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Medicare Definitions Of ‘Bona Fide Marketing,’ And ‘Single-Source Drug’ May Be Inconsistent With Law, Appeals Court Says

 
• By Sarah Karlin-Smith

An appeals court panel seemed skeptical of whether AstraZeneca has standing in its Administrative Procedure Act challenges against the IRA’s drug price negotiation program, but suggested a company with standing might be successful in their court.

close up of a dictionary on the word "definition"
The consistency between Congress and Medicare's definitions of key terms are at issue in AstraZeneca's case against the IRA. (Shutterstock)

AstraZeneca looks like it may be unsuccessful in convincing an appeals court that it has legal standing to raise its Administrative Procedure Act (APA) claims against the Inflation Reduction Act’s Medicare drug price negotiation program. However, some of the judges seemed like they might have been open to ruling in the company’s favor if did have standing.

Key Takeaways
  • AstraZeneca may not have convinced an appeals court it has standing in its APA challenges against the IRA, but some of the judges’ thoughts on...

Two of the three judges on the AstraZeneca appeals panel at the US Court of Appeals for the Third Circuit also seemed sympathetic to some of Bristol Myers...

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