ASA Urges Expanded Access to Naloxone at FDA Meeting


Anita Gupta, D.O., , testified before the U.S. Food and Drug Administration in support of expanded access to Naloxone, a medication that can rapidly reverse an opioid overdose.


On July 1 and 2, Anita Gupta, D.O., PharmD, a member of ASA’s Committee on Pain Medicine, testified before the U.S. Food and Drug Administration (FDA) in support of expanded access to Naloxone, a medication that can rapidly reverse an opioid overdose. The FDA hosted the public meeting to discuss which populations are at-risk for opioid overdose and how the federal government and stakeholders can work together to encourage the use of naloxone to reduce the risk of death from an opioid overdose. Naloxone is commonly used by trained medical personnel and first responders. Its use among nonmedical personnel, such as family members or friends who witness an overdose, has recently increased as part of an effort to reduce opioid overdose deaths.

At the FDA meeting, Dr. Gupta, who also serves as a special government employee of the FDA Anesthetic and Analgesic Drug Products Advisory Committee, expressed ASA’s support for expanding access to naloxone to more nonmedical personnel. Dr. Gupta explained that the federal government and stakeholders should increase the availability of naloxone to individuals likely to witness an opioid overdose and train them on how to recognize an opioid overdose, and on effective resuscitation and post-resuscitation care. Dr. Gupta also stressed the importance of health care professional involvement in naloxone distribution, particularly when a patient is co-prescribed naloxone with an opioid.

While management of opioid overdoses with naloxone is expected to reduce the proportion of witnessed opioid overdoses which result in death, Dr. Gupta emphasized that expanded naloxone access does not address the underlying causes of opioid overdose and it is only one small step in a positive direction that may mitigate opioid overdoses. As part of ASA’s efforts to reduce the misuse and abuse of prescription drugs, ASA collaborated with the White House Office of National Drug Control Policy to develop

a wallet-sized card

describing the signs and symptoms of an overdose and instructions for assisting a person suspected of an overdose, including instructions to administer naloxone and call 911. ASA is also working closely with federal government agencies, medical societies, and other pain care stakeholders in support of efforts that will curb prescription drug abuse while ensuring patient access to the medications they need. These efforts include supporting prescription drug monitoring programs, enhancing physician education on pain care, and increasing research directed at pain medicine therapies.

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