FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

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The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs—the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of ... continued below

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26 Pages.

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Thaul, Susan December 2, 2008.

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The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in
children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs—the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003—and enacted a new law addressing devices—the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.

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26 Pages.

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Congressional Research Service Reports

The Congressional Research Service (CRS) is the public policy research arm of Congress. This legislative branch agency works exclusively for Members of Congress, their committees and their staff. This collection includes CRS reports from the mid-1970's through the present--covering a variety of topics from agriculture to foreign policy to welfare.

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  • December 2, 2008

Added to The UNT Digital Library

  • March 19, 2016, 1:57 p.m.

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  • Aug. 4, 2016, 2:35 p.m.

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Thaul, Susan. FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, report, December 2, 2008; Washington D.C.. (digital.library.unt.edu/ark:/67531/metadc822699/: accessed November 19, 2018), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.