Appeals court upholds Gilead's injunction against drug importers, ruling overseas versions of Biktarvy are not equivalent. The decision could reshape alternative funding programs that have grown as drug costs rise.
A federal appeals court ruling this week handed Gilead Sciences a win against a growing industry of health programs that import prescription drugs from overseas, a practice federal regulators say violates FDA rules.
The U.S. Court of Appeals on Thursday upheld a preliminary injunction against several alternative funding programs, or AFPs, that Gilead sued in December 2024 over the importation of its HIV drug Biktarvy. The case began after a Maryland patient received the drug in the mail from Turkey with label instructions in Turkish.
Gilead sued Rx Valet, the AFP that arranged the shipment, along with several affiliated companies. It also named Meritain Health, a benefits manager owned by CVS Health's Aetna, and Pro-Act, a pharmacy benefits manager. Aetna spokesperson Phil Blando said in a statement that Meritain "does not support programs for non-FDA-approved medications sourced from outside the United States and does not contract with companies to facilitate the importation of non-FDA-approved medications." He added that Meritain strongly disputes the allegations and is defending itself.
AFPs have grown rapidly as drug prices have risen, a trend a CNBC investigation tracked last year. The programs argue they provide a legal safety valve against high U.S. prescription costs. Patient advocacy groups say the ruling could force many AFPs to shrink or shut down.
The appeals court rejected the defense that the imported drugs were essentially the same as U.S.-approved versions. The ruling said the differences between Gilead's U.S. medications and the international versions were "material, not theoretical," and that importing through unauthorized channels bypassed Gilead's quality controls.
"What Gilead sells in Turkey and what it sells in Maryland share a chemical formula but materially differ and travel through different quality-control systems," the ruling said.
A Gilead spokesman said the decision protects patients by keeping medicines outside FDA oversight out of the U.S. supply chain.
Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, said the court made clear that "you cannot import untraceable medicine with foreign-language labels, hand it to American patients, and call it equivalent to an FDA-approved medicine."
CVS Health, parent of Aetna, carries an Alpha Score of 50 out of 100 on AlphaScala, labeled Mixed. Gilead's Alpha Score is 42 out of 100, also Mixed. Both are in the Healthcare sector.
Rx Valet did not respond to a request for comment.
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