Caronia Decision One Year Later: Off-label Change May Be Slow, But It’s Brewing

Jan. 27, 2014 – Although FDA officials have treated the U.S. Court of Appeals for the Second Circuit decision in U.S. v. Caronia as a minor blip on its off-label regulation radar, the decision is part of a growing body of evidence which indicates that the agency will not be able to stay its strident off-label course forever, according to speakers at a recent Washington Legal Foundation (WLF) media briefing.

“Officially, FDA drug marketing regulation has not changed based on Caronia, but companies and their marketing partners must stay tuned,” according to John Kamp, Executive Director of the Coalition for Healthcare Communication. “The lawyers at the WLF media briefing are among the best in the business and will help us understand the environment when the inevitable changes occur,” he continued.

“Meanwhile, watch the statements from PhRMA General Counsel Mit Spears, who has suggested that marketing to expert formulary committees may be one of the wedge areas for change,” Kamp said. (See related story at

During the briefing, “U.S. v Caronia: One Year Later,” held Jan. 16, the speakers explored how the December 2012 decision has been interpreted by the FDA and the U.S. Department of Justice (DOJ). In February 2013, the FDA shared the following interpretation of the Second Circuit’s ruling, according to Coleen Klasmeier, partner, Sidley Austin LLP:

(1)    Caronia will not affect enforcement;

(2)    Caronia does not address whether off-label promotion may be relied on as evidence of intent; and

(3)    Caronia acknowledged that the First Amendment does not protect false or misleading speech.

This interpretation, she said, “is an attempt to confine Caronia to its narrowest possible factual ground, which is not an entirely indefensible thing to do as a matter of law, but as a matter of reality, that approach had the effect of denying the FDA a much-needed, meaningful opportunity to consider the broad implications of the First Amendment principle.”

The FDA’s position resulted in companies being “circumspect about operating under the Caronia decision for a variety of reasons,” she indicated, citing the primary reason as “the huge disconnect between the development of the doctrine in the courts and the way in which prosecutors are making decisions about the rightness of company conduct on the other.”

Importantly, in failing to see the Caronia decision as impetus for policy revision, the FDA appears to be losing touch with the reality of a changing healthcare arena, Klasmeier suggested. “If the FDA wants to remain relevant, given the explosion of information sources available to patients, it really should think carefully about whether its role as essentially a censor of health information is really consistent with what its key stakeholders want and expect,” she said.

She suggested that even though Caronia has not had an immediate effect on off-label promotion regulation, it may be paving the way for other cases that could result in the agency taking a second look at its current position. The type of case mostly likely to have success in bringing about change may come from companies suffering from what she calls the “comparative effectiveness research (CER) asymmetry problem.”“If the First Amendment is going to be ventilated in court in a pharma case, there is a very good possibility that it will be in a CER asymmetry case,” she said, because a case based on that issue shows viewpoint/speaker discrimination. “It’s the idea that out of all the participants in the healthcare arena, manufacturers are uniquely disabled from commenting on CER issues because the regulations prohibit them from doing so.”

Geoffrey Levitt, senior vice president and associate general counsel, Pfizer, agreed that the FDA’s position prohibiting other types of evidence a company may have to support an off-label use, such as observational, meta-analysis or comparative effectiveness data, is a bit limiting.

“The logic of Caronia and [the U.S. Supreme Court decision in IMS v. Sorrell] is that truthful and nonmisleading speech should not be prohibited,” Levitt said. However, “the FDA headed in the opposite direction and seems to be doubling down on rejection of these other types of data.”

There are myriad ways of showing “FDA’s unwavering commitment to a regulatory regime and an enforcement approach that denies the meaningful existence of First Amendment and due process laws,” Klasmeier said. “This issue is not going away and it is worthy of our attention.”

Levitt noted that the effect of Caronia “so far has been limited, but I think its ultimate effect as the latest in a developing line of cases that are challenging the underlying fundamental assumptions of FDA’s regulation of medical product communication may turn out to be very significant.”

Jonathan Diesenhaus, partner, Hogan Lovells US LLP, who formerly served as senior trial counsel in the Civil Division of the DOJ, told WLF media briefing attendees that the Caronia case was unusual because it focused on the issue of speech alone. He said the government generally pursues cases that pair speech issues with other types of misconduct, which he termed “plus factors,” that may point to upper management’s strategy to foster off-label use.

He noted that because of Caronia, individual sales representatives are not likely to be prosecuted, but that “two other actors” – corporations and senior executives – “are exposed.” Corporations are at risk, he said, “because piles of evidence are being pieced together that something is implicitly false when companies don’t disclose that a product is not effective for off label,” he said. As a result, “there is a business need to police your sales force that goes beyond a corporate integrity agreement.”

Further, Diesenhaus continued, “as the world looks for individuals to be held responsible for large fraud schemes, the push unfortunately is going to get bigger for senior executives to be prosecuted under strict liability standards, now that [sales reps] are off limits. That’s a dramatic concern that companies face.”