December 23, 2024

Warren Urges FTC to Protect Patients, Scrutinize Cardinal-GI Alliance Deal

Merger of Big Drug Wholesaler, Gastroenterology Service Provider Threatens Competition, Cost Increases, and Health Risks to Patients

By allowing wholesalers to control physician practices, wholesalers could pressure doctors to prescribe medicine that is most profitable for them, even if it’s not in the best interest of their patients

Text of Letter (PDF)

Washington, D.C. — U.S. Senator Elizabeth Warren (D-Mass.) wrote to Federal Trade Commission (FTC) Chair Lina Khan, urging the agency to closely scrutinize pharmaceutical wholesaler Cardinal Health’s $3.9 billion proposed acquisition of a majority stake in GI Alliance, the country’s largest gastroenterology management services organization.

“This deal threatens to limit competition by expanding Cardinal Health’s control of physician practices, while giving Cardinal an incentive to restrict those practices from contracting with Cardinal’s rival wholesalers,” wrote Senator Warren.

Cardinal Health has a long history of leveraging its dominant market power in a way that negatively impacts patients and health care providers. The company controls 28% of the prescription drug wholesale market, making it one of the three biggest wholesalers in the country. Along the way, Cardinal has pursued an aggressive vertical acquisition strategy, buying up companies to solidify its dominance in the wholesaler market , including acquiring a Group Purchasing Organization (GPO), a data analytics firm, medical device lines, specialty pharmacies, and physician practices. These acquisitions are part of a broader trend of health care conglomerates operating as both seller and buyer of prescription drug services.

“Cardinal has consistently locked its customers into restrictive contracts, blocked out rival wholesalers, and squeezed generic drug manufacturers, leading to more frequent drug shortages, higher drug costs, and poorer health outcomes,” wrote Senator Warren.

In October, Senator Warren sounded the alarm about another one of Cardinal’s proposed acquisitions: Cardinal’s acquisition of Integrated Oncology Network (ION), an MSO that oversees over 50 physician practices spanning 10 states. With this acquisition, Cardinal would be able to force its affiliated practices to enter into sole-source or prime vendor agreements, locking them in and effectively blocking competing wholesalers from offering their services — while introducing conflicts of interest that could raise drug costs. The FTC did not act, and the acquisition was completed earlier this month. The new Cardinal-GI Alliance deal is even larger in scope, posing a bigger threat.

“In addition to the concerns I outlined in my October letter, the acquisition of GI alliance introduces further opportunities for self-dealing, as Cardinal serves as the primary supplier of pharmaceutical products for Gastrologix GPO  — the only gastroenterology-focused GPO in the nation,” wrote Senator Warren. “Accordingly, I urge FTC to closely scrutinize this deal, including under Section 7 of the Clayton Act, which prohibits any acquisition that may substantially lessen competition or tend to create a monopoly.”

Senator Warren has long highlighted the negative consequences of vertical integration in the health care industry on patients, providers, and taxpayers. Senator Warren recently introduced her Patients Before Monopolies Act (PBM Act), bipartisan and bicameral legislation to prohibit joint ownership of PBMs and pharmacies, a gross conflict of interest that enables these companies to enrich themselves at the expense of patients and independent pharmacies.

Senator Warren has led efforts to use every tool available to the government to lower drug prices and fight anticompetitive business practices in the health care industry:

  • In October 2024, Senator Elizabeth Warren (D-Mass.) urged the FTC to closely scrutinize the Novo Nordisk-Catalent merger and to block it if it violated antitrust law.
  • In September 2024, Senator Elizabeth Warren (D-Mass.) and Representative Lloyd Doggett (D-Texas) wrote to Department of Health and Human Services (HHS) Secretary Xavier Becerra asking him to lower the cost of vital weight-loss drugs by using the agency’s existing legal authority to issue generic licenses for semaglutide, a prescription drug sold under the names Ozempic and Wegovy.
  • In August 2024, Senators Warren and King and Representative Doggett wrote to Department of Health and Human Services Secretary Xavier Becerra and Department of Commerce Secretary Gina Raimondo reiterating their agencies’ clear legal authority to use “march-in” rights under the Bayh-Dole Act to lower drug prices for Americans.
  • In June 2024, Senator Warren and Representative Pramila Jayapal (D-Wash.) sent letters to eight pharmaceutical companies urging them to voluntarily de-list over 100 patents that the Federal Trade Commission (FTC) has determined may be improperly or inaccurately listed in the Food and Drug Administration’s (FDA’s) Orange Book, which would open opportunity for more competition and lower drug prices for Americans.
  • In May 2024, Senator Warren and Representative Lloyd Doggett (D-Texas) sent a letter to Secretary of the Department of Commerce, Gina Raimondo, and Under Secretary Laurie Locascio, highlighting the lawmakers’ new review of public comments on the agency’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights and urged them to strengthen and finalize the guidance. 
  • In May 2024, Senators Warren,  Bernie Sanders (I-Vt.), and Jeff Merkley (D-Ore.) wrote to the Chamber of Commerce expressing concern and demanding an explanation for the organization’s opposition to the Biden administration’s proposal to boost competition and lower drug prices for American families and businesses by allowing agencies to consider price when deciding to exercise their “march-in rights” under the Bayh-Dole Act. 
  • In April 2024, Senator Elizabeth Warren (D-Mass.) sent a letter to the leadership of Novo Nordisk (Novo), slamming the company for its decision to discontinue production of Levemir (detemir) insulin, one of only three long-acting insulins on the market, and asked the company to commit to continue producing Levemir until a biosimilar is made available.
  • In March 2024, Senator Warren sent a letter in response to GlaxoSmithKline (GSK) discontinuing the brand-name version of Flovent HFA, the go-to inhaler for children, blasting the company for its price-gouging strategy that may cause millions of children to lose access to one of the few drugs that is appropriate to treat their asthma and allergies. 
  • In February 2024, Senators Warren and Angus King (I-Maine) and U.S. Representative Lloyd Doggett (D-Texas) led 75 lawmakers in sending a letter to the Biden administration in support of strengthening and finalizing its draft guidance to protect taxpayers and reduce prescription drug prices. The lawmakers submitted a public comment supporting the “Interagency Guidance Framework for Considering the Exercise of March-In Rights” and calling for changes to ensure increased transparency, oversight, and accessibility of medical products invented through taxpayer-funded research and development.
  • In February 2024, Senator Warren and Representative Jayapal announced that three drug manufacturers pulled their sham patents after warnings, and urged the FDA to continue fighting against Big Pharma’s patent abuse. 
  • In December 2023, Senator Warren published an op-ed in Newsweek commending the Biden administration’s announcement that price can be considered in the government’s decision to march-in on a drug, effectively lowering drug costs, and calling on Americans to fight back against an industry that has been taking advantage of them for decades. 
  • In December 2023, Senator Warren issued a statement after the Biden administration announced it would issue guidance to federal agencies that would allow the government to seize patents of certain expensive drugs developed with taxpayer support to create more competition and lower prices.
  • In December 2023, Senator Warren and Representative Jayapal sent letters to the CEOs of 8 pharmaceutical companies urging them to voluntarily remove sham patent claims improperly included in the FDA’s Orange Book and end their unlawful practices that delay competition and drive up costs for patients and taxpayers.
  • In December 2023, Senator Warren and Representative Jan Schakowsky (D-Ill.) reintroduced the  Affordable Drug Manufacturing Act, legislation that would radically reduce drug prices through public manufacturing of prescription drugs. 
  • In September 2023, Senator Warren and Representative Jayapal sent a letter to FTC Chair Lina Khan urging the FTC to issue a policy statement about the improper listing of drug-related patents in the FDA’s Orange Book. 
  • In August 2023, Senator Warren and Representative Jayapal sent a letter to FDA Commissioner Dr. Robert M. Califf, urging him to close loopholes that pharmaceutical companies have exploited to block generics from entering the market, keeping drug prices high and maximizing profits. 

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