A federal appeals court this week sided with Gilead Sciences in a case targeting so-called alternative funding programs that import prescription drugs from overseas — a decision patient advocates say could force many of these programs to drastically scale back or shut down entirely.
The ruling, issued Thursday by the U.S. Court of Appeals, upheld a preliminary injunction in a lawsuit Gilead filed in December 2024 against several AFPs and affiliated businesses. The case stems from a Maryland patient who received Gilead’s HIV drug Biktarvy in the mail from Turkey, with label instructions written in Turkish.
Alternative funding programs have grown more prevalent across the U.S. in recent years as drug prices have soared, according to a CNBC investigation published last year. But federal authorities have long argued the programs violate Food and Drug Administration regulations by importing medicines from international markets outside the agency’s oversight.
What the court found
The appeals court rejected the AFPs’ central defense that the imported medications are essentially the same as those sold in the U.S. The court found the differences between Gilead’s domestically sold drugs and the international versions imported by the defendants were “material, not theoretical,” and that importing through unauthorized foreign channels bypassed Gilead’s supply chain and quality-control systems.
“What Gilead sells in Turkey and what it sells in Maryland share a chemical formula but materially differ and travel through different quality-control system,” the ruling stated.
Gilead’s lawsuit named Rx Valet, an AFP, along with several affiliated companies. It also named Meritain Health, a health plan manager owned by CVS Health’s Aetna, and Pro-Act, a pharmacy benefits manager.
Defendants respond
Aetna spokesperson Phil Blando said Meritain “has long maintained a policy that it does not support programs for non-FDA-approved medications sourced from outside the United States” and does not contract with companies to facilitate such imports. Despite that policy, Meritain was named as a defendant, and the company “strongly disputes the allegations and is vigorously defending itself against the complaint,” Blando said.
Rx Valet did not respond to CNBC’s request for comment.
Industry reaction
AFPs have defended their practices as both legal and safe, positioning themselves as a remedy to high prescription drug prices. But the court’s decision is a significant blow to that argument.
Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, a coalition of nonprofit and pharmaceutical industry groups, said the ruling makes 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.”
In a statement, a Gilead spokesman said the ruling helps protect patients by keeping medicines that fall outside FDA oversight and quality safeguards out of the U.S. supply chain.
Source: www.cnbc.com — https://www.cnbc.com/2026/08/14/court-ruling-gilead-medications-overseas-afps.html
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