Executive Summary

Groups including National Lesbian and Gay Health Association, National Association of People with AIDS and Americans for a Sound AIDS/HIV Policy write to FDA asking that the application covering Johnson & Johnson's home HIV test be withdrawn because J&J has engaged in "unlawful promotion" of the test. The groups also ask that FDA conduct a full investigation of the issue. As an example of "unlawful promotion," the group cites a demonstration of the test on a TV news show by former Surgeon General C. Everett Koop, a "hired consultant" for J&J. Recently, FDA told the White House that it is committed to an expedited review of the test ("The Tan Sheet" Oct. 10, p. 15)