A Senate bill dealing with dissemination by drug firms of articles describing alternative uses of approved medications could be reintroduced soon.
CURRENT THINKING: "These are guidelines for companies to follow, says FDA’s Ilisa Bernstein. "It’s not a regulation."
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...