FDA Launches New Framework for Overdose Protection, Announces Opioid Prescribing Review

On August 30th, Dr. Robert Califf, Commissioner of the Food and Drug Administration (FDA), published a blog post introducing the agency’s new Overdose Prevention Framework to address the opioid epidemic. Building off the Department of Health and Human Services (HHS) Overdose Prevention Strategy and President Joseph Biden’s National Drug Control Strategy, the Framework includes four overarching priorities to prevent drug overdoses, reduce deaths, and adapt to the evolving epidemic. The four priorities include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing, encouraging harm reduction through innovation and education, advancing development of evidence-based treatments for substance use disorders, and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

In his blog post, Dr. Califf also noted that the agency has initiated a review of all opioid regulations to assess what revisions are needed and inform a future approach, stating “I’m optimistic this review will provide us with recommendations to move forward in this multistep process, and we are working expeditiously to address this urgent situation.”

Articles & Resources

FDA – FDA’s Overdose Prevention Framework Aims to Prevent Drug Overdoses and Reduce Death

HHS to Provide $79.1M for Overdose Prevention

On August 31st, the Department of Health and Human Services (HHS) announced that, as part of President Joseph Biden’s National Drug Control Strategy, the HHS Overdose Prevention Strategy, and the Biden-Harris Unity Agenda, it will award $79.1 million in funding for overdose prevention grants. The funding, which will be awarded through the Substance Abuse and Mental Health Services Administration (SAMHSA), includes the following allocations:

  • $14.5 million for the First Responders-Comprehensive Addiction and Recovery Support Services Act for first responder trainings on carrying and administering opioid overdose reversal medications;
  • $7.1 million for Rural Emergency Medical Services (EMS) Training grants to train EMS workers in substance use disorder;
  • $8.2 million for the Targeted Capacity Expansion: Special Projects program to implement harm reduction, treatment, and recovery support strategies in under-resourced populations;
  • $1.5 million for the Provider’s Clinical Support System – Universities program to train medical, physician assistant, and nursing students in treating opioid use disorders and prescribing medications for opioid use disorder;
  • $12.1 million for the Services Grant Program for Residential Treatment for Pregnant and Postpartum Women program to provide pregnant, postpartum women, their children, fathers, partner, and other family members with outpatient substance-use treatment and recovery support services;
  • $3 million for the Strategic Prevention Framework for Prescription Drugs grant program to fund state agencies, territories and tribal entities to raise awareness about prescription drug misuse;
  • $32.7 million for the Medication-Assisted Treatment – Prescription Drug and Opioid Addiction program to increase access to medications for opioid use disorder.

In a statement, Dr. Miriam E. Delphin-Rittmon, HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA, said “Everyone in this country deserves access to effective overdose prevention, treatment and recovery programs. SAMHSA is committed to advancing innovative and comprehensive approaches that prevent overdose, expand quality treatment and sustain recovery.”

Articles & Resources

HHS – On International Overdose Awareness Day, HHS announces awarding of $79.1 million in overdose prevention grants

Joint CDC, CMS, NIDA Study Suggests Telehealth Expansions Reduced Opioid Overdose Risk

On August 29th, the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), and the National Institute on Drug Abuse (NIDA) published the results of a national longitudinal cohort study in JAMA Psychiatry examining the effects of telehealth expansions instated during the COVID-19 pandemic on opioid use disorder (OUD) services and adult Medicare fee-for-service beneficiaries with OUD. Researchers studied Medicare data from 175,778 adults from two mutually exclusive cohorts of adults with OUD – pre-COVID-19 pandemic from September 2018 to February 2020 and during COVID-19 pandemic from September 2019 to February 2021 – to compare receipt of telehealth services, medications for opioid use disorder (MOUD) receipt and retention, and medically treated overdoses prior to the pandemic and during the pandemic. The results suggest that OUD-related telehealth services provided to beneficiaries increased during the COVID-19 pandemic and were linked to improved MOUD retention and a reduction in medically treated overdoses. In a statement, Dr. Wilson Compton, deputy director of the National Institute on Drug Abuse, said “The expansion of telehealth services for people with substance use disorders during the pandemic has helped to address barriers to accessing medical care for addiction throughout the country that have long existed. Telehealth is a valuable service and when coupled with medications for opioid use disorder can be lifesaving. This study adds to the evidence showing that expanded access to these services could have a longer-term positive impact if continued.”

Articles & Resources

CDC – Increased Use of Telehealth for Opioid Use Disorder Services During COVID-19 Pandemic Associated with Reduced Risk of Overdose

Link to Published Study

What We Read Last Week

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

CDC – A qualitative assessment of circumstances surrounding drug overdose deaths during early stages of the COVID-19 pandemic

CDC – A Time to Remember and Take Action

CDC – Patient-Level and County-Level Trends in Nonfatal Opioid-Involved Overdose Emergency Medical Services Encounters — 491 Counties, United States, January 2018–March 2022

DEA – DEA Warns of Brightly-Colored Fentanyl Used to Target Young Americans

DOJ – Meeting the Evolving Challenges of Fentanyl and Other Emerging Drugs of Abuse: Innovative Strategies for Improving Analysis

– Supporting RecoveryDOJ

FDA – Encouraging Harm Reduction

FDA – Protecting the Public from Unapproved, Diverted, or Counterfeit Drugs presenting Overdose Risks

Healthcare Finance – Substance use disorder coverage would only slightly increase Medicare spending

JAMA Network Open – Geographic Trends in Opioid Overdoses in the US From 1999 to 2020

STAT – Rahul Gupta, first physician to serve as drug czar, says stigma among doctors is key culprit in addiction crisis

The Hill – To break down barriers to addiction care, modernize the rules for sharing those medical records

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.

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