The Endocrine Society, the world’s oldest and largest organization of scientists and clinicians dedicated to hormone research and the clinical care of patients with endocrine conditions, has officially announced its endorsement of the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act. This bipartisan legislative effort, introduced by a coalition of United States Senators including Jeanne Shaheen (D-NH), Susan Collins (R-ME), Raphael Warnock (D-GA), and John Kennedy (R-LA), represents a comprehensive federal attempt to address the escalating crisis of insulin affordability in the American healthcare system. By seeking to expand the $35 monthly out-of-pocket co-pay cap—currently limited to Medicare beneficiaries—to the commercial insurance market, the bill aims to provide financial relief to millions of Americans who rely on insulin for daily survival.
The endorsement by the Endocrine Society signals a critical alignment between the medical community and federal lawmakers. The INSULIN Act is designed not only to provide immediate cost-sharing relief but also to tackle the structural inefficiencies within the pharmaceutical supply chain that have allowed insulin prices to remain prohibitively high for decades. Beyond the price cap, the legislation includes provisions to create a robust program for the uninsured, reform the practices of Pharmacy Benefit Managers (PBMs), and foster a more competitive market for generic and biosimilar insulin products.
A Comprehensive Legislative Framework for Affordability
The INSULIN Act is structured as a multi-pronged solution to a complex economic problem. At its core, the bill mandates that private insurance plans cap the monthly cost-sharing for at least one of each dosage form (such as vials or pens) and each type of insulin (including rapid-acting, short-acting, intermediate-acting, and long-acting) at no more than $35. This provision is modeled after the success of the Inflation Reduction Act of 2022, which implemented a similar cap for seniors enrolled in Medicare Part D. However, a significant portion of the diabetic population remains under the age of 65 and is covered by private employer-sponsored plans or individual market plans, where high deductibles often result in thousands of dollars in annual out-of-pocket expenses for insulin alone.
In addition to the commercial cap, the legislation addresses the "uninsured gap." It proposes the creation of a program that ensures individuals without health insurance can access insulin at the same $35 price point. This is particularly vital given that the uninsured are the demographic most likely to experience catastrophic health outcomes due to price-driven medication non-adherence.
Furthermore, the bill targets the role of Pharmacy Benefit Managers (PBMs), the intermediaries that negotiate drug prices between manufacturers and insurers. Currently, PBMs often collect significant rebates from manufacturers in exchange for placing a specific drug on a "preferred" formulary. Critics argue this system creates a perverse incentive for manufacturers to keep list prices high so they can offer larger rebates to PBMs. The INSULIN Act includes provisions to ensure that these rebates and discounts are passed down to the patients at the point of sale, rather than being retained by middlemen.
The Clinical Necessity and the Crisis of Rationing
The urgency behind the INSULIN Act is underscored by the physiological reality of diabetes. For the approximately 2 million Americans living with type 1 diabetes, insulin is not an optional supplement; it is a hormone required for life. Without it, the body cannot process glucose, leading to a life-threatening condition known as diabetic ketoacidosis (DKA). For many of the millions more living with type 2 diabetes, insulin is the final and most effective line of defense against complications such as kidney failure, blindness, limb amputation, and cardiovascular disease.
According to data from the U.S. Centers for Disease Control and Prevention (CDC), roughly 38.4 million Americans, or 11.6% of the total population, are living with diabetes. The financial strain of the disease has led to a national health emergency. A study published in the Annals of Internal Medicine revealed that in 2021, nearly one in five American adults with diabetes—approximately 1.3 million people—rationed their insulin due to cost. Rationing involves skipping doses, taking less than the prescribed amount, or delaying prescriptions, all of which significantly increase the risk of long-term disability and premature death.
Dr. Whitney Goldner, Chair of the Endocrine Society’s Clinical Affairs Core Committee, emphasized the stakes involved in this legislative push. "Many people living with diabetes struggle to pay for the insulin they need to survive," Dr. Goldner stated. "This important legislation would ensure that people living with diabetes on private insurance are able to access this life-saving medication at no more than $35 per month. The legislation also includes provisions to help people who are uninsured afford their insulin. We are pleased to endorse this bipartisan bill and thank Senators Shaheen, Collins, Warnock, and Kennedy for their commitment to addressing this urgent issue."
Historical Context and the Evolution of Insulin Pricing
The struggle over insulin pricing is particularly poignant given the drug’s history. When Frederick Banting, Charles Best, and James Collip discovered insulin in 1921, they famously sold the patent to the University of Toronto for just $1 each, believing that a life-saving discovery belonged to the world rather than to a corporation. For much of the 20th century, insulin remained relatively affordable.
However, the landscape shifted with the development of "analog" insulins in the 1990s and early 2000s. These lab-engineered versions offered more predictable absorption rates and improved quality of life but were introduced at much higher price points. Between 2002 and 2013, the average price of insulin in the United States nearly tripled. Unlike other medications that see price drops as they age, insulin prices continued to rise due to "evergreening"—a practice where minor tweaks to delivery systems or formulations allow manufacturers to extend patent protections and prevent generic competition.
The INSULIN Act seeks to break this cycle by encouraging the market entry of biosimilar insulins. Biologics like insulin are more complex to manufacture than traditional chemical drugs, and the regulatory pathway for "generic" versions (biosimilars) has historically been arduous. By streamlining the approval process and ensuring that PBMs cannot block biosimilars from formularies, the bill aims to introduce the kind of price-lowering competition that is standard in other sectors of the pharmaceutical industry.
Stakeholder Reactions and Economic Implications
While the Endocrine Society has been vocal in its support, the bill exists within a complex ecosystem of stakeholders. Patient advocacy groups such as JDRF (formerly the Juvenile Diabetes Research Foundation) and the American Diabetes Association (ADA) have long campaigned for similar measures, noting that the United States pays significantly more for insulin than any other developed nation. Data from the RAND Corporation indicates that U.S. insulin prices are, on average, ten times higher than in other OECD countries.
On the other hand, the pharmaceutical and PBM industries have historically offered mixed reactions to price-capping legislation. While the "Big Three" insulin manufacturers—Eli Lilly, Novo Nordisk, and Sanofi—announced voluntary $35 caps for many of their products in 2023 following intense public and political pressure, advocates of the INSULIN Act argue that voluntary measures are insufficient. Legislative action is viewed as necessary to codify these protections into law, ensuring they cannot be rescinded during future market shifts.
From an economic perspective, the bill’s impact on insurance premiums remains a point of debate. Some industry analysts suggest that capping out-of-pocket costs could lead insurers to raise monthly premiums to offset the loss. However, proponents of the bill argue that the long-term savings to the healthcare system would be immense. The ADA estimates that the total economic cost of diagnosed diabetes in the U.S. reached $412.9 billion in 2022. By preventing the complications associated with insulin rationing, the INSULIN Act could significantly reduce the billions of dollars spent annually on emergency room visits, hospitalizations, and long-term disability care.
Timeline of Federal Action on Insulin
The introduction of the INSULIN Act follows a series of incremental federal steps:
- 2020: The Centers for Medicare & Medicaid Services (CMS) launched a voluntary model (the Part D Senior Savings Model) to test a $35 monthly cap for Medicare beneficiaries.
- 2022: The Inflation Reduction Act (IRA) was signed into law. While it successfully capped insulin costs for those on Medicare, a provision to extend that cap to the private market was stripped from the final bill after failing to meet the strict requirements of the Senate’s reconciliation process.
- 2023: In response to the IRA and public pressure, the major manufacturers announced voluntary price reductions and co-pay assistance programs.
- 2024: Senators Shaheen, Collins, Warnock, and Kennedy reintroduced the INSULIN Act as a standalone bipartisan bill to finish the work started in the IRA, targeting the private market and the uninsured.
Analysis of Broader Health Policy Impact
The INSULIN Act represents a shift in how the United States approaches drug pricing. By targeting a specific, high-volume, life-saving medication, lawmakers are testing a model of intervention that could eventually be applied to other therapeutic areas. The focus on PBM reform is particularly noteworthy, as it addresses a part of the "black box" of drug pricing that has long frustrated both patients and providers.
For the Endocrine Society, the bill aligns perfectly with their "Insulin Access and Affordability Position Statement." The Society has consistently advocated for a system where the list price of insulin is lowered through rebate reform and where patient out-of-pocket costs are strictly limited. By endorsing the bill, the Society is reinforcing the clinical consensus that financial barriers to medication are a primary obstacle to effective disease management.
As the legislation moves toward potential floor votes, the Endocrine Society has pledged to work closely with members of Congress to ensure its passage. The organization emphasizes that while scientific advancements in insulin delivery have been remarkable, those advancements are meaningless if the patients who need them are priced out of the pharmacy. The INSULIN Act stands as a critical test of whether bipartisan cooperation can resolve one of the most persistent and visible failures of the American healthcare market.