May 8 (Reuters) - A federal appeals court on Thursday
shut down AstraZeneca's ( AZN ) challenge to the U.S. government's
program that gives the Medicare health insurance plan the power
to negotiate lower drug prices.
The 3rd U.S. Circuit Court of Appeals upheld a lower court's
ruling dismissing the British drugmaker's challenge to the
program, which was part of former President Joe Biden's
signature Inflation Reduction Act.
The court said AstraZeneca ( AZN ) hadn't shown how it had suffered
a specific injury related to the program or that the company's
due process rights were violated.
The program, a first of its kind in the U.S., requires
pharmaceutical companies to negotiate drug prices with the
government's Medicare health insurance plan that covers 66
million people. AstraZeneca ( AZN ) makes diabetes drug Farxiga, which
is among the drugs chosen for price negotiation, according to
the Centers for Medicare and Medicaid Services.
While AstraZeneca ( AZN ) had said the price negotiations would
impact its ability to make research and development decisions,
it failed to give an example of how that impact had
materialized, the court said.
As to its due process argument, the court said there was no
protected property interest in selling medication to Medicare
members at a price higher than what the government is willing to
pay.
Representatives for AstraZeneca ( AZN ) did not immediately respond
to a request for comment, nor did spokespeople for the U.S.
Department of Health and Human Services, which oversees the
Centers for Medicare and Medicaid Services.
AstraZeneca ( AZN ) filed its lawsuit against the program in 2023,
according to court records. The lawsuit is one of several
challenges to the program, including those brought by leading
industry group PhRMA and drugmakers Johnson & Johnson ( JNJ ),
Merck & Co ( MRK ), Bristol Myers Squibb ( BMY ), and
privately-held Boehringer Ingelheim.
The negotiations process has proceeded, with the initial
round of drug prices set to take effect next year.
In September, the 5th U.S. Circuit Court of Appeals in New
Orleans revived PhRMA and other industry groups' challenge to
the program. Like the 3rd Circuit's ruling, the opinion in the
PhRMA case did not touch on the merits of the law. The 5th
Circuit ruled that a lower court was wrong to dismiss the case
over jurisdictional issues.