The Endocrine Society has officially announced its endorsement of the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act, a landmark piece of bipartisan legislation designed to fundamentally alter the pricing landscape of insulin in the United States. Introduced by a coalition of senators including Jeanne Shaheen (D-NH), Susan Collins (R-ME), Raphael Warnock (D-GA), and John Kennedy (R-LA), the bill seeks to extend financial protections to the millions of Americans who rely on insulin to manage diabetes but are currently excluded from existing federal price caps. By addressing both the immediate out-of-pocket costs for consumers and the systemic market complexities that drive prices upward, the INSULIN Act represents a comprehensive attempt to resolve a decades-long public health crisis.
The legislation primarily targets the commercial insurance market, proposing a $35 per month cap on out-of-pocket costs for individuals with private insurance. This move is intended to mirror the protections recently afforded to Medicare beneficiaries under the Inflation Reduction Act, thereby closing a significant gap in the national healthcare safety net. Beyond the co-pay cap, the bill introduces a specialized program to assist the uninsured, mandates that pharmacy benefit managers (PBMs) pass through negotiated rebates to patients, and implements measures to foster a more competitive market for generic and biosimilar insulin products.
The Evolution of the Insulin Affordability Crisis
To understand the necessity of the INSULIN Act, it is essential to examine the historical trajectory of insulin pricing in the United States. When insulin was first discovered in 1921 by Sir Frederick Banting and his colleagues, the patent was sold to the University of Toronto for a mere $1. The inventors famously stated that "insulin does not belong to me, it belongs to the world," intending for the medication to remain accessible and affordable for all who needed it. However, over the subsequent century, the manufacturing and distribution of insulin evolved into a highly concentrated market dominated by three global pharmaceutical giants: Eli Lilly, Novo Nordisk, and Sanofi.
Throughout the early 21st century, the list prices for insulin products skyrocketed. Between 2002 and 2013, the price of insulin nearly tripled, far outpacing the rate of inflation. This surge was attributed to a variety of factors, including incremental "evergreening" of patents, where manufacturers make minor adjustments to a drug’s delivery system or formulation to extend patent protection and delay the entry of generic competitors. Unlike simple chemical drugs, insulin is a biologic—a complex protein manufactured in living cells—which makes the development of biosimilars significantly more expensive and regulatorily demanding than traditional generic medications.
The human cost of these price increases has been devastating. According to data cited by the Endocrine Society and published in the Annals of Internal Medicine, nearly one in five American adults with diabetes—approximately 1.3 million people—reported rationing their insulin in 2021 due to cost concerns. Rationing, which involves skipping doses or taking less than the prescribed amount, can lead to severe medical complications, including diabetic ketoacidosis (DKA), kidney failure, blindness, lower-limb amputations, and premature death.
Core Provisions of the INSULIN Act
The INSULIN Act is structured to provide both immediate relief and long-term structural reform. The $35 monthly cap is the centerpiece of the legislation, providing a predictable and manageable cost for those on private insurance plans. This cap is particularly vital for patients with high-deductible health plans (HDHPs), who often face thousands of dollars in out-of-pocket costs at the start of each calendar year before their insurance coverage begins to pay for their prescriptions.
Another critical component of the bill is its focus on Pharmacy Benefit Managers (PBMs). PBMs act as intermediaries between insurance companies, pharmaceutical manufacturers, and pharmacies. They negotiate rebates from manufacturers in exchange for placing specific drugs on an insurance plan’s "formulary," or list of covered medications. Historically, these rebates have been kept by the PBMs or the insurers, while the patient’s co-insurance is calculated based on the high "list price" of the drug rather than the lower "net price" after rebates. The INSULIN Act includes provisions to ensure that these rebates and discounts are passed directly to the patients at the point of sale, effectively lowering the cost at the pharmacy counter.
Furthermore, the bill seeks to stimulate market competition. By streamlining the pathway for biosimilar and generic insulins to reach the market, the legislation aims to break the oligopoly currently held by the major manufacturers. Increased competition is widely regarded by economists as the most sustainable way to drive down the underlying list prices of medications over the long term.
Statistical Context of Diabetes in the United States
The scale of the diabetes epidemic in the United States underscores the urgency of the INSULIN Act. Data from the Centers for Disease Control and Prevention (CDC) indicates that 38.4 million Americans, or 11.6% of the population, currently live with diabetes. Of these, approximately 5% to 10% have type 1 diabetes, an autoimmune condition where the body produces no insulin. For these individuals, daily insulin injections are not optional; they are a biological necessity for survival.
An additional 29 million to 32 million Americans live with type 2 diabetes, a condition characterized by insulin resistance. While many people with type 2 diabetes can manage their blood sugar through diet, exercise, and oral medications, a significant portion eventually requires supplemental insulin as the disease progresses. The CDC also estimates that 97.6 million adults have prediabetes, suggesting that the demand for affordable insulin will only continue to grow in the coming decades.
The economic burden of diabetes is equally staggering. The American Diabetes Association (ADA) reported that the total estimated cost of diagnosed diabetes in the U.S. in 2022 was $412.9 billion, including $306.6 billion in direct medical costs and $106.3 billion in indirect costs such as reduced productivity. By making insulin more affordable, the INSULIN Act aims to reduce the incidence of expensive emergency room visits and hospitalizations resulting from poorly managed blood sugar levels.
Medical Community and Stakeholder Responses
The Endocrine Society’s endorsement carries significant weight within the medical community. As the world’s oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions, the Society represents the frontline of diabetes care.
Dr. Whitney Goldner, MD, 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 Sens. Shaheen, Collins, Warnock, and Kennedy for their commitment to addressing this urgent issue."
The endorsement aligns with the Society’s long-standing "Insulin Access and Affordability Position Statement." This document outlines a multi-pronged approach to the crisis, advocating for transparency in the insulin supply chain, the elimination of barriers to biosimilar entry, and the protection of patients from high out-of-pocket costs.
While pharmaceutical manufacturers have recently made voluntary moves to lower the list prices of some insulin products—largely in response to public pressure and the threat of regulation—health policy experts argue that voluntary measures are insufficient. They contend that without the force of law, manufacturers could raise prices again in the future, and many "legacy" or newer insulin formulations might not be covered by voluntary price drops.
The Legislative Path and Future Implications
The introduction of the INSULIN Act comes at a time of intense political scrutiny regarding healthcare costs. The successful implementation of the $35 cap for Medicare beneficiaries under the Inflation Reduction Act served as a "proof of concept," demonstrating that price caps can be implemented without disrupting the supply chain. However, because that cap was passed via the reconciliation process, it could only apply to government-funded programs, leaving those with private or employer-sponsored insurance subject to the fluctuations of the commercial market.
The bipartisan nature of the INSULIN Act is a strategic attempt to overcome the gridlock in Congress. By involving sponsors from both sides of the aisle, the bill’s proponents hope to secure the 60 votes necessary to clear the Senate filibuster. Senator Jeanne Shaheen has frequently pointed out that the cost of insulin is not a partisan issue, as it affects constituents in every state and of every political affiliation.
If passed, the INSULIN Act would represent one of the most significant interventions in the American pharmaceutical market in recent history. It would set a precedent for how the government might handle the pricing of other essential, life-saving biologics. Critics of such measures often argue that price controls can stifle innovation by reducing the revenue available for research and development. However, proponents of the INSULIN Act counter that insulin is a century-old drug and that the current pricing models reflect market failure rather than the costs of innovation.
Conclusion
The endorsement by the Endocrine Society highlights a critical consensus between the medical community and legislative reformers. As the INSULIN Act moves through the legislative process, the focus remains on the millions of Americans who currently face the impossible choice between purchasing their medication and covering basic living expenses like food and rent. By capping costs, reforming the PBM rebate system, and encouraging competition, the bill seeks to restore the original vision of insulin’s discoverers: that this life-saving hormone should be available to everyone who needs it, regardless of their financial status. The Endocrine Society has signaled its intent to work closely with Congress to ensure the bill’s passage, marking a pivotal moment in the ongoing battle for healthcare equity and pharmaceutical affordability in the United States.