Overdose Epidemic

FDA naloxone guidance helps harm-reduction groups’ work to save lives

Jennifer Lubell , Contributing News Writer

The drug overdose epidemic claims more than 100,000 lives in the U.S. a year. Naloxone is an emergency treatment to reverse the effects of an opioid-related overdose. However, the process for obtaining the drug has posed access barriers to communities everywhere.

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The guidance issued by the Food and Drug Administration (FDA) offers important clarity on requirements for bulk purchase, making it possible for naloxone manufacturers to provide the drug directly to harm-reduction organizations that offer services to people at risk for opioid-related overdose.

“Throughout the drug overdose epidemic, harm-reduction organizations have been at the front lines, offering care and hope in hundreds of communities. These organizations have accomplished amazing work despite shoestring budgets and bureaucratic challenges,” said Bobby Mukkamala, MD, chair of the AMA Substance Use and Pain Care Task Force.

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If it weren’t for naloxone and the work of harm-reduction organizations, it is likely that tens of thousands of additional people would have died. Harm-reduction organizations, however, have largely been dependent on buying naloxone through complicated arrangements with prescribers, wholesalers, distributors, state health departments and others. 

The FDA guidance clarifies that naloxone manufacturers can provide opioid-overdose antidote directly to harm-reduction organizations—cutting out the many middlemen—to enable these organizations to buy and distribute more naloxone. (View this graphic explainer.)

“Physicians recognize the work of harm-reduction organizations and welcome the government’s willingness to remove obstacles as they—day in and day out—save lives,” said Dr. Mukkamala.

The FDA said it was seeking to “strike a balance between the need to facilitate the effective distribution of lifesaving FDA-approved naloxone products to harm-reduction programs and harm reduction suppliers under emergency conditions while helping to protect consumers from exposure to products that may be counterfeit, stolen or otherwise harmful.”

The FDA’s guidance does not address the prescription-only status of FDA-approved naloxone products. The AMA continues to urge the agency and naloxone manufacturers to remove the prescription status of the opioid-overdose antidote.

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The guidance is just one step in a multipronged effort to combat the drug-overdose epidemic.

The AMA outlines other measures in the “2022 Overdose Epidemic Report.” Physicians and policymakers should support increased access to syringe services programs (SSPs) to more effectively distribute naloxone, the report’s authors stated.

A yearlong study that captured the responses of 263 such programs—sometimes called needle-exchange programs—found that they distributed more than 700,000 doses of naloxone, including refills, the AMA reported.

Dr. Mukkamala said the AMA urges doctors "to prescribe naloxone to patients at risk of overdose and to others who may be able to save a life from unintentional overdose while waiting for naloxone to become available over the counter.”

He added that “physicians, harm-reduction organizations, government and all others must work together to end the drug overdose epidemic.”

The AMA believes that science, evidence, and compassion must continue to guide patient care and policy change as the nation’s opioid epidemic evolves into a more dangerous and complicated illicit drug overdose epidemic. Learn more at the AMA’s End the Epidemic website.