Issue Date: February 25, 2008
FDA Eases Limits On Drug Promotion
FDA is proposing guidelines that would allow pharmaceutical companies to alert doctors about medical or scientific journal articles that involve unapproved uses of a company's prescription drug products. "Articles that discuss unapproved uses of FDA-approved drugs can contribute to the practice of medicine and may even constitute a medically recognized standard of care," says Randall Lutter, FDA deputy commissioner for policy. Drugmakers are prohibited from marketing products for uses that have not been cleared by FDA as safe and effective. However, under a law that expired on Sept. 30, 2006, the agency made an exception that allowed companies to give physicians reprints of journal articles with information on unapproved uses. "The dissemination of such materials was not viewed by FDA as evidence of an intent to promote the product for an 'off-label' use," the agency says. Since the law expired, companies have continued the article-alerting practice but have sought guidance to clarify its legality. Under the guidelines proposed on Feb. 15, FDA would allow drugmakers to continue distributing scientific or medical journal reprints on off-label uses, provided they adhere to certain principles. Among other things, articles must come from a peer-reviewed journal that has a conflict-of-interest disclosure policy.
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