Federal Judge Deals Another Blow To Pharmaceutical Industry Lawsuits, Upholds Medicare’s Drug Price Negotiation Program

Judge Zahid N. Quraishi rejected all of Novo Nordisk’s constitutional challenges alleging that the program violates free speech, separation of powers, and reiterated the observation he made in the Bristol Myers Squibb-Janssen case earlier this year that participation in Medicare by pharmaceutical companies is voluntary. This decision marks yet another win for patients, and comes as negotiations between the Centers for Medicare and Medicaid (CMS) and the pharmaceutical companies who manufacture at least one of the 10 drugs selected for price negotiation conclude tomorrow.

Merith Basey, Executive Director of Patients For Affordable Drugs, issued the following statement: 
“For a sixth time, a pharmaceutical corporation pulled out all the stops in an attempt to halt Medicare from negotiating lower prices for patients, and yet again they have lost. This ruling against Novo Nordisk, who has for decades price-gouged Americans who depend on insulin, will be especially well received by those on Medicare who are eagerly awaiting the announcement of the new maximum fair prices in the coming days. The rejection by Judge Quraishi of the drug company’s constitutional claims reaffirms the voluntary nature of the negotiation program.

“Patients For Affordable Drugs stands firm in our commitment to defending the hard-won Medicare negotiation program against Big Pharma’s relentless attempts to undermine it at the expense of patients. These six consecutive victories demonstrate that we are making progress in the battle against pharma’s monopoly power and we must keep going. It’s truly US v Pharma.”
Novo Nordisk’s diabetes medications — Fiasp, Fiasp FlexTouch, Fiasp PenFill, NovoLog, NovoLog FlexPen, and NovoLog PenFill — are among the first 10 drugs selected for Medicare negotiation.

This ruling represents a victory for patients like Kathy from Kalamazoo, Michigan who is on a fixed income and struggles with out-of-pocket costs for her medications. Under current prices, Kathy has had to obtain help from her children as she has struggled with affording her Novolog and Lantus insulins. After negotiation, a month’s supply of Novolog could be reduced to $30 a month, allowing Kathy and the millions of patients on Medicare who use Novolog or Fiasp to access these essential medications at more affordable prices.

Patients For Affordable Drugs NOW has signed onto seven amicus briefs, including in Novo Nordisk’s case, led by Public Citizen and supported by Protect Our Care, Doctors for America, and Families USA to support the government’s opposition to the lawsuits and amplify the experiences of patients harmed by high drug prices.

Background on Medicare negotiation:

• The average annual prescription cost for people on Medicare Part D taking one of Novo Nordisk’s drugs selected for Medicare negotiation is $3,316.
• The 10 drugs chosen for negotiation were identified as the top spending drugs covered under Medicare Part D without generic or biosimilar equivalents that have been on the market for at least seven years and also meet other selection criteria.
• Negotiations between CMS and drug manufacturers of the first 10 drugs selected for Medicare negotiation end on August 1, 2024.
• The negotiation process will only apply to a maximum of 10-15 drugs each year. Even after reforms take effect, Medicare will continue to be the largest purchaser of prescription drugs, maintaining its status as a significant source of revenue for drug companies, and Americans will still pay the highest drug prices globally.
• Unlike every other sector in health care where Medicare sets prices – such as doctor fees, hospital costs, and equipment – pharmaceutical companies have been exempt from any form of negotiation.
• Medicare negotiation is supported by more than 80 percent of voters.

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Patients For Affordable Drugs is the only national, bipartisan patient advocacy organization focused exclusively on lowering drug prices. P4AD does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more, visit PatientsForAffordableDrugs.org.