Remarks by Patrizia Cavazzoni, M.D.
Director, Center for Drug Evaluation and Research
Food and Drug Administration
Naloxone Access: Answering Questions – Public Meeting
March 29, 2022
(Remarks as prepared for delivery)
Good afternoon, everyone, and welcome to our public workshop on discussing naloxone access.
I would like to thank all of the speakers, panelists, and attendees for coming together today and contributing to our exploration of the issues surrounding naloxone availability. I would also like to thank the organizers of this workshop, the Reagan-Udall Foundation, and acknowledge their dedication in putting together this virtual gathering.
Over the course of the COVID-19 pandemic, we saw drug overdose deaths reach a record high, with CDC’s provisional estimate of over 100,000 drug overdose deaths last year. FDA acknowledges the devastating toll that overdose deaths have inflicted on our country, and we continue to prioritize the urgent public health needs resulting from opioids and the overdose crisis. The agency’s approach to advancing solutions that address the overdose crisis are grounded in the Department of Health and Human Services’ Overdose Prevention Strategy. This strategy focuses on primary prevention, harm reduction, evidence-based treatment, and recovery support.
Under this strategy, an integral part of our efforts is making naloxone more readily available and accessible. Naloxone is a lifesaving emergency treatment that reverses opioid overdose. It is a medicine with no abuse potential and is not a controlled substance. It can also be administered by individuals with or without medical training to help reduce opioid overdose deaths.
With this in mind, the agency understands the importance of having all forms of naloxone available for community use. This includes injectable naloxone, which is the least expensive option. We know that it is especially important for first responders and harm reduction groups to have access to this low-cost product as part of their community-based distribution programs.
The FDA acknowledges the critical work of harm reduction groups to make naloxone available in their communities, and the agency does not intend to interfere with these efforts.
While countless dedicated organizations at the federal, state, and local levels have committed themselves to make naloxone more readily available, FDA understands that some barriers to access still exist.
In response, the agency has taken a number of steps over the last several years to support increased availability of naloxone products. This includes our proactive efforts to encourage drug companies to enter the nonprescription market by developing a model Drug Facts Label for over-the-counter (OTC) naloxone, one of the critical requirements for an OTC product. This was the first time the FDA proactively developed and tested a Drug Facts Label to support development of an OTC product, and with it, FDA intended to ease the burden for industry and facilitate a timely switch from prescription to OTC naloxone.
However, despite our efforts, naloxone is still a prescription drug. FDA is aware of the recent calls for broadening naloxone access by switching naloxone to OTC.
Over the years, we have explored all options available under our authorities, and acknowledge that the transition to OTC remains challenging.
Specifically, FDA has heard the calls for improving the availability of all forms of naloxone. This includes the intramuscular formulation (for example the vial and syringe injectable naloxone), which is a product that poses particular challenges for OTC development.
- In FDA’s statute, nonprescription drugs are defined as drugs that are safe and effective for use by the general public without the supervision of a healthcare professional.
- This includes individuals who have never injected drugs and must demonstrate the ability to administer medication with minimal instructions.
- As such, other naloxone formulations, such as intranasal or autoinjector formulations, might be better suited for OTC transition. But even for these products, we still need data to support safe and effective OTC use.
It has also been brought to FDA’s attention that the transition from prescription to OTC status may generally result in a loss of reimbursement through health insurance, and pricing of an OTC product may create new, unintended barriers to access. This is an issue we are actively examining with our federal colleagues, and we also invite private payors to consider this important issue of naloxone coverage.
Despite these challenges, FDA is forging ahead. Using all available evidence and tools at our disposal, the agency is committed to increasing options for opioid overdose reversal and improving access. As part of this, the agency plans to continue working to advise industry, encourage the development of OTC naloxone, and bring new products to market. We are also supporting development of novel opioid overdose reversal products, and engaging stakeholders across the healthcare continuum to explore effective solutions that increase naloxone availability.
During this pivotal time in our country, we realize that it is essential to advance the conversation on naloxone access.
Through this workshop, the Reagan-Udall Foundation has brought together a range of stakeholders, including harm reduction specialists, physicians, pharmacists, and regulators to develop meaningful insight on the current landscape of naloxone access.
Thank you again for joining, and I look forward to today’s thoughtful discussions.