October 10, 2024

Warren Urges FTC To Closely Scrutinize Novo Nordisk-Catalent Merger, Block if Illegal Under Antitrust Law

Deal could reduce competition, increase prices of vital medications like Ozempic and Wegovy

Text of Letter (PDF)

Washington, DC – U.S. Senator Elizabeth Warren (D-Mass.) sent a letter to Federal Trade Commission (FTC) Chair Lina Khan, urging the FTC to closely scrutinize a proposed merger between Novo Nordisk and contract development and manufacturing organization Catalent, and block the deal if it is found to be illegal under antitrust law. In the letter, Senator Warren raises concerns that the merger could hurt Americans by limiting competition and leading to higher cost for prescription drugs. 

“Given the proposed merger’s potential to further limit competition in the weight loss and diabetes drug markets, making it harder for patients to access these drugs, I urge FTC to closely scrutinize this acquisition and block any activity found to be illegal under antitrust law,” wrote Senator Warren.

Novo Nordisk controls 55% of the exploding market for GLP-1 inhibitor drugs used to treat obesity and Type 2 diabetes, primarily through its sales of Ozempic and Wegovy. Catalent fills and packages GLP-1 syringes and injection pens for Novo Nordisk and other drug manufacturers like Eli Lilly, Novo Nordisk’s biggest competitor in the GLP-1 market. The deal has already received heightened attention from the FTC, which issued a Second Request to the merging parties for additional information.

“I am concerned that Novo Nordisk’s merger with Catalent will give Novo Nordisk unprecedented visibility into and control over its competitor’s production capacity, costs, and business practices, and the ability to preference its own products and obstruct its competitors’ use of Catalent to produce GLP-1 drugs,” wrote Senator Warren.

Senator Warren also noted Novo Nordisk’s past efforts to restrict competition and maximize profits, including the company’s improper listing of patents for Ozempic and two other drugs used to treat Type 2 diabetes in the Food and Drug Administration’s Orange Book, which resulted in a warning letter from the FTC and oversight from Senator Warren.

“While Novo Nordisk claims to ‘provide access to the medicines . . . to the greatest number of people living with diabetes . . . while addressing varying levels of affordability,’ the company’s actions suggest otherwise,” wrote Senator Warren.

Americans already pay exceedingly high prices for prescription drugs. Ozempic is 10 times more expensive in the U.S. at $936 per month compared to the United Kingdom, where the drug costs just $93 per month. Wegovy carries a monthly cost of $1,349 in the U.S., compared to just $296 per month in the Netherlands. Reducing competition will make the affordability crisis worse, potentially rendering GLP-1s — which help control blood sugar levels — unaffordable for a large number of Americans. 

“As diabetes and obesity rates continue to rise — 38 percent of Americans were estimated to be prediabetic in 2021, while more than 40 percent of adults in the U.S. experience obesity — it is all the more crucial that Americans can access life-changing drugs to treat these conditions at a fair price,” wrote Senator Warren.

Senator Warren has led efforts to use every tool available to the government to lower drug prices and fight Big Pharma’s anti-competitive business practices:

  • 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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