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: A Georgia Lawyer

FDA Warns Drug Makers On Misleading Promotional Efforts

The FDA  sent letters to several companies requesting that they stop distributing misleading promotional materials for their drugs.

The letters were sent in recent weeks to several companies and posted on the FDA's website this week.

The FDA said a 60-second television advertisement for Sepracor's Lunesta sleep aid makes "unsubstantiated superiority claims" in violation of federal law. A voice-over in the ad says viewers who have trouble sleeping even after taking a sleep aid should ask their doctors about switching to Lunesta because Lunesta is "different." The ad says Lunesta "keys into receptors that support sleep."

The FDA said this language misleadingly implies that Lunesta is clinically superior to other insomnia medications, and that Lunesta might work where others fail. The agency says it isn't aware of any evidence to support these claims. Also, the agency said the claim about how Lunesta works is misleading because there's still some uncertainty about the drug's mechanism of action.

Full post as published by A Georgia Lawyer on June 22, 2010 (boomark / email).