Improving Access to Safe Drugs and Medical Devices for Children

Pediatric Drug Legislation

The American Academy of Pediatrics (AAP) has led efforts for decades to ensure that the medications used in children are tested and labeled appropriately for their use. For over ten years, pediatricians have strongly advocated for the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), two laws that encourage and require drug companies to study their products in children. Together BPCA and PREA have generated a wealth of pediatric drug information for physicians and parents.

BPCA rewards drug companies with 6 months of additional market exclusivity after the completion of studies in children as requested by the Food and Drug Administration (FDA). PREA requires new drugs to be studied in children and allows FDA to mandate child studies in certain already marketed drugs.

In 2007, Congress reauthorized these laws (as part of Public Law 110-85) with the strong support of the American Academy of Pediatrics and a broad coalition of partners including the Elizabeth Glaser Pediatric AIDS Foundation and the National Organization for Rare Disorders. The reauthorization strengthened the transparency and accountability of BPCA and PREA and increased the authority of FDA to require studies. Other improvements included increasing the speed, accuracy, and dissemination of label changes and enhancing the role of the National Institutes of Health (NIH) in meeting pediatric drug research needs.

• Legislative and Regulatory History of BPCA and PREA

2007 BPCA/PREA Reauthorization

• Summary of BPCA/PREA Improvements
• Side-by-Side Comparison of 2007 Reauthorization and Prior Law
• Pediatric Drug Coalition Document on BPCA/PREA Reauthorization

Implementation of 2007 Amendments

• Formation of FDA Pediatric Review Committee (PeRC) (October 23, 2007)
  

FDA Links

• Office of Pediatric Therapeutics
• BPCA Written Requests
• Safety Reporting
• Full Medical, Statistical, and Clinical Pharmacology Reviews
• Summaries of Medical and Clinical Pharmacology Reviews

Additional AAP Resources

• Uses of Drugs Not Described in the Package Insert (Off-Label Uses) (Policy Statement)
• Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations
• Committee on Drugs
• Section on Clinical Pharmacology and Therapeutics

Other Resources

• Pediatric Drug Research: Studies Conducted Under Best Pharmaceuticals for Children Act (Government Accountability Office)
• Best Pharmaceuticals for Children Act (BPCA) Activities at NICHD (National Institute of Child Health and Human Development)
  

Pediatric Device Legislation