Halting the Epidemic of Addiction and Loss Act of 2025
The Halting the Epidemic of Addiction and Loss Act of 2025 would require the Department of Health and Human Services (HHS) to ensure that, whenever it issues regulations or guidance for grant programs addressing opioid misuse and use disorders, references to opioid overdose reversal drugs (such as naloxone) are inclusive of any FDA-approved reversal agent available for emergency treatment of an opioid overdose. It also directs HHS to update existing references within one year to include any opioid overdose reversal drug that has been approved or otherwise authorized by the FDA. The provisions apply to specific HHS grant programs, notably State Opioid Response Grants and Tribal Opioid Response Grants (as referenced in the 21st Century Cures Act) and the regional/national significance priority prevention grants (Public Health Service Act Section 516). In short, the bill broadens regulatory language so that non-nalidoxone reversal drugs can be used within these grant programs. The bill is introduced in the Senate (S. 2336) by Senators Cornyn and Hassan. It does not modify existing grant authorities or funding levels; rather, it broadens the regulatory language governing which opioid overdose reversal drugs can be referenced in grant-related regulations and guidance, ensuring the language keeps pace with new approved reversal therapies.
Key Points
- 1Broadens scope of references: When HHS issues grant regulations or guidance addressing opioid misuse and use disorders, any reference to an opioid overdose reversal drug (currently exemplified by naloxone) must be inclusive of any reversal drug approved under FDA’s 505 authority for emergency treatment of opioid overdose.
- 2Applies to specific grant programs: The expanded, inclusive references would affect grants such as State Opioid Response Grants and Tribal Opioid Response Grants (per 21st Century Cures Act, Section 1003) and the regional/national significance prevention grants (Public Health Service Act, Section 516).
- 3Update requirement: Not later than one year after enactment, HHS must update all existing references that fit the above scope to include any FDA-approved reversal drug.
- 4Definition of scope: The term “opioid overdose reversal drug” is tied to FDA approval or authorization for emergency treatment of known or suspected opioid overdose (i.e., drugs approved under FDA’s 505 authority for this use).
- 5Purpose and expected impact: The goal is to prevent regulatory language from inadvertently limiting grant programs to naloxone alone, thereby enabling broader use of other approved reversal agents in funded overdose response efforts.