The recent decision in United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012) dealt a blow to the government's efforts to prosecute off-label marketing. In reversing the conviction of a pharmaceutical sales representative, the Court in a 2-1 decision squarely rejected the simplistic theory that the Food, Drug and Cosmetic Act ("FDCA") imposes a blanket prohibition against off-label promotion by pharmaceutical and device manufacturers but it does leave open the door to future prosecutions that rely in part on off-label promotion.

The Court held that the First Amendment bars the prosecution of truthful speech about the off-label uses of a drug. It reasoned that a prohibition against off-label promotion by pharmaceutical manufacturers would not be a narrowly drawn means of advancing a legitimate governmental interest. According to the Second Circuit, restricting speech regarding off-label uses did not directly advance the government's interest in preserving the effectiveness and integrity of the FDA's drug-approval process, since physicians were free to prescribe drugs off-label, and it is expected that they will do so.

In sum, the Caronia decision squarely rejects the prosecution theory that promotional speech itself is unlawful under the FDCA. This decision could make it more difficult for the government to prosecute rogue sales representatives for truthful off-label promotion.

However, while Caronia injects uncertainty, it is far from the final word on the matter and provides no basis for relaxing compliance efforts or programs. The Second Circuit's decision leaves open the possibility that the government could rely on off-label promotional evidence to demonstrate that a pharmaceutical company had the "objective intent," under 21§ C.F.R. 201.128, that its drug be used for non-approved indications. It is also likely that the government will seek further review by the Second Circuit en banc or by the Supreme Court.

For a more detailed discussion of Caronia and its implications, visit Drinker Biddle's blog, Life Sciences Now, at, and the article "Second Circuit Rejects Government's Off-Label Enforcement Approach," written by Drinker partner and former co-chair of the Department of Justice's Health Care Fraud Task Force, Jesse Witten. For help with health care regulatory and enforcement matters and to strengthen or establish effective compliance programs, contact Jesse, Ronald Sarachan, Barry Gross, Scott Coffina, Charles Leeper, Gregory Miller, William McSwain or Gordon Nash, partners in the White Collar Team at Drinker Biddle & Reath.