Gilead Continues Efforts to Halt the Distribution of Counterfeit HIV Medications and Protect Patient Safety
Foster City, Calif., September 28, 2022 – Gilead Sciences announced today new actions to halt an expansive, criminal counterfeiting network responsible for selling illegitimate Gilead medications. As part of the previously announced investigation and litigation, which resulted in the removal of counterfeit HIV medications from the U.S. supply chain, Gilead has now identified and named as defendants two individuals responsible for leading and orchestrating the counterfeit scheme. Gilead initiated this litigation in July 2021 to halt the distribution of counterfeits and protect the health and safety of the public.
Gilead’s ongoing investigation revealed that these two kingpins directed the initial sale of the counterfeits through suppliers created solely to sell counterfeit medications. The suppliers sold the counterfeits to pre-existing licensed gray-market distributors with an established pharmacy customer base. The distributors then sold the counterfeit medication to U.S. pharmacies who dispensed the medication. The investigation also identified individuals who illegally buy bottles of HIV medication from patients to create more counterfeits and entities that launder the conspiracy’s illicit gains. To disrupt this complex criminal network, Gilead named as defendants in this litigation entities and individuals across all levels of the conspiracy that have been identified to date. All defendants responsible for distributing counterfeits are currently prohibited by court order from transacting in Gilead medicine.
Counterfeit and tampered medicines can result in serious and or life-threatening health risks. They are not equivalent in quality, safety and/or efficacy to genuine medicines. They often do not contain the correct medicine or amount of active ingredient and may also contain impurities. Additionally, counterfeit or tampered medicines may be produced in unsafe manufacturing conditions and travel through insecure supply chains. Gilead will continue to work closely with the U.S. Food and Drug Administration (FDA), pharmacies and the Department of Justice to remove counterfeit and tampered medication from circulation and to prevent future distribution of counterfeit medications.
Critical Information for Healthcare Providers and Consumers
Gilead-branded medicines obtained by legitimate pharmacies directly from Gilead authorized distributors are authentic and safe for use as prescribed. A list of Gilead’s authorized distributors can be found here and information on how to identify authentic Gilead product can be found here.
Gilead has issued alerts to consumers and potentially impacted pharmacies to make them aware of the potential for counterfeit or tampered Gilead medication sold by unauthorized Gilead distributors.
Individuals who believe they have been dispensed a counterfeit Gilead medication should immediately report the medicine to their healthcare provider, pharmacy and Gilead Product Quality Complaints (1-800-445-3235, Option #2; QualityComplaints@gilead.com). If an individual is experiencing any side effects that may be related to a Gilead medication or to the use of a counterfeit drug, that person should immediately contact their healthcare provider and is additionally encouraged to report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program (1-800-FDA-1088 or www.fda.gov/medwatch) or Gilead (1-800-445-3235, Option #3). If you believe a website is selling counterfeit medicines, you may report the site to the FDA. Healthcare professionals are encouraged to report sales solicitation of suspect drug products by emailing DrugSupplyChainIntegrity@fda.hhs.gov and by calling the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989; Reporting to OCI.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, and cure research. Today, millions of people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.