Trump Administration Applauds Itself for Rx Access Agreements, But Will They Help Patients?

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

In May 2025, President Donald J. Trump signed an executive order requiring, among other things, that pharmaceutical companies lower the prices of certain drugs to align with those charged in other comparably developed nations (e.g., most of Europe; Simons & Hopkins, 2025). Those companies that failed to comply with this order would be subject to administrative retaliation that imposes what the Trump Administration is calling “Most-Favored Nation” (MFN) pricing.

Photo Source: The White House

ADAP Advocacy covered this executive order last May, bringing several questions to the fore:

1. How will the U.S. Department of Health and Human Services (HHS) determine what the MFN price is for medications?
2. Which classes of medications and how many will be included in this pricing scheme?
3. Will these pricing agreements apply only to drugs purchased through public insurance programs, such as Medicaid, Medicare, and the Veterans Affairs (VA), or will these pricing agreements apply to drugs purchased using commercial insurance? (Franco, 2025)

In 2026, the Trump Administration’s "negotiations-at-gunpoint" approach has borne some fruit. The Trump Administration released a fact sheet late last year indicating that pricing and manufacturing agreements had been reached with 9 drug manufacturers (The White House, 2025). The details are available in the list below, which outlines each manufacturer’s agreement.

As with the executive order itself, the majority of the details of each manufacturer’s agreement with the Trump Administration are proprietary. What is striking about many of these deals is that the drugs sold direct-to-consumer are already off-patent, have cheaper biosimilars, or are no longer actively prescribed.

The latter is true for many of the medications used to treat HIV that will sold directly to patients, including Reyataz (Briston Myers Squibb; atazanavir), an oral protease inhibitor medication that was commonly used in combination with other medications, including Norvir (ritonavir; used to slow down the breakdown of Reyataz) and a nucleoside/nucleotide reverse transcriptase inhibitor (NRTI), such as Truvada (emtricitabine/tenofovir disoproxil fumarate).

Other drugs, such as Humira (Amgen), have multiple biosimilar options available at lower prices than Amgen's direct-to-patient pricing. Of greater concern is the possibility that these lower prices are merely stopgap measures that will remain in place only as long as the Trump Administration remains in office.

Photo Source: Houston Public Media | Win McNamee | Getty Images

While the optics of lower drug prices through forced “voluntary” negotiations look great on paper, most of these agreements come with three-year exemptions from tariffs imposed by the Trump Administration, which are currently facing a pending Supreme Court ruling on the legality of those tariffs under the International Emergency Economic Powers Act (IEEPA; Chung, 2026).

Should those tariffs be overturned by the Supreme Court or by a future president, drug manufacturers will have little incentive to honor many of the provisions of their respective deals, particularly U.S.-based manufacturing and research and development investments.

Further still, the opacity of these agreements, as well as HHS's determination of what “MFN” pricing is for individual drugs, means there remains little transparency into the drug pricing process. What’s to stop manufacturers from drastically increasing list prices to offset the “discounts” offered (Buntz, 2026)?

Finally, how many Americans will actually be able to access and afford these medications hinges on whether they have public (e.g., Medicaid, Medicare, VA) or commercial insurance (e.g., employer-sponsored, marketplace). While each manufacturer was voluntarily forced to sell medications on TrumpRx.gov, there is still no “TrumpRx”—the website is a placeholder site that promises “the lowest prescription drug prices in America,” but no details or actual drugs are listed. Instead, visitors are “graced” with a scowling (and AI-edited) photo of the president.

Photo Source: TrumpRx

The reality, here, is that Trump’s increasingly unpopular brand, as well as his long-documented failures to make good on the vast majority of his promises, are likely to drive away consumers, rather than convincing them to put their faith in anything with his name on it. But that’s the way of the day in our Trumpian dystopia: a power-hungry madman obsessed with branding everything with his name, like some heifer at the O.K. Corral.

In the short term, state Medicaid programs are the likeliest to benefit, as nearly every manufacturer has agreed to sell their medications to those programs at prices comparable to other developed nations (Lim, 2026). That will save states money, but most Medicaid patients already pay very low prices for most medications, meaning that the savings here are mostly to state governments rather than patients.

For direct-to-patient purchasing, while many patients may choose this route rather than enrolling in commercial insurance, for those who receive federal subsidies to offset monthly premiums, the complexity and secrecy of the U.S. healthcare system make it virtually impossible to determine whether patients will actually save money by skipping the middlemen.

ADAP Advocacy will continue to monitor MFN pricing and how that might impact people living with HIV/AIDS.

Drug Manufacturer MFN Agreement Outlines:

• Amgen
• Amgen will expand its direct-to-patient program, AmgenNow™, to include Aimovig® (migraine treatment) and Amjevita® (biosimilar to Humira to treat autoimmune conditions), at a discounted monthly price of $299. This expands the available drugs, which also includes Repatha® (cholesterol-lowering medication) at a monthly price of $239 (Amgen, 2025).
• Bristol Myers Squibb (BMS)
• BMS agreed to make Eliquis® (blood thinning medication) available to Medicare for free starting January 1st, 2026.
• Agreed to donate 7 tons of Eliquis to fill the U.S. Strategic Active Pharmaceutical Ingredient Reserve (SAPIR).
• Agreed to launch new medications with “…a more balanced pricing approach across developed nations”.
• Agreed to enable direct-to-patient access for cash-paying patients for Sotyktu® (plaque psoriasis), Zeposia® (relapsing multiple sclerosis and ulcerative colitis), Reyataz® (HIV), Baraclude® (Hepatitis B), Orencia® SC (autoimmune conditions).
• Each of these drugs will be sold at approximately 80% off the current list price through TrumpRx.gov (BMS, 2025).
• Boehringer Ingelheim
• Boehringer will offer medications directly to consumers through TrumpRx.gov
• Will sell Jentadueto (Type-2 Diabetes) for $55.
• Will invest $10 billion through 2028 to expand pharmaceutical research and development (R&D) and manufacturing operations in the U.S.
• Includes $1b specifically earmarked for capital expenditures (Boehringer Ingelheim, 2025).
• Genentech
• Genentech will provide medications to state Medicaid programs at prices comparable to other developed nations.
• Will allow certain drugs, including Xofluza (inflluenza) through TrumpRx.gov and through its recently established direct-to-patient program.
• Commits to increasing U.S. manufacturing, infrastructure, and R&D (Genentech, 2025).
• Gilead Sciences
• Gilead will offer discounts on certain existing medications, including those used to treat HIV, Hepatitis C, Hepatitis B, and COVID-19, for state Medicaid programs.
• Agreed to price future medications “…at parity” with other key developed nations.
• Will launch a direct-to-patient program for Epclusa® (Hepatitis C) at a discounted cash price that can be accessed through TrumpRx.gov (Gilead Sciences, 2025).
• GSK (formerly GlaxoSmithKline) / ViiV
• GSK will lower the prices of certain medications to state Medicaid programs, including most of its respiratory drug portfolio.
• GSK will also make most of its inhaled medications and other products available through a direct-to-patient program (TrumpRx.gov) at savings up to 66%.
• Will provide SAPIR with a reserve of albuterol (active ingredient in many inhalers used to treat asthma and chronic obstructive pulmonary disorder [COPD]; GSK, 2025).
• Merck
• Merck will provide direct-to-patient access to Januvia (Type-2 Diabetes), Janumet (Type-2 Diabetes), and Janumet XR through TrumpRx.gov.
• This will be expanded to include enlicitide decanoate, an investigational drug currently being developed to lower cholesterol, once it has received approval from the U.S. Food and Drug Administration (FDA; Merck, 2025).
• Novartis
• Novartis agreed to launch future medications at prices comparable with other developed nations.
• Will build direct-to-patient platforms for Mayzent (multiple sclerosis), Rydapt (acute myeloid leukemia and rare blood disorders), and Tabrecta (metastatic non-small cell lung cancer) through TrumpRx.gov.
• Will apply to participate in the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) model announced by the Trump Administration in November 2025 (HHS, 2025) aimed at improving access to medications through state Medicaid programs.
• Will support efforts to “…address the global imbalance in investment in pharmaceutical innovation” (Novartis, 2025).
• Sanofi
• Sanofi agreed to ensure that state Medicaid programs can access Sanofi medications at the same prices as other developed nations.
• Will reduce prices by an average of 61% for certain medications used to treat diabetes, cardiovascular and neurological conditions, and cancer.
• Will offer direct-to-patient access for certain drugs through TrumpRx.gov.
• Will implement a “…more balanced approach” on pricing in other nations.
• Agreed to increase investments in upgrading existing manufacturing facilities and expand manufacturing partnerships (Sanofi, 2025).

In addition to these companies, the Administration has entered into pricing and manufacturing agreements with:

• AbbVie
• AbbVie agreed to spending $100 billion in U.S. R&D and other capital investments over the next decade.
• Will provide “low prices” to state Medicaid programs.
• Will provide direct-to-consumer access to Humira (rheumatoid arthritis), Alphagan (glaucoma or ocular hypertension), Combigan (glaucoma or ocular hypertension), and Synthroid (hyperthyroidism) through TrumpRx.gov (Fidler, 2026).
• AstraZeneca
• AstraZeneca will provide direct-to-consumer sales to eligible patients with chronic diseases at a discount of up to 80% off list prices through TrumpRx.gov.
• Will invest $50 billion in manufacturing and R&D through 2030, 50% of which is expected to be generated in the U.S. (AstraZeneca, 2025).
• .ohnson & Johnson (J&J)
• J&J will provide direct-to-patient access through TrumpRx.gov.
• Will “…[enable] American patients to access medicines at comparable prices to other developed countries”.
• Will provide state Medicaid programs with access to medications at prices comparable to other developed nations.
• Announced two new U.S. manufacturing facilities in Pennsylvania and North Carolina (J&J, 2026).
• Eli Lilly
• Eli Lilly and Company will provide Medicare beneficiaries with Zepbound (weight management GLP-1 medication) and orforglipron, an investigational oral GLP-1 drug awaiting FDA approval, for no more than $50/month.
• State Medicaid programs will also be able to access these medications at reduced prices (prices not stated).
• Will enable self-paying (cash-paying) patients to access Zepbound at its lowest dose for $299, with additional doses up to $449 through direct-to-patient access, representing a $50 savings.
• Patients refilling their multi-dose pens will pay no more than $449.
• Will provide direct-to-patient orforglipron at the lowest dose for $149, with additional doses up to $399.
• Nota bene – the scope of this agreement DOES NOT include commercial pricing.
• Will add Emgality (migraines and cluster headaches), Trulicity (Type-2 Diabetes), and Mounjaro (specific to Type-2 Diabetes) to direct-to-patient channels at 50-60% off current list prices.
• Will continue to offer insulin to patients for no more than $35/month, whether a patient is commercially insured or uninsured (Eli Lilly, 2025).
• Pfizer
• Pfizer agreed to implement measures to ensure Americans receive “…comparable drug prices to those available in other developed countries,” and will price new medications at parity with other developed markets.
• Will participate in direct-to-patient sales through TrumpRx.gov, allowing Americans to purchase primary care treatments and specialty drugs at an average discount of 50% and at discounts of up to 85%.
• Committed to investing an additional $70 billion in the U.S. for R&D and capital projects over the next few years (Pfizer, 2025).

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] Amgen. (2025, December 19). Amgen takes action with the U.S. government to lower the cost of medicines for American patients. Thousand Oaks, CA: Amgen: Newsroom: Press Releases. https://www.amgen.com/newsroom/press-releases/2025/12/amgen-takes-action-with-the-u-s--government-to-lower-the-cost-of-medicines-for-american-patients

[2] AstraZeneca. (2025, October 10). AstraZeneca announces historic agreement with US Government to lower the cost of medicines for American patients. Cambridge, UK: AstraZeneca: Media Centre: Press Releases. https://www.astrazeneca.com/media-centre/press-releases/2025/astrazeneca-announces-historic-agreement-with-us-government-to-lower-the-cost-of-medicines-for-american-patients.html

[3] Boehringer Ingelheim. (2025, December 19). Boehringer Ingelheim announces broad agreement with the U.S. Government to lower the cost of medicines for American patients and expand its U.S. footprint. Ridgefield, CT: Boehringer Ingelheim: US: Media: Press Releases. https://www.boehringer-ingelheim.com/us/media/press-releases/boehringer-ingelheim-announces-agreement-us-government

[4] Bristol Myers Squibb. (2025, December 19). Bristol Myers Squibb Announces Agreement with U.S. Government to Improve Affordability and Access to Critical Medicines for Americans. Princeton, NJ: Bristol Myers Squibb: News: Corporate/Financial News. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Announces-Agreement-with-U-S--Government-to-Improve-Affordability-and-Access-to-Critical-Medicines-for-Americans/default.aspx

[5] Buntz, B. (2026, January 02). Drug companies sign “Most Favored Nation” deals, then raise prices anyway. Cleveland, OH: WTWH Media LLC: Drug Discovery & Development. https://www.drugdiscoverytrends.com/drug-companies-sign-most-favored-nation-deals-then-raise-prices-anyway/

[6] Chung, A. (2026, January 09). Supreme Court plans rulings for January 14 as Trump's tariffs remain undecided. London, UK: Reuters: Legal: Government. https://www.reuters.com/legal/government/supreme-court-set-issue-rulings-trump-awaits-fate-tariffs-2026-01-09/

[7] Eli Lilly and Company. (2025, November 06). Lilly and U.S. government agree to expand access to obesity medicines to millions of Americans. Indianapolis, IN: Eli Lilly and Company: News Releases. News Release Details. https://investor.lilly.com/news-releases/news-release-details/lilly-and-us-government-agree-expand-access-obesity-medicines

[8] Fidler, B. (2026, January 13). AbbVie pledges $100B to US production in drug pricing deal with Trump. Newton, MA: Industry Dive: Biopharma Dive: News. https://www.biopharmadive.com/news/abbvie-drug-price-deal-trump-most-favored-nation/809441/

[9] Franco, M. A. (2025, May 14). Trump Administration Revives Most-Favored-Nation Drug Pricing: Here's What to Know. Holland & Knight: Insights. Retrieved from https://www.hklaw.com/en/insights/publications/2025/05/trump-administration-revives-most-favored-nation-drug-pricing

[10] Genentech. (2025, December 19). Genentech Announces Agreement With U.S. Government. South San Francisco, CA: Genentech: Media: Press Releases. https://www.gene.com/media/press-releases/15094/2025-12-19/genentech-announces-agreement-with-us-go

[11] Gilead Sciences. (2025, December 19). Gilead and U.S. Government Enter Agreement to Lower Costs of Medicines for Americans. Foster City, CA: Gilead Sciences: News: News Releases. https://www.gilead.com/news/news-details/2025/gilead-and-u-s--government-enter-agreement-to-lower-costs-of-medicines-for-americans

[12] GSK. (2025, December 19). GSK enters agreement with U.S. government to lower drug prices and expand access to respiratory medicines for millions of Americans. London, UK: GSK: Media: Press Release Archive. https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-with-us-government-to-lower-drug-prices-and-expand-access-to-respiratory-medicines-for-millions-of-americans/

[13] Johnson & Johnson. (2026, January 08). Johnson & Johnson Reaches Agreement with U.S. Government to Improve Access to Medicines and Lower Costs for Millions of Americans; Delivers on U.S. Manufacturing and Innovation Investments. New Brunswick, NJ: Johnson & Johnson: Media Center: Press Releases. https://www.jnj.com/media-center/press-releases/johnson-johnson-reaches-agreement-with-u-s-government-to-improve-access-to-medicines-and-lower-costs-for-millions-of-americans-delivers-on-u-s-manufacturing-and-innovation-investments

[14] Lim, D. (2026, January 04). Trump’s drug-pricing deals won’t benefit most Americans today. They could over time. Politico: News. https://www.politico.com/news/2026/01/04/trumps-drug-pricing-deals-wont-benefit-most-americans-today-that-could-over-time-00706529?cid=Connatix

[15] Merck. (2025, December 19). Merck Reaches Agreement With U.S. Government to Expand Access to Medicines and Lower Costs for Americans. Rahway, NJ: Merck: Media: News Releases. https://www.merck.com/news/merck-reaches-agreement-with-u-s-government-to-expand-access-to-medicines-and-lower-costs-for-americans/

[16] Novartis. (2025, December 19). Novartis and US government reach agreement on lowering drug prices in the US. Basel, CH: News. https://www.novartis.com/news/media-releases/novartis-and-us-government-reach-agreement-lowering-drug-prices-us

[17] Pfizer. (2025, September 30). Pfizer Reaches Landmark Agreement with U.S. Government to Lower Drug Costs for American Patients. New York, NY: News: Press Release. Press Release Details. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reaches-landmark-agreement-us-government-lower-drug

[18] Sanofi. (2025, December 19). Press Release: Sanofi reaches agreement with the US government to lower medicine costs while strengthening innovation. Paris, FR: Sanofi: English: Media Room: Press Releases. https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-19-19-21-43-3208697

[19] Simons, R. & Hopkins, M. J. (2025, May 22). Is Trump's executive order on Most Favored Nations drug pricing a wet noodle? Nags Head, NC: ADAP Advocacy. https://adapadvocacyassociation.blogspot.com/2025/05/is-trumps-executive-order-on-most.html

[20] United States Department of Health and Human Services. (2025, November 06). CMS Announces New Drug Payment Model to Strengthen Medicaid and Better Serve Vulnerable Americans. Washington, DC: United States Department of Health and Human Services: Press Room. https://www.hhs.gov/press-room/cms-announces-new-drug-payment-model-to-better-serve-vulnerable-americans.html

[21] White House, The. (2025, December 19). Fact Sheet: President Donald J. Trump Announces Largest Developments to Date in Bringing Most-Favored-Nation Pricing to American Patients. Washington, DC: The White House: Fact Sheets. https://www.whitehouse.gov/fact-sheets/2025/12/fact-sheet-president-donald-j-trump-announces-largest-developments-to-date-in-bringing-most-favored-nation-pricing-to-american-patients/

Trump Administration Pushes Two New Rebate Models, But Will They Help Patients?

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

The Centers for Medicare and Medicaid Services (CMS) has released information about a new proposed mandatory pricing model—the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model—that would assess the inflation rebate amounts paid for certain medications covered under Medicare Part D using a benchmark derived from international pricing information rather than using current domestic benchmarks (CMS, 2025).

Photo Source: CMS

The GUARD model is one of two pricing models being proposed by the Trump Administration—the other being the Global Benchmark for Efficient Drug Pricing (GLOBE), which would assess inflation rebates for drugs covered under Medicare Part B.

In both models, the Trump Administration plans to use modeling to employ drug “rebate models,” which are payment models ostensibly intended to lower the cost of medications by having drug manufacturers return a percentage of the purchase price to the buyers. These rebates are generally negotiated behind closed doors between payors, including pharmacy benefit managers (PBMs), insurers, and government programs, with drug manufacturers. Once those rebate amounts are set, drug manufacturers remit rebate payments to payors only after the drugs have been purchased and dispensed (SmithRx, 2025).

CMS's GUARD Model would attempt to reduce Medicare drug spending by tying prices to international benchmarks and collecting rebates from manufacturers when prices exceed those. 

Rebates, such as the proposed 340B Drug Pricing Program rebate model, can be an effective means of introducing cost savings into health care systems and indirectly helping patients, because they bring added transparency. In the case of the GUARD Model, they can also disadvantage patients. That is because the rebated price is not known at the time that the patient is dispensed the medication. Accordingly, out-of-pocket costs are calculated based on the higher "list" prices of drugs, forcing patients to pay more in deductibles, coinsurance, and copayments at the pharmacy counter.

In essence, the wider health care system may benefit from a rebate, but the patient may see no reduction in their costs. The 340B rebates differ from GUARD/GLOBE in that 340B rebates are specifically designed to be passed onto the consumer in the form of increased investment in/access to/savings for healthcare services. GUARD/GLOBE rebates are specifically designed to go to payors, with no requirements whatsoever that those revenues be reinvested or savings passed on.

Drug rebate models have been in place in the U.S. since the 1990s, with the creation of the Medicaid Prescription Drug Rebate Program (MDRP) under the Omnibus Reconciliation Act. They are also actively used in at least 31 European countries, including Italy, Portugal, Spain, France, Germany, and the United Kingdom (Vogler et al., 2012).

Photo Source: ADAP Advocacy | iStock

The primary rationale behind these rebate models is that requiring manufacturers to pay rebates to payors incentivizes drug manufacturers to keep drug prices lower. While this might be true in nations where this is a single payor, such as those listed above, rebate models in the U.S. have objectively poorer outcomes.

Recent research from the Leonard D. Schaeffer Institute for Public Policy & Government Service out of the University of Southern California found that, on average, every $1 increase in rebates was associated with $1.17 increase in list prices, particularly for single-source drugs—a Food and Drug Administration (FDA)-approved medication available from only one manufacturer, often lacking a generic equivalent, and specifically the types of drugs that will be evaluated under both the GUARD and GLOBE models being proposed (Sood et al, 2020).

Another study examined rebates for 444 unique branded medications and found that, while drug manufacturers may increase list prices in order to offer larger rebates to payors, consumers—particularly those lacking health insurance coverage—experienced statistically significant increases in out-of-pocket costs for those medications (Yeung et al., 2021).

Decades of research confirm what people living with HIV/AIDS already know: out-of-pocket costs lead to skipped doses, delayed refills, or complete abandonment of prescriptions. 

Public health data from the Centers for Disease Control show that a significant share of people living with HIV/AIDS (PLWHA) report cost-related non-adherence. A 2019 study found that 7% of PLWHA in the U.S. reported non-adherence to prescribed dosing due to cost-related concerns, with another 4% reporting skipping doses, 4% reporting taking less medicine, and 6% reporting delaying medication purchases (Beer et al., 2019).

Sadly, PLWHA facing affordability challenges may delay or abandon medications because they are unable to afford out-of-pocket costs.  These cost-saving behaviors are directly associated with lower rates of viral suppression, poorer health outcomes, and increased strain on the healthcare system.

Research has also demonstrated that very small cost-sharing amounts can have outsized effects. Studies examining HIV prevention and treatment medications have found that prescription abandonment rates rise sharply when out-of-pocket costs increase from $0 to even $10 (Dean et al., 2024). Persistence on therapy drops as costs rise—a finding that should concern everyone.

Photo Source: ADAP Advocacy | iStock

Put simply, when patients pay more, adherence suffers, and people's health suffers.

In order for rebates to truly result in lower costs for consumers, the U.S. would need to do away entirely with our multi-payor healthcare model, which requires different payors (both for-profit and government-based) each have to enter into pricing and rebate negotiations with drug manufacturers to set prices and rebate amounts.

Pressure campaigns are effective only when pressure is applied from all sides. While drug manufacturers are unlikely to abandon a revenue cash cow like the Medicare program, they still have non-Medicare-enrolled consumers onto whom they can push increased drug prices with few to no negative outcomes. Consumers have come to not only accept but also expect medication price inflation, especially when there are few, if any, viable comparable alternative therapies available to them.

What the GUARD and GLOBE programs are intended to do is force manufacturers to provide higher rebates for medications that CMS deems “too expensive.” This, they posit, will result in lower drug costs for seniors and those non-seniors who rely on Medicare for drug coverage. The reality is that those consumers will likely realize few, if any, net savings from these programs, so long as there are multiple payors willing to pay whatever price is needed to move medications to their customers.

Although the GUARD proposal may seem promising to some, it does not require that these rebates be automatically passed on to patients in the form of lower out-of-pocket costs. That central problem needs to be addressed before the proposal is finalized and implemented.

The proposal states that it hopes that lower GUARD prices will benefit patients. The proposal says that "[i]t is possible that in response to the alternative payments]" GUARD creates manufacturers might "reduce their net price" in an effort to reduce the GUARD Model rebate payments. If so, then there might be some chance that patients would benefit from the GUARD prices. 

But the "possibility" that GUARD "might" help patients at the pharmacy counter just is not good enough. ADAP Advocacy plans to submit public comment in response to these proposals that address the patient perspective.

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] Beer, L., Tie, Y., Weiser, J., & Shouse, R. L. (2019, December 13). Nonadherence to Any Prescribed Medication Due to Costs Among Adults with HIV Infection — United States, 2016–2017. Morbidity and Mortality Weekly Report, 68(49): 1,129-1,133 http://dx.doi.org/10.15585/mmwr.mm6849a1

[2] Centers for Medicare and Medicaid Services. (2025, December 29). GUARD (Guarding U.S. Medicare Against Rising Drug Costs) Model. United States Department of Health and Human Services: Centers for Medicare and Medicaid Services: Priorities: Overview: Innovation Models. https://www.cms.gov/priorities/innovation/innovation-models/guard

[3] Dean, L. T., Nunn, A. S., Chang, H. Y., Bakre, S., Goedel, W. C., Dawit, R., Saberi, P., Chan, P. A., & Doshi, J. A. (2024). Estimating The Impact Of Out-Of-Pocket Cost Changes On Abandonment Of HIV Pre-Exposure Prophylaxis. Health affairs (Project Hope), 43(1), 36–45. https://doi.org/10.1377/hlthaff.2023.00808

[4] SmithRx. (2025, March 21). How Drug Rebates Influence Prescription Costs for Employers. San Francisco, CA: SmithRx. https://smithrx.com/blog/how-drug-rebates-influence-prescription-costs-for-employers

[5] Sood, N., Ribero, R., Ryan, M., & Van Nuys, K. (2020, February 11). The Association Between Drug Rebates and List Prices. Los Angeles, CA: University of Southern California: Leonard D. Schaeffer Institute for Public Policy & Government Service. https://schaeffer.usc.edu/research/the-association-between-drug-rebates-and-list-prices/ 

In Memoriam: Edward "Rick" Macsata

By: Brandon M. Macsata, CEO, ADAP Advocacy

The ADAP Blog has a longstanding tradition of presenting facts about policy issues, typically in the third person. On a rare occasion, our blog presents "opinion" pieces, and even more rarely, about something personal. I ask that you please indulge me this week to share some personal news about the passing of my father, Edward "Rick" Macsata.

Edward "Rick" Macsata

I do so because my father had a keen interest in ADAP Advocacy, not only because his son was the CEO. Upon learning about my HIV-diagnosis, my father asked me to educate him about the condition. I recall using a diagram shared by Dr. Princy N Kumar, chief of the Division of Infectious Diseases and Travel Medicine at MedStar Georgetown University Hospital, during one of her presentations at an ADAP Conference. When news stories would post about a possible cure, he would ask me if it was real.

My father met and relished in conversation with William "Bill" Arnold, Edward "Eddie" Hamilton, and Brent Shimmin, all of whom he will now join in Heaven. In fact, he met many of the people reading this memorial.

My father and my mother donated financially to the organization annually. He attended a congressional briefing hosted by ADAP Advocacy in Washington, DC, where he met former Senator Richard Burr (R-NC) and former Representative Donna Christensen (D-VI). He attended multiple wine-tasting fundraisers in the early years of our organization. He read nearly every report published by our organization, and most recently, he absolutely loved our 340B commercials, asking me why we couldn't run them in Connecticut so he could see them.

On January 6, 2026, at 10:02 a.m., my father hit the apex of the surly bounds of Earth, most likely straddling his 2006 Harley-Davidson Electra Glide, listening to Waylon Jennings’ "Good Hearted Woman." A lifelong resident of Torrington, Connecticut, he was known to those who knew and loved him as Rick, and they undoubtedly appreciated his unmatched precision with a measuring tape or construction levels. My father had two true loves in his life: my mother and her cooking. God called my father home, waving the checkered flag for the last time. Few could match his grasp and navigational prowess with an old-fashioned Atlas. Yet over the forty years since their mainstreaming in American households, almost anyone could operate a microwave oven better than he could. The stove was his nemesis, but a circular saw sang to him better than any music by the supergroup, The Highwaymen. He was stubborn, yet humble. He was stern, yet a big teddy bear. He was an immovable object, yet light as a feather. He was always right, followed only by admitting he was wrong. His life’s simple pleasures included lemon meringue pie, NASCAR, Kansas City Chiefs’ games on fall Sunday afternoons, Landline truckers’ magazine, Yuengling, Asiago Cheese, Clams Casino, grilled hamburgers, skiing, car roadshow programs, or watching sailboats on the Atlantic Ocean. But few things in his life brought him more joy than my mom’s kisses or his grandson’s intoxicating laughter. My father’s transition to the After Life, though a loss to those close to him, means Heaven has now added a devoted husband, loving father, and grandfather for the ages.

Grandpa with his little guy, Sebastian

No amount of education, career achievements, or lived experience can prepare us for the loss of a parent.

This summer, I gave my father the song by Luke Combs, “My Old Man Was Right,” because I knew in my heart that I was losing him to cancer. It was a painful self-admission, and it made me look inward at my feelings toward him. No words can express the gratitude that I hold in my heart for my father. Sometimes, I’m told that I'm too compassionate with people and that I offer to help too much. But I learned that compassion from my father. As a kid, I remember him helping a woman in need at the market when her car wouldn’t start. I'm often told that I work too hard. But I learned that work ethic from my father. As a kid, I remember how he poured his soul into every project. I also remember him always offering a helping hand to virtually anyone who walked into his life. He fixed my friend’s bike. He fixed our neighbor’s lawnmower. He fixed cars. He fixed faucets. I’m always helping the people in my life because that is all I ever saw my father do. I had the opportunity to share with my father that I am the man that I am today because he helped to shape me. 

Rest in peace, dad.

Edward "Rick" Macsata's Obituary: https://www.cookfuneralhomect.com/obituaries/edward-rick-macsata

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.

2025: A Look Back on Our Advocacy

By: Brandon M. Macsata, CEO, ADAP Advocacy

ADAP Advocacy inches toward the conclusion of an active year in advocacy, one defined by chaos, perseverance, and targeted success. At the outset of 2025, we issued a call to serve for grassroots patient advocates. The MAGA movement's return to power set the stage for upheaval. Still, very few advocates could have predicted the scope of the damage being done to the nation's public health system, ranging from vaccine skeptics driving misinformation into the mainstream to dangerous price control schemes, or draconian cuts to both prevention and treatment services for people living with HIV/AIDS. ADAP Advocacy was among the first national advocacy organizations to warn that cuts were coming to popular programs, like the Ryan White HIV/AIDS Program, despite the widely accepted belief these programs were "safe" from ideological attacks.

Our contribution to fighting the Trump Administration's dangerous policies was to re-engage our grassroots network, which had last been deployed during the ADAP Crisis in 2008-2012. It's older now, with even more ailments, but still vibrant and committed enough to deliver effective patient advocacy. At no time was it more necessary than when the bombshell hit that HIV prevention funding was being gutted at the Centers for Disease Control & Prevention. When these critical HIV prevention programs faced elimination, ADAP Advocacy, like so many other organizations, stepped up and warned lawmakers about the negative repercussions. These cuts were only exacerbated by the One Big Beautiful Bill Act (OBBBA) and its steep cuts to Medicaid, which our grassroots efforts also opposed. Whereas far too many funding cuts have occurred this year, they have also sparked a renewed call for patient advocates to be more vocal about the policy decisions that could affect them.

There is no greater example of the need for patient advocates to engage than the 340B Drug Pricing Program. In 2025, ADAP Advocacy launched its 'Too Big To Fail?' national advocacy campaign, comprised of blogs, television commercials, fact sheets, policy papers, and op-eds. Our commercial calling out hospitals for aggressive debt collection garnered over half a million views on YouTube, alone. Our op-ed in POZ Magazine, "Why the 340B Rebate Model Puts Patients Before Profits", added the patient perspective to this important policy debate.

Photo Source: POZ Magazine

As long-overdue reforms to the program appear within reach, primarily designed to improve access to care and treatment through better accountability and transparency, special interest groups are turning up the heat. These paternalistic ableist voices are a growing threat to silence patient advocates. Provider groups with executives making hundreds of thousands of dollars in compensation packages, and in some cases, exceeding $1 million, telling patients who cannot afford their copayments what is "best" for them is something even the best Hollywood screenwriter couldn't dream up. Starting this year, we're calling a spade a spade when it comes to this behavior.

One key area of success was on long-acting injectables. Despite more state AIDS Drug Assistance Programs (ADAP) following in the footsteps of their state Medicaid programs and covering Cabenuva on their drug formularies, there remain some holdouts. Until 2025, Texas's HIV Medication Program (THMP) had refused to offer Cabenuva...that is, until Texas advocates mobilized and relentlessly pushed for change. ADAP Advocacy, to the extent it was asked to help, chimed in on several occasions. But it was the local voice that brought about real change for people living with HIV/AIDS in their state. We've long embraced the need for national organizations to lead on federal policy, leaving state and local policy debates to the folks who call them home. National groups "meddling" in state policy affairs are rarely successful.

Photo Source: Prism Health North Texas

Our collaborative work was highlighted with the Partnership for Safe Medicines, combating counterfeit drugs, with PlusInc, about the patient perspective on prior authorization, with the Global Coalition on Aging, safeguarding innovation and access for older adults, or spearheading 37 organizations seeking an HIV carveout from the harmful impacts of the Inflation Reduction Act. We hosted key stakeholders for Health Fireside Chats in Minneapolis, Minnesota, and Atlanta, Georgia. Our three patient advisory committees engaged throughout the year to ensure that the voice of persons living with HIV/AIDS shall always be at the table and the center of the discussion.

As ADAP Advocacy enters 2026, patient-centered advocacy resources and tools will become even more critical, and our organization is eagerly preparing to deliver some new ideas. A look back at our advocacy has to focus on the future, mainly by improving access and addressing affordability. 

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.

We Humbly Thank You, Ranier

By: Brandon M. Macsata, ADAP CEO

Since January 2022, Ranier Simons has delivered the weekly ADAP Blog to thousands of stakeholders across the country. Beginning with his first guest blog on COVID-19 breakthrough infections among people living with HIV, Ranier has approached his writing with objectivity, quality, and sensitivity. Patients writing blogs, or anything else for that matter, about patient perspectives keeps the focus on people living with HIV/AIDS, which has been one of our organization's value statements since its founding 18 years ago. Ranier embodied that spirit for us over the last four years.

Ranier Simons

ADAP Advocacy's reputation for delivering timely, relevant updates about the issues impacting patients has been strengthened thanks to Ranier. No topic was too simple or too complex for him to analyze, summarize, and present its information in a patient-centric tone. Ranier has tackled issues like prenatal HIV transmission, counterfeit medications, HIV criminalization, drug formularies, and the 340B Program. In fact, his recent blog, Courts Put Guardrails on 340B Program, Aiding Reform Efforts to Ebb Abuse, was among the most-read, reaching nearly 5,000 readers.

Ranier's writing offered a unique lens as a patient, caregiver, advocate, and numbers cruncher. He certainly lived up to his mantra, "Finding the data story for informed decision making!"

On December 5th, Ranier penned his last guest blog for ADAP Advocacy. He has accepted a new, full-time position with the Community Access National Network. Ranier's service to our organization can only be measured by the grace and humility that he brought to our ADAP family, and it is deserving of our recognition.

On behalf of the ADAP Advocacy Association and its board of directors, we humbly thank you, Ranier!

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.    

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.