FDA and CDC leaders to join September 26 All-Participants Meeting at 3PM Eastern

CEPOP will be hosting its September All-Participants Teleconference on September 26th at 3:00pm EST. The meeting will include presentations from Dr. Christopher Jones from CDC’s National Center for Injury Prevention and Control on their study on telehealth and opioid use disorder services, and Dr. Marta Sokolowska from FDA’s Center for Drug Evaluation and Research on the agency’s Overdose Prevention Framework. Please contact Sanjyot Sangodkar for more information.

FDA Releases Guidance to Facilitate the Availability of Naloxone

On September 23rd, the Food and Drug Administration (FDA) issued a final guidance document, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency, for immediate implementation to help expand the availability of and access to naloxone to harm reduction programs. The DSCSA established requirements to facilitate the tracing of products through the pharmaceutical distribution supply chain and, upon the declaration of a public health emergency, specific distribution activities were excluded from DSCSA requirements. The declaration of the opioid public health emergency triggered an exemption and an exclusion in the Federal Food, Drug, and Cosmetic Act where certain DSCSA requirements do not apply to product distribution activities that address the public health emergency. The FDA’s guidance document attempts to clarify the scope of the public health emergency exclusion and exemption under the DSCSA as they apply to the distribution of FDA-approved naloxone products. In the guidance document, FDA notes that the agency “interprets the exemption and exclusion to apply to the distribution of FDA-approved naloxone products to harm reduction programs and to harm reduction suppliers to address the opioid public health emergency during the public health emergency.” The guidance is effective immediately, but FDA is accepting public comments to the Federal Register here.

Articles & Resources

FDA – FDA Issues New Guidance to Help Facilitate Availability of Naloxone to Prevent Opioid Overdoses and Reduce Death

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.

Bloomberg Government – W.Va. Announces $147M Opioid Settlement With CVS, Walmart

Congressman Ron Estes – Reps. Estes, Panetta Introduce The Fighting Stimulant And Other Substance Use Disorders Act

Congresswoman Abigail Spanberger – During National Recovery Month, Spanberger Presses House Leadership to Support Addiction & Recovery Programs Through the Substance Abuse Block Grant Program

FDA – Encouraging Harm Reduction

Psychology Today – The Opioid Public Health Crisis: One Mother’s Mission

Rand Corporation – Consensus-Based Guidance on Opioid Management in Individuals With Advanced Cancer-Related Pain and Opioid Misuse or Use Disorder

Roll Call – With overdoses rising, a push for syringe service programs

Scientific American – A Recent Supreme Court Ruling Will Help People In Pain

Senator Maggie Hassan – NH Delegation Announces Pivotal SOR Funding for NH to Tackle Substance Use Disorder Crisis

TIME – Why Overdose Deaths Skyrocketed After Opioid Prescriptions Dropped

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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