AstraZeneca Seeks High Court Review of Medicare Drug Price Talks

AstraZeneca PLC is asking the US Supreme Court to weigh in on a Biden-era program that allows the government to negotiate Medicare drug prices with pharmaceutical giants.

The petition asks the justices to review a federal appeals court order that dealt a blow earlier this year to the drugmaker’s challenge against the Inflation Reduction Act’s Medicare drug price negotiations. The US Court of Appeals for the Third Circuit ruled AstraZeneca couldn’t successfully state a due process violation to challenge the program and lacks standing to pursue its argument that the program violates the Administrative Procedure Act.

“With the IRA’s price-controls set to take effect on January 1, review is warranted now,” AstraZeneca said in a petition filed Sept. 19, but was made public on the high court’s docket days later.

“The constitutionality of this massive, novel program would warrant this Court’s review even without any split of authority,” the drugmaker added.

The Medicare negotiation program, created under President Joe Biden, seeks to lower drug prices through back-and-forth talks between the government and drugmakers. AstraZeneca’s diabetes drug, Farxiga, was selected for the first round of the program.

The manufacturer is the first among a slew of challengers to ask the high court to review its case. Drug industry groups and some of the world’s largest pharmaceutical companies have opposed the program since its early stages, but claims that the program is unconstitutional have largely been rejected by federal courts.

The Trump administration has so far been supportive of the program, advancing its implementation and doubling down on efforts to reduce US drug prices.

The Centers for Medicare & Medicaid Services is expected to release final guidance for the third cycle of the negotiation program in the fall.

The case is AstraZeneca v. Kennedy, U.S., No. 25-348, writ of certiorari 9/19/24.