Benzinga | Jan 19, 2022 04:58AM EST

Gilead Announced Actions to Remove Counterfeit HIV Medications From U.S. Supply Chain; Gilead Executed Seizures at 17 Locations in Nine States, Seizing Thousands of Bottles of Gilead-labeled Medication With Counterfeit Supply Chain Documentation

Gilead Sciences announced today that the company has taken action to protect the health and safety of the public from an expansive, criminal counterfeiting network responsible for distributing counterfeit and tampered Gilead HIV medication within the U.S. supply chain. As part of an ongoing investigation and litigation, in coordination with the U.S. Marshals and local law enforcement, Gilead has executed seizures at 17 locations in nine states, seizing thousands of bottles of Gilead-labeled medication with counterfeit supply chain documentation, including bottles labeled as the HIV medicines Biktarvy(r) (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and Descovy(r) (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets). Gilead continues to work closely with the U.S. Food and Drug Administration (FDA) and law enforcement to remove counterfeit and tampered medication from circulation and to prevent future distribution of counterfeit medications.

The investigation revealed that pharmaceutical distributors not authorized by the company to sell Gilead medicine were selling drugs to pharmacies that they sourced from various fly-by-night entities as part of the illegal counterfeiting scheme. Gilead reported counterfeit medication in circulation to federal law enforcement authorities including the FDA, as well as dispensing pharmacies and consumers, and took direct and urgent legal action to stop counterfeit Gilead medication from reaching patients. The U.S. District Court for the Eastern District of New York has ordered all defendants involved in this litigation who are responsible for distributing the counterfeits to stop selling Gilead-branded medication.

"Patient safety is our first priority, and our actions were instrumental in removing counterfeit HIV medications from the U.S. supply chain and protecting individuals who rely on our medications," said Lori Mayall, Head of Anti-Counterfeiting and Brand Protection, Gilead Sciences. "Gilead will continue to pursue necessary measures, including working closely with the FDA and law enforcement, to protect public health and safety by thwarting the illegal distribution of medication that is fraudulently misrepresented as a Gilead product. Based on our actions, we believe that we have successfully stopped these defendants from distributing additional counterfeit versions of Gilead medication to patients."

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's investigation uncovered purported Gilead-branded product with one or more counterfeit elements within the U.S. pharmaceutical supply chain. Federal law requires that a drug product be sold with a history of each transaction tracing back to the manufacturer to validate the legitimacy of the supply chain. Evidence showed that the distributor defendants sold 85,247 bottles of purported Gilead drug product to pharmacies over the past two-years using counterfeit supply chain documentation to conceal their illicit origin. All seized product included counterfeit drug supply chain documentation and many had additional counterfeit elements such as patient leaflets and/or caps. The company also received a limited number of reports of bottles labeled as Gilead medication that did not contain the HIV treatment or prevention medication listed on the label.

Many of the counterfeits originated from suppliers who purchased Gilead HIV medication from individuals after it was dispensed to them, often exploiting individuals with low incomes who were experiencing homelessness or substance use. Then, the suppliers unlawfully resold these individuals' medication on the secondary market by way of counterfeit supply chain documentation, concealing and fraudulently misrepresenting its origin. All of these counterfeits were sold as though they were legitimate Gilead product.

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.

Gilead issued a consumer alert with information to help people identify authentic Gilead product after the company became aware that tampered and counterfeit versions of its HIV medications were in circulation within U.S. drug distribution networks. Gilead has also alerted potentially impacted pharmacies, making them aware of the potential for counterfeit or tampered Gilead medication sold by distributors not authorized by Gilead that may be within their recent supply and urging them to remain vigilant to the potential for this to occur in the future.

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.