A U.S. appeals court upheld the preliminary injunction blocking the import of Gilead's drugs
A U.S. appeals court has upheld a preliminary injunction in the case of Gilead Sciences v. several companies operating under the alternative healthcare financing (AFP) model and their affiliated businesses. The ruling concerns the importation of Gilead’s drugs into the U.S. from foreign markets through unauthorized supply channels.
According to CNBC, AFP programs have become widespread in the U.S. amid rising prescription drug costs. These programs claim that the drugs they source from abroad are identical to those on the U.S. market and that their operations are a response to high prescription drug prices. At the same time, U.S. federal authorities consider such imports a violation of U.S. Food and Drug Administration (FDA) regulations.
In December 2024, Gilead filed a lawsuit against the AFP company Rx Valet and several of its affiliates. Also named as defendants were Meritain Health, which manages employee health insurance plans and is part of Aetna (owned by CVS Health), as well as pharmacy benefits manager Pro-Act.
For more breaking news, follow the UA.News Telegram channel.
The lawsuit concerned Gilead’s allegations of the likely illegal importation of its HIV drug Biktarvy. According to the complaint, a patient in Maryland received this drug by mail from Turkey with instructions on the label written in Turkish.
The court concluded that the differences between Gilead’s drugs sold in the U.S. and the international versions imported by the defendants are “substantial, not theoretical.” The ruling states that the medications may have the same chemical formula but undergo different quality control systems. The court also found that imports through unauthorized foreign channels bypassed Gilead’s supply chain.
Gilead stated that the ruling will help protect patients by preventing drugs that are not subject to FDA oversight and its quality assurances from entering the U.S. supply chain. A spokesperson for Aetna said that Meritain Health does not support programs for drugs that are not FDA-approved and are sourced outside the U.S., but the company disputes Gilead’s claims and will defend itself in the case. Rx Valet did not respond to CNBC’s request for comment.
