Lawmakers Urge Manufacturers to Make Naloxone Available Over-the-Counter

In response to the United States experiencing a record 100,000 overdose deaths in a 12-month period last year, a bicameral, bipartisan group of lawmakers sent letters to the chief executive officers (CEOs) of seven naloxone manufacturers urging them to apply for over-the-counter (OTC) status for their naloxone products. In their letter, the lawmakers propose that OTC status for naloxone will encourage its widespread use, reduce stigma, lower prices, and increase supplies in at-risk communities. The lawmakers note that the U.S. Food and Drug Administration has already developed and validated key labeling data needed to approve an OTC version of naloxone and, to support future OTC applications, has provided model OTC labels and usage instructions for both the nasal spray and auto-injector versions of naloxone. Currently, several states have standing orders that allow people to access naloxone without a prescription.

Articles & Resources


Senator Sherrod Brown – Brown, Bipartisan Group of Colleagues Call on Drug Manufacturers to Make Naloxone Available Over The Counter

GAO Report Highlights Impact of Opioids on Older Workers

The U.S. Government Accountability Office (GAO) recently published their “Older Workers: Opioid Misuse and Employment Outcomes” report which examined how employment experiences differ between older workers who misuse opioids and those who do not and assessed the challenges local workforce agencies identified in helping older workers affected by opioid misuse during the COVID-19 pandemic. GAO analyzed the Department of Health and Human Services’ (HHS) National Survey on Drug Use and Health data from 2015 to 2019, interviewed officials from 12 workforce agencies, and interviewed Department of Labor and HHS officials. Researchers found that adults ages 50 and older who misused opioids were more likely to be unemployed or experience employment instability. The report stemmed from a request by Senators Tim Scott (SC), Susan Collins (ME), and Bob Casey (PA) and builds on the work of the Senate Special Committee on Aging, which aims to support older Americans in the workforce. In a press release, Senator Collins said, “The opioid epidemic has had a devastating effect on countless families and communities. One of the consequences of this public health crisis has been a decline in overall labor force participation rates, contributing to workforce shortages and trapping individuals struggling with addiction in a cycle of poverty. This report explores this issue in depth and provides insight into how we can develop and improve programs to better support older adults with substance use disorders.”

Articles & Resources

Older Workers: Opioid Misuse and Employment Outcomes

Senate Special Committee on Aging – New Report Requested by Scott, Collins, and Casey Sheds Light on Opioids’ Impact on Older Workers

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.

Associated Press – EXPLAINER: Where do US opioid trials, settlements stand?

CNN – Drug overdose deaths in the US tick up again to another record high, according to CDC data

DEA – Schedules of Controlled Substances: Temporary Placement of Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene, Metonitazene, N-Pyrrolidino etonitazene, and Protonitazene in Schedule I

FDA – Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry

FDA – FDA and DEA Warn Online Pharmacies Illegally Selling Adderall to Consumers

JAMA – ​ Trends in Drug Overdose Deaths Among US Adolescents, January 2010 to June 2021

JAMA Network Open – Longitudinal Analysis of Substance Use Disorder Symptom Severity at Age 18 Years and Substance Use Disorder in Adulthood

JD Supra – Supreme Court To Rule On Physician Opioid Prescribing Habits And Criminal Liability

Law360 – Mapping The Top Trials To Know In The Opioid Litigation Wave

Psychiatry Advisor – Benefits of Buprenorphine for Opioid Use Disorder Go Beyond Addiction Recovery

Senator Bill Cassidy – Cassidy, Hirono Urge Transparency on Opioid Treatment for Veterans

Stanford Medicine – Teaching medical students how to prevent, treat addiction

STAT – As a pain specialist, I may have caused more harm by underprescribing opioids

The Pew Charitable Trusts – Can Medicaid Help Improve Opioid Use Disorder Treatment in Correctional Facilities?

The Washington Post – Number of adolescents prescribed opioids after surgery has declined

U.S. House Committee on Oversight and Reform – The Firm and the FDA: McKinsey & Company’s Conflicts of Interest at the Heart of the Opioid Epidemic

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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