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

Pediatric Device Legislation

Too few critical medical and surgical devices are designed specifically with children’s needs in mind. To increase the quality and availability of devices made specifically for children, AAP worked with other stakeholders to assess the unmet needs in pediatric drug development and marketing. This collaboration led to the passage of the Pediatric Medical Device Safety and Improvement Act of 2007, included in Public Law 110-85.

The Pediatric Medical Device Safety and Improvement Act will increase the tracking of pediatric device approvals by FDA, coordinate the federal response to pediatric device needs, establish a pediatric device research agenda, and strengthen postmarket surveillance of devices used in children. FDA will now be able to require studies longer than 36 months if necessary to assess the safety and effectiveness of devices used in growing children.

The bill also contains two provisions to stimulate pediatric device development. It eliminates the profit restriction on devices approved under the Humanitarian Device Exemption (HDE), and authorizes appropriations for grants to non-profit consortia to facilitate the development, production, approval, and distribution of pediatric medical devices.