Patient advocates urge U.S. court to halt AFP prescription operations

A coalition of patient advocacy groups is urging a federal court to halt the practices of third-party companies that purchase drugs from countries outside the FDA-regulated U.S. supply chain; groups claim it puts the health of U.S. patients at risk.

The court filing follows a CNBC investigation that documented how these third parties, often called alternative financing programs, or AFPs, have spread into employer-sponsored health plans across the country. Under the growth business model, AFPs source high-cost specialty drugs from abroad at lower prices and charge employers a fee or a percentage of the savings. AFPs then provide the medications to patients at little or no cost.

AFPs are especially appealing to small employers such as local school districts, county governments and others who pay their staff’s health care costs out of pocket. But there’s a balance: Federal officials at the U.S. Department of Homeland Security and the Food and Drug Administration told CNBC that these drugs are being imported illegally and are putting patients’ lives at risk. Last year, an official with Homeland Security Investigations told CNBC that criminal investigations into AFPs were ongoing.

The Dec. 26 case in the U.S. Court of Appeals in Maryland was led by the HIV+Hepatitis Policy Institute, a nonprofit organization that advocates for safe and affordable treatment for people living with HIV and viral hepatitis.

“Forcing a person with employer-sponsored health insurance to sign up with an unknown third-party vendor to receive life-saving medication provided by a foreign country is not only illegal but also endangers the health and safety of patients,” wrote Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. Press release. “Federal regulators need to shut them down, while the courts need to step in to protect patients.”

In the court filing, patient groups said the regulations could delay treatment, confuse patients and expose them to different medications than those distributed through the heavily regulated U.S. system. They warned that patients with chronic and life-threatening diseases should not be forced to sell the safety and certainty of approved U.S. supply chains to employers at lower costs.

The amicus brief was filed in a lawsuit filed by . Gilead Sciences After the company learned that the HIV patient was taking a Turkish-labeled Gilead drug. Gilead claims the drug passed through an unsafe supply chain that does not comply with US laws. Türkiye is a It is known to be a hotbed of counterfeit drugs.According to US officials.

Gilead has sued several companies involved in administering employer health plans, including its alternative financing program Rx Valet.

Greg Santulli, CEO of Georgia-based AFP, told CNBC last year that he is confident in the safety of the drugs his company provides, adding that Türkiye is a “modern, sophisticated country” that can track drugs throughout the supply chain.

The lawsuit also named Meritain Health, which manages and owns the patient’s employee health plan, CVS Health.

A spokesperson for CVS Health told CNBC last year that it “has long maintained a policy that it does not support programs for non-FDA-approved drugs from outside the United States and does not contract with companies to facilitate the importation of non-FDA-approved drugs from abroad.”

A federal judge issued an injunction barring all parties in the case from importing Gilead drugs from abroad. While the defendants appealed the decision, Meritain argued that the injunction was not necessary and would adversely affect its business. In its filing to the court, Rx Valet stated that the measure prevents access to safe medicines, adding that the HIV medicine shipped by Gilead from Türkiye is the same as those sold in the USA at a much higher cost.