Governor Gavin Newsom’s first executive order back in 2019 called for California to reduce costs for certain medications and led to the creation of CalRx, the state’s project for creating and distributing low-cost, common medicines.
In 2023, Newsom announced that CalRx would make its own biosimilar insulin available the following year.
But it’s 2025, and Department of Health Care Access and Information Director Elizabeth Landsburg told lawmakers at a hearing on Wednesday they’re still waiting to begin clinical trials.
“Our internal and external experts all believe that the implementational time frame, while not as fast as we had hoped, are not outside of industry norms,” she said.
After the trials, the state can apply for US Food and Drug Administration approval, which normally takes about a year.
Democratic Senator Scott Wiener from San Francisco recently resurrected a bill — now Senate Bill 40 — to cap insulin prices that Newsom vetoed last year. His veto message said CalRx made it unnecessary.
“I guess I’m expressing to you my fundamental objection that because this important program of CalRx exists, that means it’s the only solution to driving down drug costs,” Wiener said.
He also has concerns that the Trump administration could hold up drug approvals like this.
“When the governor first announced this initiative, it was an innovative, exciting, and promising step toward addressing insulin affordability,” American Diabetes Association Director of Government Affairs Christine Fallabel said at the hearing.
“However, we are more than a year behind schedule with no end in sight for the wait for what people deserve — to afford their insulin without going into debt or worse, taking less than they need to be healthy.”
Landsburg with HCAI added that Civica Rx — the nonprofit drug company contracting with California to produce insulin — has a facility in Virginia ready to produce it.
She added the state is looking into adding 15 more drugs to the program — including ones for cancer and weight loss.
Landsburg also said that CalRx’s Naloxone Access Initiative — where the state has partnered with a pharmaceutical company on low-cost and free supplies of overdose reversal drug — has distributed over 5 million twin packs.
