Adopting the Therapeutic Orphan: An Examination of FDA and Congress: Efforts to Promote the Inclusion of Children in Clinical Drug Studies

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Adopting the Therapeutic Orphan: An Examination of FDA and Congress: Efforts to Promote the Inclusion of Children in Clinical Drug Studies

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Patterson, Staci E. en_US
dc.date.accessioned 2012-06-07T05:20:29Z
dc.date.issued 2001 en_US
dc.identifier.citation Adopting the Therapeutic Orphan: An Examination of FDA and Congress: Efforts to Promote the Inclusion of Children in Clinical Drug Studies (2001 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8846808
dc.description.abstract This paper examines both the Food and Drug Administration’s Final Rule, which mandates drug sponsors to conduct pediatric research on their products prior to FDA approval and Section 111 of the Food and Drug Modernization Act, which provides economic incentives for drug sponsors to include children in research studies on their products. This paper concludes that Congress should renew the pediatric exclusivity provision of the Food and Drug Modernization Act, but with modifications as to provide incentives to drug sponsors for testing products on children that are not as burdensome to the elderly and the poor. After a historical review of the ills of pediatric testing, the paper discusses the need for more studies to be conducted regarding the effects of drugs commonly prescribed in children. The paper then discusses the need for regulation in clinical trials involving children. Next, the paper discusses past efforts of Congress and the FDA to encourage drug sponsors to include the pediatric population in research trials before marketing their products and then examines the latest efforts of both to encourage such studies. In the final section, the paper proposes modifications to FDAMA Section 111 to ensure that the legislation is meeting its goal of including children in more clinical trials in efforts to provide more labeling information in therapies used on children. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject FDA en
dc.subject drug testing en
dc.subject approval en
dc.subject pediatric en
dc.subject children en
dc.subject drugs en
dc.title Adopting the Therapeutic Orphan: An Examination of FDA and Congress: Efforts to Promote the Inclusion of Children in Clinical Drug Studies en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T05:20:29Z

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