The U.S. Court of Appeals upheld a preliminary injunction against several AFPs accused of illegally importing Gilead's HIV drug Biktarvy from overseas. This ruling follows a lawsuit initiated by Gilead after a Maryland patient received the drug from Turkey, raising concerns about the legality and safety of imported medications.
Gilead argues that the imported drugs differ materially from those sold in the U.S., which could undermine patient safety and quality control. Patient advocacy groups warn that this decision may force AFPs to significantly reduce their operations or cease altogether, limiting options for patients facing high prescription drug costs.
Aetna's Meritain Health, one of the defendants, disputes the allegations and maintains its policy against supporting non-FDA-approved medications. The ruling emphasizes the importance of FDA oversight in ensuring the safety and efficacy of medications available to American patients