The unfinished business of U.S. drug safety regulation

Barbara J. Evans, David A. Flockhart

Research output: Contribution to journalReview article

8 Scopus citations


Various proposals have been advanced in response to recent problems with the safety of Food and Drug Administration (FDA)-approved drugs. Many call for incremental change, such as new safety oversight bodies or minor expansions of FDA's existing powers. "Fixing" FDA may not fix the problem, without related reform of the broader legal framework in which FDA operates. Key reform challenges include promoting clinical compliance with important safety warnings while preserving needed flexibility for physicians to adapt drug use to the individual patient; developing a clearer distinction between pre- and postapproval safety regulation; and devising mechanisms for funding investments in safety improvements. Until these fundamental problems are addressed, the United States will face ongoing problems with drug safety and patients will be denied the full measure of safety and therapeutic benefit that today's technologies could support. This article proposes a new direction to address these problems in the context of an insurance-based framework for promoting drug safety.

Original languageEnglish (US)
Pages (from-to)45-63+i-ii
JournalFood and Drug Law Journal
Issue number1
StatePublished - Apr 24 2006

ASJC Scopus subject areas

  • Pharmacology
  • Public Health, Environmental and Occupational Health
  • Law

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    Evans, B. J., & Flockhart, D. A. (2006). The unfinished business of U.S. drug safety regulation. Food and Drug Law Journal, 61(1), 45-63+i-ii.