Web Date: February 20, 2008
FDA Seeks To Loosen Restrictions 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 medical journal articles that provide 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 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.
Advocates of the new rule maintain that drug companies should be able to distribute medical journal articles so that doctors are informed immediately when new life-saving uses of their products are discovered.
"Journal articles can offer physicians valuable insight that helps them make informed decisions regarding appropriate medical treatments for their patients," says Ken Johnson, senior vice president for the Pharmaceutical Research & Manufacturers of America, the brand-name drug industry's trade group.
Critics charge that manufacturers have a history of promoting unapproved drug uses. The proposed rule is "terrible for the public health," says Rep. Henry Waxman (D-Calif.), chairman of the House Oversight & Reform Committee. "It caters to the industry's desire to market their products without adequate testing or review."
State medical boards allow doctors to prescribe FDA-approved drugs however they deem appropriate. According to a 2006 analysis in the Annals of Internal Medicine, more than 20% of all prescriptions are for unapproved uses.
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