Pharmanex v. Shalala
This article was originally published in The Tan Sheet
Executive Summary
Reply brief submitted by FDA Sept. 9 contends "the notion that a dietary supplement and a drug containing the same active ingredient serve utterly distinct markets is highly dubious." The comment comes in response to Pharmanex' Aug. 23 brief asserting that supplements labeled in accordance with DSHEA are unlikely to take business away from drug products (1"The Tan Sheet" Sept. 6, p. 10). The agency also maintains the effects of Cholestin on the drug industry should be considered, since DSHEA does not stand alone, but rather is "part of the FDCA and must be harmonized with the broader statute's purposes, which include the preservation of important incentives for new drug research and for the marketing of generic drugs." The litigation began in May 1998 when FDA told Pharmanex its red yeast rice supplement, which contains lovastatin, the same ingredient in Merck's cholesterol-reducer Mevacor, was a drug. The case is being considered by a Salt Lake City federal court
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