US Appeals Court Upholds Injunction Barring Alternative Funding Programs from Importing Gilead's HIV Drug

A US federal appeals court this week ruled in favor of Gilead Sciences, upholding a preliminary injunction against several alternative funding programs (AFPs) that federal authorities accused of illegally importing drugs from overseas. The court found that there are "substantive, not theoretical" differences between the drugs Gilead sells in the United States and those the defendants import through international channels. The defendants bypassed Gilead's supply chain by importing pharmaceuticals through unauthorized overseas sources. The ruling noted that while the products Gilead sells in Turkey and those sold in Maryland share the same chemical formula, the quality control systems differ.

In December 2024, Gilead filed a lawsuit over the illegal importation of its HIV drug Biktarvy. The case arose after a patient in Maryland received the drug mailed from Turkey, with label instructions in Turkish. The defendants include AFP Rx Valet and its affiliates, as well as Meritain Health, which administers employee health plans, and pharmacy benefit manager Pro-Act. Meritain Health, a unit of CVS Health's Aetna, said its long-standing policy does not support the procurement of non-FDA-approved drugs from outside the United States and that it does not contract with the relevant companies. Nevertheless, it remains a named defendant and is actively defending itself.

AFP organizations typically argue that the drugs they import are identical to those sold in the United States, but the court did not accept this argument this week. A Gilead spokesperson said the ruling helps protect patients by preventing drugs that have not undergone FDA regulation and quality assurance from entering the US supply chain. The AFPs maintain that their practices are legal and safe, describing their business as a way to combat high drug prices.