California’s ambitious plan to produce its own low-cost insulin remains stalled, with no confirmed timeline for delivery. Governor Gavin Newsom initially promised a “2024 delivery” for the state-branded insulin, but as of now, the product is not available. The delay has raised concerns among diabetics and advocates, including the American Diabetes Association, which has highlighted the urgent need for affordable insulin options.
The initiative, known as CalRx, was announced two years ago as a bold move to disrupt the insulin market and reduce drug costs. However, the project is behind schedule, with no clinical trials started or applications submitted for approval from the U.S. Food and Drug Administration (FDA). According to CalMatters, the nonprofit drug manufacturer Civica, Inc., contracted to produce the insulin, has begun manufacturing but has not completed the necessary steps for FDA approval.
During a recent Senate oversight hearing, Christine Fallabel, regional director for government affairs for the American Diabetes Association, expressed concern over the delays, noting that Californians might have to wait until 2030 for the insulin. Industry experts suggest that the FDA’s review process could take a year or more, depending on the complexity of the drug.
Despite the setbacks, the Newsom administration maintains that the pace of development is not unusual for such a complex project. Elizabeth Landsberg, director of the state Department of Health Access and Information, stated that while the timeline is slower than anticipated, it is not outside industry norms. The state plans to sell the insulin for $30 per 10-milliliter vial or $55 for a box of five 3-milliliter pens once it becomes available.
The delay in California’s insulin production comes amid broader efforts to lower insulin costs nationwide. While some manufacturers have independently reduced prices, many diabetics still struggle with high out-of-pocket costs. In response, Senator Scott Wiener has reintroduced a bill to cap insulin prices, which Governor Newsom previously vetoed, citing the CalRx initiative as a solution.
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