California Governor Gavin Newsom has teamed up with Civica Rx to offer affordable insulin to residents of California at a reduced price of $30 for 10 milliliters, significantly lower than previous costs. The initiative aims to make insulin more accessible to those in need, as depicted in the photo by Ringo Chiu, Sipa USA via Reuters.
In a nutshell
In 2020, Newsom approved a law allowing California to produce its own insulin in order to lower expenses. While the progress has been slow, various factors have contributed to the decreased prices of insulin.
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The plan to manufacture generic insulin for the 3.2 million diabetic residents of California, as proposed by Newsom, is facing delays and is unlikely to be available in the market anytime soon, according to experts.
The company contracted for manufacturing, Civica, Inc., has not yet started trials or sought FDA approval, a process that could extend over a year.
Although California had projected the sale of $30 vials to commence in 2024, that timeline has already passed.
Realistically, experts estimate that the approval process may take anywhere from 1 to 3 years.
The 2020 law enabled Newsom to negotiate a $50 million contract with Civica, along with an additional $50 million for a manufacturing facility.
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Simultaneously, national insulin prices have decreased due to public pressure and policy adjustments.
Newsom opted out of a monthly insulin copay cap in favor of addressing the underlying costs contributing to the high prices.
The state is striving to find sustainable solutions to combat escalating pharmaceutical costs.
Newsom remains steadfast in his commitment to producing affordable insulin.
Industry experts anticipate a lengthier timeline and higher costs for establishing a manufacturing facility.
Insulin production at Civica’s facility in Virginia is ongoing without a set market date.
FDA approval for new drugs takes years
The development and approval of a drug, particularly insulin biosimilars, entails a lengthy process that requires compliance with FDA regulations.
Manufacturers must ensure the safety, quality, purity, potency, stability, and clinical similarity of biosimilars to the original innovative drugs.
Insulin biosimilars like Semglee and Rezvoglar took years from application to market release.
Bringing biosimilar insulin to the market can take 2-4 years, depending on the available data and experience.
Civica, experienced in manufacturing generic drugs, is now venturing into biosimilars with insulin production.
While the FDA can expedite the review process, it typically takes a minimum of six months for high-profile drugs.
The average review cycle lasts 12 months, further delaying Newsom’s insulin project.
California aimed to disrupt pharmaceutical market
Newsom’s partnership with Civica aimed to offer affordable insulin by bypassing price manipulations that have led to soaring insulin prices between 2012 and 2021. Major manufacturers eventually reduced prices in 2024.
Insulin used to be affordable due to the availability of generic alternatives and competition in the market. However, in recent years, the prices have skyrocketed, making it unaffordable for many patients. Several factors have contributed to this sudden increase in prices, including the lack of competition, patent protections, and the high cost of research and development for new insulin products.
Pharmaceutical companies have been criticized for taking advantage of their monopoly on insulin production and setting high prices for this life-saving medication. The rising prices have put a strain on individuals with diabetes, forcing them to make difficult choices between paying for insulin or other necessities.
The new California rule aims to address these issues by promoting the production of biosimilar insulin and negotiating lower prices for medications like naloxone. By increasing competition and implementing cost-saving measures, California hopes to make insulin more affordable and accessible for all residents.
It is crucial for policymakers and pharmaceutical companies to work together to ensure that essential medications like insulin remain affordable for those who need them. By prioritizing the health and well-being of the population, we can create a healthcare system that is both efficient and equitable for all.
Insulin used to be universally regarded as a cheap drug in the United States — but then greed got in the way
Published November 16, 2022 12:00PM (EST)
Following Elon Musk’s acquisition of Twitter, significant changes were expected to impact real-world situations. Musk’s decision to allow account verification for $8 led to fraudulent accounts posing as Eli Lilly offering free insulin, resulting in a decrease in stock prices.
The issue of skyrocketing insulin prices was brought to the forefront by these pranks, prompting Congress to consider imposing caps, although a recent attempt to cap prices at $35 for all Americans was unsuccessful. Many individuals are forced to cut expenses or ration their insulin due to the excessively high costs.
Insulin was originally intended to be accessible to all, with its creators considering it unethical to make a profit off a life-saving invention. However, insulin prices in the U.S. have surged, with some patients paying up to $1000 per month. The complex reasons behind these rising costs involve manufacturers, intermediaries, and policymakers, with potential solutions including market-based approaches and increased competitiveness that might lead to price reductions.
Advocates are calling for Congress to impose direct price caps on insulin to provide immediate relief to consumers, highlighting the ongoing challenges faced by those in need of insulin.
- Republican Senator Chuck Grassley sends mixed messages regarding his vote on insulin price caps
- Republicans block insulin price cap for private insurance in the Inflation Reduction Act
- Dr. Oz invests up to $715,000 in companies accused of inflating insulin costs
By Matthew Rozsa
Matthew Rozsa, a former staff writer at Salon, holds a master’s degree in History from Rutgers-Newark and was a recipient of a science journalism fellowship from the Metcalf Institute in 2022.
In contrast to other developed nations, affordability is less of a concern when it comes to insulin.
Update: March 1, 2023: Eli Lilly announced a $35 monthly cap on out-of-pocket insulin costs following a provision in the Inflation Reduction Act. This move comes several months after a fake Eli Lilly account on Twitter claimed to offer free insulin.
The Build Back Better Act includes provisions to limit monthly out-of-pocket copays for insulin to $35, a significant step in addressing insulin affordability issues. With over 34 million diabetes patients in the U.S., including over 7 million who need insulin, the tripling of insulin costs over the past decade has made diabetes the costliest chronic illness in the country.
Almost a hundred years ago, insulin was intended to be affordable and easily accessible. What went wrong?
A breakthrough discovery
In 1922, a 14-year-old boy named Leonard Thompson in Toronto, diagnosed with Type 1 diabetes, was treated with beef pancreas extract, marking the first successful treatment of a Type 1 diabetic with insulin. This breakthrough was a turning point in medical history, leading to the Nobel Prize for its creators and being hailed as one of the significant medical discoveries of the 20th century.
Insulin, the hormone produced by the pancreas that regulates blood sugar levels, revolutionized the treatment of diabetes. Before its discovery, individuals diagnosed with Type 1 diabetes faced certain death. With the introduction of insulin therapy, diabetes became a manageable condition, saving countless lives and improving the quality of life for those living with the disease.
The development of insulin paved the way for further research into diabetes and other related conditions, leading to the development of improved insulin formulations, insulin pumps, and continuous glucose monitoring devices. Today, insulin remains a vital treatment for individuals with Type 1 and Type 2 diabetes, highlighting the enduring impact of this breakthrough discovery.
A dream of accessibility
The original creators of insulin envisioned the drug to be accessible for free or at a minimal cost, exemplified by Frederick Banting and John Macleod’s decision to decline patenting insulin. Although Charles Best and James Collip patented it, they sold the rights to the University of Toronto for a nominal fee of $1. The evolution of insulin production has seen the shift towards synthetic insulin, that replaced animal-derived insulin in the late ’70s.
A dream dashed
Currently, global insulin markets are dominated by Eli Lilly, Novo Nordisk, and Sanofi, with the U.S. facing high insulin costs due to production complexities and lack of generic options. In contrast, many other countries offer insulin at a significantly lower cost compared to the U. S., with Canada selling it on average for $12 per unit as opposed to $98.70 in the U. S., according to the RAND Corporation.
Given the disparity in costs, many Americans seek more affordable insulin options across the border, or resort to rationing their insulin supply, resulting in severe health consequences.
A century later, change is slow
Insulin marked its 100th anniversary last year since its discovery, underscoring its crucial role in saving lives. As the anniversary of its patent approaches and with the fate of the Build Back Better Act uncertain, there is a growing concern over the continued unaffordability of insulin. Despite advancements, the original creators would have expected more progress toward ensuring effective and affordable insulin production that benefits everyone.
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