Dr. Gupta Applauds FDA Announcement to Make First Naloxone Product Available Over-the-Counter

WASHINGTON, D.C. – Today, Dr. Rahul Gupta, Director of the White House Office of National Drug Control Policy (ONDCP), issued a statement following the U.S. Food and Drug Administration (FDA) approval of the first nonprescription, “over-the-counter” (OTC) Naloxone nasal spray (Narcan). Naloxone – a medicine that can reverse an opioid-related overdose – has been shown to be a critical tool to prevent fatal overdoses and save lives.

“As a physician, I have used Naloxone on people to reverse an opioid-overdose hundreds of times and have witnessed firsthand its life-saving effects,” said Dr. Gupta. “FDA’s announcement to make Narcan available over-the-counter is an important step to make this medicine accessible to more people at a time when the majority of overdose deaths are being driven by illicit opioids like fentanyl. This move will also build on the progress made under the Biden-Harris Administration to get more Naloxone into communities, expand access to treatment for substance use disorder, and reduce the supply of illicit drugs, which has resulted in a decline or flattening of overdose deaths for seven months in a row.”

Expanding Naloxone is a key focus of President Biden’s National Drug Control Strategy and supports his Unity Agenda call to action to beat the overdose epidemic. Today’s announcement builds on a holistic set of actions the Administration has taken to increase access to this life-saving tool, including supporting states through enhanced technical assistance, policy academies, and convenings to ensure existing State Opioid Response funds are used to saturate hard-hit communities with Naloxone; delivering funds directly to local public health departments so they can purchase Naloxone; and calling for an additional $100 million for harm reduction services like Naloxone in the President’s FY24 budget request.

Today’s important step to make this life-saving medicine more accessible will help build on the progress the Biden-Harris Administration has made to reduce overdoses by expanding access to addiction care, reduce the supply of illicit drugs like fentanyl, and save lives. In his first State of the Union address, President Biden announced a four-part Unity Agenda focused on areas where members of both parties can come together and make additional progress for the American people including beating the opioid and overdose epidemic to enhance public health and public safety outcomes.

During his State of the Union Address last month, the President announced that his Administration is accelerating these efforts by:

• Providing 123 new large-scale scanners along the Southwest Border to stop more fentanyl from getting into the U.S.
• Stopping more packages from being shipped into the U.S. with fentanyl and the material used to make it.
• Leading a sustained diplomatic push that will address fentanyl and it supply chain abroad.
• Working with Congress to make permanent tough penalties on suppliers of fentanyl.
• Expanding access to evidence-based prevention, harm reduction, treatment, and recovery support.

This month, President Biden released his FY 2024 budget request to Congress, which calls for a historic investment of $46.1 billion for National Drug Control Program agencies. The FY2024 budget request continues the Biden Administration’s trend of calling for dramatic investments to address the overdose epidemic driven by fentanyl, and represents a $5.0 billion increase from the FY2022 request and a $2.3 billion increase over the FY2023 enacted level. The FY2024 budget also includes an increase in funding for efforts to reduce the supply of illicit drugs like fentanyl and combat drug trafficking. It also includes an increase in funding to support the expansion of prevention, treatment, harm reduction, and recovery support services. Read more HERE.

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