Today’s approval will expand access to critical life-saving medications

Washington, D.C. – Today, White House Office of National Drug Control Policy (ONDCP) Director Dr. Rahul Gupta released a statement following the FDA’s approval of another over-the-counter overdose reversal product. The FDA approved the first over-the-counter naloxone nasal spray earlier this spring. This additional approval means more options for consumers and more competition in the market, which will help increase access to this life-saving medication. It also marks the first time a non-profit company has received approval for an overdose reversal product.

“I applaud all companies working to heed the President’s call to increase access and affordability of these life-saving medications, and we urge more companies to follow their lead,” said Dr. Gupta. “As we are seeing overdose death rates level off after years of rapid increases, we must do everything we can to double down on our efforts to end this epidemic. Today’s approval means that more life-saving overdose reversal products will be available over-the-counter for consumers, and more competition in the market should drive down costs.”

Last month, U.S. drug manufacturers convened at the White House. During the meeting, Dr. Gupta and senior Biden-Harris Administration officials reiterated President Biden’s clear and urgent call to increase access and affordability of these life-saving overdose reversal medications, and underscored the critical role manufacturers play in the all-of-society effort to help end the nation’s overdose crisis. The officials also called on manufacturers to take robust actions in support of the Biden-Harris Administration’s guiding principles, which include that no one who needs overdose reversal medications should lack access because of costs or availability; that at-risk communities should be saturated with these medications to reduce fatality rates; that organizations serving high-risk individuals should not need to ration these medications; that more must be done to raise public awareness; and that public health agencies need timely, actionable data on distribution and gaps in access.

Expanding access to overdose reversal medications is a key focus of President Biden’s National Drug Control Strategy and supports his Unity Agenda call to action to beat the overdose and opioid epidemic. Over the past two years, the Biden-Harris Administration has taken historic action to increase access to this life-saving tool, including:

  • Convening U.S. drug manufacturers who have FDA-approved overdose reversal medication products to discuss ways to increase access and affordability to save more lives;
  • Launching a campaign to educate young people on the dangers of fentanyl and the life-saving effects of naloxone with the Ad Council;
  • Making it easier for harm reduction organizations to obtain naloxone directly from manufacturers and distributors while expanding public availability of this critical medicine.
  • 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;
  • Allowing the use of CDC Overdose Data to Action funds—up to $2 million per state—for naloxone purchasing by local public health departments;
  • Delivering funds directly to states 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.

As the Biden-Harris Administration works to fully implement President Biden’s National Drug Control Strategy, the United States has now seen a continued flattening of drug overdose deaths throughout 2022 and early 2023, halting a years-long period of rapid increases from 2019 – 2021.

To read about President Biden’s FY24 Drug Control Budget Request, click HERE.

To read President Biden’s National Drug Control Strategy, click HERE.


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