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SMITHKLINE Rx-TO-OTC DEVICE SWITCH: HEMOCCULT HOME TEST

Executive Summary

SMITHKLINE Rx-TO-OTC DEVICE SWITCH: HEMOCCULT HOME TEST introduction to non-Rx market this fall is being planned by the firm's Menley & James consumer products division. The product would be the second OTC fecal blood screening device to become available OTC, and would enter the market about a year after C.B. Fleet's DetecaTest, the first blood screening device to be sold OTC. Like DetecaTest, the Hemoccult Home Test will be labeled as a screening device for health problems that may be indicated by the presence of blood in the stool, such as colitis, diverticulitis, hemorrhoids and colorectal cancer. FDA required that DetecaTest labeling be comprehensible at the sixth grade level. Through an Rx device, Hemoccult has been available directly to some consumers who request it in response to public health announcements on TV and radio, a SmithKline spokesman noted. FDA, however, has noted at least once that public service spots mistakenly referred to the test as a cancer diagnostic. C.B. Fleet so far has been the sole marketer of an OTC fecal blood screening device. However, in addition to SmithKline, at least two other companies -- Warner-Lambert and Helena Labs -- are reportedly developing products that could compete in the potentially large self-screening market. Warner-Lambert already is positioned in the OTC diagnostics market with its e.p.t. home pregnancy test. The company recently bolstered that niche with e.p.t-Plus, a portable home test which indicates pregnancy via a color change. Introduced in January, e.p.t.-Plus is being backed with an aggressive advertising campaign, including television and print ads. The company recently has been touting self-diagnosis as an area of corporate interest. Last year, Warner-Lambert broke its consumer products group into two divisions, gums and mints, and consumer health care. The firm invested about $16 mil. in a new consumer products research center, which opened in December 1983, and which will be a center for worldwide Warner-Lambert consumer products research, a spokesman said. Warner-Lambert is not releasing any details on its work in the OTC occult blood test area. The company did, however, file a patent infringement suit against Fleet's DetecaTest last December in federal district court in Newark, New Jersey. The Warner-Lambert suit is one of a number of patent disputes in the occult blood testing market. For example, litigation reportedly is pending between Helena Labs and Warner-Lambert over a "throw-in-the-bowl" version of a home screening test, which Helena Labs says was developed at its facility. Texas-based Helena Labs hopes to file a 510(k) for its throw-in-the-bowl test in the next couple of weeks, the firm said. That test incorporates a peroxide substitute and a guaial paper substitute, with a nonhemoglobion-based control, Helena Labs said. Helena currently markets an occult blood test for the Rx market.
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