Law360

The U.S Food and Drug Administration cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use - making the product misbranded. The tortured path of this "logic" should, by itself, render this off-label regulatory regime questionable, but the FDA's recent reaffirmance of it amounts to incoherent defiance.

Authors: Stephen J. McConnell

The FDA takes the position that a company's truthful, non-misleading statements about off-label use can constitute evidence of an intended use outside the label. Even while acknowledging that off-label use can be absolutely necessary for some maladies, and even while getting repeatedly clobbered by courts holding that truthful, non-misleading communications about off-label use are protected by the First Amendment, the FDA stubbornly asserts the power to clamp down on such speech.

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