Join Congressman David Trone and FDA Drug Security Leader During October 1 CEPOP All-Participants Teleconference

CEPOP will be hosting its next All-Participants Teleconference on Thursday, October 1st at 2:00pm ET. We’re pleased to share that we’ll have to fantastic focus topic speakers joining us to discuss timely and pressing components of the national response to combat the opioid epidemic. We’ll first hear from Dr. Sangeeta Chatterjee, Acting Deputy Director for the Office of Drug Security, Integrity and Response in FDA’s Center for Drug Evaluation and Research around their recent actions to combat illegal online opioid sales and takedown of seventeen infringing websites.

Congressman David Trone of Maryland’s Sixth District will also join as a Focus Topic Speaker to discuss his work leading the Freshman Working Group on Addiction and continued efforts to promote policy and education initiatives during National Recovery Month and throughout his tenure in Congress.

CEPOP All-Participants Teleconference Logistics
To join WebEx, please CLICK HERE.
Or, to join via conference call:
Conference Line: (855) 244-8681
Participant Code: 126 191 3083
Quick Dial: (855) 244-8681;;1261913083#

Articles & Resources

NIH Newsroom – Substance Use Disorders Linked to COVID-19 Susceptibility

Bipartisan, Bicameral Effort Launched to Improve MAT Education and Access

Led by Senators Michael Bennet (D-CO) and Susan Collins (R-ME) and Representatives Lori Trahan (D-MA) and Jack Bergman (R-MI), the Medication Access and Training Expansion (MATE) Act was introduced earlier this week into the Senate aimed at improving education around opioid addiction and prescribing medication-assisted treatment. Covering physicians, PAs, nurses, NPs, and other clinical providers, this language would require completion of a comprehensive training to ensure those prescribing controlled substances foundationally understand addiction, pain management, treatment and recovery. As part of the bill, medical schools and residency programs would also be encouraged to integrate clinical rotations around substance use disorders, addiction and treatment into curriculum.

In introducing the bill, Senator Collins said, “Our bipartisan bill would ensure that all health care professionals who prescribe controlled substances are also equipped with the tools and training they need to prevent, identify, and treat addiction. The opioid crisis requires an all-of-the-above approach, but increased access to evidence-based addiction prevention and treatment is a critical component of supporting those in need and ultimately tackling this crisis.”

Articles & Resources

Senator Bennet Newsroom – Bennet, Collins Introduce Legislation to Significantly Expand Opioid and Substance Use Training Nationwide for Providers

LINK to the Medication Access and Training Expansion (MATE) Act

HHS OIG Urges Increased Naloxone Access in Medicaid

A report issued by the HHS Office of Inspector General last week found that while there was significant growth in the Medicaid program’s coverage of naloxone 2014 and 2018 (21-times growth), the program was only responsible for approximately 5% of all naloxone distributed in 2018. While the Medicaid program covers 2-in-5 non-elderly adults with an opioid use-disorder, the discrepancy between beneficiary risk and access remains large and should be addressed. As part of the report, HHS encouraged CMS and State Medicaid programs to identify additional opportunities to target at-risk beneficiaries and improve access to the overdose reversal drug. In response to the report, CMS did note that several programs were underway to address this issue.

Articles & Resources

HHS OIG – CMS Should Pursue Strategies To Increase the Number of At-Risk Beneficiaries Acquiring Naloxone Through Medicaid

LINK to Report

FDA Revising Boxed Warning for Benzodiazepines

The Food and Drug Administration announced this week that it would be revising the boxed warning included with popular benzodiazepine prescriptions in order to better address concerns around product-specific misuse, abuse and addiction. In particular, there is concern around the impacts of co-prescribing benzodiazepines and opioids in which there are greater risks for overdose or other adverse drug events. The updated boxed warning will provide greater clarity around prescribing information and further clarify the risks associated with misuse, abuse, physical and chemical dependence and withdrawal.

Articles & Resources

FDA CDER – FDA Requiring Boxed Warning Updated to Improve Safe Use of Benzodiazepine Drug Class

LINK to FDA Drug Safety Communications

Negotiation Class Tossed Out by Sixth Circuit in Opioid MDL

On Thursday, the United States Court of Appeals for the Sixth Circuit promulgated a 2-1 ruling in reversing a lower courts decision to permit the creation and use of a negotiation class in seeking a global settlement in the widespread opioid multidistrict litigation housed in the Northern District of Ohio under Judge Dan Aaron Polster. Citing Rule 23 of the Federal Rules of Civil Procedure, the reversal nullified the lower courts certification of the negotiation class given the intent to seek global settlement rather than litigate a common issue. This ruling comes one year after Polster allowed for the creation of the negotiation class. In citing the Federal Rules for Civil Procedure, the court determined the novel class was outside the scope of what was permitted and formed from “whole cloth.”

Articles & Resources

LINK to the Sixth Circuit Court of Appeals Ruling

Reuters – U.S. Appeals Court Rejects Novel Opioid Settlement Framework

Law360 – Opioid MDL Negotiating Class Struck Down by 6th Circ.

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

Rep. Kuster Newsroom – Kuster, Fitzpatrick Lead Bipartisan Opioid Task Force Roundtable Discussion on Using Technology to Prevent Addiction and Promote Patient Safety

Rep. Trone Newsroom – Rep. David Trone Hosts Recovery in the Time of COVID-19 Webinar, Introduces Legislation to Fund Recovery Month Efforts

Boston Herald – Opioid Epidemic Poised to Worsen with ‘Tidal Wave of New Stressors’ Amid Coronavirus Pandemic, Experts Warn

Protocol – Pandemic Waivers Made It Easier to Get Treatment for Opioid Addiction. That Could All Go Away Next Month.

POLITICO – Manchin Targets Crimes Online with Bill to Revamp Section 230

POLITICO – New York City reports 8 percent increase in buprenorphine patients

Protenus – $183M Lost Due to Healthcare Workforce Diverting Drugs From Patient Care in 2019

ABC News – Justice Dept.” 179 Arrested in Darknet Opioid Takedown

Department of Justice – Justice Department Announces Results in Fight Against the Opioid Crisis Two Years after Launch of Operation S.O.S.

Drug Enforcement Administration – International Law Enforcement Operation Targeting Opioid Traffickers on the Darknet Results in Over 170 Arrests Worldwide and Seizure of Weapons, Drugs and Over $6.5 Million

U.S. Attorney for the District of Nevada – Supervisor Of Drug Testing Facility Who Took Bribes To Falsify Over 100 Drug Tests Sentenced To Over Four Years In Federal Prison

Department for Health and Human Services – Sickle Cell Treatment Options for Pain Management are Growing

U.S. Attorney for the Western District of Virginia – Blacksburg Doctor to Serve 90 Months in Prison on Health Care Fraud, Distribution of Controlled Substances, Obstruction of Justice Charges

U.S. Attorney for the Northern District of New York – Ulster County Dentist Arrested for Illegally Dispensing Oxycodone

U.S. Attorney for the Southern District of Texas Six ELN Members and Associates Charged With Narco-Terrorism and International Cocaine Distribution Conspiracy

U.S. Attorney for the Middle District of Florida – Local Pharmacist Sentenced To Prison For Unlawful Distribution Of Oxycodone

This Week’s Calendar

The House and Senate have no opioid-related hearings or events scheduled at this time as they continue to address several pressing topics including a Supreme Court nomination, coronavirus pandemic relief and avoiding a Tuesday government shutdown. In the instance that there are any changes to the schedule for this week, we will make additional information available.

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