FDA to hold discussion over Naloxone access

March 21, 2022

The U.S. Food and Drug Administration will host a virtual public workshop on Mar. 29, to discuss critical questions around access to naloxone, a drug used to reverse opioid overdoses. The workshop is a collaboration with the Reagan-Udall Foundation for the FDA.

“An integral part of our efforts to combat opioid-related drug overdose is making naloxone more readily available and accessible,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We will continue to work with other federal, state and local officials as well as healthcare providers, patients and community-based organizations across the country to explore innovative and meaningful approaches that place naloxone in the hands of those who need it most.”

The workshop will provide an in-depth discussion to review the current landscape of naloxone availability, address perceived barriers to naloxone access, including current misperceptions, and address questions posed by various groups on this subject. In addition to exploring these diverse topics, various stakeholders, including harm-reduction specialists, physicians, pharmacists and regulators will also share their experiences in addressing the availability of naloxone for opioid overdose.

Naloxone remains a critical tool for individuals, families, first responders and communities to help reduce opioid overdose deaths. The FDA has taken a number of steps over the last several years to support increased availability and awareness of naloxone products, including encouraging manufacturers to pursue approval of over-the-counter naloxone products, requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add new recommendations about naloxone to the prescribing information, and extending the expiration date of naloxone nasal spray from 24 months to 36 months.

The workshop further underscores the agency’s ongoing commitment to gain valuable insight from various stakeholders to increase access and availability to this potentially lifesaving treatment.

FDA Release