Advocacy Alert: December 2022 Advocacy Update for BHAP Members

December 15, 2022

Greetings, BHAP Members!

On behalf of Slingshot Solutions, thank you for your membership in BHAP 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 we come to the end of 2022, the policy picture is still very much in flux. Congress has not yet finished its appropriations work. As a result, we have no indication whether the federal programs we advocate for will receive increased funds. This has become an unwelcome pattern in recent years, and with the House and Senate now in the hands of different parties, we do not see improvement on the horizon. The fate of recovery funding is now linked to the larger overall appropriations process, which is in turn subject to harsh political wrangling and posturing.

There are, however, other developments to support. Emergent BioSolutions Inc. announced in early December that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental for NARCAN (naloxone) nasal spray as an over-the-counter emergency treatment for known or suspected opioid overdose. The application has been granted Priority Review by the FDA and, if approved, would be the first 4 mg naloxone nasal spray available OTC in the U.S. Just prior to accepting this application, the FDA issued a Federal Register notice entitled “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use,” and opened a comment period. The goal is to help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status.

The Federal Register notice includes a preliminary assessment that certain naloxone drug products — up to 4 milligrams (mg) nasal spray and up to 2 mg autoinjector for intramuscular (IM) or subcutaneous (SC) use — may be approvable as safe and effective for nonprescription use. This preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products; however, it is not a final determination that certain naloxone drug products are safe and effective for nonprescription use, and it does not mandate an immediately effective switch to nonprescription/OTC availability for naloxone.

Last month SAMHSA issued its interim Strategic Plan, offering a glimpse of the agency’s priorities for the next five years. Although it is a short document, an entire section is dedicated to recovery and the agency’s plans for advancing recovery and recovery support services. The agency cites the establishment of an Office of Recovery, charged with evaluating and initiating policy, programs and services and ensuring the voices of individuals in recovery are represented. SAMHSA has been instrumental in advancing recovery support systems to promote partnering with people in recovery and their family members to guide the behavioral health system and promote individual, program, and system-level approaches that foster health and resilience. Their goal is to continue to increase housing to support recovery, reduce barriers to employment, education, and other life goals, and to secure necessary social supports in their chosen community.

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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.