"FDA Chief Counsel, DOJ Promise Off-Label Enforcement Based On Risk, Patient Harm" article by Venable partners, Michael Blume and Kan Nawaday, and associate, Stephen Salsbury, was published in InsideHealthPolicy Daily Briefing on March 13, 2018. Here is an excerpt:
Mr. Davis's speech provides important insight into how the government now plans to procced. Three aspects of the speech merit specific attention, as they pertain to off-label promotion. First, DOJ will not back away from enforcement cases that have off-label promotion at their core – Mr. Davis signaled no radical change in how the government enforces the FDCA. But second, Mr. Davis makes clear that, as a general matter, the DOJ will focus on cases that satisfy at least one of the following specific criteria: (a) promotional activity that was false or misleading; (b) off-label use that harmed patients; and (c) conduct that misled the FDA. These criteria hark back to earlier "plus" factors – somewhat common in the Bush administration – that DOJ examined when assessing similar cases. It is important to note that Mr. Davis specifically mentioned the harm that opioid use has caused. It is also important to note, however, that, regardless of the harm that an off-label use may have caused, the government would be hard pressed to prevail in a case in which the manufacturer's promotion involved truthful and non-misleading speech. Caronia and its progeny would provide a manufacturer a robust defense to a federal action in such a circumstance. Third, Mr. Davis tied these cases to the new administration’s emphasis on the "rule of law." By that he was referring to AG Sessions' November 2017 memo ending DOJ's practice of regulation by guidance – in other words, noncompliance with guidance documents will not be seen as a violation of the law. This is particularly relevant here, as FDA has issued any number of guidance documents that discuss the ways in which it believes manufacturers can and cannot promote their products.
Mr. Davis's speech provides important insight into how the government now plans to procced. Three aspects of the speech merit specific attention, as they pertain to off-label promotion. First, DOJ will not back away from enforcement cases that have off-label promotion at their core – Mr. Davis signaled no radical change in how the government enforces the FDCA. But second, Mr. Davis makes clear that, as a general matter, the DOJ will focus on cases that satisfy at least one of the following specific criteria: (a) promotional activity that was false or misleading; (b) off-label use that harmed patients; and (c) conduct that misled the FDA. These criteria hark back to earlier "plus" factors – somewhat common in the Bush administration – that DOJ examined when assessing similar cases. It is important to note that Mr. Davis specifically mentioned the harm that opioid use has caused. It is also important to note, however, that, regardless of the harm that an off-label use may have caused, the government would be hard pressed to prevail in a case in which the manufacturer's promotion involved truthful and non-misleading speech. Caronia and its progeny would provide a manufacturer a robust defense to a federal action in such a circumstance. Third, Mr. Davis tied these cases to the new administration’s emphasis on the "rule of law." By that he was referring to AG Sessions' November 2017 memo ending DOJ's practice of regulation by guidance – in other words, noncompliance with guidance documents will not be seen as a violation of the law. This is particularly relevant here, as FDA has issued any number of guidance documents that discuss the ways in which it believes manufacturers can and cannot promote their products.