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.  

Why a Secure Drug Supply Chain Matters

By: Brandon M. Macsata, CEO, ADAP Advocacy Association
       Shabbir Imber Safdar, Executive Director, Partnership for Safe Medicines

Since the start of the AIDS crisis, people living HIV (PLWHA) have looked forward to a day when medicines could allow them to live a life in which their HIV is undetectable and untransmittable (otherwise known as, “UequalsU). Today, PLWHA with access to treatment and adherent to their antiretroviral therapy are expected to live well into their 80’s. There is so much promise in the fight to end the epidemic. 

PLWHA can be confident of the security of those medications from fraudsters because they are protected by the Drug Supply Chain Security Act (DSCSA). This medication protection system, originally created in 2013, completes its rollout next year in 2023. It assigns a number to each package of medicine at time of manufacture, and that number is tracked at every change of ownership from factory to distributor to pharmacist. “Track and trace” is the name associated with this drug supply safety system.

Photo Source: Pharmaceutical Technology

Though criminals never stop trying to defraud patients and pharmacists, we know the DSCSA works because it has been tested. A pharmacist in Texas who checked the serial numbers on “too-cheap-to-be-true” HIV medicine discovered fraud and returned that medicine to the seller without dispensing it to patients. Furthermore, because these kinds of serial numbers allow very fine-grained tracking of medicine in the supply chain, no broad recalls were necessary which might have taken perfectly good medicine off the market and endangered patient access.

DSCSA has protected PLWHA and all patients in the United States, but as with any system, it needs support. There are two key places where the federal government needs to help:

• Charge people who forge DSCSA paperwork with DSCSA fraud

Criminals, such as the recent spate of HIV counterfeit criminals, have yet to be charged with criminal offenses for DSCSA fraud. In fact, to-date there is no record of anyone ever having been charged with DSCSA fraud. To protect patients there must be a deterrent to forging DSCSA paperwork, and to do that, the DOJ must ensure that this crime draws a criminal charge.

There are currently 140 defendants in the existing civil litigation brought by Gilead Sciences and Johnson and Johnson Healthcare Systems against the criminals trafficking in counterfeit and diverted HIV and Hepatitis C (HCV) medications. Not even one has drawn a criminal charge of forging DSCSA paperwork. 

The Biden Administration’s Department of Justice needs to make prosecution of criminals who violate the DSCSA a priority with resources and training.

• Do not undermine the DSCSA for political expediency

For decades it has been in vogue to suggest buying medicine from other countries to make it cheaper. However, countries suggested, like Canada, don’t have a system like DSCSA and we cannot provide this same level of safety assurance to patients and pharmacists. Regulations that intentionally break the DSCSA, like the regulations that govern bulk importation of drugs from Canada that break the DSCSA will endanger HIV, HCV, and many other categories of American patients.

The Administration’s Department of Health & Human Services needs to revoke the rules governing bulk importation until Canada has an interoperable DSCSA system to protect medicine imported.

Ensure broad understanding of DSCSA features for physicians

As the DSCSA finishes its rollout, one part of the dispenser community unlikely to get the message is physicians who administer long-acting HIV injectables. These injectables, which can control HIV with just two shots every month or two months, are an enormous innovation.

However recent history includes a few failures of physicians to understand the dangers of criminals in the supply chain, including:

• Physicians purchasing black market oncology from unlicensed sellers (including Canadian criminals) and administering in their offices it to cancer patients;
• Physicians in thirteen states who purchased black market none-sterile IUDs and implanted them in patients, resulting in horrific medical adverse events; and
• Physicians who purchase black market Botox, and administered them to patients, endangering them.

Unlike pills taken by PLWHA, which can be examined by the pharmacist and patient, injectables administered by physicians don’t necessarily have this protection. Additional steps are needed to ensure patients can participate in medication verification safety. All too often, patients never see touch the injectable, and likely never see the packaging it came in. Physicians, who are not typically trained to check pharmaceutical wholesaler licenses or verify DSCSA safety features, have repeatedly been the targets for criminals. PLWHA need to be empowered to involve themselves more in this process.

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As the DSCSA rollout proceeds, we urge the Biden Administration to resource the U.S. Food & Drug Administration (FDA) so they can prioritize education of physicians about the new security features of the DSCSA and the risks to their patients and their practice if they ignore them.

People living with HIV in the United States have witnessed significant progress in managing their condition. The advent of new medicines has greatly improved their quality of life greatly, and equally the safety of their drug supply has been enhanced by the Drug Supply Chain Security Act. It’s critical that we do everything possible to support it.

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.  

Ramifications of Pharmaceutical Supply Chain Challenges

By: Ranier Simons, ADAP Blog Guest Contributor

The COVID-19 pandemic has globally brought awareness to many aspects of daily life that previously remained in the shadows, discussed only by select groups of people in siloed industries and centers of knowledge. A spotlight has been shone on food insecurity, lack of infrastructure to effectively manage global public health crises, inequalities regarding social determinants of health, and supply chain issues affecting everything from housing building materials to Starbucks menu ingredients. One serious supply chain pain point is the pharmaceutical supply chain. Drug supply chain issues are more than just an inconvenience, and they can lead to grave harm or death.

Photo Source: theworldcreate.net

Drug supply chain issues come in many forms: production limits, storage, and distribution problems, reduced shipping capacity, and even transportation problems.[1] These problems lead to drug price inflation, the proliferation of counterfeit drugs, the dissemination of contaminated or poorly manufactured drugs, and even extreme shortages, leaving people without needed pharmaceuticals.

Zebra Technologies Corporation conducted a study called the Pharmaceutical Supply Chain Vision, releasing the results on February 8, 2022. The company specializes in technological solutions to workflow concerns. Zebra surveyed over 3,500 patients and pharmaceutical executives to gauge perceptions of the drug supply chain in terms of its resilience, responsibility, and trust and examine ways to improve visibility and transparency.[1] 

The most important issue identified by patients regarding drug supply chain issues is the quality of the pharmaceuticals. Ninety percent desired a guarantee that their medications were not counterfeit, were stored at correct temperatures, and had not been tampered with.[1] Eighty percent of the patients desired to know the country of origin of their medications and the manufacturing standards of those countries.[1] Other significant concerns were drug affordability and shortages. Many reported that their needed medications were often out of stock, and 69% said they feared taking the improper dosage due to misleading or incorrect label information.[1] Seventy percent reported changing medications, pharmacies, or healthcare providers due to drug supply chain issues.[1]

It is of the utmost importance to keep medications safe throughout the supply chain. Patients, healthcare professionals, and pharmaceutical executives agree that transparency and traceability in the drug supply chain are potent solutions to many present problems. Technology can be leveraged to provide tracking of medication shipments, pharmaceutical production workflow from raw material to final product, and even improvements in the ways drugs are produced. 

The only way to improve the status quo is a group concerted effort to report and gather the data. This sort of data needs to be in publicly accessible databases. These databases would bolster consumer confidence as well as enforce accountability for those along the supply chain. The National Academies of Sciences, Engineering, and Medicine (NASEM) recommends that “the FDA make sourcing, quality, volume, and capacity information publicly available for all medical products approved or cleared for sale in the U.S.”[2] 

This sort of information would make it possible to monitor weaknesses in the supply chain and address them. It would also enable predictions of shortages. Moreover, just like credit bureaus, third-party companies could use the data to create rating systems. Rating systems would enable healthcare systems and other large purchasers to make informed decisions to purchase the best possible medications for their populations. This would also create competition among manufacturers giving the incentive to create the best environment for producing and transporting high-quality medicines to patients.[2] There are legal regulatory hurdles to be overcome for such a public repository of information, but it is a very practical solution.

Photo Source: Association for Accessible Medicines

During the pandemic, people living with HIV have been especially concerned about drug shortages for their life-saving antiretroviral medications. In 2020, the ADAP Advocacy Association took action to address those concerns. It contacted antiretroviral drug manufacturers directly to inquire about what steps they were taking to secure the supply.[3] 

The ADAP Advocacy Association contacted AbbVie, Jansen Pharmaceuticals, Gilead Sciences, Merck, Theratechnologies, and ViiV Healthcare, all manufacturers of HIV antiretrovirals. Discussions with the companies resulted in the optimistic projection of no foreseen disruption in their drug supply chain. Brandon M. Macsata, CEO of the ADAP Advocacy Association, stated that “their combined assurances provided significant peace of mind for the people living with HIV/AIDS who we represent, and who rely on these life-saving medications.” 

Continuing to innovate to improve the drug supply chain is not just good for manufacturers' bottom line. It also means improved quality of life and lowered mortality for the global population.

[1] Beusekom, M. (2022, February 24) Patients, pharma execs express low trust in drug supply chains. Retrieved from https://www.cidrap.umn.edu/news-perspective/2022/02/patients-pharma-execs-express-low-trust-drug-supply-chains
[2] Frieden, J. (2022, March 4). How can the U.S. preserve its medical supply chain? Retrieved from https://www.medpagetoday.com/publichealthpolicy/healthpolicy/97524
[3] Macsata, B. (2020, April 24). Nation's HIV drug supply secure despite coronavirus pandemic. Retrieved from https://adapadvocacyassociation.blogspot.com/2020/03/nations-hiv-drug-supply-secure-despite.html

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