Sponsors (2)
Last progress July 17, 2025 (6 months ago)
Introduced on July 17, 2025 by John Cornyn
Updated 2 days ago
Last progress December 1, 2025 (2 months ago)
Requires the Department of Health and Human Services to make sure any references to opioid overdose reversal drugs in HHS grant program regulations and guidance explicitly cover any drug that the FDA has approved or otherwise authorized (for example, naloxone and any future FDA‑authorized products). It also directs the Secretary to revise existing HHS references issued before this law to be inclusive of any FDA‑approved or authorized opioid overdose reversal drug, with those updates completed within one year of enactment.
When the Department of Health and Human Services issues a regulation or guidance for any grant program addressing opioid misuse and use disorders, the Secretary must ensure that any reference to an opioid overdose reversal drug (such as naloxone) is inclusive of any opioid overdose reversal drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act for emergency treatment of a known or suspected opioid overdose.
Not later than one year after the date of enactment of this Act, the Secretary must update all pre‑enactment references (described in paragraph (2)) so they are inclusive of any opioid overdose reversal drug that has been approved or otherwise authorized for use by the Food and Drug Administration.
A covered reference is any reference to an opioid overdose reversal drug (such as naloxone) in any HHS regulation or guidance that (A) was issued before the date of enactment of this Act and (B) is included in specified grant programs: (i) the grant program for State and Tribal response to opioid use disorders under section 1003 of the 21st Century Cures Act (commonly called State Opioid Response Grants and Tribal Opioid Response Grants) (42 U.S.C. 290ee–3a), and (ii) the grant program for priority substance use disorder prevention needs of regional and national significance under section 516 of the Public Health Service Act (42 U.S.C. 290bb–22).
Who is affected and how:
HHS and HHS program offices: Required to review and revise grant regulations and guidance language to explicitly include any FDA‑approved or FDA‑authorized opioid overdose reversal drug. This is an administrative task with modest implementation effort, including updating written materials and outreach to grantees.
Grant recipients (state/tribal/local governments, public health entities, nonprofits, community organizations, and health centers): Benefit from clearer, more inclusive language in HHS grant regulations and guidance. This reduces legal or procurement uncertainty about whether particular FDA‑approved or FDA‑authorized overdose reversal products are permissible for use or purchase under HHS grants.
Healthcare providers, first responders, and organizations that distribute overdose reversal drugs: Indirectly benefit because grant-funded programs will more easily be able to acquire and use any FDA‑approved or FDA‑authorized products without needing special approvals or relying on older product‑specific language.
People at risk of opioid overdose and their families/communities: May benefit through more consistent access to a broader set of FDA‑approved or authorized opioid overdose reversal products under HHS‑funded programs.
Fiscal/administrative impact: Limited to agency administrative costs for reviewing and revising guidance/regulatory text and communicating changes; no new mandated spending for states or grantees is created by the legislation.
Overall effect: Low‑complexity administrative change that reduces ambiguity in HHS grant materials and supports flexible use of any FDA‑approved or authorized opioid overdose reversal products in HHS‑funded programs.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.