The unfinished business of U.S. drug safety regulation

Barbara J. Evans, David A. Flockhart

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

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
JournalFood and Drug Law Journal
Volume61
Issue number1
StatePublished - 2006

Fingerprint

Drug and Narcotic Control
drug
Safety
regulation
drugs
United States Food and Drug Administration
insurance
Pharmaceutical Preparations
reform
physicians
funding
compliance
drug use
flexibility
therapeutics
Patient Safety
physician
Insurance
Technology
Physicians

ASJC Scopus subject areas

  • Law
  • Public Health, Environmental and Occupational Health
  • Food Science
  • Medicine (miscellaneous)
  • Pharmacology

Cite this

The unfinished business of U.S. drug safety regulation. / Evans, Barbara J.; Flockhart, David A.

In: Food and Drug Law Journal, Vol. 61, No. 1, 2006.

Research output: Contribution to journalArticle

Evans, BJ & Flockhart, DA 2006, 'The unfinished business of U.S. drug safety regulation', Food and Drug Law Journal, vol. 61, no. 1.
Evans, Barbara J. ; Flockhart, David A. / The unfinished business of U.S. drug safety regulation. In: Food and Drug Law Journal. 2006 ; Vol. 61, No. 1.
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