From: Reuters
Published December 3, 2007 02:57 PM

FDA seen easing marketing of drugs for new uses

By Kim Dixon

WASHINGTON (Reuters) - The U.S. Food and Drug Administration plans to loosen its stance on the ability of pharmaceutical companies to promote their drugs for uses not yet approved, a U.S. lawmaker said on Friday.

A draft policy describes conditions under which drugmakers can distribute medical studies to doctors about their products, for uses not yet cleared by the FDA, according to Rep. Henry Waxman, the Democratic chair of the House panel on oversight and government reform, who released the FDA document.

"A fundamental tenet of our drug and device laws is that a manufacturer cannot market a drug or device for a therapeutic use without FDA approval," Waxman wrote in a letter dated Friday to FDA Commissioner Andrew Von Eschenbach.


The proposed guidance "would carve a large loophole in the law," putting "the public at risk for ineffective and dangerous uses of drugs."

FDA spokeswoman Rita Chappelle said the FDA would respond to Waxman but would not further comment, nor would she describe the agency's current policy.

Drugmakers by law are prohibited from marketing their drugs for uses not approved by the FDA. But doctors can prescribe drugs for uses beyond approved indications, a practice known as "off-label" use.

An area under dispute for years has been the distribution of medical literature, such as an article in the Journal of the American Medical Association, suggesting a drug may have merit for a use not yet FDA-approved.

The FDA "recognizes the important public policy reasons for allowing manufacturers to disseminate truthful and non-misleading medical journal articles and medical or scientific reference publications on unapproved uses of approved drugs," the document, dated October 2007 and released by Waxman's office, said.

Waxman and other critics say that allowing the practice would promote untested uses of drugs and would be dangerous for patients. Moreover, if drugmakers can promote products in this way, it discourages them from conducting clinical trials for new uses.

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