Facing HIV Health Disparities in Black Communities

By: Ranier Simons, ADAP Blog Guest Contributor

Although great strides have been made toward fighting HIV in the United States, several groups remain disproportionately impacted. Black communities are one of the groups experiencing a higher impact of HIV-related health disparities. Health disparities are differences in the incidence, prevalence, and mortality of a disease and its associated related adverse health conditions.[1] Multiple factors contribute to Black communities bearing more of the HIV burden than other groups. The characteristics of many communities of color social determinants of health are part of those factors. Social determinants of health (SDOH) include economic stability, education access, and quality, health care access and quality, neighborhood and built environments, and social and community context.[2] These SDOH are influenced by things like discrimination, racism, and poverty. In 2022, Black persons were disproportionately impacted by new HIV infections.[3]

Photo Source; HIV.gov

According to PlusInc, which addresses health disparities in the United States, HIV disproportionately impacts Black and Hispanic/Latino Americans. PlusInc's HIV health disparities statement notes:

"While Black and Hispanic/Latino make up just 13.4% and 18.5% of the U.S. population, respectively, Black Americans account for 40.3% and Hispanic/Latino Americans account for 24.7% of the total population of Persons Living with HIV/AIDS (PLWHA). Additionally this disparity extends to the incidence, with 42% of new HIV diagnoses occurring in Black Americans and 27.8% in Hispanic/Latino Americans. According to the Centers for Disease Control and Prevention (CDC) 26% of new HIV diagnoses were among Black gay and bisexual Men who have Sex with Men (MSM), 23% were among Hispanic/Latino gay and bisexual MSM, and 45% among gay and bisexual MSM under the age of 35."

The lived experiences and cultural commonalities among Black communities contribute to the disproportionate HIV burden. Larry Scott-Walker, Executive Director for Thrivess, Inc., explains, “Many within the Black community have experienced some form of medical racism or implicit bias that prevents them from trusting those within the medical industrial complex.” Distrust in the medical system means a person has a lowered likelihood of actively seeking out medical knowledge and intervention, especially concerning HIV. Furthermore, many medical professionals lack cultural competency. 

Cultural competency is understanding and respecting the beliefs, values, and histories of individuals of all cultural backgrounds.[4] In an article for Medical News Today, Dr. Luz Maria Garcini, assistant professor in the Department of Psychological Sciences at Rice University, stated, “Cultural competence improves interpersonal interactions, helps to build trust, conveys respect, reduces biases that may lead to inaccurate diagnoses and treatments, and increases the chances that patients may be more compliant with the medical recommendations given.”[4]

Socially, a good deal of HIV stigma also still exists in Black communities. Stigma can result in people not seeking out or maintaining HIV care, regularly testing, or even having discussions of an intimate nature socially. Traditionally, Black culture has been heavily influenced by the institution of the church. Thus, open sex-positive discourse is not pervasive. Shame and stigma are not only barriers to obtaining HIV-related knowledge but also facilitate poor decision-making and even partner selection. Most importantly, shame leads to isolation when data shows HIV-related stigma is mitigated by social support.[5]

Economically, the poverty rate in Black communities in 2022 was 17.1%. The overall national poverty rate was 11.5%. Black persons were 13.5% of the population but represented 20.1% of those living in poverty.[6] The South, regionally, had the highest rate of new HIV diagnoses. Coincidentally, the South also contained the highest concentration of the Black population in the United States at 56%, and next to the Northeast had the highest level of poverty.[7] Poverty usually results in one’s focus being centered on many things, with personal healthcare residing lower on the list. Poverty also usually lends itself to segregation. Black communities segregated in some impoverished areas are not located near quality hospitals or clinics. This is a barrier to access to care in terms of prevention, treatment, and medical education.

Photo Source: PlusInc

Regarding poverty, Black communities have a higher likelihood of being uninsured or on publicly funded insurance.[8] The result is inadequate, non-existent, or inconsistent primary care. This also is a barrier to HIV and STI testing, HIV treatment and prevention, and management of other chronic medical issues. Even with access to private insurance, Black persons of lower socioeconomic status may not be able to afford the cost-sharing associated with utilizing their insurance plans in addition to the premiums. Avenues of medical assistance in terms of co-pay assistance, living expenses, insurance premium assistance, and even charity care exist. However, they are useless for those who find accessing them too complicated or are unaware of the options, especially when it comes to prevention.

One glaring prevention strategy discrepancy identified among Black communities is the utilization of PrEP. As expressed by Scott-Walker, “When we look at the poor uptake of PrEP within Black communities, it is clear that not enough education, community buy-in, and galvanization efforts have been attempted.” When appropriately used, PrEP, whether oral or injectable, has proven to be 99% effective at preventing sexual HIV infection while reducing injection drug use-related HIV transmission by 74%.[9] However, data shows that 94% of Whites who can benefit from PrEP have been prescribed it, contrasting with 13% of African Americans who can benefit from it.[10]  

Utilizing PrEP requires laboratory tests and medical visits usually covered by insurance, whether private or Medicaid. Additionally, by law, insurance plans are not supposed to charge co-pays, co-insurance, or deductibles for PrEP.[11] However, for the uninsured, it is more expensive. For the uninsured, beginning PrEP could cost around $2,700, which includes $1,000 for lab tests and medical visits.[10] The uninsured monthly prescription of generic Truvada would cost about $60 per month, with the brand name costing upwards of $2,000 per month. Moreover, without insurance, the required quarterly lab tests and medical visits would be, on average, around $15,000 per year.[11,12,13]

Tragically, lifesaving long-acting injectable (LAI) PrEP is even farther out of reach for some Black communities. Cabotegravir, trade name Apretude, is a long-acting injectable form of PrEP. It is administered by injection every other month. Logistically, this would be very beneficial to Black populations who dealt with transportation difficulties, housing instability, or treatment adherence. However, long-acting injectable PrEP is very expensive, and access is even more challenging than with standard oral PrEP. Apretude is administered in a clinic setting and covered under the medical portion of insurance, not the prescription drug benefit. Therefore, it is subject to cost-sharing that oral PrEP is not. Additionally, it is too expensive to pay for out of pocket. Moreover, some African Americans are not located in areas with feasible access to physicians who can administer Apretude.

Photo Source: American Psychological Association

The machinations of the diverse factors contributing to the disproportionate impact of HIV in the Black community are complex. The interactions of various aspects of policy, economics, culture, and social frameworks create a web that is hard to navigate for a solution to HIV health disparities in Black communities. This is why Scott-Walker states, “organizations that are explicitly committed to and reflective of Black communities are so essential in bringing about real change.”

[1] CDC. (2024, January 17). Health Disparities in Black or African American People. Retrieved from https://www.cdc.gov/health-disparities-hiv-std-tb-hepatitis/populations/black-african-american.html

[2] U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2024). Healthy People 2030. Retrieved from https://health.gov/healthypeople/objectives-and-data/social-determinants-health

[3] CDC. (2024, May 21). Fast Facts: HIV in the U.S. by Race and Ethnicity. Retrieved from https://www.cdc.gov/hiv/data-research/facts-stats/race-ethnicity.html.

[4] Pelc, C. (2022, November 9). What is cultural competency, and why is it crucial to healthcare? Retrieved from https://www.medicalnewstoday.com/articles/what-is-cultural-competency-and-why-is-it-crucial-to-healthcare

[5] Williams, R. S., Stetten, N. E., Cook, C., Cook, R., Ezenwa, M. O., & Lucero, R. (2022). The Meaning and Perceptions of HIV-Related Stigma in African American Women Living With HIV in Rural Florida: A Qualitative Study. The Journal of the Association of Nurses in AIDS Care: JANAC, 33(2), 118–131. https://doi.org/10.1097/JNC.0000000000000252

[6] Shrider, E. (2023, September 12). Poverty Rate for the Black Population Fell Below Pre-Pandemic Levels. Retrieved from https://www.census.gov/library/stories/2023/09/black-poverty-rate.html#:~:text=The%20official%20poverty%20rate%20of,Census%20Bureau%20data%20released%20today.

[7] Moslimani, M., Tamir, C., Budiman, A., Bustamante, L., & Mora, L. (2024, January 18). Facts about the U.S. Black population. Pew Research Center. https://www.pewresearch.org/social-trends/fact-sheet/facts-about-the-us-black-population/ 

[8] N.D. (2022, April 14). HIV and AIDS Among Black Americans. Retrieved from https://www.webmd.com/hiv-aids/hiv-aids-in-blacks-alarming-crisis

[9] HIV.GOV. (2024, June 27). Pre-Exposure Prophylaxis. Retrieved from https://www.hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxis#:~:text=Why%20Take%20PrEP%3F,74%25%20when%20taken%20as%20prescribed.

[10] Scaturro, M. (2024, April 16). HIV crisis in Atlanta made worse by racial disparities in treatment. Retrieved from https://www.ajc.com/news/health-news/hiv-crisis-in-atlanta-made-worse-by-racial-disparities-in-treatment/XPM2SEVXBRADJHMIBFH4C2O2U4/

[11] HealthHIV. (2024). Insurance and paying for PrEP. Retrieved from https://pleaseprepme.org/paying-prep/#:~:text=Did%20you%20know%20that%20most,PrEP%20a%20Grade%20A%20recommendation.

[12] Varney.S. (2022, March 3). HIV Preventive Care Is Supposed to Be Free in the U.S. So, Why Are Some Patients Still Paying? Retrieved from https://kffhealthnews.org/news/article/prep-hiv-prevention-costs-covered-problems-insurance/#:~:text=The%20costs%20can%20be%20daunting,can%20total%20%2415%2C000%20a%20year.

[13] Srikanth, K., Killelea, A., Strumpf, A., Corbin-Gutierrez, E., Horn, T., & McManus, K. A. (2022). Associated Costs Are a Barrier to HIV Preexposure Prophylaxis Access in the United States. American journal of public health, 112(6), 834–838. https://doi.org/10.2105/AJPH.2022.306793

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.  

HIV LONG-ACTING INJECTABLES: Patient Access Considerations for Injectable HIV Therapies & Injectable HIV Pre-Exposure Prophylaxis

By: Brandon M. Macsata, CEO, ADAP Advocacy; Jen Laws, President & CEO, Community Access National Network (CANN); Marcus J. Hopkins, Founder & Executive Director, Appalachian Learning Initiative (AAPLI); and Riley Johnson, LGBTQ Health and HIV Policy Consultant

On June 26th, after nearly one year of community engagement, ADAP Advocacy published its final report, HIV LONG-ACTING INJECTABLES: Patient Access Considerations for Injectable HIV Therapies & Injectable HIV Pre-Exposure Prophylaxis. 

Photo Source: ADAP Advocacy

In pursuing this project, ADAP Advocacy sought to understand patient perspectives on long-acting injectables (LAIs). This occurred through three methods – a quantitative survey, a qualitative focus group, and an examination of data – across two populations – those who are HIV-positive (the use of LAIs for treatment) and those who are HIV-negative (the use of LAIs for prevention). This project was made possible by support from Gilead Sciences, Merck, and ViiV Healthcare.

ADAP Advocacy received 305 responses to the Perspectives Survey on LAI Treatments for People Living with HIV (“Treatment Survey”), which resulted in a total of 262 eligible participants from 38 states, the District of Columbia, and Puerto Rico. In addition, ADAP Advocacy conducted a post-survey focus group with 8 participants to further explore patient awareness and knowledge of, perspectives about, and access to LAI treatment options. 

ADAP Advocacy received a total of 184 responses to the Perspectives Survey on LAI HIV Prevention Medications (“Prevention Survey”), which resulted in a total of 154 eligible participants from 35 states, the District of Columbia, and Puerto Rico. ADAP Advocacy conducted a post-survey focus group with 8 participants to further explore patient awareness and knowledge of, perspectives about, and access to LAI prevention options.

The findings from this project serve as a starting point for ADAP Advocacy to conduct additional patient-centric research to learn more about the barriers as well as facilitators faced by patients seeking LAIs. This project’s research questions concerned patient treatment preferences, information pathways, utilization, and barriers to access. 

 Key findings include:

• The majority of respondents to the Treatment Survey (52.3%) indicated that they would prefer receiving LAI medication to treat their HIV over a daily pill-based regimen; In the Prevention Survey, the majority of respondents (71.4%) indicated they would prefer an LAI over a daily pill-based regimen to prevent HIV.
• The vast majority of respondents to the Treatment Survey (87.8%) indicated being aware of Cabenuva as an LAI to treat HIV. Of those respondents who learned about the existence of LAI medications through this survey, half (50%) reported being open to discussing them with a medical provider; Just over half of respondents to the Prevention Survey (58.4%) indicated being aware of Apretude for use as LAI PrEP. More than four out of every ten respondents (42.2%) who learned about the existence of Apretude through this survey reported being open to discussing it with a medical provider;
• A majority of respondents to the Treatment Survey (87.7%) indicated having no issues finding information about LAI medications. Of those respondents who did have trouble finding information (12.3%), most respondents had trouble finding information about insurance coverage (78.6%), prior authorization requirements (78.6%), and the cost they would have to pay to access LAIs (71.4%);
• Insurance coverage barriers impacted respondents’ ability to pursue LAIs, with more than 1 in 4 survey respondents (27%) reporting this barrier in the Treatment and Prevention surveys. In the case of PrEP, a majority of those experiencing this (66%) indicated that the barriers to access were so cumbersome that they decided Apretude was not right for them.

The authors wish to also thank community partners and individual advocates who helped publicize the survey. The following community partners offered their assistance: Avita Care Solutions, Community Access National Network (CANN), Georgia Equality, HealthHIV, Human Rights Campaign, International Association of Providers in AIDS Care (IAPAC), New Haven Pride Center, PlusInc, Positive Women’s Network (PWN), Positively Aware Magazine, The AIDS Institute, Vivent Health, and Yale University’s LGBTQ Resource Center. The following individual advocates helped to spread the word with this project: Guy Anthony, Wanda Brendle-Moss, Rick Guasco, Lynne Maureen Hurdle, Patrick Ingram, Kate McManus, M.D., Maria Mejia, La Kia Mondale, Kalvin Pugh, Matt Toresco, and Jennifer Vaughan. The authors also wish to express their gratitude to Perry Communications Group for their amazing work advertising both of the surveys. Lastly, this project would not be possible without the assistance of those individuals who shared the survey and those who took the time to share their perspectives.

Additional research on patient perspectives is warranted in this space. Download the final report, here.

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.

PDABs: A Threat to Ending the HIV Epidemic?

By: Ranier Simons, ADAP Blog Guest Contributor

****Blog original published on June 18th and reprinted with permission from the Community Access National Network****

The Community Access National Network (CANN) continues to be active in the advocacy and policy space concerning Prescription Drug Advisory Boards (PDABs), also known as Prescription Drug Affordability Boards. PDAB activity is growing and advancing. Not only are more states considering or working through PDAB creation legislation, but a few recent drug-specific advisory board decisions have already been made. 

Photo Source: CANN

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A previous blog post untangles the warnings and concerns regarding PDABs. On the surface, they are presented as a simple solution to a complex issue. The complex problem is the extremely high healthcare expenditure in the United States. Accessing modern healthcare results in high amounts of spending from costs associated with hospitals and other facilities, medical technology creation and utilization, and even prescription drugs. Although prescription drug expenditures are only a small part of the billions spent annually on healthcare, the price of prescriptions is the low-hanging fruit that PDABs aim to attack. The money patients pay for prescription drugs is assuredly a financial burden for many. However, while PDABs aim to expressly lower the direct cost of prescription drugs for patients, their trajectory does not achieve that goal. Their actions have the potential to cause access issues in addition to potentially increasing out-of-pocket costs to consumers. This is especially true since the primary means PDABs lean toward to lower costs is the upper payment limit. Moreover, while CANN has a focus on PDAB potential outcomes regarding HIV drugs, all drugs are of concern, given that people living with HIV (PLWH) have multiple co-morbidities. Any threat to any drug utilized by vulnerable chronic disease communities is a threat to all.

Currently, CANN is monitoring several states that are looking to activate boards or already have active boards. Those states are Colorado, Maine, Maryland, Minnesota, New Hampshire, New Jersey, Ohio, Oregon, and Washington. Attending virtual PDAB meeting sessions, engaging by contributing both written and verbal commentary/testimony, and communicating with nationwide advocacy partners have revealed trends and developing paradigms that are problematic. Currently, the PDAB that is most far along in processes is Colorado. They have already deemed two medications, Enbrel and Cosentyx, as unaffordable, thus making them eligible for a UPL. Although every state’s PDAB is different operationally, due to the language of the legislation they are created by, states are watching Colorado. They will watch each other and potentially network in the future.

A sweeping, troublesome focus of PDABs is price. The stated intent of PDABs is to reduce the out-of-pocket costs patients pay for prescription drugs. However, the focus of analysis and discussion is how much manufacturers charge for drugs instead of how much patients pay. Focusing on drug prices could potentially lower the costs of drugs for the system, i.e., health plans, sponsors, and payers, but that does not directly help the patient cost burden.

A UPL sets a limit on the reimbursement rates of entities such as state health plans. It does not directly affect what patients pay out of pocket or change what manufacturers charge for drugs. A recent board discussion revealed the thought process that a UPL would equal more drug pricing transparency, eliminate hidden price variation caused by opaque rebates and discount structures, and increase patient access. Additionally, an assumption with consensus was that a lower price via UPL suggests an insurance company would be less likely to put a drug on a higher tier, less likely to require prior authorizations and be a barrier to pricing issues caused by payer vertical integration. These thought processes are not sound.

Photo Source: CANN

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A UPL does not automatically lower the price of a drug. It has no bearing on what a manufacturer charges for a medication. A manufacturer would have to voluntarily lower its price to be at or near the UPL. Additionally, if a UPL were set to be lower than the acquisition cost for pharmacies, pharmacies would lose money stocking medications. They cannot operate at a constant loss which lowers patient access since some pharmacies would have to stop carrying certain medications. If a pharmacy can’t fill a prescription, patients are put at risk due to treatment interruptions or even treatment cessation. Deliberations on boards proceed with the assumption that a UPL would not hinder access, with no discussions of contingency plans or safeguards to guard access against unintended consequences. Unfortunately, the prevailing attitude is that loss of access to medications as a result of UPLs is an unwarranted fear. 

UPLs also threaten the 340B Drug Pricing Program. The value of 340B is found in the spread between reimbursement rates and a reduced acquisition cost by way of drug manufacturer 340B rebates. UPLs will significantly reduce reimbursement rates, devaluing the funding realized by 340B rebates. Taking dollars out of the 340B program means that entities benefiting from 340B rebates will lose the ability to provide services to the vulnerable communities they serve. Furthermore, state AIDS Drug Assistance Programs (ADAP) heavily depend on savings and revenues from the 340B program. For states like Michigan, New Jersey, and Oregon, roughly 70 percent of their state ADAP budgets comes from 340B funding, and Oregon doesn’t receive any state contribution. According to NASTAD, a majority of ADAP clients live at or below 300% of the Federal Poverty Level. Thus, even if they qualify for Medicaid, they still need assistance.

Photo Source: CANN

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In reality, insurance plan benefit design is what directly translates into what patients pay out of pocket. The convoluted utilization of tools such as copays, coinsurance, high cost-sharing tiers, and copay accumulators directly determines direct patient expenditures. Most importantly, a drug’s price doesn’t determine the utilization management techniques an insurance plan uses. Many different factors are at play there, and those factors benefit many parties but not patients.

Drug manufacturers have patient assistance programs (PAP) that actually directly lower consumer out-of-pocket costs. One type of PAP is copay assistance programs that help pay most or all of the copays patients pay for medications due to their insurance plans. Another type of PAP is where a manufacturer will provide medications entirely for free for those who are uninsured, underinsured, those whose insurance does not cover a particular medication, or those who cannot afford their copay or coinsurance while not qualifying for other help. 

Although PAPs directly facilitate low out-of-pocket costs and bolster access, they are deleteriously used to support UPLs in PDAB board deliberations. The circular argument is that the mere existence of PAPs indicates that manufacturer drug pricing is too high. Additionally, discourse hints at the sentiment that PAPs are self-serving to drug manufacturers because it enables them to enjoy considerable tax advantages under the guise of charitable giving. As Jen Laws, CEO of Community Access National Network, points out, drug manufacturers have PAPs because “they are being made to shoulder discriminatory, profit-driven plan designs and supplement the under-reimbursement issue, all while patients are subject to predatory practices by payors.” 

PDABs, those currently active and those that are upcoming, are well-intentioned in wanting to lower drug pricing for consumers. They state that when identifying drugs they deem are unaffordable for consumers, they will consider other ways to reduce costs besides just the UPL. However, although things such as PBM reform and effecting policy change regulating insurance plans are superior options, the UPL remains the de facto consideration. It is essential that patients learn about and stay aware of PDAB activity. Above all, it is imperative that patients engage with PDABs because they are not receiving enough feedback from consumers and caregivers. Their deliberations are based on minuscule sample sizes of survey responses and low turn-out, with opportunities for in-person or virtual commentary from the public.

Boards feel as if they are aggressively seeking patient engagement but aren’t receiving it. Regardless of the veracity of PDAB's efforts to obtain robust patient-centered data, it is imperative that patients and caregivers stay informed and intentionally make their voices heard. Being vocal and active does make positive change happen. As a result of education efforts from patient advocacy groups and FQHCs regarding the damage of UPLs on 340B funding, this week, Oregon’s PDAB decided to revamp its entire affordability review process. CANN is committed to continued education, engagement, and advocacy to empower patients individually and collectively, irrespective of medical condition.

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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.  

Drug Shortages Growing, but Spares HIV-related Injectable Therapies

By: Ranier Simons, ADAP Blog Guest Contributor

Periodic shortages of all kinds of products are common. The height of the coronavirus pandemic even created a widespread shortage of toilet paper, Lysol, and baby formula. At times, drug shortages are also not uncommon. Nevertheless, drug shortages have been a trending topic in the media. The heightened discourse is atypical for so many drugs to be experiencing shortages simultaneously. Not only are there many drugs in shortage, but they have been in scarcity for a long time. Moreover, some of the drugs in shortage treat life-threatening conditions. Now shortages appear to be impacting injectable therapies.

Photo Source: Forbes

Drug shortages have increased over time, with the end of 2023 being the highest in the past ten years. At the end of 2025, according to the U.S. Food & Drug Administration (FDA), 125 drugs were in shortage status. Some of the drugs were new to the shortage list. However, many have been in shortage status for years. Furthermore, the duration of shortage status has also been increasing. In 2023, the average shortage was about three years compared to a duration of two years in 2020.[1] Unfortunately, at 2023 year-end, about a quarter of the drugs on the list had been in shortage for approximately five years, and treatments such as epinephrine injections had been in shortage for over ten years.[1,2]

Drug shortages affect all aspects of healthcare. No one therapeutic class is disproportionately harmed. Clinicians are frustrated because shortages of life-saving medications endanger many living with life-threatening conditions. Complete outages of supply mean that some patients must suffer through dangerous delays in care. In other cases, doctors must switch regimens completely due to shortages, forcing them to use medications they do not feel are the best options for patients. This results in using less efficacious medications with poorer desired outcomes and undesirable side effects. Additionally, when shortages result in switching from a regimen in progress, there is a danger of the body becoming unresponsive to the original regimen when the shortage is resolved.

A myriad of issues create drug shortages. Some of those issues are economic, supply and demand, and even manufacturing quality problems. Shortages are more common with lower-priced drugs such as generics.[3] A prescription for most of the injectables and solid oral medications in shortage costs less than five dollars to produce.[1,2] This translates into meager manufacturer profit margins, especially with wholesalers and purchasing groups driving down pricing. Thus, manufacturers are not incentivized to produce those medications in sustained large quantities. The FDA cannot force a company to make a particular medication, even if it is needed.

Photo Source: FDA

Supply and demand issues also drive shortages. In some cases, demand outpaces supply when drugs are used for expanded use cases. This is the case for drugs like Ozempic and Wegovy, which are GLP-1 drugs whose primary indications are to treat diabetes. The discovery of its effectiveness in weight loss has resulted in a vastly increased demand. The demand driven by the population of those dependent upon GLP-1 drugs to manage diabetic conditions in combination with those using them for weight loss has driven outages as well as increased pricing. Some of the demand for other drugs is driven by increases in prescriptions due to telemedicine. During the pandemic, restrictions were lifted on the prescribing of certain classes of medicines via telemedicine, such as Adderall, which is used for ADHD.[4] This resulted in increased demand for the drug which contributed to shortages that are still seen presently. This is especially pertinent since some obtain Adderall and other medications online for purposes of substance abuse.

Manufacturing problems and supply chain issues strongly contribute to drug shortages as well. The U.S. is dependent upon sources outside of the country for many of the drugs in shortage status. Less than one-quarter of the oral generics used in the U.S., and about 40 percent of sterile injectable generics are manufactured domestically. Approximately 17% of injectables used in the U.S. are manufactured in China.[5] Most importantly, many of the raw ingredients for pharmaceuticals are sourced outside of the U.S., with materials for 90-95 percent of U.S. generic injectable drugs coming from China and India.[5,6] Manufacturing certain older generic drugs, especially sterile injectables, is difficult due to the sterile manufacturing conditions required; thus, the number of capable facilities is low.

About 53 percent of the newest drug shortages are generic injectable medicines.[7] Sterile injectables include normal saline, antibiotics, flu vaccines, chemotherapy drugs, morphine, and insulin. Shortages in chemotherapy drugs have caused doctors and hospitals to resort to drug rationing. In those instances, hard decisions must be made regarding the treatment of life-threatening cancers. Doctors must choose which patients receive certain medications based on decisions based on curative intent and probability versus overall survival.

Photo Source: ADAP Advocacy

Drug shortages were also of heightened concern for those living with HIV during the coronavirus pandemic. In March 2020, ADAP Advocacy received assurances directly from each drug manufacturer that the coronavirus pandemic wasn’t negatively impacting the availability of anti-retroviral medications. The pharmaceutical industry was applauded for its efforts to protect the anti-retroviral drug supply chain.[8] At that time all of the drug manufacturers – AbbVie, Janssen Pharmaceuticals, Gilead Sciences, Merck. Theratechnologies, and ViiV Healthcare – did not foresee disruption to their supply chain.

Considering injectable therapies are increasingly showing up on the FDA’s drug shortage list, ADAP Advocacy once again inquired with its industry partners about potential concerns over shortages of injectable HIV-related medications, such as the injectables Cabenuva for the treatment of HIV, and Sunlenca for the prevention of HIV. 

Reaching out to the industry resulted in very positive feedback. A representative from ViiV Healthcare stated that “there are no current shortages nor anticipation of any prolonged shortages of any injectable within the ViiV portfolio.”

A Gilead spokesperson likewise stated, “Gilead’s commercial supply chain is robust, and we have a strong inventory position. We continually monitor the forecast and actively manage supply; thus, we do not anticipate any supply concerns related to Sunlenca®, Gilead’s twice-yearly injectable HIV treatment option for people living with the virus who are heavily treatment-experienced with multi-drug resistant HIV. We are committed to person-centric HIV treatment research and development, ensuring our advances in biomedical innovation reach the wide range of individuals and communities who are most in need.” 

Drug shortage is a serious concern that will require a multi-pronged approach to solve. The White House, FDA, and others must find solutions to the manufacturing, regulatory, and supply chain challenges. The government is already looking into investing in some of the raw materials needed for drug creation, which is a good start.

[1] Lokuwithana, D. (2024, June 15). U.S. drug shortages worsen to reach a decade high: report. Retrieved from https://seekingalpha.com/news/4116477-us-drug-shortages-reach-decade-high

[2] Silverman, E. (2024, June 4). U.S. drug shortages have reached a decade high and are lasting longer, too. Retrieved from https://www.statnews.com/pharmalot/2024/06/04/shortages-medicines-drugs-hospitals-manufacturing-cancer-adhd-gpo/

[3] IQVIA. (2023, November 15). Drug shortages in the U.S. 2023. Retrieved from https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/drug-shortages-in-the-us-2023

[4] Gilbert, D., Amenabar, T. (2023, March 14). An Adderall shortage has not let up. Here is why. Retrieved from https://www.washingtonpost.com/business/2023/03/14/adderall-shortage-telehealth-prescriptions/

[5] Owens, C. (2024, January 5). Low prices are contributing to America's drug shortage problem. Retrieved from https://www.axios.com/2024/01/05/america-generic-drug-shortage-reasons

[6] United States Senate Committee on Homeland Security and Governmental Affairs. (2023, March). Short Supply: The Health and National Security Risks of Drug Shortages. Retrieved from https://www.hsgac.senate.gov/wp-content/uploads/2023-06-06-HSGAC-Majority-Draft-Drug-Shortages-Report.-FINAL-CORRECTED.pdf

[7] U.S. Pharmocopeia. (2024, June). USP Annual Drug Shortages Report. Retrieved from https://go.usp.org/l/323321/2024-05-31/92zsjg/323321/1717187146zgOpt4vW/GEA_GC_056R_MSM_Report_2024_05_FINAL.pdf?_gl=1*e6c4sj*_gcl_au*Mjc1NzUzOTg5LjE3MTc1MTMzOTM.*_ga*OTI0OTQ1ODI4LjE3MTc1MTMzOTM.*_ga_DTGQ04CR27*MTcxNzUxMzM5My4xLjEuMTcxNzUxMzc1Ny4wLjAuMA

[8] ADAP Advocacy. (2020, March 26). Press Release: ADAP Advocacy Association Applauds Pharmaceutical Industry Efforts on Protecting the Drug Supply Chain during the Coronavirus Pandemic. Retrieved from https://www.adapadvocacy.org/pdf-docs/2020_ADAP_Press_COVID_19_Supply_Chain_03-26-20.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.  

Is Congressional Support for HIV Funding Waning?

By: Ranier Simons, ADAP Blog Guest Contributor

Federal funding is the backbone of many government functions and influences many aspects of our daily lives. Federal spending allows the Pentagon to function, supports educational programs such as Head Start, helps maintain our infrastructure, and, most importantly, affects healthcare. One aspect of healthcare with a heavy reliance on federal funding is HIV/AIDS. But has that funding kept pace with the need for people living with HIV/AIDS (PLWHA)?

Photo Source: Medical Marketing & Media

The federal government invests both mandatory and discretionary spending regarding HIV. Mandatory spending is set by laws and statutes.[1] Some of the mandatory spending related to HIV services includes Medicare, Medicaid, and Social Security Disability Insurance.[1] Discretionary spending is determined each year by Congress through the appropriations process. This includes programs such as the Ryan White HIV/AIDS Program (RWHAP) and AIDS Drug Assistance Programs (ADAP). Although needs have increased and priorities have evolved, federal funding regarding HIV has remained essentially flat and, in some cases, faces threats of cuts, which could result in unsatisfactory health outcomes. This is especially true regarding HIV and aging.

Discretionary funding supports HIV treatment and continual testing programs, helps entities to provide and promote the utilization of PrEP, and even enables assistance with social determinants of health concerns such as housing instability. However, RWHAP's core budget has been left primarily flat since 2013, although it has added 50,000 patients.[2] The program serves low-income PLWHA. Over 50% of PLWHA are dependent upon the RWHAP annually for services needed to survive and thrive, such as medication and essential support services.[3] Likewise, Emily M. Schreiber, Senior Director of Policy & Legislative Affairs for NASTAD, points out that ADAP funding last increased in FY2014. From 2014 to 2022, ADAP client enrollment increased by 60 percent.

ADAP has increasingly relied on rebates from drug manufacturers under the 340B Drug Pricing Program, but ongoing abuses by big hospital systems and mega service providers threaten the solvency of that program. Congress is knocking on 340B's proverbial door, saying: "Show Me the Money".

Exacerbating the urgency for increased spending is more extended life expectancy. Advances in medical science, such as antiretroviral therapy, mean that PLWHA are living longer. More than 50% of PLWHA in the United States are over 50, with estimates projecting that by 2030 it will be 70%.[3] Living longer means that PLWHA are dealing with many HIV-associated non-AIDS health conditions partly stemming from HIV-related chronic inflammation in the body and long-term use of strong antiviral medications.[4,5] These include diabetes, cardiovascular disease, renal disease, and cancer. Moreover, PLWHA dealing with comorbidities must navigate multiple medications, increased risk for drug reactions, and coordinate multi-specialty care.[3] 

Photo Source: Kaiser Family Foundation

Many PLWHA 65 years of age and older are covered by Medicare, and about 40% depend upon Medicaid.[3] Ten states have yet to expand Medicaid. Additionally, studies show that Ryan White-funded patients with private insurance have better health outcomes than those on Medicare. Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, states, “With people living longer, we must sustain funding just to support the services for them, but at the same time, our goal is to bring more people into HIV care and treatment. Without that additional funding, our progress in ending HIV will remain basically stalled. While we are fighting proposed cuts, we must also examine ways to use the existing federal resources in different innovative ways to make the progress we need.”

PLWHA are also being affected by discretionary funding challenges with programs that are not expressly HIV related. One such program is the Teaching Health Center Graduate Medical Education program (THC). Most primary care medical residents receive their residency training in hospitals. The Center for Medicare and Medicaid Services pays hospitals billions for primary care and other specialty residency training.[6] Conversely, the THC program trains residents in outpatient clinics instead of hospitals and has $215 million to spend through 2024. THC gives residents extensive community-based outpatient residency training in facilities such as federally qualified health centers and community clinics that are in underserved urban and rural areas.[6]

Data shows that graduates of THC residencies are more likely to remain and practice in local communities. Many PLWHA reside in underserved urban and rural communities. The THC program not only trains residents on how to care for these populations but is also a pipeline of an effective workforce to bolster care deserts. Many PLWHA in underserved areas have difficulty finding robust primary care services and infectious disease care. Effective primary care will lead to improved healthcare outcomes for PLWHA with comorbidities, in addition to enhancing their HIV care.

Photo Source: The Wright Center

Nevertheless, unlike hospital residency programs, THC funding is not guaranteed and comes from discretionary Congressional appropriations. There are 82 THC programs in the United States. Despite proven success, the program is consistently financially tenuous. Due to not having stable, long-term, reliable funding, some of the THC programs have been put on hold or stopped.[6] It was created under the Affordable Care Act in 2010 and will run out of funding in December if its appropriations funding is not replenished.

It is important to note that federal domestic discretionary spending includes Centers for Disease Control & Prevention (CDC) HIV prevention programs like the Ending the HIV Epidemic (EHE), RWHAP, ADAPs, National Institutes of Health (NIH) HIV/AIDS research, and even Housing Opportunities for Persons with AIDS (HOPWA).[1] President Biden’s fiscal year 2025 budget request eliminates barriers for Medicaid recipients to receive PrEP and proposes a program to guarantee PrEP for all uninsured and underinsured.[1] It also requests a new $10 million program to improve equity and civil rights through a DOJ program to eradicate outdated criminal statutes that target PLWHA.

The evolution of HIV is not stagnant or flat, nor should its funding be. The lives of PLWHA and efforts to end the HIV epidemic are too important to be left on unstable funding grounds due to the politicization of disease and misappropriation of scarce resources. House Republicans have expressed the desire to cut as much as 11% of a bill that supports HIV programs.[7] Failure to increase and innovate funding will adversely affect the progress that has been made as well as lead to avoidable poor healthcare outcomes and increased costs.

[1]  HIV.Gov. (2024, May 13). Federal HIV Budget. Retrieved from https://www.hiv.gov/federal-response/funding/budget

[2] Whitehead, S. (2024, June 19). Americans are living longer. Federal spending isn't keeping up. Retrieved from https://www.medpagetoday.com/hivaids/hivaids/110714?xid=nl_mpt_DHE_2024-06-19&eun=g1964022d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Evening%202024-06-19&utm_term=NL_Daily_DHE_dual-gmail-definition

[3] Health Resources and Services Administration. (2023, December). HRSA Ryan White HIV/AIDS Program Parts and Initiatives. Retrieved from https://ryanwhite.hrsa.gov/about/parts-and-initiatives

[4] HIV.Gov. (2024, June 4). Aging with HIV. Retrieved from https://www.hiv.gov/hiv-basics/living-well-with-hiv/taking-care-of-yourself/aging-with-hiv#:~:text=Health%20Issues%20and%20Aging%20with%20HIV&text=In%20addition%2C%20while%20effective%20HIV,%2C%20renal%20disease%2C%20and%20cancer.

[5] Gallant, J., Hsue, P. Y., Shreay, S., & Meyer, N. (2017). Comorbidities Among US Patients With Prevalent HIV Infection—A Trend Analysis. The Journal of Infectious Diseases, 216(12).

[6] KFF Health News. (2024, June 13). Funding instability plaques program bringing doctors to underserved areas. Retrieved from https://www.usnews.com/news/health-news/articles/2024-06-13/funding-instability-plagues-program-bringing-doctors-to-underserved-areas?src=usn_tw

[7] Burke, J. (2024, May 21). Press Release: New CDC HIV Data Demonstrates the Impact of Flat Funding. Retrieved from https://hivhep.org/wp-content/uploads/2024/05/CDC-HIV-data-press-release-5.21.24.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.  

Fireside Chat Retreat in Houston, TX Tackles Pressing Public Health Issues

By: Brandon M. Macsata, CEO, ADAP Advocacy

ADAP Advocacy hosted its Health Fireside Chat retreat in Houston, Texas among key stakeholder groups to discuss pertinent public health issues facing patients in the United States. The Health Fireside Chat convened Thursday, June 13th through Saturday, June 15th. An analysis of the collaborative relationships between patient advocacy organizations and drug manufacturers (continued from the previous retreat), patient perspectives about reforming the 340B Drug Pricing Program, and the disproportionate impact HIV is having on Latinos living in the South were each evaluated and discussed by the 23 diverse stakeholders.

Photo Source: Getty Images

The Health Fireside Chat kicked-off with a stakeholders reception sponsored by the Alliance to Save America’s 340B Program (ASAP 340B), of which ADAP Advocacy is an active member. The retreat also featured three moderated white-board style discussion sessions on the following issues:

• Patient Advocacy & Industry: HIV State of the Union — moderated by Matt Toresco, CEO at Archo Advocacy LLC
• Congress Eyes 340B Reform: Why Comprehensive Solutions Outweigh Incremental Steps —moderated by Brandon M. Macsata, CEO, ADAP Advocacy & Jen Laws, President/CEO, Community Access National Network (CANN)
• Latinos in the South: An Invisible HIV Epidemic — moderated by Judith Montenegro, Program Director at Latinos in the South and Latino Commission on AIDS

The discussion sessions were 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:

• Grant Cale, Senior Director, Strategic Alliance Liaison, Bristol Myers Squibb
• De’Shea Coney, Vaccine Access and Equity Coordinator, Iowa Department of Health
• Tori Cooper, Director of Community Engagement, Human Rights Campaign Foundation
• Hunter Fasanaro, Director of Strategic Partnerships & Healthcare Initiatives, Archo Advocacy
• Ramon Gardenhire, VGR, ViiV Healthcare
• Rick Guasco, Editor-in-Chief, POSITIVELY AWARE
• Ashley John, Director, Issue Advocacy, Novartis
• Lisa Johnson-Lett, Peer Support Specialist, AIDS Alabama
• Marsha Jones, Executive Director, The Afiya Center
• Jax Kelly, President, Let's Kick ASS (AIDS Survivor Syndrome) Palm Springs
• Kamaria Laffrey, Co-Executive Director, The SERO Project
• Jen Laws, President & CEO, Community Access National Network
• Darnell Lewis, Patient Advocate
• Brandon M. Macsata, CEO, ADAP Advocacy
• Judith Montenegro, Program Director, Latino Commission on AIDS
• David Pable, Patient Advocate
• Frank Rosas, Consumer Vice-Chair HIV Medication Advisory Committee, Texas Department of Health
• Ranier Simons, Policy Consultant, Community Access National Network
• Matt Toresco, CEO at Archo Advocacy LLC
• Denise Tucker, Executive Director, State Policy, Merck
• Steven Vargas, Executive Committee Member, National HIV and Aging Advocacy Network
• Jennifer Vaughan, Patient Advocate
• Marcus Wilson, Senior Director, Community Engagement and Patient Advocacy 
• Gilead Sciences

ADAP Advocacy is pleased to share the following brief recap of the Health Fireside Chat.

Patient-Industry Collaboration:

The first policy session was Patient Advocacy & Industry: HIV State of the Union, which was led by Archo Advocacy LLC's CEO, Matt Toresco. Archo Advocacy seeks to build the foundation, strategy, and execution plans to drive the patient to the center of all decision-making. Matt presented a detailed summary of his recently-completed research, which is designed to bridge the gap between patient advocacy and the biotech and pharmaceutical industries. Key Insights from the “ELAVAY: Patient Insights. Elevated Healthcare.” included data, analysis, and anecdotes on what biotech and drug manufacturers are doing well, and where they can do better to support patient advocacy. His presentation offered a better understanding of the myriad of internal issues that often drive their decisions on what to support and what they cannot support. He noted that the leadership of biotech and drug manufacturers think in terms of quarterly and annual profits (as businesses), but advocacy doesn't operate on the same schedule.

According to Archo Advocacy's statement upon releasing the report: "These findings highlight significant areas where patient needs are evolving and provide actionable strategies for addressing these changes. We encourage you to reflect on these insights and consider how they can be integrated into your current and future strategies to meet patient expectations better and improve overall healthcare delivery. These findings are being shared with pharmaceutical, biotechnology, medical device companies, and even payers/PBMs so that they can adjust how they interact with your organization and bring patients into the dialog to maximize patient outcomes."

The research's findings yielded interesting dialogue on health equity and social determinant of health (SDOH), as this area serves as an extension of the typical programmatic support initiatives supported by the biotech and pharmaceutical industries. Some of the things advocacy is often seeking to influence is affordable housing, food insecurity, social/economic inequalities, social support networks, transportation, just to name a few. Matt also addressed some of the limitations, in part, brought about by the historical transactional relationships between industry and the nonprofit world, as well as restrictions placed on them by the federal government. He did also note an unintended consequence of the Inflation Reduction Act, namely it is causing more organizations to "reorganize" and reallocate budgets into areas that drive revenues.

The following materials were shared with retreat attendees:

• ELAVAY: Patient Insights. Elevated Healthcare.
• The ABCs of SDOH: Meaningful strategies to improve patient outcomes
• Mental health inequities resulting in billions in expenses, Deloitte finds
• Leadership of Patient Advocacy Organizations Tied to Pharma and Device Industry (Trigger Warning)
• Health Care Operations & Compliance, Professional Perspective - DOJ Pharmaceutical & Medical Device Enforcement Continues In Line With Recent Trends

ADAP Advocacy would like to publicly acknowledge and thank Matt for facilitating this important discussion.

340B:

For the discussion focused on reforming the 340B Program, Congress Eyes 340B Reform: Why Comprehensive Solutions Outweigh Incremental Steps, ADAP Advocacy (yours truly) was joined by Jen Laws, who serves as CANN's President/CEO. This co-facilitated discussion didn't hold back any punches on highlighting the ongoing abuses by hospitals, as well as some very large Ryan White Grantees. It also provided an opportunity to reveal a teaser to the forthcoming final report being issued by ADAP Advocacy's Ryan White Grantee 340B Advisory Committee on 340B Program Eligibility, Executive Compensation, and Charity Care.

The conversation weaved back-and-forth between the federal and state levels, with discussion around several pieces of legislation before the U.S. Congress, as well as state-driven initiatives. States lack the statutory authority to legislate the 340B Program, but that hasn't stopped state legislatures from diving into it. Arguably, most state legislators are ill-equipped to understand the nuances of this massive federal program and their actions are driving it toward insolvency.  

At the federal level, lawmakers are finally catching-up with the growing chorus of stakeholders pushing for reform — including the introduction of the bipartisan 'Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now' ("SUSTAIN 340B Act"), and the Republican-led '340B Affording Care for Communities & Ensuring a Strong Safety-net Act' ("ACCESS Act"). Another less notable piece of legislation introduced was the ‘340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2024’ ("340B PATIENTS Act"). It was introduced by Rep. Doris Matsui (D-Calif.), a known drug industry antagonist and a favorite of the American Hospital Association. Despite the legislation's short title, it appears to be more concerned with providers than patients.

Photo Source: CANN

Jen reviewed high-level expected similarities between each proposal and some anticipated differences. Similarly, he touched on the direction of state actions regarding reporting requirements and the debate over contract pharmacies...though both ADAP Advocacy and CANN have argued that isn't where reform is most needed. Focused on addressing statutory vagueness, and the status of current litigation is "where the fight is", as Laws noted. There was a broader conversation on the ecosystem impacts of 340B, including consolidation concerns as they pertain to healthcare costs and patient access to care. Emphasizing the importance of both stabilizing the program and ensuring the program appropriately serves patient interests as opposed to other stakeholder groups like the Ryan White Clinics for 340B Access, which seems more driven by protecting provider coffers than helping patients. Specifically, Laws mentioned the need to address conflated interests: hospital administrators are not providers and provider voices are not a substitute for patient voices.

One important note was ADAP Advocacy's and CANN's calling for model language used for contract pharmacy arrangements as provided for under AIDS Drug Assistance Programs as a "gold standard" of the program directly serving its legislative intent - helping patients access life-saving medications.

The following materials were shared with retreat attendees:

• ASAP 340B Policy Principles
• Congress is Knocking on 340B's Door, Saying "Show Me the Money"
• House panel eyes reforms to 340B drug discount program

ADAP Advocacy would like to publicly acknowledge and thank Jen for co-facilitating this important discussion.

Latinos in the South:

Judith Montenegro, Program Director at Latinos in the South and Latino Commission on AIDS, concluded the retreat with a discussion reflective of the host city and state and how the HIV/AIDS epidemic is currently disproportionately impacting Latinos in the South. Latinos in the South: An Invisible HIV Epidemic started with an overview of realities Latinos living with and impacted by HIV in the South, often complicated by the ongoing anti-immigrant sentiments in the public discourse. 

The invisibility in healthcare access in Latine Southern Communities presents a significant barrier to accessing timely, appropriate care and treatment. For example, among Latinx patients diagnosed with HIV in Texas, approximately 25% received a late diagnosis. People living with HIV/AIDS diagnosed prior to 1996 make up about 10% of  Texas' current HIV prevalence; nationally, it's about 25%. 

Judith asked, "How can health care providers and policymakers develop and implement culturally competent strategies to engage Latinx communities, particularly in rural and migrant populations, in HIV prevention and treatment programs?"

That question yielded a passionate conversation about the very real challenges faced by Latinx communities in the South, including check-points, restricted access to federally-funded public health programs, vaccine hesitancy, lack of culturally-competent healthcare settings (hospital visitation policies, for example), and the inability to access healthcare information in Spanish. Whereas it was acknowledged there are very unique barriers faced by undocumented Latinx patients, it remains a crisis among all Latinx communities in the South. Judith acknowledged the purposeful invisibility and systems of fear perpetrated on Latinx communities, such as deportation, disclosure, criminalization, and public charge.

Now, Latinx communities are the target of political and public health misinformation. "Healthcare for Illegal Immigrants" is a political advertisement running in numerous media markets. The ad is financed by the right-wing group Building America's Future, which is the same group that ran the anti-immigrant ad the night of the 2024 State of the Union. The ongoing misinformation campaign claims the 340B Program is providing "free healthcare for illegal immigrants" and it is designed to make Republican voters angry about "those people" getting free stuff from taxpayers. Aside from the ad being factually inaccurate, it fuels the rising tide of anti-immigration, thus making it even harder to serve Latinos living with HIV.

The following materials were shared with retreat attendees: 

• Hispanic Equity Brief
• Southern Latinx LGBT Regional Assessment- pages: 8-31
• Figure 2
• Declaration of a State of Emergency
• Here’s what’s holding back Medicaid expansion in Mississippi and other Southern states
• Biden Harris Administration Finalizes Policies to increase access to Health Coverage for DACA Recipients
• Still in the Shadows: The Health Crisis of Hispanic/Latinx Communities Aging with HIV/AIDS
• The Invisible US Hispanic/Latino HIV Crisis: Addressing Gaps in the National Response
• Healthcare for Illegal Immigrants (Trigger Warning)
• 287g Program: An Overview
• Delegation of Immigration Authority Section 287g and Nationality Act
• 2022 Changes to the Public Charge Inadmissibility Rule and the Implications for Health Care

ADAP Advocacy would like to publicly acknowledge and thank Judith for facilitating this important discussion.

Additional Fireside Chats are planned for 2024 in New Haven (September), and New York City (December).

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.

What are 'Major Statements' for Direct-to-Consumer Pharmaceutical Advertisements

By: Ranier Simons, ADAP Blog Guest Contributor

In the United States, it is common to see advertisements for drugs. Ads appear in print magazines, on television, on the radio, on the internet, and mobile devices. In 2022, the pharmaceutical industry spent nearly $17.4 billion on advertising.[1] The majority of this spending is direct-to-consumer pharmaceutical advertisement (DTCPA) spending. Coincidentally, the United States and New Zealand are the only countries in the world allowing DTCPA. Other countries have banned DTCPA because they feel it does more harm than good. In addition to well-established prescription drug advertising regulations, the U.S. Food & Drug Administration (FDA) released a final rule in November of 2023, effective as of May 20, 2024.[2] Companies have until November 20, 2024, to come into full compliance. 

Photo Source: FDA

The new rule is specific to DTCPAs that are delivered in radio or television format, which name a drug and describe what it is used for. This rule focuses on the presentation of the ‘major statement’, which is the explanation of a drug's side effects and contraindications. There are five key standards the rule establishes. Major statements must be delivered in consumer-friendly language; audio information must be understandable; text must be presented clearly, conspicuously, and neutrally; text information must be readable; and ads cannot include distractions.

Requiring statements to be delivered in consumer-friendly language means that information regarding a drug's side effects and contraindications does not contain scientific and medical jargon. Most consumers must easily understand it. The rule’s requirements concerning the audio information are a direct response to the way ads used to appear and sound. Audio must be understandable in terms of volume, articulation, and pacing.[2] Previously, ads, whether on television or radio, would list a long line of side effects and concerns with a rapid cadence and sometimes in a less audible tone than the rest of the advertisement. This is because ads were required to list almost every possible side effect of a medication. The new rules now mean that only the major and most frequent side effects must be stated. They must be articulated in audio that is as clear as the remainder of the advertisement.[2]

With respect to text, the rule explains that textual information must be presented in an appropriate font, positioned in a visually advantageous manner, against an appropriately contrasting background, and appear for a proper duration of time.[2] Regarding distractions, the rule explains that ads cannot contain statements, text, images, or sounds that distract from the communication of the major statement of side effects and contraindications.[2] Most importantly, in terms of transparency, the contents of the major statement have to appear simultaneously in the audio and video portions of television ads, which is referred to as dual-modality.[2]

The new rule, in addition to the longstanding advertisement regulations, is meant to protect consumers and ensure they are not misled about what drugs can and cannot do. It also informs them about a medication’s risks. Many critics feel the new rules do not go far enough, primarily since they do not address the content of the information, only its presentation.

Photo Source: FDA

There are many pros and cons to DTCPA. Advertisements can educate patients about available treatment options, encourage people to seek care, especially regarding underdiagnosed conditions, and improve communication between doctors and patients. Moreover, when someone sees an ad for a drug they are already taking, it can be a reminder to take their medication as well as positively influence how they feel about the medication, which can increase adherence. Negative attributes of DTPCA are it can lead to overuse of some prescription drugs, which increases drug spending, can cause higher utilization of brand name drugs instead of effective lower-cost generics, and can negatively affect the patient-doctor relationship.[3] Consumers may see an advertisement for a drug and demand it from their physician. However, the physician may deny them a particular medication because the physician is knowledgeable of medical reasons why a drug may not be a good fit or actually be harmful. This could affect the trust and communication between a doctor and a patient.

A notable shift regarding DTCPA is regarding drugs to treat and prevent HIV/AIDS. Over the past few years, there has been a recognizable increase in the number of ART-related television, print, radio, and digital ads. In 2021, ads for ART accounted for six percent of total prescription drug ad spend. Gilead Sciences and GSK accounted for almost all of 2021’s pharmaceutical ad spending dedicated to HIV and AIDS.[4] For example, GSK spent all its 2021 Q4 advertising budget buying spots on ABC, A&E, CBS, CNN, Fox, NBC, and the USA network, which was 75% of what the company spent on television ads that year.[4]

ViiV Healthcare, which is majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited (Shionogi) as shareholders, has had a recognizable presence in television ads since 2017. In 2017, one of its first significant television campaigns was for Triumeq.[5] In 2022, ViiV spent $8.3 million in June alone, on television ads for Dovato. Advertisements for HIV-related drugs on television, in print ads, and digital forms are potentially not just beneficial for drug companies’ bottom lines.[6]

Photo Source: Trend Radars

Antiretroviral drug ads are educational in informing patients of drug options. The science behind treatment for HIV/AIDS is moving at a rapid pace, and many are not aware of all the treatment options available. Advertisements can empower HIV/AIDS patients to have discussions about treatment modalities their doctors may not have presented to them. Additionally, antiretroviral drug campaigns are a kind of social engineering. There are still negative perceptions and public stigma surrounding HIV despite scientific knowledge supporting the concept of undetectable viral load translating into a lack of risk of transmission, or “U=U undetectable = untransmittable.”[6] Many television ads depict subjects who are actual users of the antiretroviral medications, publicly revealing their status. This can add humanity to a disease that remains cloaked in stereotypes and misinformation for many.

Whether in a magazine, a television commercial, a print ad, a YouTube video, or a digital mobile pop-up, pharmaceutical advertisements in the United States are here to stay. There are valid pros and cons. The only way to ensure that the pros outweigh the cons is to monitor and regulate intentionally. Difficulties in the logistics of enforcing governmental regulations can mean slow adoption of and even violation of rules. Optimistically, the efforts of consumers, advocates, and medical professionals can facilitate acceptable and effective pharmaceutical advertisement utilization and execution.

[1] Faria, J. (2023, September 22). U.S. pharmaceutical preparations ad spend 2021-2022. Retrieved from https://www.statista.com/statistics/470460/pharmaceutical-preparations-industry-ad-spend-usa/#:~:text=In%20a%20survey%20of%20representatives,billion%20U.S.%20dollars%20on%20advertising.

[2] FDA. (2023, November 21). Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format. Retrieved from https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear

[3] Keller, J., Hauschild, J. (2024, January 10). FDA Issues Final Rule and FAQ Regarding Direct-to-Consumer Drug Advertising. Retrieved fromhttps://www.faegredrinker.com/en/insights/publications/2024/1/fda-issues-final-rule-and-faq-regarding-direct-to-consumer-drug-advertising

[4] Media Radar. (2022, May3). HIV/AIDS Prescription Drug Advertising: Looking Toward the Future. Retrieved from https://mediaradar.com/blog/hiv-aids-prescription-drug-advertising/

[5] Bulik, B. (2017, December 4). ViiV starts 'Moving Forward' into first branded TV ads for HIV treatment. Retrieved from https://www.fiercepharma.com/marketing/viiv-s-first-branded-hiv-tv-ad-stars-real-patients-and-their-stories

[6] Adams, B. (2022, July 11). ViiV wants HIV patients to 'detect this' as it launches new Dovato TV ad. Retrieved from https://www.fiercepharma.com/marketing/viiv-wants-hiv-patients-detect-it-launches-new-dovato-tv-ad

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.