Purdue Pleads Guilty to OxyContin Charges, Epidemic Role

OxyContin manufacturer Purdue Pharma pleaded guilty on Tuesday to three criminal charges brought by Vermont prosecutors related to violations of the Anti-Kickback Statute, conspiracy to defraud the U.S. and violation of the Food, Drug and Cosmetic Act that played a prominent role in the worsening of the nation’s opioid epidemic. Purdue admitted to obstructing federal efforts to combat opioid misuse and abuse and for not maintaining sufficient safeguards to address diversion of products onto the black market. Overall, this deception was intended to ensure the company’s profitability and continue supporting increasing manufacturing quotas. The guilty plea follows on last month’s announcement by the Department of Justice of a criminal and civil settlement and multi-billion dollar outlays in the form of penalties and forfeitures.

Earlier in the month, House Oversight Committee Chairwoman Carolyn Maloney announced the invitation of Purdue Pharma CEO and members of the Sackler family to testify in a December 8th hearing focused on the company’s role in the opioid epidemic. The status of that hearing is still to be determined as it has not been formally noticed.

Articles & Resources

Department of Justice – Opioid Manufacturer Purdue Pharma Pleads Guilty to Fraud and Kickback Conspiracies

U.S. Attorney for the District of Vermont – Purdue Pharma L.P. Pleads Guilty To Federal Felonies Relating To The Sale And Marketing Of Prescription Opioids

Associated Press – OxyContin Maker Purdue Pharma Pleads Guilty in Criminal Case

NPR – Critics Want Sacklers to Face Criminal Charges for Role in Opioid Crisis

DEA Issues NPRM for Partial Opioid Prescriptions

On Thursday, the Drug Enforcement Administration issued a notice of proposed rulemaking seeking to further clarify regulations around the partial fill for Schedule II prescriptions as set forth in the 2016 Comprehensive Addiction and Recovery Act. The NPRM clarifies existing regulatory requirements that had not been addressed in CARA but better informs patients and healthcare providers around indicating partial fills and scenarios where permitted. As noted in the NPRM, partial fills could help to lower overall costs by reducing the number of dosage units dispensed while also helping to remove the potential for unused or unwanted prescription opioids and other Schedule II substances from misuse or abuse.

Comments are due within sixty days of publication in the Federal Register, by February 2, 2021.

Articles & Resources

Federal Register – Partial Filling of Prescriptions for Schedule II Controlled Substances

FDA Reopens Public Docket for IR Opioid Packaging

The FDA announced on Tuesday that it would be reopening its public comment period focused on blister-packaging and fixed-unit dosing for immediate-release opioids through February 1, 2021. First opening in May 2019, the public docket sought stakeholder feedback on a modification to the Opioid Analgesic REMS to require certain IR opioids be made available in unit-of-use blister packs with the intent of reducing the number of unused or unwanted opioids available after dispensation and thus reducing the potential for misuse, abuse or diversion.

Based upon the feedback received series of webinars and public listening sessions, the agency is seeking to incorporate further input in the development of this program.

Comments to the Public Docket may be submitted through Regulations.gov using the docket no. “FDA– 2019–N–1845.” A copy of the Federal Register Notice is attached, for reference.

Articles & Resources

Federal Register Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid  Analgesics for Treatment of Acute Pain; Reopening of the Comment Period and Provision of Additional Information and Analysis

Report Highlights COVID-19 Threats in MH/SUD Treatment Programs

A bicameral set of lawmakers published a report this week that sought to better identify cases of COVID-19 that arose in residential settings for mental and behavioral health and addiction treatment. Massachusetts Senator Elizabeth Warren partnered with Chairwoman Carolyn Maloney (NY) and Representative Katie Porter (CA) of the House Committee on Oversight and Reform to pen the report, recognizing the critical need for continued, and often in-person, care for such mental health issues during the COVID-19 pandemic and potential best practices aimed at ensuring continuity of care.

The lawmakers found that more than half of the 376 facilities surveyed having dealt with at least one COVID-19 positive case with 14% responding to more significant outbreaks of the virus with greater than 10 cases. Of those facilities, approximately 1.8% of patients tested positive for COVID-19 along with 3.3% of staff. Shortages in tests have led to the creation of less rigorous testing protocol, further placing patients and staff at risk of transmission coupled with lax reporting standards

Understanding the potential proliferation of the virus within these settings, the authors noted the need for sufficient testing, PPE and other resources that will allow for continuation of services while reducing  transmission of COVID-19.

Articles & Resources

House Committee on Oversight and Reform – Warren, Maloney, Porter Release Findings from First Comprehensive Survey of COVID-19 Outbreaks in Residential Behavioral Health and Addiction Treatment Programs

LINK – COVID-19 in Behavioral Health & Addiction Treatment Programs

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the issue. Links to relevant articles are provided below.

Articles & Resources

Law360 – A Forgotten But Effective Tool Against Opioid Scams

New York Times – A.A. to Zoom, Substance Abuse Treatment Goes Online

POLITICO – Transition 2020: Biden’s Other Health Crisis: A Resurgent Drug Epidemic

Associated Press – Money Promised to Combat U.S. Overdose Crisis Sits Unused

Wall Street Journal – Oregon Decriminalized Drug Possession. Now It Has To Offer Treatment.

Bloomberg Law – Opioid Exec John Kapoor Permanently Banned from U.S. Drug Work

New York Times – New Guidelines Cover Opioid use After Children’s Surgery

KCCI Des Moines – Ex-Iowa Nurse Pleads Not Guilty to Stealing Clinic Fentanyl

STAT News – Misguided Federal Regulations Are Likely To Cause More Pain In People Already Living With It

New York Times – McKinsey Proposed Paying Pharmacy Companies Rebates for OxyContin Overdoses

National Safety Council – New Analysis: Employers Can Save Average of $8,500 for Supporting Each Employee in Recovery from Substance Use Disorder

Urban Institute – Supporting Children and Families Affected by the Opioid Epidemic

JAMA Network Open – Comparison of Opioids Prescribed for Patients at Risk for Opioid Misuse Before and After Publication of the Centers for Disease Control and Prevention’s Opioid Prescribing Guidelines

JAMA Pediatrics – Polysubstance Involvement in Opioid Overdose Deaths in Adolescents and Young Adults, 1999-2018

JAMA Psychiatry – Overdose-Related Cardiac Arrests Observed by Emergency Medical Services During the US COVID-19 Epidemic

Department of Justice – Florida and Tennessee Pain Clinic Owner Extradited from Italy to the United States to Face RICO Charges

U.S. Attorney for the District of Connecticut – Drug Company Manager Sentenced for Role in Kickback Scheme Related to Fentanyl Spray Prescriptions

U.S. Attorney for the District of Utah – Utah Pharmacy Accused Of Unlawfully Dispensing Thousands Of Opioids, Other Controlled Substances In Civil Lawsuit

U.S. Attorney for the Middle District of Florida – Pain Clinic Owner Sentenced To Prison For Tax Evasion And Money Laundering

U.S. Attorney for the Eastern District of Michigan – Michigan Doctor Pleads Guilty To Unlawfully Selling Prescription Drug Controlled Substances

U.S. Attorney for the Eastern District of Virginia – Physician Sentenced to Prison for Extensive “Pill Mill” Scheme

U.S. Attorney for the Western District of Texas – Odessa Pharmacy and Owner to Pay $320,000 in Civil Penalties for Alleged Violations of the Controlled Substances Act and the Combat Methamphetamine Epidemic Act of 2005

This Week’s Calendar

We are now in the final stretch of the 116th Congress with the short-term continuing resolution set to expire at the end of this week. Much of this week’s agenda is focused on avoiding a government shutdown, passing the NDAA, and pandemic response/stimulus funding. We have included below several virtual events that may be of interest to Policy Report recipients. In the instance that there are any changes to the schedule for this week, we will make additional information available.

  • House Oversight and Reform Committee
    The Role of Purdue Pharma in Fueling the Opioid Epidemic [Tentative; link]
    Tuesday, December 8th; 10:00am; Committee Homepage
  • White House Office of National Drug Control Policy
    Rural Faith Leaders Workshop Series: Empowering Faith Leaders to Help Persons with Substance Use Disorder
    Tuesday, December 8th; 1:00pm – 2:30pm ET; Please RSVP to Betty-Ann Bryce

Questions about the above content can be directed to [email protected]