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 2001-05-08 monographic deposited born digital 11 p. GA 1.13:GAO-01-705T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-01-705T P0b002ee180398ef2 f:d01705t DGPO 2010-08-12 2011-03-23 GAOREPORTS-GAO-01-705T machine generated eng fdlp REPORT GAOREPORTS-GAO-01-705T GAO-01-705T Children Drugs Pharmaceutical industry Pharmacological research Testimony A00964 Children are subject to many of the same diseases as adults and are often treated with the same drugs. However, only about 25 percent of drugs used today have been labeled for pediatric patients. The lack of pediatric testing and labeling can place children at risk of under- or overdosing, and the lack of age-appropriate formulations, such as liquids or chewable tablets, can result in improper administration of drugs. The pediatric exclusivity provision of the Food and Drug Administration Modernization Act of 1997 has been successful in encouraging drug sponsors to generate needed information about how drugs work in children. A wide range of drugs are being studied in many therapeutic areas. The infrastructure for conducting pediatric trials has also been greatly strengthened, which should help to support continued progress. While a number of drug labels have been changed to incorporate findings from research conducted under the pediatric exclusivity provision, label changes typically occur long after the Food and Drug Administration has granted the extension of market exclusivity. In addition, there continues to be little incentive to conduct pediatric research on off-patent drugs. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-01-705T/html/GAOREPORTS-GAO-01-705T.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-01-705T/pdf/GAOREPORTS-GAO-01-705T.pdf GAO-01-705T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-01-705T Testimony GAO-01-705T; Pediatric Drug Research: Substantial Increase in Studies of Drugs for Children, But Some Challenges Remain; Children Drugs Pharmaceutical industry Pharmacological research Public Law 97-414 Public Law 98-417