Appeals Court Backs Gilead in Ruling Threatening Overseas Drug Import Programs

Why a Federal Appeals Court Found Turkey's Biktarvy Is Not the Same as Maryland's

A federal appeals court has handed Gilead Sciences a significant victory in its fight against alternative funding programs that import prescription drugs from overseas. The court found that international versions of Gilead's HIV medicine Biktarvy are not simply relabeled versions of the U.S. product; they are materially different, largely because they move through different quality-control systems.

The ruling stems from a lawsuit Gilead filed in December 2024 against Rx Valet and affiliated companies. According to the case, a patient in Maryland received Biktarvy that had been shipped from Turkey, with label instructions printed in Turkish. Gilead argued that such drugs lack the FDA oversight and safeguards required for medicines sold in the United States.

Alternative funding programs, or AFPs, are health plan arrangements that try to lower employer drug costs by sourcing medications from international markets. The appeals court's decision did not ban all import programs outright, but it rejected the central argument that an internationally packaged drug with the same chemical formula is automatically equivalent to the FDA-approved version.

Also named in the lawsuit were Meritain Health, an Aetna subsidiary under CVS Health, and pharmacy benefits manager Pro-Act. Aetna said Meritain has a longstanding policy against supporting programs that use non-FDA-approved medicines from outside the U.S. and disputes the allegations. Rx Valet did not respond to a request for comment.

What the Biktarvy Ruling Changes for Alternative Funding Programs

Gilead's safety argument becomes a legal standard

The ruling matters because it treats quality-control differences as material even when the active chemical is the same. Gilead can now argue in future cases that foreign-sourced versions are not interchangeable with U.S.-regulated drugs unless they meet FDA requirements. That is a strong barrier against gray-market import programs.

This is not just about Biktarvy. The court's logic gives branded drugmakers a precedent for challenging AFPs that offer lower-cost foreign versions of expensive therapies.

Alternative funding programs face a hardening threat

AFPs depend on the savings from buying medicines in markets where prices are lower. The court's decision undercuts the premise that those savings come without sacrificing safety or legal equivalence. A program like Rx Valet now has to prove that any imported medicine it supplies is not materially different from the FDA-regulated version, which may be difficult for products with foreign-language labeling and separate quality-control systems.

Aetna and its plan-administration chain face scrutiny

Meritain Health and Pro-Act were named as defendants, and Aetna has denied supporting non-FDA-approved imports. The ruling does not establish their liability, but it keeps them inside a lawsuit that now has a clearer legal standard. Employers using AFPs will likely ask their administrators hard questions about where medications come from and whether they meet FDA safeguards.

Next Steps for Employers, PBMs and Drug Import Programs After the Gilead Ruling

• Employers using alternative funding programs: request a written confirmation that all dispensed drugs are FDA-approved U.S. versions. The Biktarvy case turned on a Maryland patient receiving medicine from Turkey with Turkish labeling, so foreign-language packaging is now a concrete red flag.
• Plan administrators and PBMs: align contracts with Aetna's stated approach by explicitly prohibiting non-FDA-approved medicines sourced outside the United States; this is the defense Meritain Health is relying on in the lawsuit.
• AFP operators: review whether imported products differ only by label or also by quality-control path. The court said the differences between Gilead's Turkish and U.S. Biktarvy are material, not theoretical, so simply matching the chemical formula is not enough.
• Patients receiving specialty medicines by mail: check the packaging and label language. In this case, a U.S. patient received a drug with Turkish instructions; the ruling treats that lack of U.S. labeling as part of the safety problem.
• Employers and benefits consultants: ask import vendors for the country of origin and FDA status of every specialty drug before renewing a contract; the Gilead ruling creates legal and reputational exposure for plans that cannot document compliant sourcing.