On December 13, 2018, a senior U.S. Department of Justice (“DOJ”) Consumer Protection Branch official (“CPB”) discussed CPB’s enforcement priorities under the Food, Drug, and Cosmetic Act (“FDCA”). The CPB has broad authority to pursue civil and criminal FDCA actions against any party, including drug, device and food manufactures and executives. In the remarks, the DOJ: (1) identified broad enforcement principles, (2) discussed the CPB’s approach to FDCA matters and (3) outlined new efforts to combat the opioid epidemic.
The DOJ emphasized that the CPB would pursue violations in a manner aimed at fostering predictability and would not stand in the way of the healthcare industry’s ability to produce life-saving innovations. Instead, the CPB will focus on matters involving: (1) actual harm, (2) unacceptable risk of harm or (3) fraud.
The DOJ indicated it will continue to focus on three FDCA enforcement priorities: (1) compounding pharmacies, (2) current good manufacturing practices (“cGMPs”) and (3) off-label promotion.
First, compounding pharmacies are an increasing area of enforcement. While the FDA has made it a priority to bolster the regulatory framework for drug compounders, the CPB recently took action against two 503B outsourcing facilities. In April of this year, it secured a permanent injunction against one company and its owner after two recalls of sterile drugs and continued evidence of unsanitary conditions and failure to comply with cGMPs.1 It also obtained a permanent injunction against another company and two of its executives in June for similar violations.2 In the remarks, the DOJ emphasized the risk to human health in these cases, as well as opportunities for reaching compliance agreements.
Second, the DOJ indicated the CPB would work to ensure compliance with the wide range of cGMPs, through both civil injunctions and the False Claims Act (“FCA”). When products are manufactured in violation of cGMPs, the DOJ indicated that such products are “adulterated” under the FDCA, and their distribution in interstate commerce becomes unlawful. The CPB recently sought and won an injunction against one company in such a case, preventing them from distributing medical devices until they were in compliance with cGMPs.3 When there is an FCA violation, the CPB will coordinate with both the FDA and the DOJ’s Civil Fraud Section. For example, last year a global pharmaceutical company paid over $18 million to settle civil and criminal liability, and entered into a deferred prosecution agreement for failure to comply with cGMPs by continuing to manufacture a sterile intravenous solution in a contaminated clean room.4 Because the company sold the solution to the Department of Veterans Affairs, it incurred FCA liability.
Third, the DOJ confirmed a focus on pursuing conduct that threatens health and safety, and said the CPB would pursue off-label marketing cases, as well as those in which illegal kick-backs were paid to doctors, or where marketing was untruthful, false or misleading. The DOJ official stated that the CPB’s approach recognizes a right of doctors to prescribe off-label uses for patients’ benefit, and acknowledged that such uses may in some cases be the standard of care. He cited United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), as illustrating the First Amendment problems involved in the use of non-misleading speech for prosecutorial purposes. The DOJ also said that the CPB would continue to assist the FDA in considering its delayed final rules regarding “intended use.”
Enforcement Priorities – Opioid Epidemic
The remainder of the remarks addressed the CPB’s priorities in curbing the nation’s growing opioid epidemic, stating flatly that “combatting it is, quite simply, our #1 priority.” The remarks stressed repeatedly that enforcement efforts will extend to “all levels of the opioid distribution chain” and that “every participant at every stage of the opioid business is coming under the microscope.”
The DOJ emphasized three enforcement tools. First is the pursuit of failures to comply with the Risk Evaluation and Mitigation Strategies (“REMS”) mandated by the FDA. When these failures render drugs misbranded under the FDCA, their sale and distribution become illegal. The CPB successfully pursued this theory last year with one company for failure to accurately convey risk information5 and a second for failure to give complete and accurate information to healthcare providers, and for filing a misleading REMS report with the FDA.6
Second, the DOJ stated that the CPB is increasingly enforcing the Controlled Substances Act (“CSA”), which subjects those who handle controlled substances to certain registration and reporting requirements, and provides for both civil and criminal enforcement. In addition to criminal enforcement under this statute, the CPB and a U.S. Attorney’s Office recently announced temporary restraining orders and civil injunctions against two prescribing physicians.7 The DOJ underscored that the CPB would be looking at all aspects of the opioid supply chain.
Third, the DOJ addressed the new tools available pursuant to the recently signed SUPPORT for Patients and Communities Act (“SUPPORT Act”). The new SUPPORT Act provides for multiple means of information-sharing and reporting amongst manufacturers, the Drug Enforcement Administration (“DEA”), state prescription drug monitoring programs (“PDMPs”) and pharmacies. Companies registered under the CSA must institute systems to identify and report suspicious orders, review DEA-generated reports that track the quantity and type of opioids distributed by pharmacies and medical professionals and comply with government-mandated recall orders, or risk prosecution under the CSA.
Healthcare companies and their executives should be particularly attuned to the DOJ’s increased and focused FDCA enforcement.