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.