AstraZeneca Appeals to Supreme Court in Final Attempt to Challenge Medicare Drug Price Negotiation Program

AstraZeneca filed a petition with the U.S. Supreme Court after the Third Circuit Court of Appeals unanimously rejected its challenge to the Medicare Drug Price Negotiation Program, a provision of the Inflation Reduction Act125.

The Third Circuit, in a May 8, 2025 decision, held that AstraZeneca does not have a valid due process or property rights claim, stating there is no constitutional right to sell goods to Medicare beneficiaries at a price higher than what the government is willing to pay1246.

AstraZeneca’s flagship drug Farxiga was selected for the program’s first round of price negotiations, prompting the legal challenge26.

The appellate court also dismissed AstraZeneca’s arguments concerning CMS’s methods of defining qualifying single source drugs and its negotiation implementation guidance, citing lack of concrete harm or standing2.

With its petition, AstraZeneca asks the Supreme Court to overturn lower court rulings and decide whether the program infringes on pharmaceutical companies' constitutional rights, including under the Fifth Amendment35.

CMS announced the first batch of negotiated maximum prices in August 2024; these will take effect in January 2026, and further drugs are being added to future rounds of negotiation3.

Other pharmaceutical manufacturers have similar challenges pending, but AstraZeneca’s case is the first to reach the appellate and now potentially the Supreme Court level124.

Sources:

1. https://www.mintz.com/insights-center/viewpoints/2146/2025-05-12-appeals-court-rejects-astrazenecas-challenge-medicare

2. https://www.manatt.com/insights/insight/appeals-court-rejects-astrazeneca-s-challenge-to-ira-negotiation-program

3. https://www.supremecourt.gov/DocketPDF/25/25-348/375372/20250919200614924_AstraZeneca--FINAL%20Petition%2009-19%20rtf.pdf

4. https://medicareadvocacy.org/court-rejects-pharmas-challenge-to-medicare-drug-price-negotiation/

5. https://www.law360.com/articles/2392162/astrazeneca-asks-high-court-to-unscramble-drug-price-law

6. https://www.bigmoleculewatch.com/2025/05/15/third-circuit-affirms-rejection-of-astrazenecas-challenges-to-ira-drug-price-negotiation-program/

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