Pediatric Drugs & Medical Devices

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Safe and Effective 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 more than 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.

In 2007 and again in 2012, Congress reauthorized these laws with the strong support of the AAP and a broad coalition of partners, including the Elizabeth Glaser Pediatric AIDS Foundation and the National Organization for Rare Disorders. The 2012 reauthorization strengthened and improved BPCA and PREA and made the laws permanent

Learn more about how BPCA and PREA make drugs safer and more effective for children.

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 device 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 law was renewed and strengthened as part of the 2012 FDA user fee legislation, and will be up for reauthorization in 2017. 

Learn more about how the Pediatric Medical Device Safety and Improvement Act makes medical and surgical devices safer for children.

2012 BCPA/PREA, Device Law Reauthorization Resources