CDC Releases Draft 2022 Practice Guideline for Prescribing Opioids for Chronic Pain

On February 10th, the Centers for Disease Control and Prevention (CDC) announced that they are updating their 2016 Clinical Practice Guideline for Prescribing Opioids for Chronic Pain by releasing a draft version of their new guidelines and opening a public comment period. In the new draft guidelines, the CDC will no longer suggests three-day limits on opioid treatments for acute pain or propose that doctors avoid opioid dosage increases that are equivalent to 90 milligrams of morphine per day, and instead offers recommendations that support individualized patient care. The new guidance recommends that providers consider the benefits and risks of starting, increasing, and stopping opioid treatments to prevent harm to patients experiencing severe pain, offers additional options for treating acute pain, and provides guidance for providers on opioid tapering. In a press release, Dr. Christopher Jones, acting director for the National Center for Injury Prevention and Control, said “The ultimate goal of this clinical practice guideline is to help people set and achieve their personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal.” Public comments will be accepted through April 11, 2022 here.

Articles & Resources

CDC – Federal Register Notice: CDC’s updated Clinical Practice Guideline for Prescribing Opioids is now open for public comment

Draft 2022 CDC Clinical Practice Guideline for Prescribing Opioids

FDA Issues Draft Guidance for Industry on Non-Opioid Analgesics

On February 9th, the U.S. Food and Drug Administration (FDA) issued draft guidance for companies developing non-opioid opioid analgesics for patients with acute pain lasting up to 30 days. The draft guidance outlines the FDA’s recommendations on non-opioid analgesic drug development including the types of drug development programs that companies may implement to generate data on the management of acute pain, the data needed to support using claims in labeling to reduce or eliminate opioid use, and the use of the agency’s expedited programs to support the development of non-opioid analgesics. In a press release, director of the Center for Drug Evaluation and Research Dr. Patrizia Cavazzoni said, “Preventing new addiction through fostering the development of novel non-opioid analgesics is an important priority for the FDA. The guidance reinforces the agency’s commitment to confront opioid misuse, abuse and addiction by taking steps to help those with acute pain get access to improved non-opioid treatment alternatives.”

The draft guidance was developed as part of the FDA’s efforts to fulfill the legal requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, which directs the agency to develop guidance on the development of non-addictive pain management products. Public comments will be accepted through April 9, 2022 here.

Articles & Resources

FDA – FDA Takes Steps Aimed at Fostering Development of Non-Addictive Alternatives to Opioids for Acute Pain Management

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

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.

AAP – Study Looks at Opioid Prescriptions, Suicidal Behavior

ABC News – Overdose deaths cost US $1 trillion annually, bipartisan report finds

AMA – AMA, Manatt Health unveil toolkit to combat drug overdoses

APhA – Two powerful drugs now adding to overdoses in U.S.

CNN – US report finds Mexico is dominant source of fentanyl trafficked into US

Congressman Dan Newhouse – Combatting the Opioid Epidemic

Harvard – What led to the opioid crisis—and how to fix it

HHS – Statement by HHS Secretary Xavier Becerra and ONDCP Director Rahul Gupta

NC State University – Study Finds Unexpected Benefits of ‘Drug Checking’ Programs

NIH – Treatment for opioid use disorder in jail reduces risk of return

Politico – Government commission: Synthetic drug trafficking a ‘national security’ emergency

Rand Corporation – Commission on Combating Synthetic Opioid Trafficking: Final Report

STAT – Fight over opioid prescribing — and when it turns criminal — heads to Supreme Court

The Hill – DOJ to evaluate providing safe havens for drug use

The Washington Post – The Biden administration is pulling out the stops to get its FDA pick confirmed

The Washington Post – The rising homicide rate in D.C. is nothing

Time – The Potent Drug Mix Causing Unprecedented Rates of Black Americans to Overdose

U.S. Senate Health, Education, Labor, and Pensions Committee – Murray, Burr Announce Bipartisan Effort to Strengthen Mental Health and Substance Use Disorder Programs

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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