Now that it is clear that the FDA is not seeking review of the 2nd circuit decision at the Supreme Court level for the case of United States vs. Caronia, 2012 WL 5992141 (C.A.2 N.Y.), what is next in the debate of "off-label promotion"? In Caronia, a pharmaceutical sales representative, Alfred Caronia, promoted a FDA approved drug, Xyrem for "off-label use," that is, for a purpose not approved by the FDA. Following a jury trial, Caronia was found guilty of conspiracy to introduce a misbranded drug. The defendant appealed the case on the grounds that his conviction was in violation of his right of free speech under the First Amendment and the appellate court agreed.
In its Guidance issued in December 2011, the FDA had put the industry on notice that "statements that promote a drug or medical device for uses other than those approved or cleared by FDA may be used as evidence of a new intended use. Introducing a product into commerce for such a new intended use without FDA approval or clearance would, under these requirements, generally violate the law." In Caronia, this position was tested. The FDA using the sales representative statements as evidence of a new unapproved intended use, charged the representative for conspiring to introduce and introducing a misbranded drug into interstate commerce in violation of 21 USC §§ 331(a) and (a)(2).
The 2nd circuit disagreed with the FDA characterization of the statements and reasoned that even if speech can be used as evidence of a drug's intended use, the court could not "adopt the government's construction of the Food Drug and Cosmetic Act (FDCA) misbranding provisions to prohibit manufacturer promotion alone, as it would unconstitutionally restrict free speech."
Regardless, the decision can not be viewed as a free ticket for promoting off-label use of approved drugs nor should it be viewed for promotion of any unapproved drug or device products that need to undergo the FDA's approval or clearance process. The court explicitly stated that the decision prohibits the FDA from prosecuting pharmaceutical manufacturers and their representatives under the FDCA "for speech promoting lawful, off-label use of an FDA-approved drug." That is manufacturers are still responsible for ensuring the accuracy and truthfulness of the statements made during the off label promotional activities of their products. (Also see our prior posting on this subject).
The question then becomes what is viewed as a scientifically truthful dissemination of information in promotion of "off-label" use of an FDA approved drug? The FDA is of the belief that the Caronia decision will not significantly affect the agency's enforcement of the drug misbranding provisions of the FDCA. Can the next challenge question the extent of scientific truthfulness needed to justify off-label promotion?
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