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  1. From Our Perspective

CDER’s Continued Efforts to Widen Naloxone Access

By: Marta Sokolowska, Ph.D., CDER Deputy Center Director for Substance Use and Behavioral Health

Marta Sokolowska, Ph.D.
Marta Sokolowska, Ph.D.

The overdose crisis is one of the most devastating public health crises affecting our country. Based on provisional Centers for Disease Control and Prevention data, over 107,000 overdose deaths occurred in the 12-month period ending in August 2022. Furthermore, in 2021, more people aged 15 to 54 died in the United States due to opioid-involved overdose than due to COVID-19. 

To address this evolving crisis, FDA announced our Overdose Prevention Framework – our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths – in August 2022. Under the Framework, one of our four priorities is encouraging harm reduction, which includes our efforts to expand access to lifesaving overdose reversal products such as naloxone.

While FDA has prioritized availability of naloxone products for years, we significantly ramped up our efforts to increase naloxone availability in 2022 as we worked to implement the Framework. Below are several key actions we have taken in the last year, as well as some scheduled activities.

Naloxone Access: Answering Questions Public Meeting

In March 2022, we partnered with the Reagan-Udall Foundation to hold a virtual public meeting to explore effective approaches that could increase naloxone availability. We heard first-hand from harm reduction groups about continued challenges in increasing access to naloxone. This feedback strengthened our resolve to support the lifesaving work of harm reduction programs and continue encouraging drug companies to enter the nonprescription market for naloxone.

Issuance of Guidance to Help Facilitate Availability of Naloxone

In September 2022, we issued an immediately-in-effect guidance that we hope helps to address some of the obstacles harm reduction programs identified in the March public meeting regarding access to naloxone. The guidance, 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, clarifies the scope of the Public Health Emergency exclusion and exemption under the Drug Supply Chain Security Act as they apply to the distribution of FDA-approved naloxone products to harm reduction programs. We hope this guidance will aid these programs’ ability to obtain prescription naloxone directly from drug manufacturers and distributors and expand public availability of this critical medicine.

Issuance of Nonprescription Naloxone Federal Register Notice

In November 2022, we issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, announcing FDA’s preliminary assessment that certain naloxone drug products may be approvable as safe and effective for nonprescription use. This preliminary assessment is intended to help facilitate development and approval of nonprescription naloxone products. However, this is not a final determination that certain naloxone drug products are safe and effective for nonprescription use, and it doesn’t mandate an immediate switch to nonprescription. Rather, by issuing this notice, we sought to make application holders of certain prescription naloxone drug products aware of the preliminary assessment and encourage drug companies to submit an application for a nonprescription naloxone product.

Harm Reduction Stakeholder Call

Also in November 2022, we held a stakeholder call to discuss naloxone access. During the meeting, we emphasized support for harm reduction programs’ ability to acquire FDA-approved naloxone products, and we acknowledged we have more work to do to expand naloxone access. The Substance Abuse and Mental Health Services Administration also participated in this call, reinforcing our shared commitment to a comprehensive federal response to increase naloxone availability and reduce overdose deaths.     

In 2023, the agency is continuing to advise industry and engage stakeholders across the healthcare continuum to explore effective solutions that increase naloxone availability. We are also seeking advice from independent experts to help us make sound decisions based on the available science. Several notable activities and actions are already in the works:

  • Advisory Committees Meetings
    On February 15th and March 20th, FDA will hold two separate Advisory Committee meetings for two nonprescription naloxone applications, both of which have been granted priority review. The February 15th meeting will discuss Narcan (naloxone hydrochloride) nasal spray, 4 mg/0.1 mL, submitted by Emergent BioSolutions Inc. The March 20th meeting will discuss RiVive (naloxone hydrochloride) nasal spray, 3 mg/0.1 mL, submitted by Harm Reduction Therapeutics, Inc. FDA hopes to gain expert advice on the adequacy of the data supporting each nonprescription application. These products represent potential first-in-class products in a new therapeutic category for nonprescription drugs.
  • Fatal Overdoses Workshop
    On March 8th and 9th, we will hold a two-day virtual public meeting, Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose, in partnership with the Reagan-Udall Foundation. To support efforts to develop products and approaches to treat overdose and prevent fatalities, speakers and panelists will explore the evolving context surrounding fatal overdoses. Participants will discuss epidemiological trends, drug supply changes, naloxone and other public health interventions to manage overdose, and drug development opportunities.

Ultimately, we recognize naloxone is a critical tool to help reduce opioid-involved overdose deaths during an evolving overdose crisis. We remain committed to using all available evidence and tools at our disposal to equitably improve naloxone access. While we know we have more work to do in collaboration with people who use drugs, harm reduction groups, clinicians, federal partners, and other stakeholders, the actions described above represent our coordinated, proactive, and urgent regulatory approach to improve access to lifesaving naloxone.

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