Improving Access to Safe Drugs and Medical Devices for Children

-A   +A

Improving Access to Safe Drugs and Medical Devices for Children

Pediatric Drug Shortages  

Pediatricians throughout the country are experiencing firsthand the impact of drug shortages on the practice of pediatrics. The American Academy of Pediatrics (AAP) has long urged Congress and the Food and Drug Administration (FDA) to develop not only immediate solutions to existing drug shortages, but also long-term solutions to prevent shortages in the future. The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law by President Obama in July 2012, contains provisions intended to require more manufacturers to provide the FDA with advance notification of a discontinuance or interruption in supply of certain drugs that is likely to result in a meaningful disruption in supply.

Learn more about the AAP’s efforts to combat drug shortages.

Pediatric Drug Legislation

The American 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 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.

2007 BPCA/PREA Reauthorization

Implementation of 2007 Amendments

FDA Links

Additional AAP Resources

Other Resources

Pediatric Device Legislation

            print           email           share