Adopting the Therapeutic Orphan? A Legal and Regulatory Assessment of the FDA's Pediatric Testing Rule

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Adopting the Therapeutic Orphan? A Legal and Regulatory Assessment of the FDA's Pediatric Testing Rule

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Ho, Derek en_US
dc.date.accessioned 2012-06-15T20:17:02Z
dc.date.issued 2000 en_US
dc.identifier.citation Adopting the Therapeutic Orphan? A Legal and Regulatory Assessment of the FDA's Pediatric Testing Rule (2000 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8889435
dc.description.abstract This paper explores the legality and the proper limits of the FDA's rule. Part I lays out the background for the rest of the paper by exploring the complicated policy and ethical problems posed by inadequate pediatric research. Part II describes the history of FDA's response to the problem of inadequate pediatric information, culminating in the 1998 rule. Part III describes the 1998 rule's potentially dramatic expansion of FDA's power over the regulated pharmaceutical industry and analyzes whether this expansion falls within the agency's statutory authority under the FDCA. Part IV explores the legislative history behind the recently passed Food and Drug Administration Modernization Act of 1997 (FDAMA) and suggests that Congress, when confronted with the 1998 Pediatric Testing rule, intended to relegate it to a policy of last resort. As a result, congressional passage of the FDAMA should limit the rule's application to the fairly narrow set of circumstances, described in Part V, in which market incentives are inadequate to induce sufficient pediatric testing. Ultimately, although the Pediatric Testing rule is a valid exercise of administrative authority, the legislative backdrop for the rule should caution FDA against imposing the mandate except as a means of correcting "market failure." 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 pediatric en
dc.subject testing en
dc.subject premarket en
dc.subject drugs en
dc.title Adopting the Therapeutic Orphan? A Legal and Regulatory Assessment of the FDA's Pediatric Testing Rule en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-15T20:17:02Z

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