The following statement is attributable to:
Bobby Mukkamala, M.D.
|Chair, AMA Substance Use and Pain Care Task Force
“The American Medical Association (AMA) strongly supports the Food and Drug Administration decision today to make the opioid overdose-reversing drug naloxone available over the counter, a position that we have long championed. While government decisions are often incremental, FDA’s decision will transform how we compassionately and logically respond to the overdose epidemic. More lives will be saved when naloxone is easily available at grocery stores and pharmacies. If it weren’t for naloxone, there would be tens of thousands more Americans dying from opioid overdose, including those related to illicitly manufactured fentanyl.
“This decision will help community-based organizations purchase and distribute naloxone to those who need it most, and it will help destigmatize obtaining and using naloxone.
“For this change to be most impactful, manufacturers must make the price of naloxone affordable, a crucial element for community organizations that are working to make it available.”
Following the FDA’s decision, the AMA recommends that:
- Every naloxone manufacturer should submit over-the-counter applications. Only one naloxone manufacturer is currently approved for over-the-counter use. There is no ethical reason for other manufacturers to delay.
- Manufacturers must speed their over-the-counter product to market as soon as possible and work with retailers to make it prominent on store shelves. Timely administration of naloxone is key in saving lives and every moment matters. Making the product easy to find in stores is a critical step to ensuring the drug is effective in emergency situations.
- Physicians and all health care professionals should talk to their patients about the risk of overdose. Knowledge of overdose risk and how to access and use naloxone, will help respond to an overdose.
- Health insurers cover the life-saving drug, whether obtained through a prescription or over the counter. All payers must continue or start to cover naloxone at no- or low-cost. There are many over-the-counter preventive health medications that are covered by insurance, such as aspirin, vitamin D, and fluoride. Naloxone should be added to that list.
About the American Medical Association
The American Medical Association is the physicians’ powerful ally in patient care. As the only medical association that convenes 190+ state and specialty medical societies and other critical stakeholders, the AMA represents physicians with a unified voice to all key players in health care. The AMA leverages its strength by removing the obstacles that interfere with patient care, leading the charge to prevent chronic disease and confront public health crises and, driving the future of medicine to tackle the biggest challenges in health care.