Comments: Affordability and education are key issues in naloxone OTC move

Regulatory NewsRegulatory News | 23 January 2023 |  By 

The US Food and Drug Administration’s recent preliminary assessment that some naloxone products are safe and effective for over-the-counter (OTC) use received overwhelming support in public comments, but stakeholders also raised concerns about affordability, end-user education and the need to include products delivered via intramuscular injection.

In November 2022, FDA published a preliminary assessment that nasal sprays that deliver up to 4 mg of naloxone, as well as intramuscular and subcutaneous autoinjectors that deliver up to 2 mg of naloxone may be safe and effective enough to be marketed without a prescription. The agency noted that more data is needed on naloxone products provided through vials, ampules, or syringes without integrated needles, so those formulations are not included in the preliminary assessment (RELATED: FDA takes first step to allow low-dose OTC naloxone on market, Regulatory Focus 15 November 2022).

Injection formulations

The Harm Reduction Legal Project was supportive of the agency’s preliminary assessment and the move to bring naloxone products OTC, but commented that the agency should not leave out intramuscular injection products “that have been widely, effectively, and safely used by laypeople in the United States for decades.”

Harm reduction organizations, public health departments, and nonprofit organizations have been providing generic injectable products at no cost to individuals at high risk of experiencing an overdose or those who could respond to an overdose, according to Corey S. Davis, director of the Harm Reduction Legal Project.

“The goal of these efforts is to ensure community saturation so that naloxone is always easily accessible should an overdose occur,” Davis wrote. “Even if one or more nasal spray or autoinjector products is approved for OTC marketing, the cost of those products will likely be prohibitive for widespread distribution by community organizations. We, therefore, find it inappropriate and misleading that the agency refers to these expensive devices as ‘community-use’ products.”


The American Psychiatric Association (APA) also raised affordability concerns, namely that payers might not provide coverage of OTC formulations of the drug. The APA suggested that the agency prioritize reviewing abbreviated new drug applications to ensure lower-cost generics are available and advise prescribers to continue writing naloxone prescriptions for patients who cannot afford OTC products.

The National Community Pharmacists Association (NCPA) expressed concerns about how OTC status would impact coverage and reimbursement for naloxone.

“Once naloxone is nonprescription, payers and PBMs will likely cease any coverage, therefore shifting payment to the consumer. This may lead the increased consumer costs, which could hurt patient access. NCPA is also concerned that this additional class may face uncertain or lower reimbursement through [flexible spending account] or [health savings account] programs,” commented Steve Postal, director of policy and regulatory affairs at NCPA.

The American Society of Anesthesiologists agreed with FDA that naloxone can be safely administered by individuals without a medical background. Still, it recommended that non-medical personnel receive training and education on recognizing an opioid overdose and provide effective resuscitation and post-resuscitation care.

“Over-the-counter availability and guidance on best practices for its use would allow naloxone to be readily available and prevent access disparities by state and allow for the widespread, equitable, and safe use of this lifesaving tool,” commented Michael W. Champeau, MD, president of the American Society of Anesthesiologists.

The APA also called for end-user education so that individuals can identify and respond to an overdose. “This could be accomplished with a packing insert that clearly describes the signs of an opioid overdose, outlines the steps necessary to administer naloxone, and reminds the user to call emergency services,” wrote Saul M. Levin, MD, chief executive officer and medical director of the APA.

Each package of naloxone could include a wallet card with printed use instructions and a QR code linking to an online video on how to manage an opioid overdose, APA recommended.

Additionally, APA suggested that FDA add naloxone nasal spray, along with the intravenous and intramuscular formulations, to the list of FDA essential medicines to help prevent supply issues. The agency should also reexamine data on expiration dates to ensure that inventory has the maximum shelf life, APA commented.

Comments on naloxone for nonprescription use  


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