James Burnham, the Deputy Assistant Attorney General for the Consumer Protection Branch (“CPB”), addressed the annual Food and Drug Law Institute Conference (“FDLI”) on December 13, 2018 about DOJ’s enforcement priorities and tools in the FDA-regulated space. As head of the branch within DOJ that has responsibility for bringing civil and criminal actions for violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”), and that works with DOJ Civil Frauds to bring actions based on those violations under the False Claims Act (“FCA”), Burnham outlined the principles that motivate enforcement action, the CPB’s current enforcement priorities, and some of the “new” enforcement tools CPB has at its disposal with respect to opioids.
I. Guiding Principles
Burnham prefaced his remarks by noting that the government has “special responsibilities beyond those of an advocate” to ensure that the legal arguments it pursues are legally “correct, not merely colorable.” In addition, Burnham explained that DOJ’s approach to enforcement would “not begin with a legal theory and then search for facts that would support it” and would “presume that people obey the law, not that people are violating it.” He reiterated the many considerations that have long motivated DOJ to take enforcement action against life sciences companies will continue. Specifically, CPB will focus on “practices that hurt people” or activities that “pose an unacceptable risk of harm.” “Marketing a product for a potentially dangerous or untested purpose” or manufacturing products or holding food in “insanitary conditions” will thus continue to draw CPB’s enforcement scrutiny. In addition, CPB will continue to “target fraud, like lying to the public about what diseases a product is effective in treating.”
II. Enforcement Priorities
Burnham focused on four general issues CPB currently is targeting for potential enforcement under the FDCA.
Reinforcing remarks made to the industry by FDA Commissioner Scott Gottlieb and other FDA officials at the FDLI conference, Burnham made clear that compounding pharmacies remain “an increasing focus of enforcement efforts.” This focus continues to be a high priority in the wake of the well-known patient safety issues caused by the New England Compounding Center (“NECC”) and more recent enforcement actions taken against other sterile drug compounders. Burnham committed that DOJ will take “swift” and “fierce” action against compounders who prepare drugs in insanitary conditions or otherwise out of compliance with current Good Manufacturing Practice regulations (“cGMPs”).
Beyond drug compounders, Burnham explained CPB’s commitment to assisting FDA in pursuing violations of cGMP regulations across the products FDA regulates. Burnham reviewed recent enforcement actions targeting medical device manufacturers, including under the FCA, premised on cGMP violations. Burnham highlighted that DOJ expects to continue to pursue cases such as these in which the risk of harm to patients is viewed as high, even where the violations did not, in fact, result in harm to patients.
Consistent with public comments by other DOJ and FDA officials over the last year on the topic of off-label promotion, discussed here, Burnham noted that “truthful, non-misleading information,” even about off-label uses of products, “can help doctors treat their patients more effectively and the “reality that there are potential First Amendment problems with using truthful, non-misleading speech as a basis for prosecuting people and companies.” As such, Burnham made clear that “[t]he provision of truthful information is not [the CPB’s] focus and is not [its] priority.” Instead, CPB will focus on “false or misleading” statements about uses of products that “pose a threat to patient health and safety.”
Describing enforcement targeted at the opioid epidemic as DOJ’s “#1 priority,” Burnham noted “every participant at every stage of the opioid business is coming under the microscope.” Burnham, who also serves as a Co-Chair of DOJ’s Prescription Interdiction & Litigation Task Force (“PIL”), referenced DOJ’s efforts to mine prescribing data to detect potentially problematic patterns and to investigate and bring actions against the physicians, pharmacies, distributors, and manufacturers that operate or enable opioid “pill mills.” Burnham also described several new “enforcement tools” DOJ is using to pursue these actions:
- Risk Evaluation and Mitigation Strategies (“REMS”). “All opioids are subject to a REMS,” which can require manufacturers to communicate certain safety information to prescribers. Violations of REMS requirements can render drugs misbranded under the FDCA and can be targeted under the FCA. Noting DOJ’s efforts to bring cases premised on REMS violations in other contexts, Burnham announced CPB’s commitment to leverage the same theory to bring cases against players in the opioid supply chain.
- The Controlled Substances Act (“CSA”). CPB will also partner with the DEA to bring cases under the CSA, which requires entities in the chain of supplying opioids and other controlled substances to register with DEA and comply with other regulatory requirements. Under the CSA, DEA also makes certain data reports available to drug manufacturers and distributors that show volumes of opioids made available to doctors and pharmacies. Burnham noted the obligation of manufacturers and distributors to review these reports, indicating DOJ can bring an action for CMPs for a failure to do so.
- The FCA. Of particular interest to readers of this blog, Burnham squarely addressed DOJ’s intent to bring cases under the FCA against actors in the opioid space. Thus, “[w]hen a company lies to doctors about the risks of an opioid,” or “[w]hen a doctor prescribes opioids to someone without a legitimate medical purpose,” DOJ may bring actions under the FCA as well as under other statutes.
Focusing in particular on the role of pharmacies, which Burnham described as the “final line of defense,” he opined that they are not obligated to “knowingly fill a prescription without a legitimate medical purpose” and that “the CSA does not require them to fill prescriptions, especially when the prescription raises red flags.” Of course, DOJ may target the filling of prescriptions despite “red flags” under not only the CSA but also the FCA.
A copy of Burnham’s prepared remarks is available here.