Patient advocacy groups urge U.S. court to halt overseas prescription drug operations

A conjugation of diligent advocacy groups is urging a national tribunal to halt the practices of third-party companies that bargain drugs from countries extracurricular the FDA-regulated U.S. proviso chain, which the groups reason enactment U.S. patients' wellness astatine risk.

The tribunal filing comes successful the aftermath of a CNBC investigation that documented however these third-parties – commonly referred to arsenic alternate backing programs, oregon AFPs – person dispersed crossed employer-sponsored wellness plans nationwide. Under the increasing concern model, AFPs root high-cost specialty drugs from overseas astatine little prices and complaint employers a interest oregon a percent of the savings. The AFPs past supply the medicine to patients astatine small oregon nary cost. 

AFPs are particularly appealing to tiny employers similar section schoolhouse districts, region governments and others who wage their staff's healthcare costs retired of pocket. But there's a tradeoff: Federal officials astatine the U.S. Department of Homeland Security and the Food and Drug Administration told CNBC that these medications are illegally imported and enactment patients' lives astatine risk. A Homeland Security Investigations authoritative past twelvemonth told CNBC that transgression investigations into AFPs were ongoing.

The filing successful a U.S. Court of Appeals successful Maryland, dated Dec. 26, was led by the HIV+Hepatitis Policy Institute, a nonprofit that advocates for harmless and affordable attraction for radical surviving with HIV and viral hepatitis. 

"Forcing a idiosyncratic who has employer-sponsored wellness security to motion up with an chartless third-party vendor to person their life-saving cause supplied by a overseas state not lone is amerciable but jeopardizes the wellness and information of patients," wrote Carl Schmid, enforcement manager of the HIV+Hepatitis Policy Institute, successful a property release. "While national regulators should beryllium shutting them down, successful the meantime, the courts indispensable measurement successful to support patients." 

In the tribunal filing, the diligent groups said the arrangements tin hold treatment, confuse patients and exposure them to drugs that disagree from those distributed done the tightly regulated U.S. system. They warned that patients with chronic and life-threatening illnesses should not beryllium forced to commercialized information and certainty of approved U.S. proviso chains for little costs to employers.

The amicus little filing was submitted successful a lawsuit brought by Gilead Sciences aft the institution learned that an HIV diligent received Gilead medicine with labeling written successful Turkish. Gilead alleges the cause traveled done an unsecured proviso concatenation that does not comply with U.S. law. Turkey is a known hotbed for counterfeit drugs, according to U.S. officials.

Gilead sued respective companies progressive successful administering leader wellness plans, including the alternate backing program, Rx Valet.

Greg Santulli, the CEO of the Georgia-based AFP, told CNBC past twelvemonth that he's assured successful the information of the medications his institution sources, adding Turkey is simply a "modern, blase country" susceptible of tracking medications done its proviso chain.

The suit besides named Meritain Health, which managed the patient's worker wellness program and is owned by CVS Health.

A spokesperson for CVS Health told CNBC past twelvemonth that it "has agelong maintained a argumentation that it does not enactment programs for non-FDA-approved medications sourced from extracurricular the United States and does not declaration with companies to facilitate the importation of non-FDA-approved medications" from overseas.

A national justice issued a preliminary injunction blocking each parties successful the lawsuit from importing Gilead medications from overseas. The defendants are appealing the ruling, with Meritain arguing the injunction is not indispensable and would adversely impact its business. Rx Valet successful a tribunal filing said the injunction undermines entree to harmless medications, adding Gilead's HIV cause shipped from Turkey was the aforesaid arsenic what is sold successful the U.S. astatine a overmuch higher cost.