Summarize this content to 2000 words in 6 paragraphs California Governor Gavin Newsom’s bold plan to produce a cheap, generic insulin for Californians by 2024 could be delayed for years.Civica, the nonprofit drug manufacturer contracted to produce insulin for California, has not even begun two of the lengthy processes required to get the drug onto shelves. Neither clinical trials nor an application for federal approval from the Food and Drug Administration (FDA) are underway, meaning it’s highly unlikely the state-manufactured insulin will be available until 2027 or later.Newsweek reached out to Newsom’s office via email for comment.Why This MattersNewsom said the insulin would be delivered by 2024, pending FDA approval, when he announced that the state would begin selling it for $30 a vial during his 2023 State of the State tour.What To KnowIn 2020, Newsom signed a law that would allow California to manufacture its own insulin as part of an effort to bring down its cost. The governor announced in 2023 that CalRx, an initiative to produce generic drugs under the state’s own label, had secured a 10-year, $50 million deal with Civica to make $30 insulin available to residents who need it.Newsom also set aside $50 million for the construction of a drug manufacturing facility in California.
California Governor Gavin Newsom holds a press conference on October 27, 2024, in Los Angeles. Newsom’s plan to provide Californians affordable insulin has hit some roadblocks.
California Governor Gavin Newsom holds a press conference on October 27, 2024, in Los Angeles. Newsom’s plan to provide Californians affordable insulin has hit some roadblocks.
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In California, 3.2 million people live with diabetes. Although those with the condition have relied on the insulin for over 100 years, prices continue to go up because of high demand.The plan aimed to bring down the price of insulin by about 90 percent, saving patients between $2,000 and $4,000 annually. By charging consumers the same price it costs the state to manufacture and distribute insulin, the expense would be reduced from $300 to $30 for a 10-milliliter vial.On the national level, insulin prices have been dropping as a result of federal action. The Biden administration capped insulin prices for some seniors with Medicare in 2023 and changed Medicaid rules that tied drug prices to inflation.At least 25 states and the District of Columbia have implemented monthly co-payment caps to help offset expenses for diabetics. But in California, Newsom rejected a $35 monthly insulin co-pay cap, citing the state’s $100 million investment in insulin production.What People Are SayingJames Bruno, a longtime chemical and pharmaceutical consultant for drug manufacturers, told CalMatters: “You could be anywhere from 12 months to two or three years before you get your actual approval—and that’s if nothing goes wrong.”David Gaugh, executive vice president of the Association for Accessible Medicines, told the news outlet: “I would make a general statement that it’s probably going to be somewhere between two and four years.”Newsom spokesperson Elana Ross said said in a Wednesday statement: “That process is underway and moving forward, though there have been delays, which is not unusual. The priorities of both the administration and Civica continue to be quality and price, and all parties continue to advance development toward FDA approval with those north stars.”Gavin Newsom said at a March 2023 press conference: “People should not be forced to go into debt to get lifesaving prescriptions. Through CalRx, Californians will have access to some of the most inexpensive insulin available, helping them save thousands each year. But we’re not stopping there: California will seek to make our own naloxone as part of our plan to fight the fentanyl crisis.”Scott Wiener, a Democratic California state senator, told CalMatters: “This is a missed opportunity that will force them to wait months or years for relief from the skyrocketing costs of medical care when they could have had it immediately.”What’s NextNewsom has not offered a new timeline on when California residents can expect the state-manufactured insulin to be made available for purchase.
