Off-Label Reprints Still A Hot Issue In FDA Reform

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 CURRENT THINKING: "These are guidelines for companies to follow, says FDA’s Ilisa Bernstein. "It’s not a regulation." As the 105th Congress gets down to business this month, reform of the Food and Drug Administration (FDA) is expected to be a lively topic of debate, especially in

Written byKaren Young Kreeger

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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 ...

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