Seroxat Archives: FDA Will Probe SmithKline On Pitch for Unlicensed Drugs

Thanks to the Truthman for digging this up.

Source: Washington Post 1991

FDA Will Probe SmithKline On Pitch for Unlicensed Drugs

SmithKline last month held three sessions in Baltimore in which a "marketing consultant" met with doctors to discuss nabumetone, a pain-killer and anti-inflammation drug the company is developing. Three more meetings are planned for this month to discuss paroxetine, an antidepressant. Neither has been approved by the FDA.

"Priming prescribing doctors to be poised to write prescriptions for a drug whose safety and effectiveness have not been established to FDA's satisfaction is a practice which FDA has clearly stated to be illegal," Sidney M. Wolfe, a physician and director of the Health Research Group, wrote to FDA Commissioner David A. Kessler. Wolfe asked Kessler to "promptly initiate criminal prosecution" of SmithKline.

"If we find that the invitation was sent out to a large number of physicians," an FDA spokesman said, "it would be considered a promotional activity and not legitimate marketing research. In that case, it would probably violate FDA rules regarding promotion of unapproved drugs."

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