Golden State Today

SACRAMENTO – On July 6, California is taking the first step towards creating a more affordable and accessible supply of Naloxone nasal products – through the broader CalRx Initiative – a vital tool in combating the opioid epidemic.

Under the CalRx Naloxone Access Initiative – unveiled by Governor Newsom earlier this year – the state will allocate $30 million to support a partner, or partners, in developing, manufacturing, procuring, and/or distributing a naloxone nasal product under the CalRx label.

“One more fatal overdose is one too many. California is tackling the opioid epidemic from all sides,” said Governor Gavin Newsom. “Naloxone is, quite literally, a lifesaver – so we are making it more accessible and affordable for anyone who needs it.”

WHY THIS MATTERS: Naloxone is an essential medication used to reverse opioid overdoses and save lives. Access to this medication is expected to improve with the recent approval by the U.S. Food & Drug Administration of Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray product for over-the-counter use. However, California recognizes that this development may not sufficiently address the needs of those who are most vulnerable, such as low-income, uninsured, or underinsured individuals and their families. A more affordable version of this medication is critical to making naloxone more accessible in communities across California.

“California is committed to leveraging its purchasing power by fostering partnerships that can address the affordability and availability of naloxone nasal products,” said California Health and Human Services Agency Secretary Dr. Mark Ghaly. “By reducing barriers and increasing accessibility, this initiative will play a significant role in combating the devastating impact of the opioid epidemic in California. To put it simply, this will help save lives.”

MAKING A DIFFERENCE: The Department of Health Care Services created the Naloxone Distribution Project (NDP) in 2018 to combat opioid overdose-related deaths in California through the provision of free naloxone. As of June 25, 2023, the NDP has distributed more than 2.6 million naloxone kits, resulting in more than 181,665 reported overdose reversals.

CALRX BACKGROUND: CalRx represents a groundbreaking solution for addressing drug affordability. Originally announced in January 2019 in Governor Gavin Newsom’s first Executive Order and later signed into law in the California Affordable Drug Manufacturing Act of 2020 (Pan, Senate Bill 852, Chapter 207, Statutes of 2020), CalRx empowers California to contract for the development, production, and distribution of generic drugs at low cost and to make them available across the country. The state will target prescription drugs where the pharmaceutical market has failed to lower drug costs, even when a generic or biosimilar medication is available. Compared to traditional procurement of prescription drugs, CalRx seeks deep, mutually beneficial partnerships with companies and non-profit organizations that share the state’s goals. Earlier this year, Governor Newsom announced CalRx was in the process of bringing to market affordable and accessible insulin generics under the CalRx label that will be available to Californians and people across the country.

ABOUT THE RFI: The funds provided by the state can support research and development, including clinical studies, manufacturing process development, regulatory submissions, FDA approval, and distribution of naloxone nasal products. For further information and to participate in the RFI, interested parties can visit [link to RFI] or contact CalRx at info@calrx.ca.gov.

Original source can be found here.