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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

Karen Young Kreeger


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 the early days of a post-Kessler era. One of the most contentious issues, according to observers, deals with agency regulations governing information dissemination by drug companies.

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...

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