DOJ Speaker Program Enforcement Relating to Opioid Medications Significantly Increases Risk to Participants

The Department of Justice (DOJ)’s enforcement efforts aimed at speaker programs have not slowed since the DOJ filed criminal and civil actions against Insys, its executives, and scores of physicians relating to the off-label promotion of Subsys, an oral fentanyl medication approved for the management of breakthrough pain in adult cancer patients. In addition, the Department of Health and Human Services previously issued a Special Fraud Alert, outlining the criteria regulators will consider and making clear that “[p]arties involved in speaker programs may be subject to increased scrutiny.” See DHHS-OIG, Special Fraud Alert: Speaker Programs, available here.

As we have repeatedly noted, when controlled substances, particularly opioids, are involved, the risk of enforcement actions increases significantly. Further illustrating this principle, the DOJ recently announced a settlement with Dr. Gerald Sacks, a California-based pain specialist, relating to his receipt of speaking and consulting fees from Depomed, Inc., the manufacturer of Lazanda, an oral fentanyl product that is included in the TIRF REMS program with Subsys. The $271,259.12 civil settlement resolved DOJ’s allegations under the False Claims Act that Dr. Sacks had been paid “kickbacks” to prescribe Depomed’s products to Medicare beneficiaries.

Suffice it to say, the foregoing settlement is quite low, even puny, by DOJ standards. It also is noteworthy that the case was brought by DOJ’s Civil Frauds Division, a/k/a “Main Justice,” which typically dedicates its time and resources to pursuing large-dollar-value frauds. Some insight into these anomalies may be gleaned from a statement by Michael D. Granston, Deputy Assistant Attorney General, that accompanied DOJ’s announcement, as follows: “Physicians are prohibited from accepting kickbacks designed to influence their decision making. Adherence to this prohibition is especially crucial with regard to dangerous drugs like opioids.” Participants of speaker programs are well-advised to consult qualified counsel regarding any speaker or consulting arrangements involving controlled substances, particularly those involving opioids. 

How Frier Levitt Can Help

Our White-Collar Defense & Government Investigations practice, headed by Anthony Mahajan, a former federal prosecutor with the DOJ, currently represents numerous physicians and specialty pharmacies in connection with government investigations relating to Subsys. If you are dealing with such an investigation, or want to further understand potential risks associated with speaker programs or consulting activities, please call us today for a consultation.