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Commentary: Making "Me-too" Drugs Benefit the Public

VA Capitol Health Care Network in Martinsburg, WV, the West Virginia University School of Medicine, and the University of Maryland School of Medicine, NusbN{at}aol.com

The Food and Drug Administration (FDA), in its review of pharmaceuticals for safety and effectiveness, has relied heavily on placebo-controlled studies. In their prescribing practice, physicians often face clinical decisions between several FDA-approved drugs for the same indication, with little guidance from the FDA on the similarities or differences of the drugs. The public could benefit if the FDA were more proactive in declaring, when applicable, that the best available evidence does not indicate any significant clinical advantage for a particular FDA-approved drug compared with others.

Key Words: Drug approval • economic competition • medical economics • United States Food and Drug Administration

American Journal of Medical Quality, Vol. 17, No. 6, 215-217 (2002)
DOI: 10.1177/106286060201700603


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