United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2007-05-22 monographic deposited born digital 18 p. GA 1.13:GAO-07-898T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-07-898T P0b002ee18037dc3e f:d07898t DGPO 2010-08-12 2011-03-28 GAOREPORTS-GAO-07-898T machine generated eng fdlp REPORT GAOREPORTS-GAO-07-898T GAO-07-898T Children Drug testing Drugs Food and drug law Labeling law Patents Pediatrics Pharmacological research Policy evaluation Research programs Testimony A69826 About two-thirds of drugs that are prescribed for children have not been studied and labeled for pediatric use, placing children at risk of being exposed to ineffective treatment or incorrect dosing. The Best Pharmaceuticals for Children Act (BPCA), enacted in 2002, encourages the manufacturers, or sponsors, of drugs that still have marketing exclusivity--that is, are on-patent--to conduct pediatric drug studies, as requested by the Food and Drug Administration (FDA). If they do so, FDA may extend for 6 months the period during which no equivalent generic drugs can be marketed. This is referred to as pediatric exclusivity. BPCA also provides for the study of off-patent drugs. GAO was asked to testify on the study and labeling of drugs for pediatric use under BPCA. This testimony is based on Pediatric Drug Research: Studies Conducted under Best Pharmaceuticals for Children Act, GAO-07-557 (Mar. 22, 2007). GAO assessed (1) the extent to which pediatric drug studies were being conducted under BPCA for on-patent drugs, (2) the extent to which pediatric drug studies were being conducted under BPCA for off-patent drugs, and (3) the impact of BPCA on the labeling of drugs for pediatric use and the process by which the labeling was changed. GAO examined data about the drugs for which FDA requested studies under BPCA from 2002 through 2005 and interviewed relevant federal officials. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-07-898T/html/GAOREPORTS-GAO-07-898T.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-07-898T/pdf/GAOREPORTS-GAO-07-898T.pdf GAO-07-898T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-07-898T Testimony GAO-07-898T; Pediatric Drug Research: The Study and Labeling of Drugs for Pediatric Use under the Best Pharmaceuticals for Children Act; Children Drug testing Drugs Food and drug law Labeling law Patents Pediatrics Pharmacological research Policy evaluation Research programs Volume 111 Page 2296 111 Stat. 2296 Volume 115 Page 1408 115 Stat. 1408 Public Law 105-115 Public Law 107-109