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AAP Applauds Institute of Medicine Report on Safe and Effective Medicines for Children

2/29/2012 Report findings highlight need for reauthorization of two vital pediatric drugs laws

​​​​​​Washington, DC—The American Academy of Pediatrics (AAP) applauds a report released today by the Institute of Medicine, Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Many of the report’s findings—including the need to plan pediatric studies earlier and promote these studies in younger age groups —are consistent with AAP’s priorities for the laws’ upcoming reauthorization.

Until the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were passed in 1997, most medicines used to treat children had been tested for safety and efficacy only in adults. Collectively, BPCA and PREA provide incentives for drug companies to conduct pediatric studies and require pediatric studies in certain circumstances. As directed by Congress, the U.S. Food and Drug Administration (FDA) tasked the Institute of Medicine with reviewing aspects of pediatric studies and product labeling changes resulting from BPCA and PREA, which are included in today’s report.

Unless reauthorized, BPCA and PREA expire on Oct. 1, 2012.

“Children are not just small adults, and drugs work differently in their growing minds and bodies,” said AAP President Robert W. Block, MD, FAAP. “The American Academy of Pediatrics supports many of the Institute of Medicine’s recommendations, which recognize the current laws’ success in providing new dosing information to guide pediatric clinical care, and identify several ways to continue improving how we study drugs in children.”

The following are among the report’s key findings and recommendations for BPCA and PREA reauthorization:

  • pediatric studies conducted under BPCA and PREA have provided important new data on drug efficacy and safety in children, resulting in more than 400 drug labeling changes;
  • pediatric studies should be planned, initiated and completed earlier to benefit children;
  • delays in the completion of FDA-mandated studies warrant further attention;
  • more information is needed in pediatric drug use among neonates (infants younger than 28 days); and
  • continued, increased transparency is needed to improve access to important information from pediatric studies.

“Together, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act have revolutionized pediatric practice,” said Daniel A.C. Frattarelli, chair of the AAP Committee on Drugs. “Drugs studied under these laws treat a wide range of diseases in children, including cancer, HIV and AIDS, diabetes, allergy and asthma.”

“Studies conducted and labeling changes made under BPCA and PREA have resulted in critical advances for our nation’s children,” said Dr. Block. “The American Academy of Pediatrics calls on Congress to reauthorize and strengthen these pediatric drugs laws as soon as possible.”


The American Academy of Pediatrics is an organization of 60,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.


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