In an unsurprising turn, the Department of Justice filed a Statement of Interest in several ongoing lawsuits against manufacturers and distributors of opioids brought by states, cities, and various localities. In announcing the plan to file the Statement of Interest, Attorney General Jeff Sessions provided the following statement about opioids: “President Trump and this administration have made ending this unprecedented crisis a priority, and the Department of Justice is committed to using every lawful tool at our disposal to turn the tide. We will seek to hold accountable those whose illegality has cost us billions of taxpayer dollars.”
This announcement regarding the Government’s continued focus on opioids occurred on the same date as the announcement regarding the creation of Prescription Drug Interdiction and Litigation (PIL) Task Force. The PIL is an extension of the Opioid Fraud Unit that was established last year.
The Prescription Drug Interdiction and Litigation Task Force stands out for several reasons:
The Task Force will focus on anyone involved in the distribution chain of opioids, including manufacturers, distributors, pharmacies, pain clinics, drug testing facilities, and individual physicians with an emphasis on manufacturers and distributors.
The PIL will use both civil and criminal resources to combat opioid fraud and abuse and will work closely with the Department of Health and Human Services (HHS).
PIL will use all available criminal and civil remedies available under federal law to hold manufacturers of opioids accountable for unlawful practices. As part of those efforts, PIL will ensure that manufacturers are marketing their products truthfully and in accordance with Food and Drug Administration rules.
The PIL will expand upon the efforts of the Opioid Fraud and Abuse Unit and sophisticated data analyses to identify and prosecute individuals who run afoul of the Controlled Substances Act and other federal laws. The Government already has the benefit of the Healthcare Fraud Prevention Partnership (HFPP) which is a voluntary public-private partnership between the federal government, state agencies, law enforcement, private health plans, employer organizations, and health care fraud trade organizations. 48 private payers belong to HFPP including the big ones which means that every day cross-analyses improves and the system of data mining with its critical advances is shifting more and more towards a real-time identification of risks process from a pay and chase system of a decade ago.
The Task Force will establish a working group who will: (1) improve coordination and data sharing across 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.
This surely marks a new enforcement regime against members of the entire distribution chain of opioids.
If you are involved in any aspect of the distribution chain of opioids as a manufacturer, distributor, wholesaler, pain management clinic, pain doctor or physician, pharmacist, pharmacist tech, pharmacy, or sales and marketing professional, it is incumbent that you are aware of these enforcement trends and the Government’s current enhanced focus on opioids and the opioid epidemic.
This announcement regarding the Government’s continued focus on opioids occurred on the same date as the announcement regarding the creation of Prescription Drug Interdiction and Litigation (PIL) Task Force. The PIL is an extension of the Opioid Fraud Unit that was established last year.
The Prescription Drug Interdiction and Litigation Task Force stands out for several reasons:
The Task Force will focus on anyone involved in the distribution chain of opioids, including manufacturers, distributors, pharmacies, pain clinics, drug testing facilities, and individual physicians with an emphasis on manufacturers and distributors.
The PIL will use both civil and criminal resources to combat opioid fraud and abuse and will work closely with the Department of Health and Human Services (HHS).
PIL will use all available criminal and civil remedies available under federal law to hold manufacturers of opioids accountable for unlawful practices. As part of those efforts, PIL will ensure that manufacturers are marketing their products truthfully and in accordance with Food and Drug Administration rules.
The PIL will expand upon the efforts of the Opioid Fraud and Abuse Unit and sophisticated data analyses to identify and prosecute individuals who run afoul of the Controlled Substances Act and other federal laws. The Government already has the benefit of the Healthcare Fraud Prevention Partnership (HFPP) which is a voluntary public-private partnership between the federal government, state agencies, law enforcement, private health plans, employer organizations, and health care fraud trade organizations. 48 private payers belong to HFPP including the big ones which means that every day cross-analyses improves and the system of data mining with its critical advances is shifting more and more towards a real-time identification of risks process from a pay and chase system of a decade ago.
The Task Force will establish a working group who will: (1) improve coordination and data sharing across 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.
This surely marks a new enforcement regime against members of the entire distribution chain of opioids.
If you are involved in any aspect of the distribution chain of opioids as a manufacturer, distributor, wholesaler, pain management clinic, pain doctor or physician, pharmacist, pharmacist tech, pharmacy, or sales and marketing professional, it is incumbent that you are aware of these enforcement trends and the Government’s current enhanced focus on opioids and the opioid epidemic.