By: Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy
The Fourth Circuit Court of Appeals recently upheld a decision in Gilead Sciences, Inc. v. Meritain Health, a lawsuit in which Gilead Sciences—makers of several HIV medications, including the most commonly prescribed medication, Biktarvy—accused Meritain Health, ProAct Inc., Rx Valet, Affordable Rx Meds, and Fetih Eczanesi (a Turkish pharmacy) of illegally importing foreign versions of their brand-name drugs not approved by the U.S. Food and Drug Administration (FDA) (Lee et al., 2026).
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| Photo Source: U.S. Court of Appeals for the Fourth Circuit |
ADAP Advocacy released a press statement lauding this decision, with CEO Brandon M. Macsata stating, “Risky decisions by profit-driven alternative funding programs should never be allowed to put patients at risk by circumventing laws designed to protect our nation’s drug supply chain, all to save a buck.”
After a Maryland patient living with HIV received a Turkish version of Biktarvy in the mail through his employer-sponsored health insurance, Gilead investigated and found that Meritain Health facilitated the illegal importation of the drug in order to save money on the purchase prices of drugs (Gilead Sciences, Inc. v. Meritain Health, Inc. et al).
While the substance of the suit lies in the illegal importation of drugs sold by Gilead Sciences in other countries—specifically Türkiye—at the heart of the issue is a more systemic problem:
Americans and American companies pay more for medications than any other country on the planet, and everyone, from patients to insurers to pharmacies, is looking for ways to get around those prices.
For patients, that looks like importing medications from other countries via sketchy websites and black-market physical sites.
For insurance companies providing employer-sponsored health insurance plans, this looks like offering “Alternative Funding Programs” (AFPs), which seek to lower costs for employer-sponsored health plans, often by illegally importing medications from overseas or sending patients on medical-tourism vacations to access cheaper medications (Zamost et al., 2025).
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| Photo Source: ADAP Advocacy |
The former model of illegal drug importation was the case in Gilead v. Meritain et al., but the bigger issue remains:
If medication costs are too high for both patients and payors, they will absolutely ignore the warnings and do what they think they have to do.
For patients who don’t know better or think they have no other options, it’s understandable. For corporations that absolutely know the laws and are looking for ways to skirt them to decrease costs and increase profits, it’s unacceptable.
The primary issue many advocates and pharmaceutical companies have with drug importation is that the supply chain does not undergo FDA screening and verification processes to ensure medications are authentic and safe for patients. By bypassing these processes, patients open themselves to ingesting counterfeit drugs that may not contain the ingredients needed to treat their diseases or may be ingesting substances that could kill them.
When patients make these choices for themselves, especially after being informed about the risks of importation, they accept those risks. They are free to make that choice.
With AFPs, those choices are made for the patients.
In one example reported by CNBC, a patient’s employer offered him an all-expenses-paid trip to the Cayman Islands and the Bahamas to retrieve the medication he needed to treat his multiple sclerosis (MS). PriceMD, a Florida-based company, offered to send them out of the country on a vacation to get his medication, rather than pay the $2,159 per week it costs in the U.S. ($112,268/year). PriceMD found that it was significantly cheaper to send him and his wife on vacation to obtain his medications than to pay U.S. prices (Zamost et al., 2025).
PriceMD’s model is an extreme one. But the risks are very real.
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| Photo Source: CNBC |
The Partnership for Safe Medicines (PSM), which has long warned about the dangers of drug importation and was among the first to sound the alarm over AFPs, promptly applauded the court's decision. In a statement, PSM's executive director Shabbir Imber Safdar said: "The appeals court's decision in Gilead Sciences v. Meritain Health is unambiguous: you cannot import untraceable medicine with foreign-language labels, hand it to American patients, and call it equivalent to an FDA-approved medicine. Track-and-trace is a cornerstone of why the U.S. drug supply chain is the safest in the world, and it is not optional" (PSM, 2026).
For most AFPs, the model involves illegally importing medications from foreign countries in order to avoid those costs.
There are some advocates who argue that concerns about drug importation are overblown. Gabriel Levitt, Founder of Prescription Justice, argues that opponents of drug importation “…wrongly conflate the importation of lower-cost drugs with counterfeit drugs and rogue online pharmacies and perpetuate the notion that the FDA remains the world’s regulatory “gold standard” in drug safety and that any drug without FDA approval or outside the US drug supply chain is unsafe” (Levitt, 2024).
Unfortunately, those arguments usually rely on hyperbole and "catchy" anti-big pharma messaging to side-step the genuine concerns over drug importation and the risky AFP-sponsored tactics. ADAP Advocacy agrees that the FDA is the gold standard, but it also recognizes that it could do more.
This is why better framing is needed, especially when news in the United States is filled with examples of the FDA failing to properly inspect food (Semuels, 2025), drugs (Cenziper & Rose, 2025), and baby formula (Fletcher et al., 2026).
If we argue that the FDA is the “gold standard,” it would help if the FDA were actually doing its job. Its failure undermines the very basis of the consumer safety argument.
In the meantime, we’re counting Gilead’s victory in this case as a win for patient safety!
Disclaimer: All funders of the ADAP Advocacy Association are publicly listed on our website.
Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association; rather, they provide a neutral platform for the author to promote open, honest discussion of public health-related issues and updates.
References:
[1] Cenziper, D. & Rose, M. (2025, December 22). The FDA Often Doesn’t Test Generic Drugs for Quality Concerns, So ProPublica Did. New York, NY: ProPublica: RxRoulette. https://www.propublica.org/article/fda-generic-drug-testing
[2] Fletcher, L., Nejman, A., & Aaron, N. (2026, August 21). After 2 infant formula botulism outbreaks, families ask if warning signs were missed. Los Angeles, CA: ABC 7 News. https://wjla.com/features/i-team/two-infant-formula-botulism-outbreaks-warning-signs-foodborne-illness-fda-cdc-byheart-whole-nutrition
[3] Gilead Sciences, Inc. v. Meritain Health, Inc. et al. (4th Cir. 2026). https://www.safemedicines.org/wp-content/uploads/2026/08/Gilead-v.-Meritain-appeals-court-decision.pdf
[4] Lee, M., Tortorelli, P., & Zamost, S. (2026, August 14). Court rules companies can’t import Gilead medications from overseas in blow to AFP health programs. Englewood Cliffs, NJ: CNBC: Health and Science. https://www.cnbc.com/2026/08/14/court-ruling-gilead-medications-overseas-afps.html
[5] Levitt, G. (2024). Enough Excuses on Drug Importation: A New Transnational Paradigm for FDA Regulation and Lower US Drug Prices. Brooklyn Journal of International Law, 49(1), 286-329. https://brooklynworks.brooklaw.edu/bjil/vol49/iss1/8
[6] Semuels, A. (2025, April 08). Food Safety Was Slipping in the U.S. Then Came Mass Layoffs. New York, NY: Time Magazine: https://time.com/7275746/food-safety-fda-layoffs/
[7] Zamost, S., Tortorelli, P., & Lee, M. (2025, November 13). Cheaper medicines, free beach trips: U.S. health plans tap prescriptions that feds say are illegal. Englewood Cliffs, NJ: CNBC: Health and Science. https://www.cnbc.com/2025/11/13/employer-health-plans-afp-prescriptions-feds-illegal.html
