Adopting the Therapeutic Orphan: An Examination of FDA and Congress: Efforts to Promote the Inclusion of Children in Clinical Drug Studies
Patterson, Staci E.
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CitationAdopting the Therapeutic Orphan: An Examination of FDA and Congress: Efforts to Promote the Inclusion of Children in Clinical Drug Studies (2001 Third Year Paper)
AbstractThis paper examines both the Food and Drug Administrationâ€™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.
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