Press Releases

AMA applauds FDA's approval of second OTC naloxone product

| 2 Min Read

The following statement is attributable to:
Bobby Mukkamala, MD
Chair, AMA Substance Use and Pain Care Task Force

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“The American Medical Association (AMA) applauds the Food and Drug Administration’s (FDA) decision today to make a second opioid overdose-reversing drug available over the counter (OTC). The AMA has long advocated for improved access to OTC naloxone as the deadly drug overdose epidemic continues to devastate communities. We continue to urge physicians to prescribe naloxone to any patient at risk of a drug-related overdose.

“Every step taken to increase the availability of safe and effective opioid-related overdose-reversal medications will save lives. Every naloxone manufacturer should submit over-the-counter applications as soon as possible. There is no medical or ethical reason for naloxone manufacturers to delay submitting these applications.

“The AMA strongly urges manufacturers to make this life-saving medication affordable. It is inexcusable for manufacturers to price their products to maximize profits over saving lives. The AMA also urges health insurers to cover naloxone, whether obtained through a prescription or over the counter, at no- or low-cost.

“The FDA’s approval is an important step in saving lives. Next, it is imperative OTC naloxone is carried by retailers, grocers and pharmacies and is stocked in a visible location on store shelves for quick access in an emergency situation, similar to other first aid items.”

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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.

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