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A Calm Look at 'Drug Lag'
Donald Kennedy, PhD
JAMA. 1978;239(5):423-426.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings. |
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IN RECENT testimony to a Senate subcommittee seeking ways to improve the drug regulation process in the United States, I insisted that an essential element in the updating of our drug laws must be the enhanced ability to expedite the approval of important therapeutic advances.
The Food and Drug Administration's responsibility to the public health is often thought of primarily as a matter of guaranteeing safety, but consumers are poorly served when they are denied access to safe products that are effective in the relief of pain or the cure of disease. We must view our role as regulators of technology transfer comprehensively and be just as conscious of the costs of foregone innovation as we are of other kinds of costs.
The view that we are not as conscious of these costs as we should be is widespread, especially among our critics in the drug industry. They have coined
. . . [Full Text PDF of this Article]
Author Affiliations
From the Food and Drug Administration, Washington, DC.
Footnotes
Reprint requests to Food and Drug Administration, Rockville, MD 20852 (Dr Kennedy).
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