Comments to the FDA Urging Approval of Over the Counter Naloxone

Executive Summary

The National Health Law Program strongly urges the Food and Drug Administration (FDA) to initiate the process of moving at least one naloxone product from prescription to over the counter (OTC) status. Naloxone, a safe and effective medication, reverses opioid overdose if given in time, but is often not available at the scene of an overdose. The current prescription status of naloxone reduces access to this lifesaving drug, particularly among people who do not access care at pharmacies because of financial or other barriers. As described in our comments, the FDA Commissioner has the regulatory authority to both initiate and approve a prescription to OTC switch, and in fact is required to move a prescription drug OTC where the prescription requirement is not necessary for the protection of the public health. In the current public health emergency of opioid-related harm, FDA should take all possible measures to increase access to this lifesaving medication, including moving appropriate naloxone drugs OTC.