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FDA to ease off-label marketing strictures

The FDA is planning to relax its strictures regarding the ability of pharmaceutical companies to promote their drugs for off-label uses

The FDA is planning to relax its strictures regarding the ability of pharmaceutical companies to promote their drugs for off-label uses, according to US media reports.

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

In the US, pharmaceutical companies are by law prohibited from marketing their drugs for uses not approved by the FDA. However, doctors can still prescribe drugs for uses beyond approved indications through "off-label" prescribing.

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

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

Waxman wrote in a letter dated Friday to FDA Commissioner Andrew Von Eschenbach: "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."

The document, dated October 2007 and released by Waxman's office, said that the FDA recognised 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.

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.

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

4th December 2007

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