Advocacy Alert: April 2023 Advocacy Update for NBHAP Members

April 14, 2023

Greetings, BHAP Members!

On behalf of Slingshot Solutions, thank you for your membership in NBHAP and your commitment to advocacy that will shape the future of behavioral health. As your advocate in Washington, D.C., it is my responsibility to keep you informed when it comes to policy developments, and to represent your interests before the federal government. We do this by working with Congress, the White House and executive agencies, and other interest groups and coalitions.

Andrew Kessler
Principal
Slingshot Solutions LLC

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As 2023 marches on, we continue to see advances in harm reduction policy. While Congress moves at a somewhat slow pace, executive agencies move forward at a much brisker clip.

The U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over the counter (OTC), nonprescription, use — the first naloxone product approved for use without a prescription. The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.

The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription. The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. Manufacturers of these products will be required to submit a supplement to their applications to effectively switch their products to OTC status. The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed.

We also have new concerns on the harm reduction front. Xylazine, a powerful veterinary tranquilizer, has become prevalent in the illicit drug supply, especially in the northeast. It presents different dangers than fentanyl, as a xylazine overdose cannot be reversed with naloxone (it is not an opioid). From 2015 to 2020, the percentage of all drug overdose deaths involving xylazine increased from 2% to 26% in Pennsylvania. Xylazine was involved in 19% of all drug overdose deaths in Maryland in 2021 and 10% in Connecticut in 2020. To combat this new danger, xylazine test strips are now available.

Unfortunately, in many states, statutes that allow for the distribution and use of test strips are specific to those that detect fentanyl. So it is unlikely — or at the very best unclear — if it will be permissible to buy xylazine strips with state or even federal dollars. The White House has declared the prevalence of xylazine to be an “emerging health threat,” the first time this designation has been utilized since its creation in 2018. The White House will publish a “whole-of-government, nationwide plan” to address xylazine within 90 days of the declaration, which took place on April 12.

Finally, we have begun our work on the federal appropriations process. The SUPTR block grant at SAMHSA (formally the SAPT block grant) received a recommended increase from $1.9 billion to $2.7 billion, along with a 10% set aside for recovery support services. The president also recommended an increase for the State Opioid Response (SOR) grant program, from $1.575 billion to $2 billion. However, due to the two chambers of Congress being split between the parties, we are not anticipating an easy time securing the requested increase.

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Questions? Concerns?

As always, we want your input. What topics would you like to see us cover in future Advocacy Alerts? If you are a representative of a state association and have something for us to consider for an Advocacy Alert, let us know! Please contact us with any questions or concerns you have about our advocacy efforts.