Biden Administration to Cancel Plan to Expand Access to Treatment for Opioid Use Disorder

The Biden Administration will cancel the U.S. Department of Health and Human Services’ (HHS) plans to issue guidelines to expand access to medication-assisted treatment (MAT) by exempting physicians from certain certification requirements needed to prescribe buprenorphine for opioid use disorder (OUD) treatment. The Administration stated that HHS’s forthcoming Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder was announced prematurely and did not have clearance from the White House budget office. In their statement on the Substance Abuse and Mental Health Services Administration (SAMHSA) website, the Administration reiterated their commitment to working with agencies and partners to “increase access to buprenorphine, reduce overdose rates and save lives”.

Articles & Resources

The Washington Post – Biden kills Trump plan on opioid-treatment prescriptions

SAMHSA – Statement Regarding X-Waiver

As Biden Considers Choice for FDA Commissioner, Stakeholders Express Support, Opposition for Acting Commissioner Janet Woodcock

President Biden has yet to announce a nominee to lead the U.S. Food and Drug Administration (FDA), but advocacy stakeholders are voicing both support for and opposition to the possibility of Acting Commissioner Janet Woodcock being tapped for the top job. Dr. Woodcock, who most recently was detailed to the Office of the Commissioner to help spearhead Operation Warp Speed, previously served as the Director of the FDA’s Center for Drug Evaluation and Research (CDER). Many groups, including over 80 rare disease patient advocacy organizations, have signed onto letters to President Biden and publicly expressed their support for Dr. Woodcock as Commissioner, citing her deep experience at the FDA and track record of advancing patient-focused drug development. Last week, a group of patient and consumer advocates concerned about Dr. Woodcock’s role in approving prescription opioids during her tenure at CDER sent a letter to President Biden cautioning him against making Dr. Woodcock his nominee.

Articles & Resources

EveryLife Foundation – Letter to President Biden in Support of Janet Woodcock as FDA Commissioner

Inside Health Policy – Former FDAer Doubts Woodcock Will Be FDA Chief, Others Not So Sure

STAT – Advocacy groups urge Biden administration not to tap Woodcock as FDA commissioner

2021 Strategy Session Recap; Senate Staff Update on CARA 2.0

On January 26, CEPOP convened its annual all-participant strategy session. Focus topic speaker, Megan Harrington of Senator Portman’s staff, opened with a presentation on plans to develop and advance CARA 2.0.  This was followed by discussions of 2020 accomplishments and the steering committee’s recommendations for strategic priorities in the coming year. A finalized 2021 work plan will be shared in early February. CEPOP’s next all-participant meeting will be held on Monday, February 22 at 3PM ET.

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

American Medical Association – Q&A: Training the physicians who will fight resurgent opioid epidemic

Bloomberg Government – Ohio Attorney General Agencies Deploy 908 Devices Handheld Mass Spec Device to Aid Law Enforcement Cases Involving Illicit Drugs

DEA – DEA warns of methamphetamine and fentanyl drug market built by aftermath of COVID-19 in New York

FDA – OPDP Reflects on 2020, Looks Forward to 2021 as It Helps Ensure Prescription Drug Promotion Is Truthful, Balanced and Accurate

Health Affairs – Critical Support Where High-Risk Pregnancy Meets Addiction

Health Affairs – Substance Use Disorders: Funding For Prevention

Johns Hopkins University – Coalition publishes principles to guide state and local spending of opioid litigation settlement funds

Law360 – Judge Doubts Walmart’s Preemptive Opioid Suit Can Prevail

Law360 – Opioid MDL Judge Takes Senior Status, Setting Up Biden Pick

Law360 – States Urged Not To Use Opioid Mega-Deals For Budgets

NPR – Biden Administration Criticized For Delay In Tackling Opioid Crisis

NPR – They Lost Sons To Drug Overdoses: How The Pandemic May Be Fueling Deaths Of Despair

Pew – Primary Care Providers Can Help Steer People to Opioid Addiction Treatment

Psychiatry Advisor – Expert Perspective: The Opioid Crisis and COVID-19

ScienceDirect – Expanding access to methadone treatment in Ohio through federally qualified health centers and a chain pharmacy: A geospatial modeling analysis

STAT – FTC sues drug makers over allegedly illegal deal over an opioid painkiller

The Hill – To battle the opioid crisis, arm more healthcare providers

The New England Journal of Medicine – At the Cusp — Reimagining Infective Endocarditis Care amid the Opioid Epidemic

U.S. Attorney’s Office for the District of Connecticut – Hartford Man Sentenced to Prison for Fentanyl and Crack Distribution Offenses

U.S. Attorney’s Office for the District of Northern District of West Virginia – Gilmer County man admits to fentanyl charge

U.S. Attorney’s Office for the District of Oregon – Leader of Portland-Area Prescription Drug Trafficking Scheme Sentenced to Federal Prison

U.S. Attorney’s Office for the Eastern District of California – Ten Indicted for Fentanyl Trafficking

U.S. Attorney’s Office for the Eastern District of California – United States Attorney’s Office Files Suit Against San Joaquin County Pharmacy for Unlawfully Dispensing Opioids

U.S. Attorney’s Office for the Eastern District of Texas – Vidor Woman Sentenced to 15 Years in Federal Prison Following Opioid Overdose Deaths

U.S. Attorney’s Office for the Eastern District of Washington – Tri-City Metro Drug Task Force Receives Over $132,800 Forfeiture Award from U.S. Department of Justice as a Result of Dismantling Fentanyl-Laced Pill Drug Trafficking Ring in the Tri-City Area

U.S. Attorney’s Office for the Middle District of Florida– Distributor Of Fake Pills Containing Fentanyl Sentenced To More Than Three Years In Federal Prison

U.S. Attorney’s Office for the Northern District of Iowa – Cedar Rapids Doctor Agrees to Pay $100,000 to Resolve Allegations that He Overprescribed Opioids in Violation of the Controlled Substances Act

U.S. Attorney’s Office for the Northern District of West Virginia – Monongalia County man admits to fentanyl distribution

U.S. Attorney’s Office for the Southern District of Georgia – Heroin, fentanyl trafficking targeted in Operation Jump Start, with seven indicted on federal charges

U.S. Attorney’s Office for the Western District of Missouri – Drug Treatment Clinic Owner Indicted for Drug Trafficking

U.S. Attorney’s Office for the Western District of New York– Former Amherst Pain Doctor Pleads Guilty To Fraud

University of Cincinnati – The dangers of drugged driving are outpacing drunk driving

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

Questions about the above content can be directed to