A U.S. Court of Appeals has upheld a preliminary injunction against several alternative funding programs (AFPs) and related businesses, siding with Gilead Sciences in a case concerning the importation of its HIV drug Biktarvy from overseas sources [1]. The ruling, issued on August 14, 2026, could significantly shrink the AFP industry, which has been importing medications from abroad in an effort to lower prescription drug costs for U.S. patients [1]. Federal officials have stated that such practices are illegal under Food and Drug Administration (FDA) regulations [1].
The lawsuit, filed by Gilead in December 2024, named Rx Valet, several affiliated companies, Meritain Health (a CVS Health-owned Aetna subsidiary), and Pro-Act, a pharmacy benefits manager, as defendants [1]. The case was prompted by an incident in Maryland where a patient received Biktarvy from Turkey with label instructions in Turkish [1]. Aetna spokesperson Phil Blando emphasized that Meritain does not support or contract for the importation of non-FDA-approved medications and is vigorously defending itself against Gilead's allegations [1]. Rx Valet did not respond to requests for comment [1].
The court found that the imported medications, while chemically similar, were materially different from Gilead's U.S. products due to differences in quality-control systems and supply chains [1]. The ruling stated: "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" [1]. Gilead argued that the decision protects patients by keeping medicines outside FDA oversight and quality safeguards out of the U.S. supply chain [1].
Patient advocacy groups warned that the decision could force AFPs to shrink dramatically or even go out of business [1]. Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, commented that the court's decision is clear: "You cannot import untraceable medicine with foreign-language labels, hand it to American patients, and call it safe" [1].
CONCLUSION
The court's decision marks a significant victory for Gilead Sciences and reinforces FDA regulations against the importation of non-approved medications. The ruling is expected to have a major impact on alternative funding programs, potentially shrinking the industry and affecting access to lower-cost drugs for some patients. Market participants should monitor the response of named companies and the broader pharmaceutical supply chain.