Therapeutic Orphans, Pediatric Victims? The Best Pharmaceuticals for Children Act and Existing Pediatric Human Subject Protection

Food and Drug Law Journal, Vol. 58, No. 4, pp. 661-710, 2003

51 Pages Posted: 5 Mar 2004 Last revised: 2 Jun 2013

I. Glenn Cohen

Harvard Law School

Abstract

In 2002 the President signed into law the Best Pharmaceuticals for Children Act, which gives incentives for research on a group that has previously been considered therapeutic orphans when it comes to drug safety and dosage testing: Children. The Act offers an extra 6 months of market exclusivity for a drug if the manufacturer conducts drug trials in pediatric populations meeting FDA's requirements. While the intent of Congress with this act was to make drugs safer for children, it is an open question whether this is being achieved at the expense of pediatric research subjects, and the threat of a race to the bottom in research ethics looms large.

This Article describes the Act, its origins, and existing federal regulations protecting children as research subjects, while reviewing the history of pediatric research and the bioethical dilemmas it poses. The Article then discusses shortcomings in the existing scheme and describes necessary changes to better protect the welfare of children in the research setting.

Keywords: Food, drug, FDA, pediatrics, children, family law, health law, bioethics, IRB, research, human subjects, administrative law, market exclusivity, patent, informed consent

JEL Classification: H5, I10, I1, I18, K00, K13, K23, K32

Suggested Citation

Cohen, I. Glenn, Therapeutic Orphans, Pediatric Victims? The Best Pharmaceuticals for Children Act and Existing Pediatric Human Subject Protection. Food and Drug Law Journal, Vol. 58, No. 4, pp. 661-710, 2003. Available at SSRN: https://ssrn.com/abstract=512002

I. Glenn Cohen (Contact Author)

Harvard Law School ( email )

1525 Massachusetts Avenue
Griswold Hall 503
Cambridge, 02138
United States

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