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

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