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FDA posts ‘off-label’ guidance

Sat., Feb. 16, 2008

WASHINGTON – The government on Friday proposed guidelines for how pharmaceutical companies can use medical journal articles to market drugs for unapproved uses.

The Food and Drug Administration guidelines, criticized by some lawmakers as too lenient, have been eagerly anticipated by drug and device companies like Pfizer Inc. and Medtronic Inc. that often use medical literature for marketing.

Companies are not allowed to market products for “off-label” uses, or those that have not been cleared by the FDA as safe and effective. However, under a law that expired in 2006, the agency made an exception for reprints of medical journal articles, which sales people often give to physicians.

Since the expiration, companies have continued the practice, but questioned its legality.

Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.

But companies that directly encourage such use can end up in legal hot water. Over the last decade, federal prosecutors have targeted companies including Pfizer Inc., AstraZeneca Pharmaceuticals, and Eli Lilly & Co. for off-label marketing.

Under the FDA’s proposal, posted online Friday, the agency says it will not punish companies for distributing literature on off-label uses if they adhere to certain practices.

Articles should not be false or misleading and should come from a peer-reviewed journal that is not influenced by the company. The proposal also says companies should attach a disclaimer to the materials indicating the FDA has not reviewed them.

Drug industry advocates said the proposal firmly establishes the FDA’s role as a regulator of medicine – not information.

“This guidance should reinforce the point that the FDA has no business interposing itself between a doctor and scientific information,” said Peter Pitts, president of the Center for Medicine in the Public Interest.

Under the expired law, companies had to submit reprints of articles to the FDA before sending them to doctors. That way, the article’s accuracy could be reviewed. Under the new proposal, drug companies don’t have to submit articles to the FDA.

The FDA still has time to revise the rules. According to its Web site, the agency will accept comments on the proposal for two months before writing final guidelines.


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