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 2007-03-22 monographic deposited born digital 54 p. GA 1.13:GAO-07-557 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-07-557 P0b002ee180385d1b f:d07557 DGPO 2010-08-12 2011-03-28 GAOREPORTS-GAO-07-557 machine generated eng fdlp REPORT GAOREPORTS-GAO-07-557 GAO-07-557 Children Diseases Drug testing Drug treatment Drugs Food and drug law Labeling law Patents Pediatrics Pharmacological research Policy evaluation Research programs Other Written Product A67124 About two-thirds of drugs that are prescribed for children have not been studied and labeled for pediatric use, which places 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 required that GAO assess the effect of BPCA on pediatric drug studies and labeling. As discussed with the committees of jurisdiction, GAO (1) assessed the extent to which pediatric drug studies were being conducted under BPCA for on-patent drugs, including when drug sponsors declined to conduct the studies; (2) evaluated the impact of BPCA on labeling drugs for pediatric use and the process by which the labeling was changed; and (3) illustrated the range of diseases treated by the drugs studied under BPCA. GAO examined data about the drugs for which FDA requested studies under BPCA from 2002 through 2005. GAO also interviewed officials from relevant federal agencies, pharmaceutical industry representatives, and health advocates. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-07-557/html/GAOREPORTS-GAO-07-557.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-07-557/pdf/GAOREPORTS-GAO-07-557.pdf GAO-07-557 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-07-557 Other Written Product GAO-07-557; Pediatric Drug Research: Studies Conducted under Best Pharmaceuticals for Children Act; Children Diseases Drug testing Drug treatment 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 Volume 120 Page 3675 120 Stat. 3675 Public Law 105-115 Public Law 107-109 Public Law 109-482