DOJ Takes New Steps In Opioid Enforcement
By: John A. Schwab
In the last few weeks, the Department of Justice has announced new initiatives in the fight against the opioid crisis. These initiatives included the creation of the Prescription Introduction & Litigation Task Force and a directive that the DEA review regulations regarding production quotas for prescription opioids.
In late February, Attorney General Jeff Sessions announced the creation of the Prescription Introduction & Litigation Task Force – termed the “PIL Task Force” – which will focus DOJ’s civil and criminal enforcement tools on manufacturers, distributors, prescribers and pharmacies. For manufacturers, the task force will use “all available criminal and civil remedies” to hold them liable for illegal activities, including false or misleading marketing of opioids. DOJ will also examine pending litigation against manufacturers filed by state and local governments to determine if federal law can assist the litigation.
For prescribers, pharmacies, and distributors, the PIL Task Force will investigate whether DEA regulations are being followed and if the federal False Claims Act can be used to “crack down on pain-management clinics, drug testing facilities and physicians that make opioid prescriptions.”
The PIL Task Force will also partner with HHS to (1) improve coordination and data sharing against the federal government to better identify violations of law and patterns of fraud related to the opioid epidemic; (2) evaluate possible changes to the regulatory regime governing opioid distribution; and (3) recommend changes in laws.
Additionally, on March 1, the Attorney General issued a memo directing the DEA to evaluate its regulations concerning production quotas for prescription opioids. As readers may know, the DEA is charged with regulating the amount of opioids that manufacturers are allowed to produce as set forth in DEA regulations establishing these production and manufacturing quotas. However, as the Attorney General’s memo notes, “the United States is an outlier in the number of opioid prescriptions issued each year.” The Attorney General directed the DEA to revisit the quotas and accompanying regulations to determine if they are appropriate in light of the opioid crisis
For the Record
Remarks by Attorney General Sessions
PIL Task Force: “The PIL Task Force will aggressively deploy and coordinate all available criminal and civil law enforcement tools to reverse the tide of opioid overdoses in the United States, with a particular focus on opioid manufacturers and distributors.” (February 27, 2018).
Opioid production quotas: “Time is of the essence. Given the urgency of this crisis, with an estimated 175 Americans dying per day, we need DEA to act quickly to determine if changes are needed in the quotas.” (March 1, 2018).
If you become the subject of a PIL investigation, please do not hesitate to contact one of our Attorneys today.