Seven Pillars of a New Evidentiary Paradigm: The Food, Drug, and Cosmetic Act Enters the Genomic Era
106 Pages Posted: 14 Mar 2009 Last revised: 28 Apr 2015
Date Written: March 17, 2009
To assess the impact of the March, 2009 decision in Wyeth v. Levine, 2009 WL 529272 (U.S.Vt.), it is crucial to understand that the Supreme Court was ruling on actions that the U.S. Food and Drug Administration (FDA) took under a statutory scheme that already had been amended by the time the case was decided. The Food and Drug Administration Amendments Act of 2007 (FDAAA) transformed drug regulation, adding significant new powers to develop evidence and make new types of decisions in the postmarket period. This article sets out how the contours of drug regulation are likely to change after FDAAA, which is the most profound reworking of the U.S. drug regulatory framework in half a century.
FDAAA envisions heavy use, during the period after drugs are approved, of evidence from large observational studies that rely on interoperable health data networks. Understanding what was wrong with FDA's old evidentiary paradigm, which dates back to 1962, is essential to understanding its new one. Parts II and III of this article provide the first comprehensive account in legal literature of the evidentiary limitations of premarket drug trials; important aspects of modern legal doctrine rest on misconceptions about their evidentiary power. Part IV then explores how scientific advances flowing from the Human Genome Project over the past decade further undermined FDA's old evidentiary paradigm. FDAAA was Congress' response to these problems.
Part V identifies seven pillars of the new evidentiary paradigm: seven novel propositions that reject foundational assumptions of twentieth-century drug regulation. Collapse of these assumptions sets off ripple effects in various doctrinal areas. Part VI explores two examples of these impacts: New forms of regulatory action FDA will be taking in the future may preempt state tort actions, under the same reasoning that the Court applied to find no preemption in Wyeth v. Levine. Constitutional questions already are welling up at the boundary between federal and state regulation of medical practice, which FDAAA left blurred. This article aims to open scholarly debate about these and other impacts of FDA's new evidentiary paradigm.
Keywords: drug safety, torts, preemption, Wyeth v. Levine, Food & Drug Administration, FDA, genetic tests, drug regulation, clinical trial, health data network, Food & Drug Administration Amendments Act, FDAAA, pharmacogenomics
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