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2024 Session

Budget Amendments - SB30 (Member Request)

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Chief Patron: Pillion
Opioid Overdose Reversal Agent Program

Item 275 #1s

Item 275 #1s

First Year - FY2025 Second Year - FY2026
Health and Human Resources
Department of Health FY2025 $8,000,000 FY2026 $8,000,000 NGF

Language
Page 303, line 24, strike "$245,718,468" and insert "$253,718,468".
Page 303, line 24, strike "$245,663,468" and insert "$253,663,468".

Page 304, after line 56, insert:

"M. 1. The Virginia Department of Health shall establish and execute the Opioid Overdose Reversal Agent Program (“Program”), a manufacturing program for a quality, lowest sustainable cost, opioid overdose reversal agent. Out of this appropriation, $8,000,000 the first year and $8,000,000 the second year from the Commonwealth Opioid Abatement and Remediation fund shall be provided to administer the Program. The Virginia Department of Health shall coordinate the Program with the Virginia Opioid Abatement Authority. Key objectives of the Program shall be: i) providing a long-term, sustainable supply of opioid overdose reversal agent to help combat Virginia's opioid epidemic; ii) providing pricing stability and increase access for this critical life-saving medication; and, iii) leveraging, when possible, existing federal and state investments building the advanced pharmaceutical development and manufacturing CAMPUS in Petersburg.


2. The Program shall contract with the private sector to lead an end-to-end opioid overdose reversal agent nasal spray development program to provide a new FDA-approved generic version resulting in a lower cost product to help drive down state and locality budgets for opioid overdose reversal agent and improve access, quality, and availability through a domestic supply. Funding provided to the contracting entity may be used for: i) investment in research and development activities supporting an opioid overdose reversal agent API, formulation development, manufacturing process qualification and validation, and regulatory approval; and ii) capital expenditures, including custom machinery for assembly of the drug/device combination product and semi-automated packaging. All intellectual property developed by the program would be owned by the private entity and all capital expenditures, including custom equipment, would be owned by the Authority or partner agency."



Explanation

(This amendment provides $8.0 million each year from the Commonwealth Opioid Abatement and Remediation fund for the establishment of the Opioid Overdose Reversal Agent Program which is intended to address inconsistent availability of opioid reversal agents by establishing a public-private manufacturing program for them in Virginia using funds from the Commonwealth Opioid Abatement and Remediation fund.)