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Drug Company Sponsorship of Education: The Response to the FDA Draft Concept Paper
Eliot J. Lazar, MD;
David Banks, RPh;
Cheryl Graham, MD;
David Adams, JD;
Peter H. Rheinstein, MD, JD;
Mary Gross;
Ann M. Witt, JD
US Food and Drug Administration Department of Health and Human Services Rockville, Md
JAMA. 1992;268(1):53-54.
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To the Editor.
—The recent US Food and Drug Administration (FDA) initiative in the area of industry support of scientific and educational activities led to the release of a draft "concept paper" (DCP) in late October 1991.1-3 The stated objective of this initiative was to define more clearly a category of drug company—supported scientific and educational activity that is not subject to the rules governing advertising and labeling. This clarification is deemed essential so as not to chill industry support of nonpromotional, educational, and scientific programs. Food and Drug Administration officials have stated that the agency's policy is to avoid undue intrusion into continuing medical education and scientific exchange.
The DCP describes this category as "independent scientific and educational activity" and identifies four criteria: independence, objectivity, balance, and scientific rigor, which distinguish it from promotional activity. A number of specific "factors" are listed for each criterion, which would serve
. . . [Full Text PDF of this Article]
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