FDA Approves Guidelines for 'Off-Label' Drug Use
The U.S. Food and Drug Administration has OK'd guidelines that would make it easier for drug companies to use medical journal articles to promote drugs for unapproved uses, the Associated Press reported Tuesday.
While pharmaceutical firms are not allowed to advertise products for "off-label" uses, the agency has allowed salespeople to distribute articles about such uses if they have been published in a peer-reviewed medical journal. A law permitting that distribution expired in 2006, and drug makers have been lobbying for its renewal ever since. The FDA said the new guidelines, posted online Monday, are designed to discourage "ghostwriting" of medical reviews and recommended that companies disclose financial relationships with article authors, the wire service said.
The veracity of some journal articles were questioned last year when Merck & Co. was accused of ghostwriting articles about its painkiller Vioxx. The drug was withdrawn from the market in 2004 for safety reasons, the AP reported.
Companies such as Pfizer Inc. and Eli Lilly said the guidelines merely reauthorize a longstanding policy that benefits doctors and patients, but critics contend the new directives contain a loophole allowing firms to distribute product articles to doctors even when they involve uses that have not been federally approved, AP reported.