD, FAAP. "BPCA and PREA have revolutionized pediatric practice because all studies result in labeling changes that provide valuable new pediatric information. Now we have new dosing information, new indications of use, new safety information, and new data on effectiveness."
Drugs studied under BPCA and PREA treat a wide range of diseases in children, including HIV/AIDS, cancer, diabetes, allergy and asthma.Over 425 drug labels have been revised with important pediatric information as a result of these policies. While this represents significant success, more progress is needed to promote timely labeling of drugs for pediatric use.
"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 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."
The BPCA and PREA Reauthorization Act of 2012 renews the two laws and makes several important policy improvements that are consistent with the recommendations made by the Institute of Medicine (IOM) in its recent Safe and Effective Medicines for Children report. The bill will improve the timing and quality of pediatric research by moving pediatric study planning earlier in the drug development process. The legislation also gives the FDA new tools to ensure that studies required under PREA are completed by their due dates unless there is an appropriate reason for delay. The IOM and our organizations have called attention to the continued lack of pediatric data for certain pediatric age groups, particularly neonates. This legislation will help increase the collection of pediatric data for this vital pediatric age group.
The legislation also reauthorizes the important BPCA program at the National Institutes of Health that provides for pediatric studies of older drugs that no longer qualify for pediatric exclusivity, which can include some of the most commonly used drugs in children. In addition, the bill preserves the role of two FDA advisory committees in monitoring pediatric drug safety and advising the FDA on pediatric issues.
"Studies conducted and labeling changes made under BPCA and PREA have resulted in important advances for our nation's children," said Dr. Block. "The reauthorization of these laws is critical. We praise Representatives Rogers, Eshoo and Markey for their dedication to the health and well-being of all children, and urge the U.S. House of Representatives to pass this legislation as soon as possible."