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.    

Why the 340B ACCESS Act Prioritizes Patients

By: Marucs J. Hopkins, ADAP 340B Consultant

In September 2025, Representatives Earl L. “Buddy” Carter (R-GA) and Diana Harshberger (R-TN) introduced the 340B Affording Care for Communities and Ensuring a Strong Safety-Net (ACCESS) Act. H.R.5256 attempts to rein in what members of both parties have come to view as the excesses of the 340B Drug Pricing Program.

This act, as written, includes several provisions that have the potential to fundamentally change the 340B program, including:

• A very specific, if not clear, definition of who constitutes a “patient” for a 340B covered entity;
• New rules that would require hospitals to provide their 340B discounted drugs to patients who qualify as “low-income” at a reduced price or free;
• New provisions that would allow the Secretary of Health and Human Services (HHS) to set limits on the fees that third-party administrators (TPAs) and Pharmacy Benefit Managers (PBMs) can charge for 340-related services;
• Provisions that would tighten the rules for how 340B hospitals calculate their disproportionate share (DSH percentage) by requiring hospitals to demonstrate that each child site (e.g., off-site clinics) independently meets standards for serving low-income and vulnerable patients, including when registering for state Medicaid programs; 
• A provision that allows hospitals to enter contracts with “contract pharmacies” without limiting the number of said pharmacies with which a hospital can enter a contract, except for some covered entities, free-standing cancer hospitals, and rural referral centers, which can only contract with a maximum of 5 contract pharmacies; and,
• Provisions that would create a clearinghouse for prescription drug data;
• New reporting requirements for hospitals.

While many of these provisions address several of the issues that patients, advocates, providers, and manufacturers have with the program (e.g., duplicate discounts, contract pharmacy “discrimination,” and transparency requirements), specific provisions raise concerns about both the short- and long-term impacts on vulnerable patient populations, older patients, live in remote or rural areas, and/or living with chronic conditions that require specialty care and medications.

Photo Source: Congress.gov

Defining a “Patient”

Sec. 2, (a)(3)

One of the key issues with the 340B Drug Pricing Program, as originally drafted, is that the legislation did not define which patients qualify as “patients” for 340B drug discounts and rebates.

H.R. 5256 defines a patient by using a 4-part checklist (with some specific restrictions):

1. The patient receives care from the covered entity (CE) on a regular enough basis that they have an established relationship with the CE, and the CE keeps and maintains patient records;
2. The patient receives services from a provider who is either directly employed by or contracted to provide services for the CE;
3. The patient receives a prescription for a 340B discounted drug that is the direct result of the services a patient receives in step 2; and,
4. The patient must have an “ongoing relationship” with the provider, defined as at least one in-person visit within the prior 24 months (2 years).

To qualify as a “patient,” the patient must satisfy all four conditions. These provisions are designed to reduce the number of “patients” receiving 340B-discounted drugs—an issue that manufacturers and advocacy groups have been raising since the program's inception.

There are two specific issues within the patient definition that have the potential to severely and negatively impact patients who are older, remote or rural, and/or living with a chronic condition:

For patients who receive a prescription via a telemedicine or telehealth visit, the patient must have undergone an in-person examination by the CE within the six months prior to the prescription being written. This appears to have been designed to reduce the potential for hospitals and other CE to receive 340B rebates for ineligible patients receiving telehealth services. Still, it could recreate the distance, transportation, and geographic barriers that telehealth was designed to overcome (Sec. 2, (a)(3)(B)).

For patients requiring specialty care from providers not directly employed or contracted by the CE, another provision requires strict documentation of the coordination of care between the CE and the outside specialist provider. This provision has the potential to limit the available care options available to vulnerable patients, particularly those with chronic conditions. In order for that care to qualify, the patient’s case must satisfy each of the following conditions:

• The Initial Visit: The patient must have an in-person visit with a provider at the 340B hospital or clinic.
• The Formal Referral: During that visit, the 340B provider must formally evaluate the patient, determine that they need specialty care that the hospital does not offer (e.g., advanced rheumatology), and make a formal recommendation (a referral) for them to see that outside specialist.
• The Documentation: The 340B provider must document this evaluation and recommendation in the patient’s medical record at that time.
• The 1-Year Window: The patient must then see that outside specialist for the recommended service within 1 year of the date of that initial recommendation.

Again, this provision was designed to solve two issues:

1. The "Pop-in" Problem: A patient with HIV sees a private infectious disease doctor (unaffiliated with a 340B hospital) and gets a prescription for an expensive HIV medication.
2. The "Referral" Loophole: That doctor then "refers" the patient to a 340B hospital's contract pharmacy. The patient walks into the pharmacy, registers, and gets their prescription filled at a massive discount, even though they never received any actual care from the 340B hospital itself.

While the patient definition is vital for reining in abuses of the 340B program, there are still some issues to work out before this bill goes into effect (Sec. 2, (a)(3)(C)).

Who Gets the Discount?

Sec. 6, (a)(G)

One of the primary issues raised by patient advocates about the 340B Program is that the savings for patients rarely “trickle down” to them.

If the purpose of the 340B Program was to increase access to affordable or free care and treatment for lower-income patients, shouldn’t those deep drug discounts be directly extended to the patients whose income nets hospitals and other CE 340B revenue?

Sadly, too many hospitals don't think so.

Photo Source: iStock - rights purchased

H.R. 5256 would require hospitals to establish a sliding fee scale, which requires the CE to provide a direct discount to eligible patients that would result in that patient paying no more than a pre-defined maximum out-of-pocket obligation as it relates to each 340B-covered outpatient drug:

• If the patient’s income is less than the Federal Poverty Level (FPL), the out-of-pocket obligation is $0;
• If the patient’s income is at or above the Federal poverty guidelines but below 200 percent of the Federal poverty guidelines, the lesser of 20 percent of the otherwise applicable out-of-pocket obligation or $35; and,
• If the patient’s income is at or above 200 percent of the Federal poverty guidelines, the lesser of 30 percent of the otherwise applicable out-of-pocket obligation or $50 applies.

This provision requires any contract pharmacies contracted with the CE to provide these discounts on behalf of the CE.

While these provisions are a welcome change, hospitals could make the process so cumbersome for patients that these discounted prices become inaccessible. To receive this discount, hospitals will likely require patients to formally apply and be approved by the hospital’s financial assistance policies. This is very likely to include administrative paperwork and income verification hurdles that are regularly used to dissuade patients from applying. Moreover, this could result in the creation of scenarios where patients would receive those discounts at off-site pharmacies (e.g., Walgreens, CVS), but the pharmacy must act as a “financial screener” to ensure that the patient has applied for and received approval for those discounts, which could result in delays of care at the point-of-sale.

It could also result in a backend administrative nightmare for providers and pharmacists, requiring real-time eligibility checks, the calculation of a drug-specific sliding-scale price, and proper claim processing. This could also lead to higher operating costs for pharmacies.

Limiting Third-Party Fees for Providing 340B-Related Services

Sec. 17, (f)

This provision essentially prohibits third-party administrators (TPAs) and pharmacy benefit managers (PBMs) from applying specific fee scales to 340B-related services. For example, TPAs would be required to provide services at a flat fee that is NOT based, directly or indirectly, on a percentage of the 340B savings the TPA helps the hospital identify.

For example, many TPAs and PBMs operate on a “percentage-of-savings” model, which allows them to charge a hospital a specific percentage of the savings it receives (e.g., 20%). In this case, the TPA/PBM gets 20% of the savings.

Under this new provision, this highly lucrative business model would be eliminated. For the TPAs/PBMs, this could prove financially disastrous, requiring them to compete on a new model, such as a simple flat-rate or per-prescription fee, or forcing TPAs to exit the 340B space (a net win for hospitals and patients).

It also addresses one of the primary issues manufacturers have been complaining about for decades: that 340B revenues aren’t going just to CEs but are being siphoned off by third-party administrators.

Reining in the Expansion of 340B Eligibility to Child Sites

Sec. 4, (a)

This provision would eliminate the ability of hospitals to extend 340B program eligibility to numerous off-campus “child sites,” specifically those that are located in affluent areas and those that do not independently meet the disproportionate share percentage requirements that would allow them to be eligible for the 340B program on their own.

This would make it much harder for hospital systems to purchase private practices in wealthy areas and immediately begin receiving 340B revenues from drugs provided by those locations. It would also require those child sites to be fully integrated into the hospital system, specifically by requiring those facilities to enroll as Medicaid providers. Finally, this provision would require hospitals to de-register any off-campus sites that cannot meet these new requirements.

Contract Pharmacy Rules

Sec. 5

This section would allow CEs to engage an unlimited number of contract pharmacies to provide services (with specific exceptions) and require drug manufacturers to furnish drugs to those pharmacies.

The 340B program is ripe for abuse, specifically by major hospital systems, large pharmacy chains, and Pharmacy Benefit Managers (PBMs), where little to no oversight exists to ensure that 340B revenues are used for their intended purposes. Despite this lack of oversight, the number of retail contract pharmacies has exploded over the last 15 years.

From 2009 to 2022, the number of retail contract pharmacies participating in the 340B program increased from just 789 to an astonishing 25,775. By 2023, five for-profit pharmacies and Pharmacy Benefit Managers (PBMs)—CVS Health, Walgreens, Cigna (via Express Scripts), UnitedHealth Group (via OptumRx), and Walmart—accounted for 75% of all 340B contract pharmacy relationships with covered entities, bringing in an estimated $3 billion in gross profits.

Photo Source: Drug Channels Institute

Editor's Note: According to Dr. Adam Fein with the Drug Channels Institute, "The 340B contract pharmacy has become increasingly concentrated with five multi-billion-dollar, for-profit, publicly traded pharmacy chains and pharmacy benefit managers (PBMs)—Cigna (via Express Scripts), CVS Health, UnitedHealth Group (via Optum Rx), Walgreens, and Walmart."

One of the chief complaints from manufacturers and some patient advocacy organizations is that this unlimited expansion of contract pharmacies creates scenarios where patients are receiving medications from pharmacies that are nowhere near them, such as a patient living in urban Colorado, but their contract pharmacy only has physical locations in Hawaii (this is not a specific example).

This bill would require a contract pharmacy to be located within the service area of the CE, except for mail-order pharmacies (Sec. 5 (F)(iv)).

Of particular concern here is the cap on contract pharmacies for standalone cancer hospitals and rural referral centers. H.R. 5256 limits the number of contract pharmacies these providers may engage for pharmacy services to 5. Moreover, this subset of CEs may NOT engage a mail-order pharmacy to provide 340B drugs (Sec. 5, (F)(iii)).

This could result in scenarios where patients who currently receive one or more specialty drugs from one or more mail-order pharmacies may no longer have those options, forcing them to get all of their medications from a single pharmacy, or forcing the CEs in this subset to simply not contract with any specialty pharmacy at all, leaving patients with no options to receive 340B-discounted drugs.

Creating a 340B Clearinghouse

Sec. 16, (a)(C)

H.B. 5256 also requires the Health Resources Services Administration (HRSA) to create a federal 340B program claims data clearinghouse for the submission of claims-level data for covered outpatient 340B.

This clearinghouse is designed to prevent “duplicate discounts”—a scenario in which a manufacturer is required to both provide a 340B discount and pay a Medicaid rebate for the same drug sale. The bill also requires all state Medicaid programs, Medicaid Managed Care Organizations (MCOs), Medicare Part D plans, and Medicare Advantage plans to submit their claims data to this clearinghouse within 5 days following the date of claim payment.

In this new system, the process would work like this:

• A patient receives a drug.
• Medicaid pays the claim.
• Data is sent to the clearinghouse within 5 days.
• Data is cross-referenced with prescription data from 340B hospitals and instantly identifies if the drug was purchased with a 340B discount.
• The system flags the claim, preventing the state Medicaid program from also putting the same drug on its quarterly rebate invoice to the drug manufacturer.

This is widely viewed as a win for manufacturers, but could create a compliance risk if the clearinghouse is inaccurate. It basically requires hospitals to be 100% accurate at all times, which is virtually impossible.

The creation of this clearinghouse may also raise patient privacy concerns, specifically if those claims data are accessible to bad-faith actors, such as law enforcement agencies attempting to use patient data to identify non-citizens for targeting. Moreover, this clearinghouse would likely be a high-value target for data breaches, potentially putting a significant percentage of the population at risk of having their private health information in a consolidated location.

Photo Source: Cimarron Consulting

Transparency for Hospitals

Sec. 10, (a)(L)

This provision requires CEs to “…report how they are using the 340B margin using standardized rules established by HHS that are consistent with reporting requirements that federally qualified health centers use for Uniform Data System (UDS) reporting” (Buddy Carter, 2025).

One of the primary complaints against the 340B program has been the wholesale lack of transparency for virtually all types of CEs, with the exception of federally sponsored providers, such as AIDS Drug Assistance Programs and certain specialty providers, such as those that treat hemophilia or Black Lung Disease.

H.B. 5256 would require CEs to report the number of patients served, the amounts of 340B revenue, and how those revenues are used. It requires, for the first time, that CEs justify how they spend 340B dollars, which hospitals vehemently oppose.

Closing

In general, the 340B ACCESS Act is an excellent first step. Ultimately, it will come down to whether legislators can muster the political will to pass this legislation without caving to the very influential hospitals and their lobbyists, who have regularly threatened to respond to such requirements with closures, service suspensions, and job losses.

Further, the 340B program is largely unknown to the vast majority of constituents, many of whom have virtually no idea how the American healthcare system “works” (or doesn’t). 340B is a wonky issue that even experts on the subject admit is virtually impenetrable without extensive knowledge of how the drug procurement and dispensing model in the U.S. “works.”

That said, it’s a bill that should be high on the priority list if the goal is to save taxpayers’ money. ADAP Advocacy contends these reforms are an investment in patients.

[1] 340B ACCESS Act, H.R. 5256, 119th Cong. (2025). https://www.congress.gov/bill/119th-congress/house-bill/5256/text

[2] Buddy Carter. (2025, September 10). Carter, Harshbarger introduce legislation to ensure access and transparency in 340B Drug Pricing Program. Buddy Carter: Press Releases. https://buddycarter.house.gov/news/documentsingle.aspx?DocumentID=15906

[3] Fein, A. J. (2023, July 11). EXCLUSIVE: For 2023, five for-profit retailers and PBMs dominate an evolving 340B contract pharmacy market. HMP Omnimeida, LLC: Drug Channels. https://www.drugchannels.net/2023/07/exclusive-for-2023-five-for-profit.html

[4] Nikpay, S., McGlave, C. C., Bruno, J. P., Yang, H., & Watts, E. (2023, August 04). Trends in 340B Drug Pricing Program contract growth among retail pharmacies from 2009 to 2022. JAMA Health Forum, 4(8): e232139. https://doi.org/10.1001/jamahealthforum.2023.2139

[5] U.S. Government Accountability Office. (2018, June 21). Drug discount program: Federal oversight of compliance at 340B contract pharmacies needs improvement. U.S. Government Accountability Office: Reports & Testimony https://www.gao.gov/products/gao-18-480

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.

Trump's Memorandum on Pharma DTC Advertising is a Solution in Search of a Problem

By: Ranier Simons, ADAP Blog Guest Contributor

Adding to the growing list of edicts issued by the Trump Administration is a presidential memorandum issued in September 2025 regarding prescription drug advertising. The memorandum was not an executive order; thus, it listed no detailed implementation or specified remedy for a perceived problem that probably doesn’t exist. It simply implied that the U.S. Food & Drug Administration (FDA) has not been effective at “protecting the public” from inappropriate direct-to-consumer (DTC) advertising. The memorandum directs the Commissioner of Food and Drugs to enforce the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) prescription drug advertising provisions to ensure pharmaceutical DTC advertising is transparent and non-misleading. While it is laudable to emphasize the need for patient protection, DTC advertising by other industries, including alcoholic beverage companies, also poses significant harm to the public.

Photo Source: BioSpace

In coordination with the release of the presidential memorandum, the FDA also released a press release on the same day (FDA, 2025). The release stated that the FDA would send 100 cease-and-desist letters to pharmaceutical companies using what it described as deceptive ads. Additionally, the release noted the FDA would be initiating rulemaking to close the “adequate provision loophole”, a 1997 FDA regulation regarding disclosures in DTC broadcast advertising. The loophole allowed drug advertisements, particularly DTC broadcast radio and television ads, to be considered compliant if they contained a brief “major risk statement” indicating major side effects and included information directing people to a website or phone number for very detailed drug information. Before 1997, the level of detail required resulted in drug information presentations of the length and breadth of infomercials in order to display a complete safety list of risks and contraindications.

Back in 2023, the FDA had actually already established a final rule specifying advertising requirements to fulfill the major statement requirement in a “clear, conspicuous, and neutral manner” (Craven, 2023). The standards required that:

• The major statement is presented in language and terminology that is consumer-friendly and readily understandable
• Audio information in the major statement is as understandable as audio information in the rest of the ad in terms of volume, articulation, and pacing
• During presentation of the major statement, the ad does not contain audio or visual elements that might interfere with a consumer’s understanding of the content
• During TV ads, the text information is presented in a way that is easy to read
• During TV ads, the major statement is to be presented simultaneously in audio and text, and is shown for long enough to be read easily

Presently, the FDA has issued over 100 untitled letters to various manufacturers regarding specific drug advertisements. The agency lists many of those DTC violation letters on the FDA website under the “untitled letters” and “warning letters” areas. The letters’ claims revolve around a few key ideas. A major complaint is that the advertising makes claims that the cited literature or associated clinical trials do not support. Another purported issue is that the presentation of the subjects indicates a quality-of-life improvement that is not supported by the data. Regarding the presentation, there are letters stating that the on-screen information is too detailed to be read in the brief screen time available. 

Photo Source: US Pharma Marketing

The violation letters are not just targeting patient-facing ads. The FDA is also targeting promotional materials to healthcare professionals (HCP). One letter sent to Amgen Incorporated showed that the Center for Drug Evaluation and Research was not satisfied with the level of detail in the analysis of one of the studies used to support the efficacy and depth of response section of a website dedicated to the drug Imdeltra. The letter complained that outcomes were reported based on a single-arm clinical trial, thus improperly substantiated. A single-arm clinical trial is one in which all subjects receive the same medication under study, without a control or placebo group. A single-arm clinical trial is actually appropriate in several instances. For example, there are some studies conducted where rare diseases are involved; thus, it is unethical to subject participants to placebos for life-threatening conditions (Hembara, 2025). 

The violation letters all state that, due to the stated violation, the distribution of a drug violates the FC&C Act. Thus, an accused entity must file a written response explaining how it will remedy the specifically stated violation or pull a drug from distribution. To date, over 60 enforcement letters have been issued, along with 58 warning letters sent to online pharmacies regarding the promotion of compounded products that seemingly erroneously indicate they are FDA-approved (Propharma, 2025). Presently, there have been no adverse governmental actions in response to any of the letters that have been issued.

The potential final outcome of the FDA’s actions is unclear. No rulemaking has been set regarding the adequate provision loophole. Thus, it is entirely plausible that, at some point, drug manufacturers would have to pull all broadcast DTC advertising in its current form. That would be devastating financially for networks in terms of advertising dollars. Drug manufacturers spent $7.9 billion in television advertising from January to October 2024 (Wolk, 2025). Switching from television to online advertising is not as beneficial for pharmaceutical companies, as older Americans are their audience. Older Americans are heavy consumers of broadcast television and cable news outlets (Wolk, 2025). Thus, if eventually a ban on broadcast DTC advertisements were to occur, networks would take a heavy financial hit.

It also poses a challenge for the network's viewers...patients. Creating artificial barriers has never yielded positive health outcomes, but the presidential memorandum overlooks this for patients. It also artificially targets a single industry while conveniently overlooking or ignoring abuses that truly do exist in television advertising by other industries.

Photo Source: Federal Trade Commission

Conversely, the focus on DTC pharmaceutical advertising in the name of public health ignores the alcohol industry and the food supplement industry. Regarding alcohol, one media data sample estimates that 1.6K companies spent over $1.4 billion on broadcast and digital advertising in 2023, Q4 (Media Radar, 2023). Alcohol advertisements depict a high quality of life and enjoyment for everyone who consumes the beverages. There are no major statements about the adverse medical realities of alcohol consumption. Yet the FDA is not focused on how alcohol ads would indicate that consumption is directly correlated to positive social interactions with no side effects. Alcohol ads also do not have disclaimers to raise concern about the interaction between alcohol and a person’s prescription drugs, health supplements, or contraindicated pre-existing health conditions, or addiction. 

No concrete legal rulings on DTC drug advertising are expected in the near future. The government is not only in a shutdown but is already operating at a diminished capacity, given the administration’s elimination of 3,500 FDA jobs earlier this year (Frank & Glied, 2025). Moreover, any future rulemaking or aggressive penalty pursuit will be followed by lawsuits. Most importantly, bona fide patient harm from DTC pharmaceutical advertising has not been proven. Drug advertising, in some ways, increases patient access by bringing awareness to disease states and therapy modalities. Time will tell whether the FDA's actions are performative politics or a means to a beneficial end.

[1] Craven, J. (2023, November 21). FDA issues new standards for DTC prescription drug ads. Retrieved from https://www.raps.org/news-and-articles/news-articles/2023/11/fda-issues-new-standards-for-dtc-prescription-drug

[2] Frank, R., Glied, S. (2025, May 14). The Trump administration’s NIH and FDA cuts will negatively impact patients. Retrieved from https://www.brookings.edu/articles/the-trump-administrations-nih-and-fda-cuts-will-negatively-impact-patients/#:~:text=The%20Trump%20administration%20has%20made%20unprecedented%20cuts,biological%20products%20*%20Develop%20competitive%2C%20lower%2Dpriced%20products

[3] Hembara, N. (2025, January 13). Single Arm Studies: What Are They & When Are They Used? Retrieved from https://www.allclinicaltrials.com/blog/what-are-single-arm-studies

[4] Media Radar. (2023, December 26). Q4 2023 12 for ‘24 - Alcohol. Retrieved from https://www.mediaradar.com/blog/blog/q4-2023-12-for-24-alcohol.

[5] Propharma. (2025, October 28). FDA Tightens the Reins on DTC Drug Ads: Big Picture Insights and Industry Implications. Retrieved from https://www.propharmagroup.com/thought-leadership/insights-fda-2025-enforcement-letters-ccn-standards

[6] U.S. Food & Drug Administration (2025, September 9). FDA Launches Crackdown on Deceptive Drug Advertising. U.S. Department of Health & Human Services. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising

[7]7 Wolk, A. (2025, March 4). Could A Pharma Ad Ban Shake Up The TV Industry? Retrieved from https://www.tvrev.com/news/could-a-pharma-ad-ban-shake-up-the-tv-industry#:~:text=Pharmaceutical%20advertising%20has%20long%20been,and%20they%20aren't%20pretty.

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.    

Opioid Use Disorder Among Medicare Beneficiaries

By: Ranier Simons, ADAP Blog Guest Contributor

The United States has the highest levels of opioid consumption worldwide (Cornell et al., 2021). This consumption level is not solely attributed to recreational use but is also a product of prescription rates. United States healthcare providers prescribe opioids for pain more often and at earlier points in treatment, sometimes as first-line therapy (Cornell et al., 2021). This is especially concerning regarding people living with HIV/AIDS (PLWHA). Compounding the potential adverse effects of medically prescribed opioids, PLWHA also have a much higher prevalence of non-medical opioid use compared to the general population of HIV-negative individuals (West et al., 2023). A recent study examined opioid use among older PLWHA specifically.

Photo Source: Clinical Trials Arena

A recently published retrospective cross-sectional study analyzed opioid utilization and the prevalence of opioid use disorder (OUD) among Medicare beneficiaries. The study subjects were aged 65 and older and beneficiaries of Medicare fee-for-service with Part D prescription drug coverage. The study covered the period from January 1, 2008, to December 31, 2021 (Shiau et al., 2025). The researchers examined 163,429 PLWHA, comparing them to 490,287 individuals without HIV, matching based on demographic criteria. 

During the study timeline, 35% of PLWHA, compared to 28.3% of HIV-negative subjects, were prescribed at least one opioid annually (Shiau et al., 2025). PLWHA had a higher prevalence of being prescribed higher-risk prescriptions. High-risk opioid prescriptions are those with higher dosages and longer durations. Dosages are commonly measured in morphine milligram equivalents (MME). Dosages higher than 100 MMEs have twice the risk of misuse and overdose as lower doses, while dosages of 20-50 MME also carry risk (U.S. Dept of Labor, n.d.). In the study cohort, 5.3% of PLWHA received prescriptions with total daily MMEs higher than 90mg compared to 2.2% of those without HIV (Shiau et al., 2025). Additionally, 3.1% of PLWHA, compared to 1.6% of those without HIV, were prescribed opioids with MMEs higher than 120mg (Shiau et al., 2025). Regarding prescription duration, 6.1% of PLWHA, compared to 3.9% of individuals without HIV, were prescribed high-risk opioids with coverage of longer than 90 consecutive days of use (Shiau et al., 2025). 

Photo Source: AIDS Map

It is notable that among the study participants, there was a higher prevalence of OUD indicators in PLWHA compared to those who were HIV-negative. The data analyzed were administrative; thus, OUD indicators include formal diagnosis, OUD medication, and opioid-related emergency department visits (Shiau et al., 2025).  

PLWHA are prescribed opioids for chronic pain. That pain can have multiple causes, such as HIV-related nerve damage, pain from opportunistic infections acquired due to lowered immune response, antiretroviral treatment side effects, and more (Lutton, 2025; Madden et al., 2020). Opioid abuse is not only medically detrimental overall but also has HIV-specific adverse outcomes. PLWHA with OUD are more likely to have difficulty with ART adherence. This is especially true for PLWHA who are also living with mental health challenges. Gravely, ART, opioids, and drugs used to treat OUD are metabolized in the body via the same biochemical pathways (Cernasev et al., 2020). Thus, there can be adverse drug interactions. Moreover, ART medications can enhance or decrease the levels of opioids or OUD treatment drugs in the bloodstream (Cernasev et al., 2020). There are times when the interactions can increase the effectiveness of the ART, opioids, or OUD treatment medications (Cernasev et al., 2020). However, many times the result is often reduced effectiveness or even toxicity (Cernasev et al., 2020). All these potential adverse outcomes are compounded by the fact that many PLWHA have comorbidities.

Photo Source: Valley Spring Recovery Center

Studies indicate that over half of PLWHA will have nonmalignant chronic pain at points throughout their lives (Madden et al., 2020). As a result of medical advances in HIV treatment, PLWHA are living longer. Thus, the population of PLWHA over the age of 65 is going to continue to increase, as will chronic pain issues. The Shiau study indicates the importance of examining better ways to treat chronic pain in PLWHA that do not rely on high-risk opioids. A direct quote from the study text includes, “…clinicians treating older adults with HIV should consider alternative therapies for pain, and public health researchers and policy makers should consider screening and prevention programs for opioid use disorder in older adults living with HIV” (Shiau et al., 2025). 

It is essential to emphasize the holistic well-being of older PLWHA. Physical health, mental health, sexual health, and addiction are all realities that need to remain priorities for all medical professionals who give care to aging populations.

[1] Cernasev, A., Veve, M. P., Cory, T. J., Summers, N. A., Miller, M., Kodidela, S., & Kumar, S. (2020). Opioid Use Disorders in People Living with HIV/AIDS: A Review of Implications for Patient Outcomes, Drug Interactions, and Neurocognitive Disorders. Pharmacy (Basel, Switzerland), 8(3), 168. https://doi.org/10.3390/pharmacy8030168

[2] Cornell, A., Davis-Castro, C., Duff, H., Romero, P. (2021, June 2). Consumption of Prescription Opioids for Pain: A Comparison of Opioid Use in the United States and Other Countries. Retrieved from https://www.congress.gov/crs-product/R46805

[3] Lutton, L. (2025, October 7). Opioid Prescriptions, Addiction More Common in Older HIV Patients. Managedhealthcareexecutive.com; Managed Healthcare Executive. Retrieved from https://www.managedhealthcareexecutive.com/view/opioid-prescriptions-addiction-more-common-in-older-hiv-patients

[4] Madden, V. J., Parker, R., & Goodin, B. R. (2020). Chronic pain in people with HIV: a common comorbidity and threat to quality of life. Pain management, 10(4), 253–260. https://doi.org/10.2217/pmt-2020-0004. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC7421257/#:~:text=Abstract,(e.g.%2C%20stigma)%20factors.

[5] Shiau, S., Drago, F., Kinkade, C. W., Getz, K., Bushnell, G., Samples, H., Bender, A. A., Bennett, L., Dave, C., Halkitis, P. N., Gerhard, T., Roy, J. A., Martins, S. S., Yin, M. T., & Crystal, S. (2025). Prescription opioid use and opioid use disorder among older adults with HIV in the USA from 2008 to 2021: a retrospective repeated cross-sectional study. 100017–100017. https://doi.org/10.1016/j.lanprc.2025.100017. Retrieved from https://www.thelancet.com/journals/lanprc/article/PIIS3050-5143(25)00017-2/fulltext

[6] West, B. S., Diaz, J. E., Philbin, M. M., & Mauro, P. M. (2023, April). Past-year medical and non-medical opioid use by HIV status in a nationally representative US sample: Implications for HIV and substance use service integration. Journal of Substance Use and Addiction Treatment, 147, 208976. https://doi.org/10.1016/j.josat.2023.208976. Retrieved from https://www.sciencedirect.com/science/article/abs/pii/S2949875923000267#:~:text=Conclusion,%2Drelated%20outcomes%2C%20including%20overdose.

[7] U.S. Department of Labor. (nd). Risk Factors for Opioid Misuse, Addiction, and Overdose. Retrieved from https://www.dol.gov/agencies/owcp/opioids/riskfactors

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

Why are Price Cap Proposals on Medicines Dangerous to Pharmacies and Patients?

By: Shabbir Imber Safdar, ADAP Advocacy Board Member and Executive Director, Partnership for Safe Medicines

**Reposted with Permission from PSM**

Price cap proposals, like upper payment limits currently being debated by prescription drug affordability boards (PDABs) and Medicare maximum fair prices (MFPs), often assume a simple drug/price supply chain which doesn’t reflect reality in the United States. They also don’t account for the fact that members of the drug/price supply chain will react to price caps in ways that could bankrupt pharmacies and reduce patient access.

Colorado approved an upper payment limit on Enbrel a few days after we posted this. We anticipate that this decision will be bad for pharmacies and patients.

The U.S. healthcare system is uniquely complex

Pharmaceuticals in the United States have an incredibly complex supply chain. Everyone agrees that more should be done to address the cost of medicine, but developing workable cost-reduction policies is challenging. This is because unlike a hardware store, where the maker, distributor, and retailer of a hammer are linear and all actors fear competition, the U.S. healthcare market is far more complex.

Healthcare system players like pharmacy benefit managers (PBMs) gatekeep patients from their local pharmacies. It’s as if the maker or distributor of a hammer could tell your local hardware store whether customers could use your hardware store and what you were allowed to charge for the hammer, regardless of how much it costs for you to buy it.

A teachable moment

Recently Dr. Emily Zadvorny of the Colorado Pharmacists Society provided public comment to the Colorado Prescription Drug Affordability Board about their efforts to set upper payment limits for several medicines. Several other states are in this process, and the federal government has been engaged in setting MFPs for medicines in Medicare.

Dr. Zadvorny’s testimony underscored problems with price-setting policy solutions to healthcare costs in the U.S.

"...up to 90% of independent pharmacies are already saying they will not participate in the medication in the Medicare Drug Price Negotiation Program, precisely because there is no guarantee that they can not be underwater on those drugs." [Dr. Emily Zadvorny, 7/11/2025]

Dr. Zadvorny was talking about multiple risks to pharmacies and to patients, which we’ll explain below.

PBM reactions to price caps that affect pharmacy

Most price cap proposals only concern themselves with the maximum price manufacturers, distributors, pharmacies, and insurance companies can charge or reimburse for a medicine. Reducing the maximum price means that players, such as PBMs, will make less money when drugs are dispensed to patients.

Policies like UPLs and MFPs don’t always prevent monopolistic players like PBMs from lowering reimbursements to maintain their profits under the price cap. For example, imagine a medicine that costs a pharmacy $1,000 to purchase. The PBM makes $150 on that medicine and reimburses the pharmacy $1,010. If a price cap says that you can only charge $500 for the medicine, the PBM is likely to lower the reimbursement for the pharmacy to $350. The PBM maintains their $150 profit, and the pharmacy loses money.

Even if the UPL rules say that a medicine can only be sold for $500 and must be reimbursed at the same price of $500, the pharmacy will make $0. Your local hardware store cannot stay in business buying and selling items for $0 profit, and neither can your local pharmacy. How will it pay for salaries, rent, insurance, utilities, and other costs of doing business?

This 2-page summary explains the problem of PBM under reimbursements

Pharmacies as financial lenders to the healthcare system

The Medicare MFP system sets a maximum reimbursement Medicare will pay for a medicine, but leaves the cost of medicines untouched. It requires drug manufacturers to rebate pharmacies for the difference between the two. If the manufacturer is not required to compensate the pharmacy for their full cost, it will be catastrophic. Pharmacies can not stay in business without being made whole on their costs or without making profits.

However, there is another problem: The time between when pharmacies purchase medicine and when they are fully reimbursed is an enormous interest-free loan that pharmacies, which are already operating on razor thin margins, cannot afford. Estimates are that this could be thirty days, or even more. In January 2025, 3Axis Advisors found that under Medicare’s drug price negotiation program pharmacies could see a weekly cash flow shortfall of $10,838.25 compared to prior operations. Nearly 2,300 pharmacies shut their doors during 2024, primarily for financial viability reasons, and cash flow problems because of these proposals will accelerate closures.

Read Unpacking the Financial Impacts of Medicare Drug Price Negotiation on the 3Axis site

What effect will this have on patients?

Many pharmacies have already decided not to stock price-controlled medications rather than risk financial ruin. In fact, the National Community Pharmacists Association (NCPA) January 2025 survey of independent pharmacies found that over 90 percent of independent pharmacies may decide, or have already decided, not to stock price controlled drugs from the Medicare Drug Price Negotiation Program.

Patients cannot get quality healthcare from a pharmacy that’s out of business or that can’t afford to stock the medicine that patients need. Additionally, PBMs may make less profitable price-controlled medicines harder to obtain by placing them on a harder to reach tier, or by hiking patient co-pays, which also impedes access.

Community pharmacies are wary of stocking price controlled drugs from the Medicare Drug Price Negotiation Program (NCPA member survey, January 2025)

Don’t pharmacies make their money on “dispensing fees” anyway, instead of the cost of medicine itself?

Dr. Zadvorny brought this up in her public comment:

We did get [a dispensing fee] into the rules. We got it into the law. But what I heard earlier today that concerns me is that it would be left up to private contracts to ensure that. I can tell you right now that a lot of private contracts are either pennies for a dispensing fee, or sometimes it's not even made whole.

It can be $0. I think if there's any possibility to pay for this, for the board to ensure that there's a fair dispensing fee, I would absolutely implore you to do that. The state of Colorado does gather, cost of dispensing surveys. And there is data on what the real cost of dispensing a medication is. I would encourage that the dispensing fee that's included in these UPL [upper payment limit] drugs is no less than what is in that data from the cost of dispensing survey. [Dr. Emily Zadvorny, 7/11/2025]

Dr. Zadvorny is referring to PBMs giving pharmacies a dispensing fee of a penny (yes, an actual penny) or a few cents for the cost of all the work that goes into dispensing a medicine. This, combined with reimbursements for the cost, or sometimes less than the cost of medicine, explains why pharmacies are wary of proposals that might incentivize PBMs to cut their reimbursements further.

The actual cost of dispensing has been studied in Colorado and at the national level. The state of Colorado does an annual survey of dispensing fees to ensure that fees paid to pharmacies for serving Colorado Medicaid members are aligned with the actual costs of dispensing. In 2025, that cost was estimated at $9.31 to $13.40 per prescription for non-rural pharmacies, based on volume.

A 2020 NCPA study determined a normal dispensing fee should be $12.40, with a higher fee of $73.58 for specialty medicines. Many of the medicines the Colorado PDAB are looking at for upper payment limits are considered specialty medicines.

Example from a 2023 PBM contract showing no payment of dispensing fees

Why can’t we have negotiated prices like Canada?

The Canadian healthcare system for medicine has shortcomings around patient access that we don’t talk about. However, one advantage they do have is a lack of pharmacy benefit managers. PBMs exist in Canada, but do not dictate the terms of every other player in the system as they do in the U.S. healthcare system.

What should we be doing instead?

Stakeholders from all across the supply chain are nearly unanimous in their calls for PBM reform. The business practices of PBMs hamper patient access and bankrupt pharmacies that provide critical patient care.

Managed Medicaid reform

States looking for savings ideas could learn a great deal from states that have reformed the role of PBMs in their Medicaid programs. West Virginia and North Dakota carved prescription drug benefits out of their managed program and saved $54 million and $17 million respectively in a single year. Kentucky moved to a single PBM in 2020 and documented $282.7 million in savings for the 2021-2022 cycle. For more information on savings in this area, see this NCPA publication “Medicaid Managed Care Reform.”

PBM reform to reduce costs in the private insurance market

The Washington State Pharmacists Association, the Washington Health Alliance, and 3Axis Advisors recently undertook the largest state-focused study of the drivers of prescription drug costs. They studied prescription drug costs in the state using data collected from plan sponsors and pharmacies. They found that:

• Markups at PBM-affiliated mail-order pharmacies were more than three times higher than those at retail pharmacies.
• Plan sponsor (employer) costs increased by 30 percent, while commercial pharmacy reimbursement decreased by 3% between 2020-2023.
• PBMs charged employers vastly different amounts for the same prescription medications.
• PBMs drove an increase in employer health care costs over the past four years.

The evidence is that PBMs are increasing costs and decreasing reimbursements, taking money from all other players in the supply chain in ways that benefit themselves. Reforming their role in healthcare by putting strict guardrails on their business practices would create enormous cost reductions and increase access for every other stakeholder.  The full study is available online.

Original Post: Why are price cap proposals on medicines dangerous to pharmacies and patients?

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.    

Fireside Chat Retreat in Atlanta, GA Tackles Inflation Reduction Act's Adverse Impact on Patient Care

By: Brandon M. Macsata, CEO, ADAP Advocacy & Matt Toresco, Chief Executive Officer, Archo Advocacy LLC

ADAP Advocacy hosted its Health Fireside Chat retreat in Atlanta, Georgia, among key stakeholder groups to discuss the adverse impact on patient care being caused by the Inflation Reduction Act (IRA). The Health Fireside Chat was held from Thursday, September 25th, to Saturday, September 27th. It was a continuation of the conversation surrounding the IRA's drug price controls, which convened earlier this year in Minneapolis, MN. Over two dozen diverse health policy stakeholders attended the event.

Photo Source: Getty Images

The IRA discussion —including its pill penalty provisions, challenges community pharmacies are facing, more restrictive drug formularies increasing, non-medical switching, and patients absorbing greater costs due to shifts from co-pays to co-insurance—was designed to capture key observations, suggestions, and thoughts about how best to address the challenges being discussed at the Health Fireside Chat. The following represents the attendees:

• Guy Anthony, Founder & Executive Director, Black, Gifted & Whole Foundation
• Ninya Bostic,  National Policy & Advocacy Director, Johnson & Johnson
• Richard Brown, Development Manager, Patient Advocate Foundation
• Tori Cooper, Director of Community Engagement, Human Rights Campaign
• Erin Darling, Associate Vice President & Counsel for Federal Policy, Merck
• Nick Garlow, Managing Director, Rational360
• Dusty Garner, Patient Advocate
• Kathie Hiers, President & CEO, AIDS Alabama
• Mark Hobraczk, Director of Public Policy, Ai Arthritis
• Connie Jorstad, Director of Government Relations, ViiV Healthcare
• Amanda Kornegay, Owner, Kornegay Consulting, LLC
• Jen Laws, President & CEO, Community Access National Network
• Darnell Lewis, Paramedic Crew Chief & Patient Advocate
• Brandon M. Mascata, CEO, ADAP Advocacy
• Travis Manint, Director of Communications, Community Access National Network
• Michiel Peters, Head of Advocacy Initiatives, Global Coalition on Aging
• Kalvin Pugh, Director of State Policy, 340B, Community Access National Network
• Stacy Reliford, Alliance Development Director, Pfizer
• Andrew Scott, Director Strategic Alliances and Issue Advocacy, Bristol-Myers Squibb
• Larry Scott-Walker, Patient Advocate
• Ranier Simons, Consultant, ADAP Advocacy
• David Spears, Founder & Director, Magic Box LLC
• Jason Sterne, Director, Policy Advocacy and Alliances, Gilead
• Matt Toresco, CEO, Archo Advocacy
• Monique Whitney, Executive Director, Pharmacists United for Truth and Transparency
• R. Wayne Woodson, Executive Diretor, NEASM

To level set and provide background for discussions, attendees are sent suggested readings in advance. The following are just a few from the thorough list provided for this session:

• The Inflation Reduction Act (IRA): Impact on Medication Pricing, Spending, Affordability, and Access – Analysis by Pioneer Institute
• Alarm Bells are Ringing: Medicare Drug Price Negotiation Program Will Fail Without Changes – Op-Ed by B. Douglas Hoey, RPh, MBA in Drug Topics
• CMS Draft Guidance Creates Regulatory Vacuum in 340B Drug Pricing – Blog by Travis Manint, Community Access National Network
• Is Trump's Executive Order on Most Favored Nations Drug Pricing a Wet Noodle? – Blog by Ranier Simons, ADAP Advocacy
• Three reasons Congress should fix the IRA’s pill penalty – Blog by Brianna Allen, PhRMA
• The Inflation Reduction Act’s Impact Upon Early-Stage Venture Capital Investments – Article in Therapeutic Innovation & Regulatory Science

ADAP Advocacy is pleased to share the following brief recap of the Health Fireside Chat. There were two discussion frameworks:

What Does Effective Advocacy Look Like:

• Defining Effective Advocacy: Data-Guided Strategies for Patient & Policy Impact
• What Works: Cutting Through the Noise in Patient Advocacy
• Shaping Advocacy That Moves Policy
• Building the Blueprint: Effective Advocacy Together

Measuring What Success Looks Like:

• Redefining Success: Measuring Advocacy Wins for Patients & Policy
• What Counts: Defining Real Success for Patients & Policy
• From Policy to Impact: What Success Really Means & Looks Like in Action
• Measuring The Wins: Success Through Shared Impact

Every major policy fight (IRA, 340B, PDABs) ultimately comes back to protecting the patient–provider relationship and the decisions made within it. Patient advocacy is most effective on these issues through branding and and demonstrating value. To that end, patient advocacy must grow its brand and demonstrate both its current and future impact. Meanwhile, pharmaceutical industry partners need to better communicate the value of advocacy internally across medical, policy, regulatory, commercial, and patient support teams. Building capacity, whether alone or in partnership, is essential.

The group identified numerous policy priorities and the need for better coalition building. Future patient advocacy has to address gaps in access to care and treatment. The IRA weakens Medicare's Six Protected Drug Classes and policymakers need to be reminded why these health conditions were protected in the first place. Advocacy organizations need to focus on clearly describing the impacts of policy issues and helping patients see them, as is being done with educating patients on why reforms are needed to strengthen the 340B Drug Pricing Program.

The ongoing government shutdown also shaped much of the policy discussion, with an agreement that longtime allies in Congress need to be engaged but also potential new voices should be cultivated. The work done by patient advocacy groups and healthcare provider associations working with North Carolina Republican Senator Thom Tillis was cited as a prime example. Sen. Tillis has introduced legislation—"Ensuring Pathways to Innovative Cures (EPIC) Act"—to fix the Inflation Reduction Act's small molecule “pill penalty” to ensure continued R&D investments into small molecule medicines.  The Global Coalition on Aging and the Alliance for Aging Research spearheaded 70+ organizations in sending a letter to congressional leadership urging them to support the EPIC Act.

Photo Source: Government Printing Office

Some recent and upcoming milestones offer patient advocacy organizations additional opportunities to shape the policy conversation. They include:

• September 30, 2025: CMS released final guidance for third cycle (IPAY28) of the MDPNP. CMS released IPAY28 draft guidance in May 2025 for public comment, with the final guidance outlining the process for the third cycle of negotiations.
• October 2025 [Anticipated]: Release of expert report detailing drugs anticipated to be selected in 2026 for the MDPNP. Based on 2024 activities, it is expected that a new white paper or brief will be issued in September 2025 that identifies drugs that are likely to be subject to price negotiation in the third cycle of the MDPNP.
• February 1, 2026: CMS releases the list of drugs selected for negotiation. In 2026, CMS will announce the selection of 15 Part D and Part B drugs for which negotiated prices will go into effect in 2028.
• February 1 – March 1, 2026: Public input period (Information Collection Request, or ICR) following CMS announcement of drugs selected for negotiation. The ICR period is intended to help CMS understand how selected drugs are used and their relative value in clinical practice. Individuals can answer questions across varying respondent types (manufacturers, patients/caregivers, physicians, researchers, and "others"), often with a ~3,000-word limit per question. Question topics include therapeutic alternatives, clinical effectiveness, cost/affordability, unmet needs, patient experiences, and other considerations. 

Aligned stakeholders must use every opportunity to create a public record on the issues related to the Inflation Reduction Act and its impact on chronic health conditions and rare diseases.  No additional Health Fireside Chats are planned for 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.