Counterfeit Drug Rings Increasingly Peddling Fraudulent HIV, Cancer, and GLP-1 Medications

By: Ranier Simons, ADAP Blog Guest Contributor

Healthcare expenditures remain a significant source of contention for many Americans. A recent West Health-Gallup poll indicated 47% of adults fear they will not be able to afford their healthcare next year, with 37% specifically citing prescription drug expenses as the issue (Lovelace, 2025). Unfortunately, counterfeit drug activity has been on the rise, taking advantage of people in need who live with severe chronic and life-threatening conditions. Counterfeit drug rings peddling fraudulent HIV drugs, cancer treatments, and weight loss GLP-1 medications are increasingly coming to light. Convictions of ill-intentioned players in these rings are positive steps to bolster public health. However, what appears to be an international network endangers the lives of many Americans and sometimes kills.

Photo Source: The Star Democrat

Last month, following a history of pharmaceutical malfeasance, brothers Patrick and Charles Boyd (as seen above in a 2014 photo of Patrick Boyd (left) and Charles Boyd, who co-founded Safe Chain Solutions in 2011), in business partnership as Safe Chain Solutions, were convicted of trafficking over $90 million of counterfeit drugs (Weaver, 2025). The brothers operated their wholesale drug company primarily by unlawfully buying and distributing counterfeit HIV medications. Knowingly, they purchased black market HIV drugs at very low cost from illegitimate suppliers, then sold them to legitimate pharmacies and patients, unaware of the dangerous, mislabeled products.

Court documents indicate that one of their suppliers obtained HIV medication by soliciting vulnerable patients on the street (Weaver, 2025). This particular supplier removed the labels from the bottles and shipped them to the Boyd brothers in improperly secure packaging, such as discarded diaper boxes from the trash. Storing and shipping prescription drugs improperly can reduce the efficacy of the medication or even render them hazardous to use due to contamination (Sykes, 2018). Moreover, buying the HIV drugs from vulnerable people on the street means that those people will break their medication adherence. Consistent antiviral adherence is necessary to reach and maintain an undetectable viral load. People on the street selling their medications are already in a precarious socioeconomic position. Lack of medication adherence translates into adverse health outcomes, including HIV disease progression, compounding negative social determinants of health.

In some other instances, the counterfeit drugs sourced and sold by the Boyds were sealed in bottles labeled as HIV medications, but were not HIV drugs. In one of the cases highlighted during the court case, a patient was rendered unconscious for 24 hours after taking what they thought were HIV antiretrovirals but turned out to be anti-psychotic medication (Levi, 2025). This is not only dangerous regarding maintaining an undetectable viral load, but is medically dangerous due to the possibility of overdose or adverse reactions to ingesting medications that are not compatible with patients’ medical conditions. As a result of their conviction, the Boyds could face over 40 years in prison while they await sentencing. 

Photo Source: Medical Professionals Reference

Popular weight loss drugs are another lane in which counterfeiters are operating. There has been a 40-fold increase in the use of GLP-1 drugs from 2017 to 2021, with a 700% increase in non-diabetic prescriptions for them from 2018 to 2022 (Logan, 2024). With insurance, patients pay in the range of $25-$150 per month for GLP-1 drugs. But without insurance, the cost could range from $800 to $1000 (Resbiotic, 2025). Although in high demand, many are unable to have their insurance cover the medications because insurance typically only covers GLP-1 medications for diabetes unless weight is a significant health concern. This leads many to pay out of pocket, creating demand for more affordable options.

The rapid proliferation of online sales of counterfeit weight-loss medications has even prompted the U.S. Food and Drug Administration (FDA) to issue an official alert about their dangers. Counterfeit GLP-1 drugs could contain the wrong medications, could contain too much or too little of the active ingredients, could be contaminated with pathogens, and much more. People desiring GLP-1 medications are lured by counterfeit marketers advertising offering GLP-1 drugs with no prescriptions at low prices. It is important to note that these are prescription drugs, which makes procurement from legitimate channels impossible without a prescription (ABC News, 2025).

Photo Source: Yahoo News

Cancer drugs, which literally can make the difference between life and death, are also lining counterfeiters’ pockets. In February of this year, two brothers from India, Kumar and Rajnish Jha, were extradited to the United States after being arrested in Singapore for selling counterfeit Keytruda in the United States (Sutich, 2025). Keytruda is a treatment for late-stage cancer developed by Merck. A coordinated operation between the Office of Criminal Investigations (OCI), Food and Drug Administration (FDA), U.S. Immigration and Customs Enforcement (ICE), and Homeland Security Investigations (HSI) confirmed the Jha brothers were selling fake Keytruda that contained none of the ingredients of the real product. One of the undercover agents received a bottle of Keytruda from the Jha brothers’ company, Dhrishti Pharma International, which contained heartburn medication (Sutich, 2025).

The brothers were convicted and sentenced to 30 months in prison, as well as fined thousands of dollars. However, this does not remedy the fact that people suffering from terminal cancers were sold drugs that not only did not benefit them, allowing their cancer to progress, but also exposed them to additional harm.

Photo Source: Partnership for Safe Medicines

The Jha brothers’ enterprise is indicative of the organization and sophistication of counterfeit drug markets. Counterfeit medications are an international racket that not only increases the danger of the products but also makes it harder to detect. The Jha brothers had U.S. co-conspirators who processed and packaged their drugs and retrieved cash payments to maintain stealth (Sutich). Some counterfeit drugs, referred to as grey market medications, are drugs that are approved for markets outside of the United States (ABC News, 2025). Even though grey-market medications may contain the correct ingredients, they are sourced, labeled, and handled in ways that are not compliant with the strict standards established in the safe U.S. supply chain.

The Boyd brothers, having knowledge of the operations of the safe U.S. drug supply chain, falsified documents to deceive pharmacists. The United States has strict rules regarding drug product tracing under the Drug Supply Chain Security Act. Part of that includes maintaining paperwork, called T3s/pedigrees (Weaver, 2025). These documents are intended to verify the movement of drugs from the original manufacturer to the final point of sale. This is how many well-meaning pharmacies were fooled into purchasing counterfeit drugs after reading falsified documentation. Some of the drugs were sold in bottles that were immediately identifiable as suspect. However, the ones that were not obvious, coupled with fake documentation, slipped under the radar.

According to the World Health Organization, counterfeit medications result in approximately one million deaths globally annually (Health First, 2025). Not only are counterfeit drugs dangerous for patients, but they also defraud the manufacturers who develop them. The U.S. biopharmaceutical industry loses between $37.6 billion and $162.1 billion in revenue annually due to counterfeit products (Pritchett, 2025). Counterfeits translate into lower sales, damaged reputation from being associated with drugs that have had adverse outcomes, and expenses from investigations and fighting associated legal battles.

The current trajectory of U.S. healthcare policy is poised to exacerbate medication affordability issues. Criminals are gaining sophistication in the way they infiltrate and manipulate what is supposed to be a safe U.S. Drug Supply system. Because counterfeit malfeasance is on an international scale, it will be harder to educate the public and medical professionals on how to avoid becoming victims.

[1] ABC News. (2025, October 9). What to know about the world of counterfeit weight loss drugs sold online. Retrieved from https://abcnews.go.com/GMA/Wellness/world-counterfeit-weight-loss-drugs-sold-online/story?id=126365574

Health First. (2025, March 19). Counterfeit Drugs: A Global Problem. Retrieved from https://www.healthfirst.com/articles/counterfeit-drugs-a-global-problem/

[2] Logan, P. (2024, June 27). On the Increase in Use of GLP-1s. Retrieved from https://medicine.iu.edu/blogs/bioethics/on-the-increase-in-use-of-glp-1s#:~:text=GLP%2D1s%20are%20seemingly%20miracle,from%20the%20FDA%20in%202013.

[3] Lovelace,B. (2025, November 10). A record number of Americans are anxious about health care costs going into next year. Retrieved from https://www.nbcnews.com/health/health-news/gallup-poll-record-number-adults-anxious-health-costs-2026-rcna244358

[4] Miller, L. (2025, November 18). Maryland Siblings Found Guilty in $92M Misbranded HIV Meds Scam, Facing Decades Behind Bars. Retrieved from https://hoodline.com/2025/11/pharma-bros-busted-maryland-siblings-found-guilty-in-92m-misbranded-hiv-meds-scam-facing-decades-behind-bars/

[5] Pritchett, A. (2025, November 19). RAI Explainer: How Counterfeit Drugs Threaten U.S. Health and Innovation. Retrieved from https://www.csis.org/blogs/perspectives-innovation/rai-explainer-how-counterfeit-drugs-threaten-us-health-and-innovation

[6] Resbiotic. (2025). How much is GLP-1 without insurance?. Retrieved from https://resbiotic.com/blogs/news/how-much-is-glp-1-without-insurance

[7] Sutich, J. (2025, July 10). Brothers from India sentenced in Seattle for selling fake, contaminated medicine to U.S. patients. Retrieved from https://mynorthwest.com/crime-blotter/indian-brothers-fake-drugs/4108899

[8] Weaver, J. (2025, October 30). Two brothers convicted of selling black-market HIV drugs to pharmacies, patients. Retrieved from https://www.miamiherald.com/news/local/article312679531.html

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.    

Fake HIV Medicine Finds Its Way into NYC Pharmacies

By: Ranier Simons, ADAP Blog Guest Contributor

Counterfeit medication is a serious threat to public health in 2025. There have been numerous warnings issued over fake cancer drugs, fake Botox, and more recently, counterfeit GLP-1s. While obscure online pharmacies and other non-traditional sources remain easy access points for fake drugs, they are increasingly infiltrating the legitimate supply chain. On several occasions in recent years, the HIV drug supply chain has been at the center of counterfeit drug schemes, often perpetrated by nefarious actors using gay dating apps, like Grindr and Jack'd. And now, according to an alert by the Partnership for Safe Medicines, alleged fake HIV medicines have been found in a New York City pharmacy.

Photo Source: American Medical Women's Association

Gilead Sciences has been a repeat victim of counterfeit drug schemes over the past few years. In 2021, taking advantage of the COVID-19 pandemic, counterfeiters targeted Gilead’s remdesivir. The investigation revealed that a significant portion was coming from Mexico and Turkey (Gilead Sciences, n.d.). In 2022, Gilead filed a lawsuit against a ring of counterfeiters selling over 85,000 fraudulent bottles of its HIV antiretrovirals Biktarvy and Descovy (Walker & Ramey, 2022). Although Gilead has seized thousands of bottles of counterfeit drugs from unauthorized distributors and won lawsuits, the harm continues. A U.S. District court in New York recently unsealed another complaint filed by Gilead Sciences.

A patient contacted Gilead because the bottle of Biktarvy they purchased from their local pharmacy was short by eight pills. Upon investigating the bottle, Gilead discovered that the label was a high-quality fake. The lot number on the bottle was outdated, and the expiration date was falsified. The packaging was a well-done counterfeit, as it contained only a minor typo, and the print resolution of the branding was only moderately off. Alarmingly, the patient had already consumed all the pills; thus, it was impossible to know if the pills in the bottle were Biktarvy or some other substance (Gilead vs. City Plus, 2025). Notably, evidence showed that the contents were filled by the counterfeiters, not Gilead. In past counterfeit transgressions involving Gilead medications, bottles were filled with medications other than the ones intended to be in them. Taking medications not prescribed to a patient could result in adverse effects ranging from overdoses of unnecessary medications to the advancement of disease states because of non-treatment with the proper drug.

Photo Source: Partnership for Safe Medicines

The most pertinent issue of the lawsuit Gilead is filing against the pharmacy that sold the counterfeit drug is that the pharmacy’s owner and operators will not voluntarily reveal the source of the fraudulent medication (Gilead vs. City Plus, 2025). As Gilead points out in the complaint, “Any legitimate pharmacy would be horrified to learn it had dispensed counterfeit HIV medicine and would do all in its power to identify the source of the counterfeit and stop it from happening again. The Defendants here instead obstructed Gilead’s investigation and refused to provide any information about the counterfeit they sold” (Gilead vs. City Plus, 2025). The fake packaging is very sophisticated and requires expensive equipment. Thus, Gilead explains that the elaborate effort indicates a larger counterfeit manufacturing scheme. Gilead accuses the pharmacy of participating in the counterfeiting and distribution of fraudulent medications, not just Biktarvy, but also others, given the sophistication of the machinery necessary to create the fake packaging.

Gilead Sciences is poised to suffer significant monetary losses due to the sale of counterfeit medications, as well as potential damage to its brand and reputation. However, the most alarming issue is the danger to public health (Gilead vs. City Plus, 2025). Hiding the source of the counterfeit medications delays the stoppage of the flow of harmful medications into the drug supply. The investment necessary to procure the labeling and printing equipment used to create the fake Biktarvy means that other medications are likely being counterfeited on a large scale. In addition to the cessation of selling any Gilead-branded medications, whether legitimate or counterfeit, and punitive damages, Gilead Sciences demands the destruction and impounding of the pharmacy’s Gilead-branded supply. It also demands that the offending pharmacy turn over all documentation associated with the purchase and sale of Gilead-labeled medications.

Counterfeiters target expensive and widely utilized medications, other than just HIV antiretrovirals. "This is another benefit of the Drug Supply Chain Safety Act (DSCSA) for patient safety. The DSCSA created a standard way to trace medicine, and a standard way for honest pharmacies to prove their innocence," said Shabbir Imber Safdar, Executive Director of the Partnership for Safe Medicines. He added, “This standardization of documentation means that a supply chain member who has strayed from the safe supply chain cannot stall investigators for weeks hiding their crime." Popular targets are painkillers, antibiotics, and ‘lifestyle’ drugs. In April 2025, the FDA issued a warning about several hundred units of counterfeit Ozempic it had seized (Lovelace, 2025). Previously, thousands of counterfeit Ozempic 1 milligram injections had been seized by the FDA from warehouses outside of Novo Nordisk’s authorized supply chain in 2023 (Reuters, 2023). Additionally, a group of patients in Australia were harmed by fake Ozempic. The patients experienced hypoglycemia and seizures, indicating the counterfeit injections contained insulin instead of Ozempic’s semaglutide (Burger & Murray 2023). The adverse effects could have been deadly. The counterfeit injection pens had been obtained online. The European Medicines Agency (EMA) confirmed that none of the fake Ozempic had reached retail pharmacies.

Photo Source: Statista

The cost of prescription medication remains a trending topic in the news cycle as well as a financial concern for many Americans. Legislation, such as parts of the Inflation Reduction Act, in addition to pharmacy benefit manager (PBM) operations, currently places pharmacies, especially independent ones, under financial strain. This creates an environment for counterfeit drug manufacturers to find inroads to circulate fraudulent products in the legitimate supply chain. The pharmacy in the recent Gilead suit appears to be a willing participant in the fraud (Gilead vs. City Plus, 2025). Safdar adds, "if true, these allegations of dispensing counterfeit medications reveal a deep betrayal of patients and a violation of patient safety. American patients should never have to worry if they are receiving real medicine when dealing with licensed bricks and mortar pharmacies." However, given the growing sophistication of counterfeit drug production, in an attempt to stay financially sound, unknowing pharmacies could fall victim to improperly sourced products. Counterfeiters create false sourcing documentation in addition to fake products and packaging. 

The World Health Organization estimates the global counterfeit pharmaceutical market value to be between $75 billion and $200 billion (Izgi & Altunay, 2025). It is imperative for the United States to propagate policies that strengthen the drug supply chain and bolster pharmacy support. It is not hyperbole to say that counterfeit medications are a matter of life and death. They are both an international and a domestic issue, given that pharmaceuticals are global products. It would be beneficial for the Department of Justice to take an interest in the current Gilead Sciences complaint, as well as the broader issue of counterfeit pharmaceuticals.

[1] Burger, L., Murray, M. (2023, October 24). Suspected fake Ozempic puts several in hospital in Austria. Retrieved from https://www.reuters.com/world/europe/several-people-taken-hospital-austria-after-taking-suspected-fake-ozempic-2023-10-24/

[2] Gilead Sciences vs. City Plus Care Pharmacy. 2025, March 17). Case 1:25-cv-01469-RER-RML. Retrieved from https://www.safemedicines.org/wp-content/uploads/2019/09/Heal-the-World-Complaint-as-filed.pdf

[3] Izgi, G., Altunay, M. (2025, June 2). Counterfeit pharmaceuticals: innovative strategies for combatting global health threats. Retrieved from https://www.ibanet.org/counterfeit-pharmaceuticals-innovative-strategies 

[4] Lovelace, B. (2025, April14). FDA warns about fake Ozempic in U.S. supply chain. Retrieved from  https://www.nbcnews.com/health/health-news/fda-warns-fake-ozempic-us-supply-chain-rcna201184

[5] Reuters. (2023, December 22). US FDA warns about counterfeit versions of Novo's diabetes drug Ozempic. Retrieved fromhttps://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-warns-about-counterfeit-versions-novos-diabetes-drug-ozempic-2023-12-21/

[6] Walker, J, Ramey, C. (2022, January 18). Drugmaker Gilead Alleges Counterfeiting Ring Sold Its HIV Drugs. Retrieved from https://www.wsj.com/health/pharma/drugmaker-gilead-alleges-counterfeiting-ring-sold-its-hiv-drugs-11642526471

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

Fraudsters are Using Grindr to Buy HIV Meds

By: Brandon M. Macsata, CEO, ADAP Advocacy; Shabbir Imber Safdar, Executive Director, Partnership for Safe Medicines

Earlier this year, ADAP Advocacy, in collaboration with the Partnership for Safe Medicines (PSM),  issued an important safety alert warning Grindr's users to stop selling their HIV and other medications on the popular gay dating App. Medicine buyback schemes falsely claim to be "Buyers Clubs" making medicine available to people who cannot afford them. In reality criminals buy medicine, and sometimes empty bottles, from patients and sell them at a discount to unsuspecting pharmacies who dispense it to patient victims. The safety alert urged Grindr's users to be more mindful of patient safety.

Photo Source: ADAP Advocacy

Grindr, as well as potentially other dating Apps, are being used as a platform for fake user profiles operating under counterfeit drug rings to buy prescription medications. This seemingly innocent practice is not only illegal, but it is jeopardizing the drug supply chain and putting the health of patients at risk for health complications, severe illness, and even death. It often targets high-cost drugs – because the potential profit spread is higher – often associated with the treatment of cancer, diabetes, and HIV (and others).

This is not a theoretical patient danger: over the past five years, hundreds of millions of dollars of HIV medicine has been diverted and counterfeited in the drug supply this way, resulting in some patients getting fake medicines. 

ADAP Advocacy and PSM potentially uncovered one such counterfeit drug ring in New Orleans Parish earlier this year and immediately alerted both the U.S. Food & Drug Administration, as well as Gilead Sciences. Earlier this year, Gilead Sciences uncovered a criminal enterprise centered in Florida distributing over $230 million of counterfeit drugs, some of which were their HIV antiretroviral medications.

In response to the Florida fraudsters, ADAP Advocacy and PSM aired a public service announcement sharing some important steps patients can take to combat counterfeit drugs. Additionally, PSM hosted an online briefing focused on recent breaches in the United States drug supply chain that put patients living with HIV at risk.

If you see people trying to buy medicine on dating apps, please report them to us.

• REPORT FRAUDSTERS by filling out this webform
• By emailing us at report@safemedicines.org
• By texting us at (415) 367-0067.

Additional collaboration on patient safety in the fight against counterfeit drug rings is warranted in this space. Download the safety alert, here.

Photo Source: ADAP Advocacy

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Fraudsters Target Medicine being Reimbursed at a Loss for Counterfeit Crime

By: Ranier Simons, ADAP Blog Guest Contributor

Pharmacy Benefit Managers (PBMs) don’t make medicine or dispense medicine, but their business decisions determine what medicines you have access to. Some of those decisions are now creating openings for drug counterfeiters to enter the legitimate supply chain, according to a report by the Partnership for Safe Medicines (PSM) and subsequent analysis by the Community Access National Network (CANN). This is a pressing matter because counterfeit drugs can result in adverse side effects, treatment failure, resistance, toxicity, and death.[1]

Photo Source: Center for Medical Economics & Innovation

The U.S. market value for PBMs in 2023 was $523.9 billion.[2] PBMs have always been marketed to reduce drug expenditures for payers and lower drug costs for patients, but historically, that has not happened. The $523 billion results from questionable practices that bring in sizable profits for PBMs while shortchanging insurance payers with opaque contracts and to the detriment of patients.  Some patient advocacy groups have argued PBMs are harmful to patients’ health. One common PBM practice, below-cost pharmacy reimbursement, creates supply chain contamination opportunities.

Insurance companies reimburse pharmacies for the medications they dispense to patients. A pharmacy purchases medication from a wholesaler and then submits a claim to a patient’s insurance to be paid for the medication. PBMs handle the payments to the pharmacies on behalf of insurance companies. In 2023, 332 million people in the U.S. had health insurance, and 275 million of them were served by Pharmacy Benefit Managers (PBMs) via commercial insurance, Medicare Part D, Managed Medicaid, and Medicaid Fee-For-Service.[3] Thus, pharmacies are forced to deal with PBMs. In order to dispense medications to patients with insurance, pharmacies must sign contracts with PBMs that are agreements to accept whatever price the PBM dictates for reimbursement. Currently, three PBMs control 75% of the health insurance market; thus, there is no competition.[4] 

The predicament is that PBMs are reimbursing pharmacies below cost. This means that PBMs are paying pharmacies less money than the pharmacies spent to acquire the drugs. Effectively, pharmacies are dispensing drugs at a loss to serve patients. A real-world example of one of the big three PBMs' contracts with a pharmacy for brand-name drugs listed reimbursement of the average wholesale price (AWP) minus 25.5% + $0.00. The same contract listed AWP minus 57% + $0.00 for generics. 

The following examples are actual claims submitted by pharmacies and their resulting losses based on the PBM contracts. For Biktarvy, a pharmacy acquired a 30-day wholesale supply of the drug for $3700.36, but the PBM only reimbursed $3661.75, resulting in a loss of $38.61. For Genvoya, a pharmacy paid $3,534.78 and was only reimbursed $2,852.92, resulting in a loss of $681.86. A pharmacy in Florida purchased a 30-day supply of roflumilast for $43.86 and was reimbursed by a PBM for $11.22, resulting in a $32.64 loss. PSM has many other examples of losses on other various pharmaceuticals here. 

Photo Source: Partnership for Safe Medicines

The situation is dire, as indicated by a statement given by a pharmacist from an independent pharmacy in Weatherford, Texas: 

“I spent hours on the phone with my wholesaler and even the drug manufacturer trying to explain that we simply cannot sustain such drastic underpayment on this critical medication and every time my concerns fell on deaf ears. After years of trying to affect some kind of change on either the cost or the reimbursement, we simply could not take losses of any kind on a drug that has a price tag of $3000.00. Our losses ranged from $17.46 to $572.30, and we were expected to accept this arrangement from day one. We were a safe haven and trusted health partner for these patients; however, we were forced to notify our patients that we would no longer be able to provide this life-saving medication.”

This pharmacist decided to stop providing the referenced medication. However, all pharmacists do not make that decision, which creates opportunities for criminal exploitation. 

Pharmacists want to do what they can to provide the medicines people need. When they cannot source medications through their prime wholesalers, they turn to the secondary wholesaler market. Secondary wholesalers are also licensed by the state, and many are secure and reputable channels, but this is also where criminals operate. Criminal counterfeiters take advantage of the situation and set up marketplaces for popular, expensive drugs, using black-market diverted or counterfeit products at prices lower than traditional wholesale sources.

Pharmacies do not haphazardly search for and purchase lower-cost medications. They do their due diligence to make sure they are sourcing proper supplies. However, counterfeit criminals have sophisticated and elaborate systems to perpetrate fraud. They sell through companies with legitimate state-issued wholesale licenses and use forged Drug Supply Chain Security Act (DSCSA) transaction tracing histories. A deep dive into the paperwork can reveal the forgery. However, it takes significant resources of time and effort to dig into that kind of tracing. Resources that pharmacies do not have. Thus, when things have the appearance of propriety, pharmacists get duped by criminals, and patients get sold fraudulent medication. 

Photo Source: Partnership for Safe Medicines

In 2022, the U.S. District Court unsealed documents of a civil case in which Gilead Sciences sued a group of criminals. The criminal enterprise distributed over $230 million of counterfeit drugs, some of which were HIV antiretroviral medications.[5] Some of the drugs were diverted, meaning they were purchased from people who had obtained them legitimately and resold on the black market. Some of the drugs were bottles containing medication that did not match what was on the label. Diverted medication indicates that patients were not adhering to their treatment regimens since they were selling their medications. The mislabeled medication bottles meant patients could have been ingesting medications not meant for them, in improper dosages, and possibly contaminated. Situations such as PBM below-cost reimbursement contribute to creating a demand for cheaper medications in an artificially created predatory pricing-induced supply scarcity.

Low PBM reimbursement not only endangers the drug supply chain but also puts independent pharmacies out of business. Pharmacies cannot operate under fiscal loss. In addition to low reimbursement rates, PBMs give pharmacies very low or often zero dispensing fees, which pharmacies need for operating costs. Moreover, PBMs saddle pharmacies with many other opaque fees, audits, and clawbacks, adding to their financial burden. When pharmacies go out of business, patients lose access. This is especially true in areas with very few pharmacies for a large geographical region. If a pharmacy closes, entire communities lose familiar and convenient continuity of care.

A group named Pharmacists United for Truth and Transparency wrote a letter to one of the big three PBMs. A quote from this letter explains what needs to be done: “Reimburse independent pharmacies the full drug acquisition cost and eliminate the practice of reimbursing above some and below other drug costs. Make a fair and universal reimbursement policy the unbreakable operating principle of the PBM-independent pharmacy partnership.” PBM reform is not just fiscally sound; for patients, it indeed could mean the difference between life and death.

[1] Williams, L., McKnight, E. (2014, June 19). The real impact of counterfeit medications. Retrieved from https://www.uspharmacist.com/article/counterfeit-meds#:~:text=The%20use%20of%20substandard%20drugs,enforced%20to%20prevent%20this%20crime

[2] Fortune Business Insights. (2024, April 19). Pharmacy benefit management market. Retrieved from https://www.fortunebusinessinsights.com/pharmacy-benefit-management-pbm-market-103496

[3] Mikulic, M. (2023, May 22). Number of Americans served by PBMs by insurance type 2023. Retrieved from https://www.statista.com/statistics/1172652/pbms-number-of-served-us-persons/

[4] The Partnership for Safe Medicines. (2023) Are below cost reimbursement practices by Pharmacy Benefit Managers creating opportunity for criminals to enter the legitimate supply chain?. Retrieved from https://www.safemedicines.org/2024/02/pbmblackmarket.html

[5] Gilead Sciences, Inc. et al v. Safe Chain Solutions, LLC et al. Retrieved from https://fingfx.thomsonreuters.com/gfx/legaldocs/dwpkrodwdvm/gileand-amended-2022-09-28.pdf?utm_source=Sailthru&utm_medium=newsletter&utm_campaign=daily-docket&utm_term=DailyDocket-MailingList%20v2

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Colorado's Negligence: Drug Importation Continues to Miss the Mark

By: Jen Laws, President & CEO, Community Access National Network (CANN) & Board Co-Chair, ADAP Advocacy Association

Since 2019, Colorado has been trying desperately to put together a plan to import medications from Canada, known as a Section 804 Importation Plan (SIP) when applying for approval from the U.S. Food and Drug Administration (FDA). In December 2022, Colorado submitted its plan to the FDA (Colorado, 2022), thus joining Florida in a misguided state importation effort. Right now for patients living in both states, only the FDA is positioned to protect them from an ill-advised public policy.

Photo Source: Yahoo! News Canada

For what it’s worth, Florida’s plan has not yet been approved as that state continues to go back and forth with the FDA over clarifying language. The process has dragged on so long that Florida sued the FDA to speed things up (Kansteiner, 2022). Regardless of anything else that may or may not happen in either Florida or Colorado (protip: lots of things are not going to happen), Governor Polis’ promise that Coloradans are going to begin enjoying the fruits of this labor “soon” is just not going to be a thing. But beyond process, there’s some serious problems with this idea of importing medications from Canada and the idea that it will save Americans any dollars at the pharmacy counter. Those problems have been around since the idea of importation was introduced a government “solution” nearly 20 years ago and the answers to these problems has not changed or improved.

Back when the United States started toying with importation as an idea, the Canadian government balked and even introduced legislation to block the possibility. While that legislative effort failed, it’s being revived now as Colorado and Florida push to have access to the drug supply of a country with one tenth the size of the population of the United States. Outside of Canadian legislation, distribution agreements in Canada generally curtail what can and cannot be exported to other countries, a regulatory and enforcement move that neither the United States nor Colorado can do anything about. Canada’s biggest concern remains rooted in the potential for medication shortages to meet the needs of their own population, especially given the global issue of supply shortages on critically necessary medications.

It's not just the government of Canada or even manufacturers that remain concerned about the whole host of issues importation brings. Both the Canadian Pharmacists Association and the American Pharmacists Association have repeatedly cautioned against these proposals (CPhA, APhA, 2022). Despite what Colorado says these efforts will do, helping pharmacies isn’t in the reality of this effort. Targeting contracting tricks pharmacy benefit managers use to push out competition, particularly ridiculously low reimbursement rates and narrowing of network pharmacies, would go much further toward protecting independent pharmacies and ensuring patient access to them.

Photo Source: CPhA, APhA

Moving to another issue, the idea of “savings” offered under Colorado’s SIP are not rooted in reality. The first and foremost issue with any politician pitching “savings” on medication costs comes down to exactly “who” is going to enjoy these savings. Proposals to date do not establish “loss ratio” parity in medical and prescription insurance benefits – the Affordable Care Act (ACA) capped profits for medical coverage at fifteen or twenty percent but no such similar rule applies to pharmacy benefits or more commonly known as prescription drug coverage. These plans for “savings” do not necessarily translate to lower cost medications at the pharmacy counter for patients but for lower costs for governments and government programs – which should already be enjoying if those pharmacy benefit managers (PBMs) were actually fulfilling their promise of extending cost savings to their clients. They’re not and, respectfully, that’s precisely the issue most Americans care about – “What am I going to pay?” And it’s the answer politicians very carefully avoid giving.

An additional problem with Colorado’s assessment of savings is the SIP explicitly cites retail medication costs, not the costs the state government actually pays (which is often steeply discounted or enjoys rebates that bring those list prices down considerably). The calculation Colorado cites, very blatantly, is a lie.

Next, of the one hundred twelve medications Colorado specifies as targets for importation, HIV treatments are one of the highest cost medications on the list. We’ll get to why that’s particularly problematic for people living with HIV…now.

Safety security in the supply chain from importation does not align with the United States’ effort to ensure quality medications are getting to patients. The United States employs something called “track and trace” which requires electronic monitoring and labeling specific to the United States from the manufacturer throughout the entire chain of handling medications until they land in a patient’s hands. Importation from Canada (or anywhere else for that matter) would necessarily disrupt this system of tracking by requiring relabeling and Colorado, in its SIP, is challenging the FDA’s requirement to disclose when a medication is imported and from where (pg. 44-45 of the SIP). Colorado notes that while it disagrees with the relabeling requirements (which include notation when a medication is being imported without a manufacturer’s agreement), the state says it will not import medication without those same manufacturers agreeing. Generally speaking, manufacturers aren’t going to agree to participate in this program. They’ve already said so.

Photo Source: PhRMA

Safety and fear of counterfeit is such a significant concern that Colorado has promised to have a third party periodically sample medications to ensure they’re authentic. And fake HIV medications have already been an issue in the United States. Part of that comes down to this exclusive reliance on private entities (namely manufacturer) to identify counterfeit medications. ADAP Advocacy Association’s CEO, Brandon Macsata, has already detailed his own, personal, potentially life-threatening experience with counterfeit antiretrovirals. And loose guardrails which muddy up securing medication safety aren’t going to make these issues any better – indeed, they’ll expose more People living with HIV to this risk.

Florida, as the other state pushing hard for importation, already knows this is a bad idea. It’s why their SIP explicitly makes the importation program medications an experiment – to be tested on the poor and imprisoned, touting to effort at addressing the state’s medications needs for Medicaid and prisons. Florida’s plan is, quite frankly, a moral and ethical disgrace. Colorado’s is rife with gimmicks.

It's high time states and the federal government appreciate that the United States, despite our issues, enjoys one of the safest medication supply chains in the world. Few if any of us stop to consider if the medications we pick up from our pharmacy are legitimate. Let’s stop with importation proposals that, in reality, won’t help patients afford medications and only threaten our supply safety, our diplomatic relationships, and patients lives. Bringing down end-user costs of medications absolutely requires government action, but that action isn’t going to be importation.

[1] Colorado (2022, December 5). Section 804 Importation Program - Colorado's Drug Importation Program. Retrieved from https://hcpf.colorado.gov/sites/hcpf/files/Colorado%27s%20Drug%20Importation%20Program%202022%20Formal%20SIP.pdf

[2] Kansteiner, Fraiser (2022, August 31). In new lawsuit, Florida says FDA stalling on drug importation program. Fierce Pharma. Retrieved from https://www.fiercepharma.com/pharma/florida-tees-legal-showdown-fda-over-stalled-information-act-request-canada-drug-import-plan

[3] Panetta, Alexander (2022, December 8). Heads up, Canada: Colorado wants your drugs. CBC. Retrieved from https://www.cbc.ca/news/world/colorado-drug-imports-canada-1.6679290

[4] CPhA & APha(2022). American and Canadian pharmacist associations warn that drug importation policies could put patients at risk. Retrieved from https://aphanet.pharmacist.com/sites/default/files/audience/Joint%20Statement%20APhA%20and%20CPhA%20Importation%20.pdf

[5] Fein, Adam (2022, December 7). Drug Channels. Retrieved from https://twitter.com/DrugChannels/status/1600660225786318848?t=y1oWO_tiLVIuQIHrkOQmmw&s=19

[6] PhRMA (2023). Drug Importation. Retrieved from https://phrma.org/policy-issues/drug-importation 

[7] Partnership for Safe Medicines. (2022, September). Fake HIV Medication Reached U.S. Pharmacies—And Patients. Retrieved from https://www.safemedicines.org/2022/01/counterfeit-hiv-medications-in-the-u-s.html

[8] ADAP Blog (2020, November 19). How Drug Imports Can Endanger Patients. Retrieved from https://adapadvocacyassociation.blogspot.com/2020/11/how-drug-imports-can-endanger-patients.html

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Why a Secure Drug Supply Chain Matters

By: Brandon M. Macsata, CEO, ADAP Advocacy Association
       Shabbir Imber Safdar, Executive Director, Partnership for Safe Medicines

Since the start of the AIDS crisis, people living HIV (PLWHA) have looked forward to a day when medicines could allow them to live a life in which their HIV is undetectable and untransmittable (otherwise known as, “UequalsU). Today, PLWHA with access to treatment and adherent to their antiretroviral therapy are expected to live well into their 80’s. There is so much promise in the fight to end the epidemic. 

PLWHA can be confident of the security of those medications from fraudsters because they are protected by the Drug Supply Chain Security Act (DSCSA). This medication protection system, originally created in 2013, completes its rollout next year in 2023. It assigns a number to each package of medicine at time of manufacture, and that number is tracked at every change of ownership from factory to distributor to pharmacist. “Track and trace” is the name associated with this drug supply safety system.

Photo Source: Pharmaceutical Technology

Though criminals never stop trying to defraud patients and pharmacists, we know the DSCSA works because it has been tested. A pharmacist in Texas who checked the serial numbers on “too-cheap-to-be-true” HIV medicine discovered fraud and returned that medicine to the seller without dispensing it to patients. Furthermore, because these kinds of serial numbers allow very fine-grained tracking of medicine in the supply chain, no broad recalls were necessary which might have taken perfectly good medicine off the market and endangered patient access.

DSCSA has protected PLWHA and all patients in the United States, but as with any system, it needs support. There are two key places where the federal government needs to help:

• Charge people who forge DSCSA paperwork with DSCSA fraud

Criminals, such as the recent spate of HIV counterfeit criminals, have yet to be charged with criminal offenses for DSCSA fraud. In fact, to-date there is no record of anyone ever having been charged with DSCSA fraud. To protect patients there must be a deterrent to forging DSCSA paperwork, and to do that, the DOJ must ensure that this crime draws a criminal charge.

There are currently 140 defendants in the existing civil litigation brought by Gilead Sciences and Johnson and Johnson Healthcare Systems against the criminals trafficking in counterfeit and diverted HIV and Hepatitis C (HCV) medications. Not even one has drawn a criminal charge of forging DSCSA paperwork. 

The Biden Administration’s Department of Justice needs to make prosecution of criminals who violate the DSCSA a priority with resources and training.

• Do not undermine the DSCSA for political expediency

For decades it has been in vogue to suggest buying medicine from other countries to make it cheaper. However, countries suggested, like Canada, don’t have a system like DSCSA and we cannot provide this same level of safety assurance to patients and pharmacists. Regulations that intentionally break the DSCSA, like the regulations that govern bulk importation of drugs from Canada that break the DSCSA will endanger HIV, HCV, and many other categories of American patients.

The Administration’s Department of Health & Human Services needs to revoke the rules governing bulk importation until Canada has an interoperable DSCSA system to protect medicine imported.

Ensure broad understanding of DSCSA features for physicians

As the DSCSA finishes its rollout, one part of the dispenser community unlikely to get the message is physicians who administer long-acting HIV injectables. These injectables, which can control HIV with just two shots every month or two months, are an enormous innovation.

However recent history includes a few failures of physicians to understand the dangers of criminals in the supply chain, including:

• Physicians purchasing black market oncology from unlicensed sellers (including Canadian criminals) and administering in their offices it to cancer patients;
• Physicians in thirteen states who purchased black market none-sterile IUDs and implanted them in patients, resulting in horrific medical adverse events; and
• Physicians who purchase black market Botox, and administered them to patients, endangering them.

Unlike pills taken by PLWHA, which can be examined by the pharmacist and patient, injectables administered by physicians don’t necessarily have this protection. Additional steps are needed to ensure patients can participate in medication verification safety. All too often, patients never see touch the injectable, and likely never see the packaging it came in. Physicians, who are not typically trained to check pharmaceutical wholesaler licenses or verify DSCSA safety features, have repeatedly been the targets for criminals. PLWHA need to be empowered to involve themselves more in this process.

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As the DSCSA rollout proceeds, we urge the Biden Administration to resource the U.S. Food & Drug Administration (FDA) so they can prioritize education of physicians about the new security features of the DSCSA and the risks to their patients and their practice if they ignore them.

People living with HIV in the United States have witnessed significant progress in managing their condition. The advent of new medicines has greatly improved their quality of life greatly, and equally the safety of their drug supply has been enhanced by the Drug Supply Chain Security Act. It’s critical that we do everything possible to support it.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Gilead Sciences Discovers $250 Million of Counterfeit Biktarvy and Descovy

By: Ranier Simons, ADAP Blog Guest Contributor

The selling of counterfeit goods is a lucrative market. Expensive, popular, and high-demand items are counterfeited globally. The quality of the fake goods ranges from high quality to poorly made. Counterfeiting doesn’t stop at goods. There is also a large market for counterfeit drugs. Studies estimate that the global illegal drug market has sales between $200 billion and $400 billion annually.[1] Additionally, data shows that 9%-41% of medication sold in low to middle-income countries are counterfeit. The percentage drops to about %1 in high-income countries like the United States.[2]

Irrespective of the lower percentage in the U.S., counterfeit drugs are a serious issue. Unfortunately, expensive HIV medicines are on the list of valuable targets. On August 5, 2021, Gilead Sciences released a press release stating that it had become aware of counterfeit and tampered versions of Biktarvy and Descovy in the supply chain in the U.S.[3] The press release resulted from a sealed lawsuit Gilead filed against the sources of the counterfeit in July of 2021. The U.S. District Court of the Eastern District of New York unsealed the documents on January 18, 2022, revealing the details. 

Photo Source: IP Watch

Gilead reported that at a value of $250 million, about 85,247 bottles of counterfeit Biktarvy and Descovy were sold to pharmacies and patients over two years. The drugs entered the supply chain via distributors not authorized by Gilead, who sold to pharmacies and patients. The counterfeit versions were sold in genuine Gilead bottles. The tampered bottles had fake foil induction seals, fake caps, or improper labels.[4] Some of the bottles contained genuine Gilead pills. Others included other drugs, painkillers, and a powerful anti-psychotic drug with serious side effects. Since the bottles were sealed, pharmacists were not physically filling them. Thus, they were unaware of the contents. The majority of the counterfeit drugs were sold by an organized counterfeit ring that used shell companies to advertise and sell the fake drugs to pharmacies. Several licensed pharmaceutical distributors were a part of the scheme.[4] Some of the drugs were even bought off of homeless people or HIV patients before being resold.[5]

The dangers of counterfeit drugs are catastrophic. Results are poisoning, death, treatment failure, disease progression, and even drug resistance. Improper dosages of unneeded medications poison patients ingesting pills of the incorrect medications. Taking the wrong medications can also cause adverse interactions with other medications people are already taking. Fake drugs affect treatment regimens since physicians base treatment on the outcomes they see from care. If patients take counterfeit medication, their disease progression will not change or worsen. As a result, doctors would change medication or make other decisions based on false results. Improper counterfeit drugs also do not contain adequate levels of medications. In the case of antiretrovirals, that could result in drug resistance lowering a patient's options for treatment pathways. 

Photo Source: YouTube

The dangers surrounding counterfeit drugs was recently addressed in a 90-second public service announcement (PSA). Brandon M. Macsata, CEO of the ADAP Advocacy Association and a long-term survivor living with HIV, shared some important steps patients can take to combat counterfeit drugs. The PSA can be viewed online at https://www.youtube.com/watch?v=VWGUW1AAr_w. 

It is imperative that pharmacists source medications from reliable sources. Pharmacists sometimes seek out alternative suppliers to buy drugs cheaper. Scarcity also steers pharmacists into the hands of counterfeiters when legitimate suppliers of high-demand, expensive medication are unable to supply the market needs.[6] Actively examining medication bottles for suspicious appearances and informing patients about the dangers of buying medicines over the internet are effective ways to combat counterfeit medications. Moreover, pharmacists need to confirm that supplies were purchased directly from manufacturers or reputable sources with their distributors. Unfortunately, this due diligence is sometimes thwarted since source documentation is also faked, as it was, in the Gilead counterfeit case.

[1] Miller, H., Winegarden, W. (2020, October). Fraud in Your Pill Bottle: The Unacceptable Cost of Counterfeit Medicines. Retrieved from  https://medecon.org/wp-content/uploads/2020/10/CounterfeitMed_F.pdf
[2] CDC. (2021, July). Counterfeit medicines. Retrieved from )https://wwwnc.cdc.gov/travel/page/counterfeit-medicine
[3] Gilead. (2021, August 5). Gilead Warns of Counterfeit HIV Medication Being Distributed in the United States. Retrieved from https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states
[4] IPWatchdog. (2022, January 19). Court unseals documents in Gilead lawsuit alleging massive counterfeit HIV drug scheme. Retrieved from https://www.ipwatchdog.com/2022/01/19/court-unseals-documents-gilead-lawsuit-alleging-massive-counterfeit-hiv-drug-scheme/id=144591/
[5] Lonas, L. (2022, January 18). Drugmaker says counterfeit versions of its HIV medicines ended up in patients’ hands. Retrieved from https://foxlexington.com/news/health-wellness/drugmaker-says-counterfeit-versions-of-its-hiv-medicines-ended-up-in-patients-hands/
[6] Chambliss, W, Carroll, W., Kennedy, D., Levine, D., Mone, M., Ried, D., Shepherd, M., & Yevligi, M. (2012). Role of the pharmacist in preventing distribution of counterfeit medications. Journal of the American Pharmacists Association. 2012(52), 195-199. doi: 10.1331/JAPhA.2012.11085

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Fighting Fake Online Pharmacies & Counterfeit Medicines

By: Shabbir J. Safdar, Executive Director of the Partnership for Safe Medicines

If law enforcement knows that criminals in another country are shipping illegal drugs to patients in the United States, how long should we let them traffic poison while we fight the problems of prosecuting foreign nationals? How long do we let them harm Americans while they sit outside our borders and refuse to come to the U.S.? Three weeks? Six weeks?

Right now, we’re operating at delays measured in years, and the cost to Americans in medical harm and fraud is not acceptable. New bipartisan legislation would help disrupt these criminals: the DRUGS Act (S.3399 / H.R. 6352)

Let me tell you a story about a “Canadian” pharmacy: A web pharmacy named CanadaDrugCenter.com shipped an anti-inflammatory and a blood thinner to the U.S. in 2014. Their website had Canada in its name, but the medicines they sold came from Mauritius and Turkey. They didn’t even pretend. The packages were drop shipped straight from Mauritius and Turkey to the buyer in Portland, Maine.

The recipient was a professor of pharmacy with access to a lab, so he tested them. The anti-inflammatory was sub-therapeutic (not enough active ingredient) and the blood thinner had a contaminant. (Cancer-causing agent, anyone?)

What do you think happened to the company, CanadaDrugCenter.com? 

Extradition, even from a friendly neighbor like Canada, is challenging. The criminals that ran
CanadaDrugCenter had an enormous network of over 200 fake pharmacy websites, but still
could not be easily extradited. It’s hard to negotiate a plea deal with someone who knows you
can’t force them into court to face charges.

Nothing. For years.

As the Maine Board of Pharmacy and the Maine Attorney General wondered how they might be able to protect their patients from Canada Drug Center’s predatory business, CanadaDrugCenter continued selling to Maine patients. The Internet Archive shows they ran the website for at least two more years. They also ran full page ads in the local Maine newspaper. And they continued selling their counterfeit medicines to Mainers.

Eventually, the feds finally got involved. They had to conduct a long investigation, convince a U.S. attorney to bring charges, and then deal with the fact that the executives from Canada Drug Center had no interest in showing up in U.S. courts. Eventually they pleaded guilty and settled the case. Nobody went to jail but they paid a fine of over four million dollars.

Why do we let these operations continue when law enforcement knows they are selling drugs illegally online? These criminals sell fake versions of therapeutics like blood thinners, but also controlled substances like the ones driving the current opioid crisis. They do it from outside U.S. borders because they know it’s really hard to extradite them. These aren’t the first counterfeiters to simply decline to show up in U.S. court.

There is a better way: When we have clear evidence that someone is running a business selling drugs illegally online without a state pharmacy license, we should suspend their website domain name. The Food and Drug Administration and the Department of Justice could have suspended CanadaDrugCenter.com once they had proof of the crime. And the “Canadian pharmacy” could have reclaimed the domain when they cleared themselves of the charge.

This isn’t a new concept: if the police discover you’ve turned your home into an open air heroin store and shooting gallery, you don’t get to keep the supply of drugs until you’ve won your trial. You’re lucky if you even get let out of jail. If you’re caught with a pill press with an illegal mold for opioids in it, you don’t get to keep using the pill press until the trial is over.

Photo Source: Money Logue

A new law that would take these website domains away from criminals is called the DRUGS Act (HR 6352 / S 3399). It’s bipartisan, introduced by both Republicans and Democrats in the House and Senate, and would go a long way to protecting Americans from criminals who refuse to play by the rules while we go through the long process of adjudicating their cases.

To learn more about how you can support it, watch our video about this legislation and use this link to send a letter to your elected officials.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Deja Vu All Over Again: Counterfeit Biktarvy® & Descovy® Anti-HIV Medicines

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Baseball Hall-of-Fame legend Yogi Berra coined the infamous phrase, "It's deja vu all over again". For the HIV community, it finds itself once again confronting the sad reality that antiretroviral (ARV) therapy isn't immune from counterfeit and tampered medicines. The latest counterfeit warning - involving products manufactured by Gilead Sciences - represents the second such ARV-related counterfeit scheme in less than one year.

Earlier this year, we raised similar concerns over fake Symtuza® entering the U.S. drug supply chain. It came in response to Janssen Pharmaceutical Companies of Johnson & Johnson issuing a drug warning alert in late 2020 about the counterfeit HIV drug. There were no reported adverse events related to the use of the counterfeit product, but it nonetheless sounded the alarm over fake HIV medications potentially reaching medicine cabinets in American households.

Fast-forward to August 2021, Gilead Sciences alerted the U.S. Food & Drug Administration (FDA) that fake meds for its once-daily single tablet HIV treatment regimen Biktarvy® (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and its HIV treatment and prevention medication Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) were within U.S. drug distribution networks.[1]

“The safety of individuals taking Gilead medication is always our first priority,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We are taking aggressive action to ensure that healthcare providers and people who rely on our medicines can confidently distinguish authentic Gilead products from counterfeit drugs.”[2]

Photo Source: Gilead Sciences

According to Gilead Science, "counterfeit and tampered medicines can bring serious and sometimes life-threatening health risks to individuals." It is also important to note that these medicines are: 

• not the same as authentic medicine in terms quality, safety, and/or efficacy;
• not guaranteed to contain the correct drug or active ingredients;
• not likely to meet purity standards; and
• not inspected for unsafe manufacturing conditions or secure supply chains.[3]

Gilead Sciences' full statement is available online here: https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states. 

Fortunately, it appears that there have been no reported adverse events related to the use of the counterfeit product. Advocates credit the U.S. drug supply chain's internal safety protocols.

Shabbir J. Safdar, Executive Director of the Partnership for Safe Medicines, summarized, "U.S. licensed pharmacies are the safest in the world. They're so safe we often go years without seeing a fake medication in the legitimate supply chain like this. But the consequences of a fake medication in a licensed pharmacy is serious and life threatening, given the numbers of patients that could be affected. We're grateful to see how fast both Gilead's security team and the FDA have responded."

Any patient who fears they may have received counterfeit Gilead medications should immediately report the medicine to their doctor and pharmacy and Gilead Product Quality Complaints at 1-800-445-3235 or QualityComplaints@gilead.com.

People living with HIV/AIDS, or any chronic condition, need to have confidence that they're getting a safe prescription medicine. The assurance in knowing that the product has been rigorously tested with a safety-seal as appropriate for treatment is vitally important for the patient advocacy community. Forty-years into the epidemic it is clear that drug manufacturers, government agencies, and patients must remain vigilant to combat threats to the nation's drug supply chain.

[1] Gilead Sciences (2021, August 5). Gilead Warns of Counterfeit HIV Medication Being Distributed in the United States. Retrieved online at https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states.
[2] Gilead Sciences (2021, August 5). Gilead Warns of Counterfeit HIV Medication Being Distributed in the United States. Retrieved online at https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states.
[3] Gilead Sciences (2021, August 5). Gilead Warns of Counterfeit HIV Medication Being Distributed in the United States. Retrieved online at https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

Fake Symtuza® Serves as Wake-Up Call Over Counterfeit HIV Medications

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

For over a decade counterfeit drugs have been a concern of the ADAP Advocacy Association, especially with all of the hoopla over drug importation. Despite the unsubstantiated claims about lowering drug costs for Americans, drug importation would come at too high a cost for people living with chronic health conditions, including HIV. Such an ill-advised public policy change would weaken the safety of the nation's drug supply chain, and prescription anti-retroviral (ARVs) medications aren't immune from counterfeit threats. The recent news about fake Symtuza® – prescribed medicine for the treatment of HIV-1 infection – identified in the United States is a case in point about looming risks.

Photo Source: MPR

In December 2020, Janssen Pharmaceutical Companies of Johnson & Johnson issued a drug warning alert about the counterfeit HIV drug. As you can read here, Janssen was made aware that counterfeit Symtuza® had been distributed to three pharmacies in the United States. 

Janssen's alert, in part, read:

"We are working closely with the U.S. Food and Drug Administration (FDA) to prevent further distribution and to support the agency’s investigation into the reported instances. The pharmacies involved procured the counterfeit product from distributors that have not been authorized by Janssen.  We are confident that SYMTUZA® obtained through authorized distributors is authentic and safe for use, in accordance with the Prescribing Information."[1]

Whereas there were no reported adverse events related to the use of the counterfeit product, it nonetheless sounded the alarm over fake HIV medications potentially reaching medicine cabinets in American households. Fortunately, Janssen's strong ties to the patient advocacy community helped to raise awareness quickly to counter the threat (Editor's Note: The ADAP Advocacy Association at the time pushed numerous Tweets about the alert).

The most recent threat wasn't the first incident whereby fake HIV medication had found its way into the nation's drug supply chain. In 2001, counterfeit Serostim® – prescribed injectable medicine used for the treatment of HIV-related wasting – was found in U.S. pharmacies nationwide. According to news reports at the time, Serono, Inc. countered the threat by mailing drug alert letters to distributors, pharmacies, physicians and patients, as well as sending hundreds of alerts to AIDS service organizations.[2]

Photo Source: Willis QS Consulting

The Partnership for Safe Medicines (PSM), which is the preeminent policy expert on counterfeit drugs, has raised awareness about fake insulin, fake cancer medications, and fake hepatitis medicines. In the past, PSM has also tackled fake HIV medications.

Rick Roberts, an HIV-positive advocate on the PSM board of directors, has spent the past two decades warning of the threat of counterfeits. Roberts argues, "For all-in-one treatments, the possibility that a counterfeit could leave a patient without any treatment at all is a heartbreaking life-threatening situation. Having counterfeit Symtuza show up in a licensed U.S. pharmacy, as the counterfeit Serostim I received in 2000 did, is proof that our supply chain can't allow any foreign wholesalers or pharmacies that can't easily be regulated as some proposals to do foreign drug importation suggest.

According to Roberts, at least the counterfeiters that targeted him could be brought into court. Many foreign counterfeit criminals never see the inside of the U.S. courtroom.

Counterfeit medication isn't something that only happens in "other" countries, evidenced by warnings on the FDA website. Although the U.S. drug supply chain remains among the safest and most secure systems internationally, it still remains susceptible to nefarious activities. Fake HIV medications, such as Symtuza or Serostim, should serve as a reminder to patients and policy-makers alike that more needs to be done to protect our access to medications.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

[1] Marcus A. Wilson (2020, December 24). IMPORTANT DRUG WARNING: Information About Counterfeit HIV Drug. Janssen Pharmaceutical Companies of Johnson & Johnson.
[2] Naomi Aoki (2001, February 5). Maker of AIDS Drug Battles Counterfeiters / Serostim's growth hormone may give it black-market value. Boston Globe. Retrieved online at https://www.sfgate.com/business/article/Maker-of-AIDS-Drug-Battles-Counterfeiters-2955169.php.