Lawmakers Request FDA to Update Opioid Labeling Policies

Last week, Senators Maggie Hassan (NH) and Mike Braun (IN) sent a letter to Food and Drug Administration (FDA) commissioner Dr. Robert Califf urging him to direct the agency to strengthen their regulation of opioids by updating opioid prescription labeling policies and utilizing best available science when developing labels. In their letter, the lawmakers called on the agency to revise the labeling for the long-term use of opioids to remove unsupported claims about long-term efficacy, replace the term “abuse deterrent” – which patients and providers may misinterpret as less likely to cause additions – with evidence-based language to more accurately convey that a product is harder to crush or inject, and evaluate the effectiveness of enriched enrollment randomized withdrawal trials. The lawmakers request that, by May 18th, FDA provide a timeline and plan for pursuing the suggested reforms.

Articles & Resources

Senator Maggie Hassan – Citing Overdose Deaths in New Hampshire and Indiana, Senators Hassan and Braun Call on FDA to Update its Opioid Labelling Policies

DEA Holds National Take Back Day for the Safe Disposal of Unused, Unwanted Medications

On April 30th, the Drug Enforcement Administration (DEA) held their National Prescription Drug Take Back Day, a bi-annual event that provides the public with a safe, free, and convenient way to anonymously dispose of prescription drugs and education opportunities about medication misuse. During this year’s event, the DEA and their network of state and local law enforcement partners hosted over 4,000 collection sites. DEA has collected over 15 million pounds of old, unwanted, and unneeded medications through their Take Back Day events, which began over a decade ago. To supplement their bi-annual events, DEA also provides the public with year-round disposal receptables at over 13,000 pharmacies, hospitals, police departments, businesses and select Veterans Administration medical centers. DEA Administrator Anne Milgram said, as part of the announcement, “Disposing of unneeded medications can help prevent drugs from being misused. Overdose deaths continue to hit tragic record highs. I encourage everyone to dispose of unneeded prescription medications now.” Additional information on DEA disposal sites can be found here.

Articles & Resources

DEA – DEA Holds 22nd National Prescription Drug Take Back Day to prevent addiction and reduce overdose deaths

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.

AHA – What If Your Superpower Fit in Your Back Pocket?

Annals of Emergency Medicine – Opioid Prescription Reduction After Implementation of a Feedback Program in a National Emergency Department Group

Bloomberg Government – House Moderates Pushing Bipartisan Bills Before Midterm Election

Congresswoman Marilyn Strickland – Strickland Fights Opioid Addiction through Health Equity Package

Detroit Free Press – Opioid overdose crisis: Getting Narcan from a pharmacy is not as easy as you may think

Health Affairs – A Greater Focus On Harm Reduction Will Save Lives

Health Affairs – Pain, Pills, And Prejudice: Racial/Ethnic And Gender Disparities In Opioid Prescriptions

Rand Corporation – A New Approach to Fighting Synthetic Opioids: Q&A with David Luckey and Jayme Fuglesten

Senate HELP – Senator Murray Presses FDA Leaders On COVID Vaccines for Kids, Fentanyl Deaths, Lowering Costs, and More at Hearing on User Fee Programs

Senator Joe Manchin – Manchin Questions U.S. Attorney General on Addressing Voting Rights, Price Gouging And Drug Epidemic

Senator Maggie Hassan – Following Push & Questioning from Senator Hassan, FDA Announces it Has Stopped Issuing Contracts to McKinsey Pending Federal Investigations

The Hill – House committee grills McKinsey for working with both FDA, Purdue Pharma

The Washington Post – Chronic pain is terrible. A new way of understanding it may help.

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 [email protected].