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

Thaul, Susan

Library of Congress. Congressional Research Service.

关键词: Drug industry;    Medicine;    Drug law and legislation;    Consumer protection;   

RP-ID  :  RL33986
RP-ID  :  RL33986_2008Dec02

美国|英语

来源: UNT Digital Library

【 摘 要 】

The Food and Drug Administration (FDA) has approved for adult use many drugs never tested inchildren. 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.