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Rules drafted for off-label drug use

February 16, 2008|From the Associated Press

WASHINGTON — The government proposed guidelines Friday 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 such as 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 salespeople often give to physicians.

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

Off-label prescriptions account for an estimated 21% of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine.

Under the FDA's proposal, the agency 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.

According to the FDA, "these off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care."

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

Lawmakers worry that companies will over-promote potentially dangerous uses.

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

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