Foster City, Calif., January 19, 2021 - Gilead Sciencesannounced 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® (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and Descovy® (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 alertwith 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.
Additional Information about Biktarvy
What is BIKTARVY?
BIKTARVY is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in adults and children who weigh at least 31 pounds (14 kg). It can either be used in people who have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.
What is the most important information I should know about BIKTARVY?
BIKTARVY may cause serious side effects:
Worsening of hepatitis B (HBV) infection. Your healthcare provider will test you for HBV. If you have both HIV-1 and HBV and stop taking BIKTARVY, your HBV may suddenly get worse. Do not stop taking BIKTARVY without first talking to your healthcare provider, as they will need to monitor your health, and may give you HBV medicine.
For additional Important Safety Information about Biktarvy, including important warnings, individuals should talk to a healthcare provider and visit www.Biktarvy.com.
Additional Information about Descovy for the treatment of HIV-1 infection
What is DESCOVY for HIV-1 treatment?DESCOVY is a prescription medicine that is used together with other HIV-1 medicines to treat HIV-1 in people who weigh at least 31 lbs (14 kg). DESCOVY combines 2 medicines into 1 pill taken once a day. Because DESCOVY by itself is not a complete treatment for HIV-1, it must be used together with other HIV-1 medicines. Your healthcare provider will determine which other HIV-1 medicines may be used with DESCOVY. DESCOVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.
What is the most important information I should know about DESCOVY?
DESCOVY may cause serious side effects:
Worsening of hepatitis B (HBV) infection. Your healthcare provider will test you for HBV. If you have both HIV-1 and HBV and stop taking DESCOVY, your HBV may suddenly get worse. Do not stop taking DESCOVY without first talking to your healthcare provider, as they will need to monitor your health or give you HBV medicine.
For additional Important Safety Information about Descovy for the treatment of HIV-1 infection, including important warnings, individuals should talk to a healthcare provider and visit www.Descovy.com/treatment.
Additional Information about Descovy for the prevention of HIV-1 infection
What is DESCOVY for PrEP?DESCOVY for PrEP (pre-exposure prophylaxis) is a once-daily prescription medicine for adults and adolescents at risk of HIV. It helps lower the chances of getting HIV through sex.
DESCOVY for PrEP is not for everyone:
It is not for use in people assigned female at birth who are at risk of getting HIV from vaginal sex, because its effectiveness has not been studied.
You must be HIV-negative before and while taking DESCOVY for PrEP.
What is the most important information I should know about DESCOVY for PrEP?
Before and while taking DESCOVY for PrEP:
You must be HIV-negative before you start and while taking DESCOVY for PrEP. You must get tested for HIV-1 immediately before and at least every 3 months while taking DESCOVY. If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to confirm that you are still HIV-negative.
Many HIV-1 tests can miss HIV-1 infection in a person who has recently become infected. Tell your healthcare provider if you had a flu-like illness within the last month before starting or while taking DESCOVY. Symptoms of new HIV-1 infection include tiredness, fever, joint or muscle aches, headache, sore throat, vomiting, diarrhea, rash, night sweats, and/or enlarged lymph nodes in the neck or groin.
DESCOVY by itself is not a complete treatment for HIV-1. Do not take DESCOVY for PrEP unless you are confirmed to be HIV-1 negative.
DESCOVY does not prevent other sexually transmitted infections (STIs). Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs
To further help reduce your risk of getting HIV-1:
Do not miss any doses of DESCOVY. Missing doses may increase your risk of getting HIV-1.
Know your HIV status and the HIV status of your partners. If your partner is living with HIV, your risk of getting HIV is lower if your partner consistently takes HIV treatment every day.
Get tested for other STIs. Some STIs make it easier for HIV-1 to infect you.
Talk to your healthcare provider about all the ways to help reduce HIV risk.
DESCOVY may cause serious side effects:
Worsening of hepatitis B (HBV) infection.Your healthcare provider will test you for HBV. If you have both HIV-1 and HBV and stop taking DESCOVY, your HBV may suddenly get worse. Do not stop taking DESCOVY without first talking to your healthcare provider, as they will need to monitor your health or give you HBV medicine.
For additional Important Safety Information about Descovy for PrEP, including important warnings, individuals should talk to a healthcare provider and visit www.Descovy.com/prep.
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.
U.S. Prescribing Information for Biktarvy and Descovy, including BOXED WARNINGS, is available at www.gilead.com.
For more information about Gilead, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Biktarvy, Descovy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.