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Merck Sues To Stop Medicare Drug Negotiation

Pharmacist with tablet PC taking inventory in storage room

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A major pharmaceutical company is suing the Biden administration to stop Medicare from negotiating lower drug prices.

Merck (MRK), the New Jersey-based maker of widely-used cancer treatment Keytruda, filed a lawsuit Tuesday in a federal court in Washington seeking to block the drug negotiation program, created by the Inflation Reduction Act of 2022, from going into effect in 2026. The company argues the process for setting prices is less like a negotiation and more like a “gun to the head” that lets the government dictate terms.

Under the program, Medicare, the government’s health insurance program for seniors, would be able to negotiate the prices it pays for certain drugs for the first time instead of accepting prices set by manufacturers. The government would choose 10 drugs to negotiate in the first year of the program, with more being added in later years, including, potentially, Keytruda. That would save money both for the government and for Medicare recipients, with the amount of the savings depending on which drugs are chosen for negotiation. 

Merck says the negotiation process, which involves the government determining a “maximum fair price” for products, is unfair. Companies that don’t comply with the negotiation process face civil penalties and a heavy tax on the drugs they sell. Drugmakers can avoid the tax and the negotiation process if they don’t accept reimbursements from Medicare and Medicaid. Merck argues this is no choice at all.

“This is not ‘negotiation,’” the company said in the lawsuit. “It is tantamount ᩚᩚᩚᩚᩚᩚ⁤⁤⁤⁤ᩚ⁤⁤⁤⁤ᩚ⁤⁤⁤⁤ᩚ𒀱ᩚᩚᩚto extortion.ꩲ” 

The company said it expects its diabetes drug, Januvia, to potentially be one of the initial 10 drugs to be negotiated. Januvia is one of the costliest drugs covered by Medicare Part D. The government paid $3.9 billion to provide the drug for 934,686 patients in 2022—more than $4,100 per patient, according to data from the Johns Hopkins Drug Access and Affordability Initiative.

In 2022, Medicare spent $17 billion on Keytruda, an immunotherapy with a list price of up to $21,794.24 per dose. 



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  1. United States District Court for the District of Columbia. "."

  2. Center for Medicare and Medicaid Services. "."

  3. Kaiser Family Foundation. ""

  4. Johns Hopkins Drug Access and Affordability Initiative via the office of Senator Elizabeth Warren. ","

  5. Merck. "."

  6. Department of Health and Human Services, Office of the Inspector General. "."

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