Medicare Drug Price Negotiations Again Target High-Impact Prescriptions, But at what Cost?

By: Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

The Trump Administration recently released the next round of medications selected for the Medicare Drug Price Negotiation Program, which includes 15 medications payable under Medicare Part B and/or covered under Medicare Part D, largely for the treatment of chronic diseases and cancer.

Photo Source: CMS

Of greatest concern to ADAP Advocacy is the inclusion of Biktarvy, the most commonly prescribed single-pill oral regimen to treat HIV made by Gilead Sciences, currently taken by over 430,000 people living with HIV in the United States (Gilead Sciences, 2026), or 35.8% of People Living With HIV/AIDS (PLWHA).

In June 2025, ADAP Advocacy submitted public comment to the Centers for Medicare and Medicaid Services (CMS). In this public comment, it requested that CMS create a carve-out exemption for all medications used for the treatment of HIV/AIDS in order to avoid any interruptions of service for PLWHA who rely upon Medicare for their HIV medications.

ADAP Advocacy followed up on this public comment with a sign-on letter to CMS requesting the carve-out exemption, which garnered signatures from nearly 40 organizations and received a direct response from Dr. Mehmet Oz, the current CMS Administrator.

The response?

"CMS acknowledges your recommendation to implement a carve-out exemption for all medications indicated for the treatment and prevention of HIV/AIDS; however, the statute does not specify a specific exclusion for medications used for the treatment of HIV/AIDS from selection under the Negotiation Program."

Essentially, “Sorry. Can’t help you.”

Photo Source: ADAP Advocacy

What Does Price Negotiation Mean?

As ADAP Advocacy detailed in a July 2025 blog, Medicare’s Negotiation Program essentially requires manufacturers to accept the final price after four negotiation meetings set by CMS, reject the offer, and pay a 95% excise tax on all of the medications sold to Medicare payors, or remove their products from the Medicare formularies altogether (Hammond, 2024). Because no business can feasibly accept a 95% excise tax and remain viable, manufacturers are left with the unenviable decision to either accept significant profit losses in the Medicare market or withdraw their drugs (Hopkins, 2025). This process, which is supposed to resemble a negotiation, has been characterized by many as a threat with the full force of the federal government behind it. One public health stakeholder attending ADAP Advocacy’s Health Fireside Chat last year in Minneapolis, Minnesota, called it extortion. 

For PLWHA, the inclusion of one of the most effective single-pill regimens in the history of HIV treatment on this list presents a real and present danger should Gilead Sciences determine that allowing Biktarvy to be purchased at a significant loss by Medicare payors is unacceptable.

Medicare is the 2nd-largest payor of HIV treatment and care in the United States, accounting for 39% of federal spending in 2020, and serving 28% of PLWHA (Dawson, et al., 2023).

Patient advocates continue to share their concerns over Biktarvy, or any other HIV-related product, being targeted by CMS for artificial government price controls. Among them is Aging and HIV Institute’s David “Jax” Kelly, JD, MPH, MBA. Kelly argued, “Nearly 28% of PLWH in the United States are Medicare beneficiaries, and most qualified through disability rather than age… [t]his unique cost profile reflects both the effectiveness and the financial burden of HIV treatment. Interruptions in ART jeopardize not only individual health but also public health goals. Sustained viral suppression—essential to ending the epidemic—depends on reliable, affordable access to medications.”

ADAP Advocacy will follow up with its aforementioned communications with CMS by submitting public comments in response to its request for information about selected drugs and their therapeutic alternatives, because the inclusion of an antiretroviral therapeutic “is playing with fire,” as ADAP Advocacy’s CEO has noted on numerous occasions.

Photo Source: Andreas Marquardt/Shutterstock

What Can Patients Do?

Please find information below on how you can get involved:

[From CMS]:

The Negotiation Program enables Medicare to directly negotiate the prices of certain high-cost drugs. The current cycle of negotiation and renegotiation is underway, and CMS wants to hear directly from patients, caregivers, clinicians, and others to gather input relevant to the selected drugs.

CMS invites you to rally the communities you represent to share information about the public engagement events, including a virtual livestreamed town hall meeting focused on the clinical considerations related to the selected drugs, and private (i.e., not livestreamed or open to press or general public) virtual patient-focused roundtable events, one for each selected drug, for patients, patient advocacy organizations, and caregivers.  

Take Action

• Learn more about the drugs selected for the current cycle of negotiation and renegotiation here.
• Use communication tools available here so that your organization can leverage your various communication channels to share information about these opportunities:
• Complete the Drug Price Negotiation Information Collection Request (ICR).
• Register for public engagement events here. 

Key Dates

• The Drug Price Negotiation ICR is now available, and responses are due by March 1, 2026. It is worth noting that for patients wanting to submit public comments, questions 28-33 are the patient- or caregiver-focused input (so don’t get overwhelmed by the length of the online form)
• Drugs selected for the upcoming cycle of negotiation and renegotiation were announced on January 27, 2026, and registration for the public engagement events is open now until March 6, 2026.
• Public engagement events for Biktarvy include:
• Roundtable event on Monday, April 6 from 2:30 – 4:30 p.m. ET 
• Town Hall Meeting on Wednesday, April 22, Session 1 from 10:30 a.m. – 12 p.m. ET

Photo Source: Portland.gov 

Registration for the opportunity to speak at the public engagement events is now open and will close at 11:59 p.m. PT on March 6, 2026.

• To register for a roundtable event, click here. 
• To register for the town hall meeting, click here. 

Reach out to IRARebateandNegotiation@cms.hhs.gov with any questions, using the subject line “Public Engagement.”

ADAP Advocacy urges patients and patient advocates to weigh in. While financial outlays may be high for PLWHA due to treatment costs, the financial impacts of treatment interruption are far higher. While treatment cessation for any disease state can cause serious complications, the nature of the HIV retrovirus is such that it can quickly mutate to develop resistance to a treatment regimen if that regimen is suddenly halted. This can create a strain of HIV that is multidrug-resistant (MDR-HIV), making the virus more difficult and significantly costlier to treat–and result in premature death. CMS targeting an HIV-related therapeutic signals a threat to AIDS exceptionalism, and it cannot be left to chance.

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.

References:

[1] Centers for Medicare and Medicaid Services. (2026, January). Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028. Washington, DS: United States Department of Health and Human Services: Centers for Medicare and Medicaid Services. https://www.cms.gov/files/document/factsheet-medicare-negotiation-selected-drug-list-ipay-2028.pdf

[2] Dawson, L., Kates, J., Roberts, T., Cubanski, J., Neuman, T., & Damico, A. (2023, May 27). Medicare and People with HIV. KFF: HIV/AIDS. https://www.kff.org/hivaids/issue-brief/medicare-and-people-with-hiv/

[3] Gilead Sciences. (2026). Biktarvy. Foster City, CA: Gilead Sciences: Biktarvy: About Biktarvy. https://www.biktarvy.com/about-biktarvy

[4] Hammon, J. (2024, August 19). Price controls – bad policy, big problems. Washington, DC: Paragon Health Institute. https://paragoninstitute.org/paragon-prognosis/price-controls-bad-policy-big-problems/

[5] Hopkins, M. J. (2025, July 10). CALL TO ACTION: HIV Medication Carve-Out Exemption from the Medicare Drug Price Negotiation Program. Nags Head, NC: ADAP Advocacy: ADAP Blog. https://adapadvocacyassociation.blogspot.com/2025/07/call-to-action-hiv-medication-carve-out.html

Florida, Once Again, Imperils the Lives of People Living with HIV/AIDS

By: Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

The state of Florida is in the process of revamping [deconstructing] its state’s AIDS Drug Assistance Program (ADAP) to exclude nearly half of its current enrollees. That plan hit a roadblock when the Florida Department of Health ignored the state statutes governing administrative procedure, which opened it to an administrative action filed by the AIDS Healthcare Foundation (AHF). The state withdrew its proposal but plans to proceed with it…this time, actually following the rules. It represents a temporary win, but much work remains to be done to protect Floridians living with HIV/AIDS reliant on the program. The Florida Legislature appears to be taking steps to address the crisis, as both the House and Senate budget proposals call for additional funding for the drug assistance program. The Senate's budget proposal includes $118 million, while the House's plan offers only $68 million, which represents about half of the funding needed.

How This Started

The emails started circulating on January 7th, 2026 (see Figure 1):

Figure 1 - Email from an ASO

“ADAP will reduce its [Federal Poverty Level (FPL)] eligibility from 400% to 100%.”

“[Co-pay] assistance will only be provided to participants who meet the new eligibility criteria.”

“ADAP-funded insurance coverage will be discontinued.”

“Only generic medications will be covered.” *

And the panic began.

State and national organizations across the country immediately began to both panic and organize:

How can we best support patients who will lose access to their medications, as well as organizations that may face closure as a result of these changes?

The State of Florida Confirms Its Plans

By Thursday, January 8th, 2026, the state of Florida clarified its plans:

Dear Colleagues,

As you are probably aware, ADAP will be moving to a financially sustainable model to benefit the largest population of ADAP clients. We will continue to support the current model (direct dispense, CVS Caremark and insurance) for a two month period to ensure ADAP clients have ample time to seek insurance and medication assistance, if no longer eligible to receive ADAP services through the department. Following this transition period, we will move to direct medication dispensing, capping the eligible federal poverty level at 130%, as well as implementing ADAP formulary changes starting March 1, 2026.

Regarding the formulary changes, Biktarvy will be removed and Descovy will be restricted to only those with renal insufficiency (CrCl <60). All other current ART medications including Tivicay will be available. However, we will monitor cost closely and adjust if needed. A few actions to consider:

• Upon follow up visits, transition to new ART regimen such as Tivicay plus Truvada, other Truvada-based or NRTI-based regimen in combination with integrase inhibitors, or alternative class outside of integrase inhibitors. Please refer to the treatment guidelines: Initiation of Antiretroviral Therapy | NIH.
• For patients on those Biktarvy or Descovy, ensure they have adequate medication until their next clinical visit prior to March 1st.
• For Descovy, providers are required to document the reason: due to CrCl <60 or renal insufficiency on the prescription note section.

Will keep you posted on any additional changes. As always, please reach out if you have any questions.

{Source: U. Choe, personal communication, January 06, 2026}.

So, What Happened?

Florida’s controversial Surgeon General, Joseph Ladapo, stated that the cuts were necessary to prevent a “…projected $120 million shortfall” (Shepard, 2026), but state and national advocates are asking whether or not taxpayer dollars have been illegally diverted or misappropriated (Adamczeski, 2026), pointing to a recent investigation that uncovered the DeSantis Administration’s diversion of $35 million in taxpayer dollars to wage campaigns against two ballot initiatives that would have legalized recreational marijuana use (Amendment 3) and overturned the six-week abortion ban passed by the state legislature (Amendment 4; Mower et al., 2025).

What Happened Next?

Shortly after these announcements, ADAP Advocacy remained publicly quiet, but behind the scenes, it was working on two fronts to help alleviate growing concern. One route has political ties to the governor, while the other option involves potential litigation. That is all the organization has been authorized to say at this time.

AHF almost immediately filed an administrative legal action, arguing that the state of Florida failed to comply with mandatory public rulemaking processes that require it to publish a “Notice of Proposed Rule” (NPR).

Publishing an NPR starts a mandatory 21-day procedural clock during which the public may submit written comments, requests for public hearings, workshop requests, and “lower-cost regulatory alternatives” (LCRAs).

The state of Florida issued this NPR on Wednesday, February 11th.

What This Would Mean for People Living with HIV/AIDS in Florida

The “cost-containment” measures announced by the Florida Department of Health are each, by themselves, draconian cuts that would have devastating negative impacts on People Living with HIV/AIDS (PLWHA) in the state.

In its NPR, Florida proposes the following changes to the program:

Lowering the Income Eligibility Threshold from 400% of the FPL to 130% of the FPL:

In 2023, there were an estimated 123,279 PLWHA in the state of Florida, of whom 36,834 (29.9%) were enrolled in Florida’s state ADAP program (National Alliance of State and Territorial AIDS Directors, 2025).

Should Florida move ahead with its plan to lower its income eligibility cap to 130%—roughly $20,345 / year for an individual—potentially up to half of patients currently enrolled (between 16,000-20,000 PLWHA) would be disenrolled (Figure 2).

Figure 2 – Florida State ADAP Enrollees by Percentage of the Federal Poverty Level, 2024

Photo Source: ADAP Advocacy

For context, capping income eligibility at 130% would make Florida one of just 4 state ADAPs with income eligibility caps below 300% of the FPL, along with Utah (250%), Texas, and Oklahoma (both 200%; ADAP Advocacy, 2025).

Significant and Potentially Deadly Changes to the ADAP Formulary:

ADAP rules currently require that ADAP formularies include at least one medication from each class of core antivirals. The NPR issued by the state of Florida eliminates this language altogether.

Patients who remain eligible for ADAP would face significant restrictions on the medications they can take. As detailed in the email from the Florida Department of Health, the most popular and commonly prescribed medication to treat HIV/AIDS, Biktarvy, will be removed from the formulary.

Biktarvy, a single-pill oral regimen made by Gilead Sciences, is taken by over 430,000 people living with HIV in the United States (Gilead Sciences, 2026), or 35.8% of PLWHA.

By removing Biktarvy from the ADAP formulary, the Florida state government will be forcing impacted patients to transition off of the medications that are the standard of care to older, less effective multi-pill regimens in order to “contain costs.”

While this initial statement has been removed from the NPR, AHF has advised state advocates that the Florida Department of Health is separately attempting to restrict access to Biktarvy and Descovy through an informal policy outside the rulemaking process.

Dismantling the Health Insurance Premium Plus and Marketplace Premium Assistance framework:

Additionally, Florida’s plan includes discontinuing health insurance continuation payments for ADAP clients. Insurance continuation is a process that allows state ADAPs to pay for various aspects of private health insurance coverage, including those plans made available to patients on the Health Insurance Marketplace under the Affordable Care Act, and the vast majority of state ADAPs participate in some form of insurance continuation purchasing, be that through premium assistance, paying deductibles, and/or paying co-pays (Figures 3-5).

Figure 3 – State ADAP Programs That Pay Private/Marketplace Insurance Premiums, 2023

Photo Source: ADAP Advocacy

Figure 4 – State ADAP Programs That Pay Private/Marketplace Insurance Deductibles, 2023

Photo Source: ADAP Advocacy

Figure 5 – State ADAP Programs That Pay Private/Marketplace Insurance Co-Pays, 2023

Photo Source: ADAP Advocacy

In the recently filed NPR, Florida significantly narrows this framework by limiting the program to medication co-pay and deductible assistance through a limited number of contracted pharmacies.

Eliminating Part A information sharing in an effort to implement artificial administrative barriers:

Another change announced in the NPR is the removal of Ryan White Part A programs from the definition of who can issue a “Notice of Eligibility” (NOE), and the elimination of the provision that allowed Part A NOEs to satisfy ADAP (Part B) eligibility requirements.

For the uninitiated, Part A of the Ryan White Cares Act funds grants to Eligible Metropolitan Areas (EMAs) and Transitional Grant Areas (TGAs)—areas of the country with populations of at least 50,000 people that have seen between 1,000 and 2,000 AIDS diagnoses in the most recent five years.

Florida’s proposed change would require every Part A client to qualify separately for ADAP services, resulting in additional paperwork and administrative costs that increase the risk of lapses in coverage, administrative delays, and missed doses or treatment abandonment. Because of the nature of the HIV virus, missed doses or abandoning treatment can result in the mutation of the virus, creating drug-resistant strains. Lapsed treatment also assures that viral suppression will evaporate, increasing the risk of outbreaks of a multi-drug resistant strain of HIV.

Administrative burdens are a common tool used by public (in this case, the state of Florida) and private (e.g., insurance companies) payers to increase the likelihood that otherwise eligible program applicants will abandon application and/or renewal processes.

For example, in 2021, in an effort to artificially reduce its ADAP enrollment numbers, the state of Texas began requiring enrollees to recertify their eligibility in person. This was when the COVID-19 pandemic was still killing thousands of Americans each day, making this requirement potentially deadly to a patient population at severe risk of developing potentially deadly opportunistic infections, solely to serve the state’s goal of decreasing the number of enrollees to “save money.”

Limiting the types of documents acceptable for income verification:

In addition to these changes, the state of Florida is further creating administrative barriers by limiting the types of documents that can be used to verify income eligibility. This change would limit the documents available for use to W-2s, tax returns, pay stubs, unemployment documents, and Medicaid award letters.

This creates a barrier for gig workers (e.g., DoorDash drivers, Uber drivers, contractors), people paid directly in cash, and others with informal financial support by preventing them from submitting Form 1099s, contracts, or other income documents.

Changing program language to eliminate prioritization criteria, waitlist rules, and notice requirements:

Another change introduced in Florida’s NPR would revise the standard language about all program enrollment and services being subject to the availability of funds to exclude additional language that detailed prioritization criteria, rules related to the creation of a waitlist, or notice to enrollees that their coverage may or will be eliminated should funds be reduced or unavailable.

This essentially means the state can simply cease services without providing enrollees with sufficient notice to seek alternative patient assistance.

What Can Advocates Do?

The AIDS Healthcare Foundation has recommended that individuals and organizations follow the following strategy:

Figure 6 – What You Should Do Right Now

Photo Source: AHF

{Source: AIDS Healthcare Foundation, 2026}

Individuals may also directly contact their legislators using the resources below:

To find your representative in the Florida House of Representatives:

https://www.flhouse.gov/FindYourRepresentative

To find your representative in the Florida Senate:

https://www.flsenate.gov/Senators/Find

This Friday (February 20th) at 9 am ET, advocates can join a HIV Patient Access and Advocacy Strategy Convening, hosted by The AIDS Institute. 

In the meantime, ADAP Advocacy announced this week that it is rescinding its three-year travel ban to the state of Florida. This travel ban applied to ADAP board members, staff, consultants, and scholarship-funded patient advocates and precluded hosting any patient advocacy events, such as Fireside Chats, in Florida.

The severity of potential outcomes for PLWHA in the state of Florida “…warrant[s] our change in strategy,” said ADAP Advocacy CEO Brandon M. Macsata. ADAP Advocacy will continue to monitor this situation and will report any additional information as it becomes available.

*This restriction hasn't appeared in any of the formal notices, despite it initially being floated by the state.

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.

References:

[1] Adamczeski, R. (2026, January 20). Ron DeSantis will have 'blood on his hands' if HIV funding isn't restored, Democratic chair says. Los Angeles, CA: The Advocate: Politics. https://www.advocate.com/politics/florida-desantis-hiv-medication-funding

[2] ADAP Advocacy. (2025). ADAP Directory. Nags Head, NC: ADAP Advocacy. https://adap.directory/directory

[3] Gilead Sciences. (2026). Biktarvy. Foster City, CA: Gilead Sciences: Biktarvy: About Biktarvy. https://www.biktarvy.com/about-biktarvy

[4] Mower, L., Glorioso, A., & Garcia, J. (2026, January 19). DeSantis admin diverted child welfare and medical funds for consultants, ads. Miami, FL: Miami Herald: News: Florida Politics. https://www.miamiherald.com/news/politics-government/state-politics/article313630394.html

[5] National Alliance of State and Territorial AIDS Directors. (2025). 2025 Annual Report. Washington, DC: NASTAD. https://nastad.org/2025-rwhap-part-b-adap-monitoring-report

[6] Shepard, S. (2026, January 21). New Florida AIDS drug rules may leave 15,000 without HIV treatment options, Democrats say. West Palm Beach, FL: CBS 12: News: Local. https://cbs12.com/news/local/floridas-revised-hiv-treatment-eligibility-raises-questions-from-democratic-lawmakers-south-florida-news-ryan-white-aids-drug-assistance-program-adap-reps-lois-frankel-debbie-wasserman-schultz-and-sheila-cherfilusmccormick-zoom-meeting-january-21-2026

Alternative Funding Programs for Prescription Drugs Are Putting Patient Lives at Risk

By: Ranier Simons, ADAP Blog Guest Contributor

As part of ADAP Advocacy’s continued spotlight on the dangers of counterfeit prescription drugs, it is worthwhile to elevate a recent expose aired by CBNC. Two weeks ago, CBNC aired an investigative deep dive into the predatory practices of some alternative funding programs (AFPs) that illegally import medications to sell to insurance plans and patients. The expose was entitled, "How Soaring U.S. Drug Prices Fueled What Feds Call An Illegal Import Of Medications." The 30-minute documentary effectively presents how patients are pawns sandwiched between the law and entities that knowingly break it for profit. AFPs are putting patient lives in danger.

Photo Source: Alliance for Patient Access

It is worth noting that U.S. drug prices are not soaring, despite the claim in the documentary's title. According to the Drug Channels Institute, inflation-adjusted U.S. brand-name drug prices fell for the seventh consecutive year. In its annual examination of drug prices and trends, Drug Channels Institute’s President, Dr. Adam Fein, summarized, “For 2024, average brand-name drugs’ list prices grew by only 2.3%. What’s more, after adjusting for overall inflation, brand-name drug net prices dropped for an unprecedented seventh consecutive year.” The real issue is the overall unaffordability of healthcare services and the push to control costs.

Alternative funding programs are companies that promise employers and patients access to prescription medications at a low cost. Typically, AFPs operate by exploiting patients to utilize manufacturer drug assistance programs to obtain medications (NASTAD, n.d.). In the case of the CBNC expose, the AFPs subject to investigation are providing prescription drugs through illegal importation. In the documentary, Lori Mayall, who oversees anti-counterfeiting and product security at Gilead Sciences, states, “Every time you are taking a foreign medicine that has been delivered from overseas, you’re playing a game of Russian roulette.”

AFPs target vulnerable populations. The typical client of AFPs is small private employers, city and county governments, school districts, and unions. These entities have limited budgets and are thus desperate to find ways to save money. The documentary highlighted that the AFPs who promise the most outrageous bargains on prescription drugs are the ones who illegally import. Employers carve out coverage for high-cost prescription drugs and require patients they cover to use AFPs to obtain the medications. While some patients are aware that the medications they are receiving are sourced outside the United States, many are not. In most cases, the employers are aware, but they are not educated on the real dangers of importing the medications in terms of drug safety. Moreover, they are not educated about the illegality of importation.

CNBC's Melissa Lee candidly interviewed representatives from several AFPs. Overall, they all painted themselves as being altruistic by providing a public service to people. They described their actions as saving employers money while giving patients access to expensive medications they would otherwise not be able to obtain. The representatives complained that prescription drugs are much cheaper overseas, thus Americans should have access to those lower prices. They feel they are enabling Americans to exercise their rights.

AFPs incorrectly argue that their importation activities are legal under FDA guidelines. However, Leigh Verbois, the former director of the Office of Drug Security Integrity and Response at the FDA, stated on camera, “What AFPs are doing is importing misbranded and unapproved foreign drugs, which is illegal.” AFPs claim they are legal and operate under the FDA’s personal importation policy. Verbois noted this is incorrect. She explains that the importation policy is particular and limited: “If a drug is not approved or available clinically in the United States, an individual can obtain a product from a foreign source, assert they are importing that product for themselves, and then bring that product under a limited supply of 90 days into the United States.”

Photo Source: KFF News

This is not how AFPs operate. AFPs buy drugs that are approved and commercially available in the United States from foreign entities at lower prices, then distribute them to U.S. patients. Notwithstanding the illegality of the operation, AFPs are not honest in their sourcing. They claim to source only medications from reputable tier-one sources such as the United Kingdom, Canada, and Australia. However, the investigation revealed that drugs are actually also coming from places such as India, Turkey, Germany, and New Zealand. 

The foreign entities distributing these medications are not licensed to practice pharmacy anywhere in the U.S., and almost all have no assets or staff here. Should they make a mistake and harm a patient, there is no way to hold them responsible. Should they decide to cut corners and dispense subtherapeutic or counterfeit medication, they cannot have their license suspended, be brought into court in the U.S., or be forced to compensate the patients they harmed.  The medicines they dispense are not part of the U.S. track-and-trace system, so there isn’t even a way to authenticate them. Sometimes, they also break the law in their own country by exporting critical medicines meant for domestic patients.  These are not legitimate healthcare providers that patients should depend on for their lives.

Most importantly, many AFPs do not purchase foreign medications and instead distribute them to patients. In some cases, foreign suppliers and pharmacies ship medications directly to patients. This enables the drug shipments to avoid law enforcement and customs and enter the country under the radar. Thus, it makes it almost impossible to tell how many drugs are entering the country illegally.

This was part of the way Gilead Sciences was alerted, and it subsequently filed a lawsuit to prohibit the importation of foreign versions of its medications sold in the United States. A patient whose prescription drug plan was serviced by an AFP was sent a bottle of the HIV antiviral Biktarvy from Turkey, complete with labelling written in Turkish. The investigation found that, according to the Office of the U.S. Trade Representative, Turkey is one of the world’s largest suppliers of counterfeit medications. The operators of AFPs not only fail to effectively screen their sourcing but also lack the means to do so. Mayall also stated, “You don’t know how that product was stored, handled, or distributed.” She added, "and it travels through an illegal supply chain that’s easily infiltrated with counterfeits.”

Unfortunately, patients subject to utilizing AFPs who engage in foreign importation have no choice. Their employers tell them that if they do not use the AFP, they will have to pay the list price out of pocket for the medications they need. The patients who are uncomfortable with and aware of the foreign sourcing of their medications must risk their lives just to obtain their medications.

Photo Source: Partnership for Safe Medicines

Unfortunately, bad actors continue to flourish. Shabbir Safdar, Executive Director of The Partnership for Safe Medicines, revealed in the documentary that his organization discovered over $5 million in illegally imported medicines over a two-year period. CNBC’s Lee even explained that the U.S. House Appropriations Committee is so concerned about illegal drug importation that it asked the FDA to produce a comprehensive report on how to strengthen oversight. No matter how inexpensive, any drug is expensive when the price of taking it is the risk to one’s health. Continuing to raise awareness of the pervasiveness of AFPs, educating patients and employers about the dangers of obtaining foreign medications, and encouraging policy oversight are among the most effective ways to protect patients' well-being so they are not treated as pawns for profit.

[1] Fein, Ph.D, Adam. (2025, January 7). Inflation-Adjusted U.S. Brand-Name Drug Prices Fell for the Seventh Consecutive Year as a New Era of Drug Pricing Dawns. Drug Channels Institute. https://www.drugchannels.net/2025/01/inflation-adjusted-us-brand-name-drug.html

[2] NASTAD. (n.d.). Alternative Funding Programs. Retrieved from https://nastad.org/sites/default/files/2025-07/resource-afp-issue-brief-2025.pdf

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.   

Affordable Care Act Marketplace Plans & Drug Benefit Design

By: Ranier Simons, ADAP Blog Guest Contributor

Healthcare insurance policy and finance are not abstract entities relegated to the arenas of political debate and Wall Street discourse. The convoluted machinations of how money flows in healthcare insurance finance affect the bank account of anyone who has ever been prescribed a prescription drug. People living with HIV are very aware of the importance of understanding how insurance operates regarding paying for expensive antiretroviral medications that cost thousands of dollars per month. 

Photo Source: Sciworthy

When choosing insurance plans, one of the most important aspects people living with HIV/AIDS (PLWHA) consider is how or if a particular plan covers their anti-retroviral (ARV) therapy. AIDS Drug Assistance Programs (ADAP) also pay close attention to drug coverage and drug pricing, given that they help provide medications to those who are uninsured as well as those who are underinsured. The Affordable Care Act (ACA) has enabled many PLWHA to access lifesaving medicines. However, the drug benefit design of many qualified health plans (QHP) participating in the ACA Marketplaces can hinder expeditious access to efficacious drugs.

A recent study examined how insurance benefit design affects antiretroviral access. The study focused on the changes in insurance coverage of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Triumeq (dolutegravir/abacavir/lamivudine). These two drugs are first-line single-tablet regimens that have proven to be very effective. The U.S. Food & Drug Administration (FDA) approved Triumeq in 2014 and Biktarvy in 2018. Current treatment guidelines suggest that PLWHA start ART as soon as possible upon diagnosis, same day if possible. However, the study showed that access to novel treatments, such as Triumeq and Biktarvy, is slowed by delayed QHP coverage and benefit design.[1]

Photo Source: Rohan Khazanchi, MD, MPH | Twitter

The study assessed individual and small-group QHPs’ responses to the two new regimens. For the years 2018-2020, researchers examined coverage, cost sharing, specialty tiering, prior authorization (PA), and out-of-pocket (OOP) costs for Triumeq and Biktarvy nationally under QHP’s. Coverage refers to if a plan does or does not offer a drug in its formulary. Cost sharing refers to copays and coinsurance for drugs. A copay is a set fee patients pay for a prescription, whereas coinsurance is a percentage of a drug’s wholesale cost. Specialty tiering is the designation insurance drug formularies give to medications based on their costs. The higher the tier, the more of the costs are passed onto the consumer. More expensive drugs, such as ART, are in the higher tiers. Prior authorization is the bureaucratic process requiring healthcare providers to get pre-approval from a health plan before a drug is prescribed for the patient to qualify for payment coverage.

For 2018, 2019, and 2020, respectively, the study identified 19,533, 17,007, and 21,547 QHPs.[1] Overall, in 2018, 93% of the QHPs covered Triumeq, but only 60% covered Biktarvy. Triumeq coverage increased to 97% in 2019 and decreased to 91% in 2020. Biktarvy coverage decreased to 59% in 2019 but sharply increased to 86% in 2020. Concerning coinsurance, over the entire study period, a higher percentage of QHP’s required coinsurance for Biktarvy than Triumeq. The study also explicitly assessed coverage comparisons in EHE (Ending the HIV Epidemic Initiative) Phase I priority jurisdictions. Overall, across all three years studied, in both EHE and non-EHE jurisdictions, more QHPs covered Triumeq than Biktarvy. Interestingly, Biktarvy QHP coverage in 2020 was higher in EHE jurisdictions (90%) compared to non-EHE jurisdictions (85%). Biktarvy coverage in EHE jurisdictions increased from 74% in 2018 to 90% in 2020 due to increased coverage with coinsurance and copays. The study also found differences in prior authorization requirements. The prevalence of PA requirements for Triumeq was very low (2%, 2%, and 1% for 2018, 2019, and 2020, respectively).[1] PA prevalence was higher for Biktarvy, with 5% in 2018 and 8% in 2019. In 2020 all QHP had eliminated Biktarvy PAs except for 18 plans in Washington State.

Photo Source: HIVinfo

A multi-center, phase 3, double-blind, randomized control clinical trial of treatment naïve PLWHA showed that Biktarvy had the efficacy of viral suppression equal to Triumeq.[2,3] Additionally, it showed that Biktarvy had no evidence of treatment-emergent resistance and was better tolerated gastrointestinal due to its formulation and smaller pill size. Moreover, Biktarvy does not contain abacavir and thus does not require HLA-B*5701 testing making it a good candidate for same-day ARV initiation.[1] 

Evidence-based data showed Biktarvy to be a better candidate for first-line drug treatment for many than Triumeq. Yet, as stated previously, QHPs lagged in coverage of Biktarvy compared to Triumeq, even in EHE priority-1 jurisdictions. There were higher OOP costs given that more QHP’s required coinsurance for Biktarvy, and PA requirements were also initially more frequent for Biktarvy.

The critical takeaway from the study is that QHPs can slow the adoption of new HIV single-pill regimens by non-coverage decisions and other hurdles that limit access.[1] This does not stop at single-pill regimens. Ongoing HIV research continues to produce novel and innovative treatments such as Cabenuva and Sunlenca. Insurance companies base their coverage decisions mainly on the costs of the medications. Strident efforts are needed to create regulations to lower drug pricing. Additionally, cost-sharing measures need to evolve, such as basing patient coinsurance on post-PBM discounted drug prices instead of pre-discounted prices.[1] 

Increasing the pricing of novel and effective medication challenges ADAP’s ability to continue to help people. Additionally, prohibitive OOP costs for patients discourage medication adherence and treatment initiation. Many structural barriers to HIV treatment equality exist. Runaway pharmaceutical pricing and insurance drug coverage that is not scientifically evidence-based should not be amidst those barriers.

[1] Khazanchi, R., Powers, S., Killelea, A. et al. Access to a novel first-line single-tablet HIV antiretroviral regimen in Affordable Care Act Marketplace plans, 2018–2020. J of Pharm Policy and Pract 16, 57 (2023). https://doi.org/10.1186/s40545-023-00559-8

[2] Acosta RK, Willkom M, Martin R, et al. Resistance analysis of Bictegravir–Emtricitabine–Tenofovir Alafenamide in HIV-1 treatment-naive patients through 48 weeks. Antimicrob Agents Chemother. 2019;63(5):e02533-18. https://doi.org/10.1128/AAC.02533-18

[3] Coffey S, Bacchetti P, Sachdev D, et al. RAPID antiretroviral therapy: high virologic suppression rates with immediate antiretroviral therapy initiation in a vulnerable urban clinic population. AIDS. 2019;33(5):825–32. https://doi.org/10.1097/QAD.0000000000002124

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.

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.