In a series of speeches over the last week, DOJ has expanded on its commitment to organize enforcement efforts focused on manufacturers and distributors of opioids. On February 27, AG Sessions announced the DOJ Prescription Interdiction & Litigation (“PIL”) Task Force, positioning it as a means aggressively to deploy “all available criminal and civil law enforcement tools . . . with a particular focus on opioid manufacturers and distributors.” See https://www.justice.gov/opa/pr/attorney-general-sessions-announces-new-prescription-interdiction-litigation-task-force. In that regard, Sessions suggested DOJ will leverage its decades of experience pursuing “off label” cases under the Food, Drug & Cosmetic Act (“FDCA”). Specifically, “the PIL Task Force will build on and strengthen existing Department of Justice initiatives to ensure that opioid manufacturers are marketing their products truthfully and in accordance with Food and Drug Administration rules.”
This announcement was echoed in statements made last week by Deputy Assistant AG Ethan Davis, who has responsibility for DOJ’s Consumer Protection Branch, tasked with responsibility for criminal enforcement of violations of the FDCA. In that speech, Davis made clear that DOJ is turning its traditional “off label” enforcement lens towards marketing that it deems “misleading” – a very broad concept indeed – and will be motivated to bring criminal charges wherever there is evidence of patient harm, citing the opioid crisis as the first priority in this regard. See https://www.justice.gov/opa/speech/deputy-assistant-attorney-general-ethan-p-davis-delivers-remarks-fdanews-label.
Also last week, Deputy Assistant Attorney General Stephen Cox, who has responsibility for formulating and implementing DOJ policies pertaining to FCA and other litigation and DOJ enforcement efforts, noted DOJ’s intentions to leverage the Anti-Kickback Statute and FCA to further target opioid manufacturers and distributors. See https://www.justice.gov/opa/speech/deputy-associate-attorney-general-stephen-cox-delivers-remarks-federal-bar-association. Citing the importance of leveraging those laws to protect “independent medical decision-making” generally, Cox went on to note the heightened need to do so in the context of opioids. He cited a 2017 settlement with Galena Biopharma, manufacturer of Abstral, which resolved FCA claims that Galena paid kickbacks in various forms to induce doctors to prescribe the opioid, and the conviction of two physician-recipients of the kickbacks. The Galena settlement is available here (https://www.justice.gov/opa/pr/galena-biopharma-inc-pay-more-755-million-resolve-alleged-false-claims-related-opioid-drug). Cox was clear on DOJ’s intention to expand its use of the FCA in this context: “The False Claims Act provides the government with a powerful tool to pursue all of those in the opioid distribution chain that are responsible for the improper marketing, distribution, prescription and diversion of opioids – from pharmaceutical manufacturers to physicians, and everyone in between.” before reiterating that “the False Claims Act is a tool [DOJ is] increasingly using to address the opioid crisis.”
We will continue to follow and report on developments on the DOJ’s multi-faceted enforcement efforts against manufacturers, distributors, and prescribers of opioids.