A Senate bill dealing with dissemination by drug firms of articles describing alternative uses of approved medications could be reintroduced soon. |
Sidebar: Off-Labels Reprints -- For Further Information
FDA issued guidelines last fall on pharmaceutical industry-sponsored distribution of journal reprints and textbooks. The agency prohibits the dissemination of articles describing "off-label" use of approved drugs-that is, a clinical application of a drug for a use that has not yet been approved by the agency. Controversy is swirling around the dissemination of such articles to physicians.
A bill sponsored during last year's FDA-reform deliberations by Sens. Connie Mack (R-Fla.) and Bill Frist (R-Tenn.) proposed to allow firms to distribute journal articles explaining off-label uses of already approved drugs to physicians and others. The so-called Mack-Frist bill never left the Senate committee in 1996, but a different incarnation is expected to be introduced to Congress later this year.
Supporters of disseminating off-label ...
