By Ed Silverman // March 5th, 2013 // 11:40 am
Yet another drugmaker has settled charges of off-label marketing. The latest is Par Pharmaceuticals, which agreed to pay $22.5 million to resolve allegations that its Megace ES treatment for treating weight loss in AIDS patients was inappropriately marketed to seniors in nursing homes and hospices who did not suffer from the illness.
As part of the deal, Par agreed to plead guilty plea to a misdemeanor charge for introducing into interstate commerce a misbranded drug. Moreover, Par also dropped a lawsuit in which the drugmaker maintained its ability to convey “truthful” information to physicians is protected by the First Amendment, but was thwarted by FDA regulations governing off-label promotion (back story).
In convincing Par to drop its lawsuit, the FDA may have scored a victory, of sorts, in the heated debate over commercial free speech
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