The pharmaceutical industry’s billion-dollar practice of inflating drug prices and shielding itself from accountability has brought immense public outcry and inspired a profusion of legal reforms. But the precise dynamics that enable this ongoing crisis remain obscure, impeding effective resolution. This Article examines the interplay between legislative, regulatory, and new governance approaches emerging at both the federal and state levels. It exposes how a seemingly singular problem of high drug costs unfolds as a complex series of mergers, collusions, and restrictive strategies throughout the healthcare supply chain.
The poster child of big pharma greed is insulin, the lifesaving drug of diabetics. This Article presents insulin as a case study in analyzing how a drug discovered long ago evolved, through product hopping and patent evergreening, into multiple brand-name products still under patent. It further illustrates how market concentration in each link of the drug delivery chain has substantially increased with impunity, spanning from big pharma to pharmacy benefit management (“PBM”) intermediaries that broker deals between drug manufacturers, insurers, and pharmacies. The compounding effects of horizontal and vertical integration of powerful industry actors—what this Article calls “oligopoly squared”—have enabled collusive deals, including formulary exclusion, secret rebates, spread pricing, and preferred pharmacy status, each designed to artificially inflate insulin prices.
Moving from the expository and descriptive to the analytical and prescriptive, this Article then presents an equally multifaceted framework to address these harmful effects, combining cost control and transparency laws, PBM regulation, patent law and U.S. Food and Drug Administration generics approval reforms, and antitrust enforcement. This Article explains why federal law should not be interpreted as preempting state regulation of pharmaceutical supply chains. This Article further analyzes efforts using cutting-edge theories of competition law in light of broader recent developments in adjudicating market power and collusion. Most importantly, this Article examines the newest approaches emerging in the landscape of market and legal levers—direct-to-consumer transparent pharmacies and the public production of drugs—and argues that these new governance models have the greatest potential to disrupt the concentrated market. By analyzing and integrating these diverse efforts through the lens of legal theory and practical impact, this Article not only charts the course of pharmaceutical drug industry reform but also offers broader implications for regulating complex industries.
Introduction
Escalating prescription drug prices have sparked an unprecedented wave of law and policy initiatives, with numerous lawsuits and legislative reforms emerging at both the federal and state levels. These efforts aim to tackle not only the exorbitant cost of prescription medications but also the opaque and entrenched practices in each link of a complex drug delivery chain.1 1.See infra Parts III–IV.Show More
The sheer scope and diversity of new legal reforms—spanning price controls, transparency mandates, patent law and generic drug approval reforms, antitrust enforcement, and, most recently, public drug production and direct-to-patient delivery—signal a seismic shift in the understanding of how legal frameworks can be deployed to disrupt concentrated markets and protect consumers. The breadth of legal actions provides a model for studying competition and industry regulation more broadly. This Article analyzes the contemporary momentum in which policymakers simultaneously leverage legislation, regulation, litigation, and market strategies to tackle a billion-dollar industry’s harmful practices. It shows how myriad efforts to directly regulate drug prices have stalled, proven ineffective, or been challenged in courts, including in a current case in which the Supreme Court recently denied certiorari.2 2.Pharm. Care Mgmt. Ass’n v. Mulready, 78 F.4th 1183 (10th Cir. 2023), cert. denied, 145 S. Ct. 2843 (2025) (mem.).Show More Analyzing the split circuit adjudication on federal preemption of such state reforms, this Article argues that the Court should have resolved the split by holding that state regulation of pharmaceutical supply chains is not preempted by federal law. The complex structure of the pharmaceutical industry presents a test case wherein federalism offers opportunities for democratic experimentalism and new multilevel governance reforms.3 3.On new governance theory and practice, see Orly Lobel, The Renew Deal: The Fall of Regulation and the Rise of Governance in Contemporary Legal Thought, 89 Minn. L. Rev. 342, 404–07 (2004) [hereinafter Lobel, The Renew Deal] (describing the paradigm shift in legal process from command and control to more collaborative participatory regulation); Orly Lobel, New Governance as Regulatory Governance, in The Oxford Handbook of Governance 65, 65 (David Levi-Faur ed., 2012) (explaining how new governance theory provides lessons for government and market stakeholders on how to collaborate toward shared goals); Orly Lobel, National Regulation in a Global Economy: New Governance Approaches to 21st Century Work Law, in 2 Labor and Employment Law and Economics 630, 640–41 (Kenneth G. Dau-Schmidt, Seth D. Harris & Orly Lobel eds., 2009) (applying new governance theory to workplace regulation); Orly Lobel, Setting the Agenda for New Governance Research, 89 Minn. L. Rev. 498, 499–502 (2004) (describing next steps in the developments of new governance theory and practice).Show More Preemption should be narrowly tailored to allow state laws designed to protect patients and enhance consumer welfare. Even more critically, this Article argues that the novel path of public drug manufacturing and delivery is an essential lever to directly disrupt this complex concentrated market.
Insulin is the poster child for high drug costs in the United States. Insulin prices in the United States have spiked shockingly high compared to those in other developed countries.4 4.Andrew W. Mulcahy & Daniel Schwam, RAND Corp., Comparing Insulin Prices in the United States to Other Countries 17 (2024) (“Compared with other countries, and in each insulin category, the United States had dramatically higher gross prices. The average U.S. manufacturer price per 100 IUs across all insulins was $22.68, compared with $3.75 in Canada, $2.20 in the United Kingdom, $2.79 in Mexico, and $2.37 across all non-U.S. OECD countries combined . . . .”).Show More A 2024 RAND report found that the price of insulin in the United States is more than nine times higher than the price of insulin in thirty-three comparison nations combined.5 5.Id. at v.Show More Even when accounting for rebates and discounts, U.S. net prices are still, on average, 2.3 times higher than those in other countries.6 6.Id.Show More Examining insulin as a case study for addressing skyrocketing drug prices reveals the need for the multifaceted framework presented in this Article. There are three manufacturers who make nearly all insulin sold in the United States: Eli Lilly, Novo Nordisk, and Sanofi.7 7.Judith A. Johnson, Cong. Rsch. Serv., IF11026, Insulin Products and the Cost of Diabetes Treatment 2 (2018).Show More These three dominant pharmaceutical manufacturers frequently engage in practices like product hopping and patent evergreening whereby they introduce slightly modified versions of brand-name drugs—often just before patent expiration—and aggressively market them to shift patients to the newly patented formulations.8 8.See infra Part I.Show More Although insulin was discovered more than a century ago, these practices prevent generic drugs from entering the market and competing with lower drug prices. Still, if drug manufacturers alone were engaging in anticompetitive tactics, reforming intellectual property law and generic drug approval could be a straightforward and effective solution. Unfortunately, the reality is far more complex. The American insulin industry is not simply an oligopoly; it represents what this Article terms an “oligopoly squared” market—the compounded effect of both market consolidation and restrictive tactics across complex supply chains.
Big pharma colludes with another highly concentrated industry that has largely operated under the radar: pharmacy benefit managers (“PBMs”).9 9.See infra Section II.B.Show More PBMs, while surprisingly understudied in legal scholarship, are the powerful middlemen who shape prescription drug delivery.10 10.See infra Section II.B.Show More PBMs determine formularies, the lists that dictate the prescription drugs that a health insurance plan covers.11 11.See infra Section II.B.Show More Three PBMs—CVS Caremark, Express Scripts, and Optum Rx—control this key intermediary role in the market.12 12.See Adam J. Fein, The Top Pharmacy Benefit Managers of 2024: Market Share and Key Industry Developments, Drug Channels Inst. (Mar. 31, 2025), https://www.drugchannels.net/2025/03/the-top-pharmacy-benefit-managers-of.html [https://perma.cc/XY38-T4BH] (“[Drug Channels Institute] estimates that for 2024, about 80% of all equivalent prescription claims were processed by three companies: the Caremark business of CVS Health, the Express Scripts business of Cigna, and the Optum Rx business of UnitedHealth Group.”).Show More The three lead manufacturers of insulin control more than ninety percent of the drug by value globally, and three PBMs control more than eighty percent of the prescription-management market.13 13.Claudia Martínez, Camille Romero & Natalia Sánchez Villalobos, Access to Med. Found., What Are Pharma Companies Doing to Expand Access to Insulin—and How Can Efforts Be Scaled Up? 4 (2022); Off. of Pol’y Plan., U.S. Fed. Trade Comm’n, Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies 2 (2024). The six largest PBMs manage nearly ninety-five percent of all prescriptions filled in the United States. Id. at 5.Show More Furthermore, for decades, PBMs have been engaging in both vertical and horizontal integration, further concentrating the market by purchasing other key players in the healthcare supply chain, including pharmacies and health insurance providers.14 14.See discussion infra Section II.D.Show More As this Article illustrates, the combined oligopolistic structure of the industry, alongside the complex regulatory scheme for pharmaceuticals and health care, has enabled the three leading insulin producers and three dominant PBM players to exploit legal loopholes, manipulate markets, and broker collusive deals, all while aggressively and continuously increasing the price of insulin and other drugs.
Public outcry over insulin prices has prompted congressional hearings, legislative and regulatory action, and pending litigation at both the state and federal levels. At the federal level, Congress enacted the Inflation Reduction Act of 2022, empowering Medicare to negotiate drug prices and capping out-of-pocket insulin costs at thirty-five dollars per month for Medicare patients.15 15.Bisma A. Sayed et al., Off. of the Assistant Sec’y for Plan. & Evaluation, U.S. Dep’t of Health & Hum. Servs., Insulin Affordability and the Inflation Reduction Act: Medicare Beneficiary Savings by State and Demographics 1 (2023), https://aspe.hhs.gov/sites/default/files/documents/bd5568fa0e8a59c2225b2e0b93d5ae5b/aspe-insulin-affordibility-datapoint.pdf [https://perma.cc/TL9A-QWJU]; Tami Luhby, More Americans Can Now Get Insulin for $35, CNN, https://www.cnn.com/2024/01/01/politics/insulin-price-cap/index.html [https://perma.cc/6TAR-FBEV] (last updated Jan. 2, 2024, 5:34 PM); Jay-Donavin Ved, The Inflation Reduction Act of 2022: Addressing Prescription Drug Coverage, 32 Annals Health L. Advance Directive 131, 131 (2023).Show More In 2024 alone, dozens of new bills were introduced in Congress to address the high costs of pharmaceutical drugs.16 16.See infra Part III.Show More A 2025 bipartisan bill, the Patients Over Profit Act, seeks to prevent the increasing vertical integration in health care, where insurance companies acquire provider practices, labs, specialty practices, and outpatient clinics—although in its current form, the bill leaves intact the consolidation between PBMs and pharmacies.17 17.Patients Over Profit Act, S. 2836, 119th Cong. (2025).Show More At the state level, this Article produces an original, comprehensive, and up-to-date mapping of the twenty-nine states, plus the District of Columbia, that have passed legislation to cap insulin prices, analyzing the potential benefits and risks of such direct price controls.18 18.See infra Section III.B, Figure IV, Table I.Show More Over the past few years, each of the fifty states has also enacted legislation to tackle the PBMs’ behaviors, through measures such as prohibiting PBMs’ exclusion of nonaffiliated pharmacies from health plans.19 19.T. Joseph Mattingly II, Maisie Lewis, Mariana P. Socal & Ge Bai, State-Level Policy Efforts to Regulate Pharmacy Benefit Managers (PBMs), 18 Rsch. Soc. & Admin. Pharmacy 3995, 3995, 3999 (2022).Show More The validity of these state reforms is uncertain in light of a circuit split regarding whether they are preempted by federal law. Moreover, in the past few years, and accelerating in 2024, state attorneys general across the country, as well as the Federal Trade Commission (“FTC”), have filed lawsuits against the major insulin manufacturers and PBMs, alleging anticompetitive practices and price-fixing.20 20.Many of these actions—including those by Arkansas, Illinois, Kansas, Mississippi, Montana, California, Louisiana, Puerto Rico, Hawaii, Arizona, Texas, Utah, Missouri, as well as by unions and local governments—have been consolidated. Docket, In re Insulin Pricing Litig., No. 3080 (J.P.M.L. May 9, 2023). The FTC filed its own complaint against PBMs, alleging violation of Section 5 of the FTC Act, 15 U.S.C. § 45, in September 2024. Complaint, In re Caremark Rx, LLC, No. 9437 (F.T.C. Sept. 20, 2024) [hereinafter FTC Complaint]. Class actions have also been filed by patients against insurers for paying PBMs inflated drug costs. Daniel Wiessner, Wells Fargo Sued Over Employee Prescription Drug Costs, Reuters (July 30, 2024), https://www.reuters.com/legal/wells-fargo-sued-over-employee-prescription-drug-costs-2024-07-30/ [https://perma.cc/7MM5-VF5N].Show More In 2023, those states filed In re Insulin Pricing Litigation, the consolidated multidistrict litigation centering on the allegations that major insulin manufacturers—such as Eli Lilly, Novo Nordisk, and Sanofi—colluded with PBMs—like CVS Caremark, Express Scripts, and Optum Rx—to artificially and fraudulently inflate the price of insulin.21 21.First Amended Complaint at 6, Arkansas ex rel. Rutledge v. Eli Lilly & Co., No. 22-cv-00549 (E.D. Ark. Aug. 8, 2022); Complaint at 6, Illinois ex rel. Raoul v. Eli Lilly & Co., No. 2022CH11699 (Ill. Cir. Ct. Dec. 2, 2022); Petition at 6, Kansas ex rel. Schmidt v. Eli Lilly & Co., No. 2022-cv-000735 (Kan. Dist. Ct. Dec. 2, 2022); Third Amended Complaint at 5, Mississippi ex rel. Fitch v. Eli Lilly & Co., No. 21-cv-00674 (S.D. Miss. Feb. 17, 2022).Show More Since 2023, the number of states in the multistate litigation has grown to include seventeen U.S. states and territories.22 22.These states and territories are Arizona, Arkansas, California, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, and West Virginia. Docket, In re Insulin Pricing Litig., No. 3080.Show More Drawing on antitrust principles, this Article presents the first scholarly analysis of this sea of new lawsuits and contends that the pharmaceutical companies and pharmacy managers have conspired to artificially inflate drug prices, thereby exploiting the vulnerability of millions of patients.
California’s approach to high insulin prices is broader than most state reforms, the majority of which have focused solely on direct price controls. California’s legislation to cap the price of insulin was initially vetoed by Governor Gavin Newsom, though such caps were enacted in 2025.23 23.See Lexington Souers, State Legislation Provides Hope for Rising Insulin Costs, Council of State Gov’ts (Mar. 31, 2023), https://www.csg.org/2023/03/31/state-legislation-provides-hope-for-rising-insulin-costs/ [https://perma.cc/6R4D-7937] (contrasting the legislation that Governor Newsom initially vetoed with insulin price cap legislation in eleven other states); Jess Berthold, CA Governor Just Vetoed Price Caps on Insulin. Now What?, Univ. of Cal. S.F. (Oct. 11, 2023), https://www.ucsf.edu/news/2023/10/426351/ca-governor-just-vetoed-price-caps-insulin-now-what [https://perma.cc/8MPV-MT6D] (explaining California’s alternative plan to produce its own insulin for thirty dollars per vial); see also infra note 237 (detailing California’s newly enacted insulin price cap legislation).Show More In the wake of Newsom’s original veto, the state instead enacted a revolutionary state-produced insulin initiative. In 2023, California announced a contract with a nonprofit drugmaker, Civica Rx, to produce government-funded, affordable insulin. Named CalRx, the public program aims to develop, produce, and distribute generic drugs at low costs, starting with insulin.24 24.S.B. 852, 2020 Leg., Reg. Sess. (Cal. 2020).Show More This novel approach to public drug production has the potential to disrupt not just the diabetes medication market, but healthcare delivery more broadly. The next drug on the agenda is naloxone, a drug used to reverse opioid overdoses that the U.S. Food and Drug Administration (“FDA”) recently approved as an over-the-counter generic.25 25.Lynn La, California Will Buy Cheaper Naloxone to Stop Fentanyl Deaths, CalMatters (Apr. 30, 2024), https://calmatters.org/newsletter/california-fentanyl-deaths-naloxone/ [https://perma.cc/KS48-3QPT]; see also Kristen Hwang, Newsom Committed California to Making Its Own Insulin. It’s at Least a Year Behind His Schedule, CalMatters (Jan. 15, 2025), https://calmatters.org/health/2025/01/insulin-production-gavin-newsom/ [https://perma.cc/K9FR-NX92] (detailing the ties between the state’s efforts to make both insulin and naloxone more affordable).Show More Other states, as well as a federal bill, are looking to emulate this public intervention. In parallel, market initiatives such as Transparency-Rx and Mark Cuban’s Cost Plus are emerging to bypass the dominant PBMs and directly disrupt the concentrated market of drug delivery.26 26.See infra Section V.A.Show More
The high cost of insulin and other essential medications is often framed as a straightforward, single-issue problem: drug prices are simply inflated by their sellers.27 27.See, e.g., Lev Facher, It’s the Insulin, Stupid: How Drug Pricing’s Simplest Case Study Became a Top Issue for 2020 Democrats, STAT News (Jan. 28, 2020), https://www.statnews.com/2020/01/28/insulin-pricing-becomes-top-issue-for-democrats [https://perma.cc/GB8L-EVKQ] (“Even in a primary dominated by broader health care issues, insulin has emerged as particularly alluring campaign fodder for Democrats. Unlike more perplexing topics like health insurance reform or the cost of drug research, candidates have a plain and simple rallying cry for insulin: That it’s corporate profiteering.”).Show More However, this reductive view obscures the intricate web of market dynamics and regulatory vulnerabilities that sustain and exacerbate the crisis. The source of the illness lies in the inscrutable structures of the pharmaceutical market, characterized by concentrated but convoluted supply chains, opaque pricing mechanisms, and a labyrinth of middlemen whose incentives are misaligned with public health goals. This Article explains how the compounded structure of multiple oligopolies enables actors to leverage legal loopholes, exploit patent laws, and engage in explicit and tacit collusions that further entrench market dominance and stifle competition. What appears to be a straightforward economic issue is, upon closer examination, a systemic pathology supported by an inadequate legal landscape. This Article argues that it is precisely the reality of oligopoly squared that has resisted traditional regulation. Most importantly, by offering a rigorous analysis of the new legal landscape, this Article explains the comparative advantages and interplay between federal and state law and policy, uncovering why complex market structures require an antidote of equally robust legal innovation.
This Article makes three major contributions. First, it demonstrates that the high cost of drugs is not the result of a single problem but instead has emerged through a series of anticompetitive practices throughout the healthcare industry. Mining through the profusion of new congressional reports, governmental investigations, lawsuits, and interdisciplinary research, this Article presents the multiple ways in which key actors in the pharmaceutical supply chain engage in anticompetitive and unfair business practices that artificially inflate the costs of prescription drugs.
This Article’s second contribution is its timely, novel analysis of the ongoing court challenges to state law reforms aiming to address healthcare industry anticompetitive practices. In 2025, the Supreme Court denied a petition to help resolve Pharmaceutical Care Management Ass’n v. Mulready.28 28.78 F.4th 1183 (10th Cir. 2023).Show More The case presented the Court with a circuit split on whether state laws regulating PBMs are preempted by the federal Employee Retirement Income Security Act (“ERISA”) and Medicare Part D. The circuit decision was also in tension with a recent Supreme Court case, Rutledge v. Pharmaceutical Care Management Ass’n, wherein the Court unanimously upheld a state law regulating PBMs.29 29.141 S. Ct. 474 (2020).Show More Through an analysis of the preemption issues and long-standing case law balancing uniformity and federalism, this Article explains why the Court should have granted certiorari and ruled that the states clearly have the authority to regulate PBMs.
Third, this Article shows how the perfect storm of public outcry, new state and federal legislation, and escalating court battles presents a unique opportunity to study the comparative advantages of and interactions between legal approaches: legislative, regulatory, adjudicative, and public-private governance.30 30.On public-private governance theory and practice, see Lobel, The Renew Deal, supra note 3, at 344–45.Show More In particular, it classifies the law reforms into three emerging frontiers: (1) reforming patent law and drug approval regulations to prevent product hopping and encourage generic competition, as well as direct price caps and price transparency; (2) preventing horizontal and vertical collusions in the drug delivery chain, including by addressing the role of PBMs in brokering unfair formulary and rebate deals systems; and (3) launching innovative models for drug production and distribution, including transparent pharmacies and public manufacturing initiatives. This Article argues that among the many paths of law reform, the third category has the most revolutionary potential.
This Article proceeds in five parts. Part I presents insulin as a prominent example of a drug that was discovered long ago and has evolved into a variety of brand-name products that are still patented today because of big pharma’s manipulative product hopping and patent evergreening practices. Part II turns to the structure of the pharmaceutical and pharmacy benefit management markets, explaining how market concentration is compounded when each link in the drug delivery chain is dominated by powerful actors. It further describes the collusive practices among these actors that artificially inflate drug prices, including formulary exclusion, rebates, spread pricing, convoluted fees, and preferred pharmacy status. Part III documents and classifies the recent law reforms at both the state and federal levels, including cost control and cost transparency laws, PBM regulation, and antitrust lawsuits. This Part also analyzes the split circuit case law on federal preemption and argues that such preemption should be narrowly tailored to allow for democratic experimentalism. Part IV examines the dozens of new lawsuits by state attorneys general and the FTC that use antitrust and unfair competition law to put a stop to the range of collusive practices and deals between pharmaceutical manufacturers and PBMs. This Part analyzes frontiers of competition law and doctrine in relation to new enforcement efforts. Finally, Part V introduces the most novel approaches emerging in the landscape of market and legal levers: alternative public production and delivery of drugs.
The interplay between market realities and legal innovation described in this Article comes at a pivotal moment in the evolution of healthcare governance. This Article concludes by arguing that the emerging framework lends itself to examining more broadly the rich landscape of legal levers on consumer welfare, equitable access, and market competition. By analyzing this breadth of efforts through the lens of legal theory and practical impact, this Article aims not only to chart the course for pharmaceutical drug industry reforms, but also to explore broader implications for regulating complex concentrated industries.
- See infra Parts III–IV. ↑
- Pharm. Care Mgmt. Ass’n v. Mulready, 78 F.4th 1183 (10th Cir. 2023), cert. denied, 145 S. Ct. 2843 (2025) (mem.). ↑
- On new governance theory and practice, see Orly Lobel, The Renew Deal: The Fall of Regulation and the Rise of Governance in Contemporary Legal Thought, 89 Minn. L. Rev. 342, 404–07 (2004) [hereinafter Lobel, The Renew Deal] (describing the paradigm shift in legal process from command and control to more collaborative participatory regulation); Orly Lobel, New Governance as Regulatory Governance, in The Oxford Handbook of Governance 65, 65 (David Levi-Faur ed., 2012) (explaining how new governance theory provides lessons for government and market stakeholders on how to collaborate toward shared goals); Orly Lobel, National Regulation in a Global Economy: New Governance Approaches to 21st Century Work Law, in 2 Labor and Employment Law and Economics 630, 640–41 (Kenneth G. Dau-Schmidt, Seth D. Harris & Orly Lobel eds., 2009) (applying new governance theory to workplace regulation); Orly Lobel, Setting the Agenda for New Governance Research, 89 Minn. L. Rev. 498, 499–502 (2004) (describing next steps in the developments of new governance theory and practice). ↑
- Andrew W. Mulcahy & Daniel Schwam, RAND Corp., Comparing Insulin Prices in the United States to Other Countries 17 (2024) (“Compared with other countries, and in each insulin category, the United States had dramatically higher gross prices. The average U.S. manufacturer price per 100 IUs across all insulins was $22.68, compared with $3.75 in Canada, $2.20 in the United Kingdom, $2.79 in Mexico, and $2.37 across all non-U.S. OECD countries combined . . . .”). ↑
- Id. at v. ↑
- Id. ↑
- Judith A. Johnson, Cong. Rsch. Serv., IF11026, Insulin Products and the Cost of Diabetes Treatment 2 (2018). ↑
- See infra Part I. ↑
- See infra Section II.B. ↑
- See infra Section II.B. ↑
- See infra Section II.B. ↑
- See Adam J. Fein, The Top Pharmacy Benefit Managers of 2024: Market Share and Key Industry Developments, Drug Channels Inst. (Mar. 31, 2025), https://www.drugchannels.net/2025/03/the-top-pharmacy-benefit-managers-of.html [https://perma.cc/XY38-T4BH] (“[Drug Channels Institute] estimates that for 2024, about 80% of all equivalent prescription claims were processed by three companies: the Caremark business of CVS Health, the Express Scripts business of Cigna, and the Optum Rx business of UnitedHealth Group.”). ↑
- Claudia Martínez, Camille Romero & Natalia Sánchez Villalobos, Access to Med. Found., What Are Pharma Companies Doing to Expand Access to Insulin—and How Can Efforts Be Scaled Up? 4 (2022); Off. of Pol’y Plan., U.S. Fed. Trade Comm’n, Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies 2 (2024). The six largest PBMs manage nearly ninety-five percent of all prescriptions filled in the United States. Id. at 5. ↑
- See discussion infra Section II.D. ↑
- Bisma A. Sayed et al., Off. of the Assistant Sec’y for Plan. & Evaluation, U.S. Dep’t of Health & Hum. Servs., Insulin Affordability and the Inflation Reduction Act: Medicare Beneficiary Savings by State and Demographics 1 (2023), https://aspe.hhs.gov/sites/default/files/documents/bd5568fa0e8a59c2225b2e0b93d5ae5b/aspe-insulin-affordibility-datapoint.pdf [https://perma.cc/TL9A-QWJU]; Tami Luhby, More Americans Can Now Get Insulin for $35, CNN, https://www.cnn.com/2024/01/01/politics/insulin-price-cap/index.html [https://perma.cc/6TAR-FBEV] (last updated Jan. 2, 2024, 5:34 PM); Jay-Donavin Ved, The Inflation Reduction Act of 2022: Addressing Prescription Drug Coverage, 32 Annals Health L. Advance Directive 131, 131 (2023). ↑
- See infra Part III. ↑
- Patients Over Profit Act, S. 2836, 119th Cong. (2025). ↑
- See infra Section III.B, Figure IV, Table I. ↑
- T. Joseph Mattingly II, Maisie Lewis, Mariana P. Socal & Ge Bai, State-Level Policy Efforts to Regulate Pharmacy Benefit Managers (PBMs), 18 Rsch. Soc. & Admin. Pharmacy 3995, 3995, 3999 (2022). ↑
- Many of these actions—including those by Arkansas, Illinois, Kansas, Mississippi, Montana, California, Louisiana, Puerto Rico, Hawaii, Arizona, Texas, Utah, Missouri, as well as by unions and local governments—have been consolidated. Docket, In re Insulin Pricing Litig., No. 3080 (J.P.M.L. May 9, 2023). The FTC filed its own complaint against PBMs, alleging violation of Section 5 of the FTC Act, 15 U.S.C. § 45, in September 2024. Complaint, In re Caremark Rx, LLC, No. 9437 (F.T.C. Sept. 20, 2024) [hereinafter FTC Complaint]. Class actions have also been filed by patients against insurers for paying PBMs inflated drug costs. Daniel Wiessner, Wells Fargo Sued Over Employee Prescription Drug Costs, Reuters (July 30, 2024), https://www.reuters.com/legal/wells-fargo-sued-over-employee-prescription-drug-costs-2024-07-30/ [https://perma.cc/7MM5-VF5N]. ↑
- First Amended Complaint at 6, Arkansas ex rel. Rutledge v. Eli Lilly & Co., No. 22-cv-00549 (E.D. Ark. Aug. 8, 2022); Complaint at 6, Illinois ex rel. Raoul v. Eli Lilly & Co., No. 2022CH11699 (Ill. Cir. Ct. Dec. 2, 2022); Petition at 6, Kansas ex rel. Schmidt v. Eli Lilly & Co., No. 2022-cv-000735 (Kan. Dist. Ct. Dec. 2, 2022); Third Amended Complaint at 5, Mississippi ex rel. Fitch v. Eli Lilly & Co., No. 21-cv-00674 (S.D. Miss. Feb. 17, 2022). ↑
- These states and territories are Arizona, Arkansas, California, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, and West Virginia. Docket, In re Insulin Pricing Litig., No. 3080. ↑
- See Lexington Souers, State Legislation Provides Hope for Rising Insulin Costs, Council of State Gov’ts (Mar. 31, 2023), https://www.csg.org/2023/03/31/state-legislation-provides-hope-for-rising-insulin-costs/ [https://perma.cc/6R4D-7937] (contrasting the legislation that Governor Newsom initially vetoed with insulin price cap legislation in eleven other states); Jess Berthold, CA Governor Just Vetoed Price Caps on Insulin. Now What?, Univ. of Cal. S.F. (Oct. 11, 2023), https://www.ucsf.edu/news/2023/10/426351/ca-governor-just-vetoed-price-caps-insulin-now-what [https://perma.cc/8MPV-MT6D] (explaining California’s alternative plan to produce its own insulin for thirty dollars per vial); see also infra note 237 (detailing California’s newly enacted insulin price cap legislation). ↑
- S.B. 852, 2020 Leg., Reg. Sess. (Cal. 2020). ↑
- Lynn La, California Will Buy Cheaper Naloxone to Stop Fentanyl Deaths, CalMatters (Apr. 30, 2024), https://calmatters.org/newsletter/california-fentanyl-deaths-naloxone/ [https://perma.cc/KS48-3QPT]; see also Kristen Hwang, Newsom Committed California to Making Its Own Insulin. It’s at Least a Year Behind His Schedule, CalMatters (Jan. 15, 2025), https://calmatters.org/health/2025/01/insulin-production-gavin-newsom/ [https://perma.cc/K9FR-NX92] (detailing the ties between the state’s efforts to make both insulin and naloxone more affordable). ↑
- See infra Section V.A. ↑
- See, e.g., Lev Facher, It’s the Insulin, Stupid: How Drug Pricing’s Simplest Case Study Became a Top Issue for 2020 Democrats, STAT News (Jan. 28, 2020), https://www.statnews.com/2020/01/28/insulin-pricing-becomes-top-issue-for-democrats [https://perma.cc/GB8L-EVKQ] (“Even in a primary dominated by broader health care issues, insulin has emerged as particularly alluring campaign fodder for Democrats. Unlike more perplexing topics like health insurance reform or the cost of drug research, candidates have a plain and simple rallying cry for insulin: That it’s corporate profiteering.”). ↑
- 78 F.4th 1183 (10th Cir. 2023). ↑
- 141 S. Ct. 474 (2020). ↑
-
On public-private governance theory and practice, see Lobel, The Renew Deal, supra note 3, at 344–45. ↑