FDA Final Guidance on REMS Format and Content References Safe Disposal

On January 4th, the Food and Drug Administration (FDA) finalized guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for high-risk prescription drugs. The final guidance, Format and Content of a REMS Document, includes an overview of the types of information that FDA would like included in a REMS document, which FDA requires as part of a REMS to establish the goals and requirements of the REMS. The guidance includes a reference to safe disposal, stating that, if a REMS is necessary for a single product, FDA may require that the applicant “implement a requirement that a disposal system be dispensed (for the purpose of rendering the drug nonretrievable)” and that “packaging and disposal requirements can be required if they might mitigate a serious adverse event occurring from abuse or overdose.” The guidance also includes recommendations on safe use, noting that FDA may require elements to assure safe use (ETASU) for drugs that are associated with serious risk. ETASU outlined in the guidance include requiring training and certification for providers prescribing the specific drug, certifying health care setting that dispense the drug, ensuring that the drug is dispensed in certain health care settings, and ensuring patients using the drug are monitored and/or enrolled in a registry. FDA also published a supplementary guide, REMS Document Technical Conformance Guide, which contains additional information on REMS document formatting and content and that the Agency will update periodically.

Articles & Resources

Format and Content of a REMS Document

REMS Document Technical Conformance Guide

NSDUH Data Detail Substance Use Levels in 2021

Last week, the U.S. Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) released the results of its annual National Survey on Drug Use and Health (NSDUH), which includes several details about substance use disorder and recovery levels in 2021 by race, ethnicity, and age. The survey data for the past year indicate that 9.2 million people 12 and older misused opioids, 46.3 million people aged 12 or older – approximately 17% percent of the population – had substance use disorder, and 94% of people aged 12 or older with a substance use disorder did not receive any treatment, with a majority opting out of treatment due to thinking they did not need treatment. The survey also gathered details about peoples’ experiences with recovery, with data showing that over 70% of adults who ever had a substance use problem, roughly 21 million people, considered themselves to be recovering or in recovery. In a press release, Assistant Secretary for Mental Health and Substance Use and leader of SAMHSA, Dr. Miriam E. Delphin-Rittmon, said, “A commitment to data and evidence is one of SAMHSA’s four core principles. The annual NSDUH results help inform our efforts to expand access to treatment options and recovery supports across the nation. Harnessing the power of data and evidence is critical to ensuring policies and programs have the greatest opportunity to achieve positive outcomes.”

Articles & Resources

HHS – SAMHSA Announces National Survey on Drug Use and Health (NSDUH) Results Detailing Mental Illness and Substance Use Levels in 2021

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 – Addiction Treatment for Inmates Draws Biden Drug Focus for 2023

FDA – Assessing the Respiratory Effects of Approved Opioid Products When Co-administered with Commonly Prescribed Drugs

FDA – Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse

Rand Corporation – Perspectives Regarding Medications for Opioid Use Disorder Among Individuals with Mental Illness

Roll Call – Providers say Medicare Advantage hinders new methadone benefit

The Hill – FDA grants fast-track review for over-the-counter overdose drug

The New England Journal of Medicine – Buprenorphine versus Methadone for Opioid Use Disorder in Pregnancy

The Washington Post – Justice Dept. sues large drug distributor for its alleged role in opioid crisis

WSIU – Hospitals look to storytelling to reduce stigma toward people with addiction

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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