
A federal appeals court has upheld a preliminary injunction preventing companies from importing international versions of Gilead's HIV drug Biktarvy into the U.S. and distributing them via employer health plans. The court ruled that the overseas versions materially differ from FDA-regulated U.S. versions, highlighting concerns about patient safety and lack of FDA oversight. This decision could significantly impact alternative funding programs (AFPs) that source prescription drugs from international markets.
Quartz
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