Drug shortages have become a persistent challenge in the US health care system, with 277 active shortages reported in the fourth quarter of 2024, down from a peak of 323 in the second quarter of 2023.1 Despite this slight improvement, 50% of these shortages have lasted more than 2 years, disproportionately affecting life-saving medications such as intravenous fluids, sedation drugs, and peritoneal dialysis solutions.1
Drug shortages stem from a combination of systemic and operational factors. One significant issue is the vulnerability of the supply chain.2 A heavy reliance on foreign manufacturing for active pharmaceutical ingredients (APIs), particularly in countries such as China and India, leaves the US supply chain susceptible to disruptions from geopolitical tensions, pandemics, or natural disasters.3 These vulnerabilities create bottlenecks that delay the production and distribution of critical medications.
About the Authors
Kelli A. Boyden, JD, MS, completed her MS in pharmaceutical studies (regulation) at the University of Florida in Gainesville. She teaches housing law at DePaul University College of Law in Chicago, Illinois. She represents select clients with EB-5 visa, immigration, and complex regulatory and administrative law matters and appeals.
Joseph L. Fink III, JD, DSc (Hon), BSPharm, FAPhA, is professor emeritus of pharmacy law and policy as well as former Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.
Another major factor is market failure.4 Consolidation in the generic drug industry has reduced competition, making the system less resilient to disruptions. Predatory practices, such as price manipulation and exclusionary agreements, by pharmacy benefit managers exacerbate the problem, driving smaller competitors out of the market and limiting supply options. Sometimes, an insufficient financial incentive exists to continue manufacturing a relatively inexpensive generic drug.5
For pharmacists who want to get involved in these issues, there are various examples of federal legislation currently undergoing review. Pharmacists can find their senator at senate.gov and contact them to express your support.
The Patients Before Monopolies (PBM) Act requires divestiture of overlapping PBM businesses
- The Federal Initiatives for Drug Shortages is draft legislation from Senators Wyden and Crapo to address supply chain resilience
State initiatives that favor pharmacists are also in various stages of review. These include:
- Illinois’ Prescription Drug Affordability Board aims to establish a board to tackle high prescription drug prices, potentially impacting drug availability and affordability. Visit ilga.gov to learn more.
- Nevada’s Legislation Against PBM Discrimination aims to prevent pharmacy benefit managers (PBMs) from engaging in discriminatory practices against 340B-covered entities, ensuring these entities can continue to provide discounted medications to underserved populations. The Nevada State Board of Pharmacy can be contacted at bop.nv.gov or (775) 850-1440.
Finally, there are laws at the state level supporting transparency drug pricing. Seventeen states have introduced drug transparency legislation requiring pharmaceutical companies to report reasons behind significant drug price increases, aiming to control costs and prevent shortages. Examples include:
- California has implemented laws requiring drug manufacturers to notify and justify price increases.
- Oregon has enacted similar transparency measures to monitor and regulate drug pricing.
Regulatory barriers further compound the issue. Prolonged timelines for FDA approvals of new manufacturing facilities or product substitutions during shortages hinder rapid responses. However, the FDA is increasingly expediting approvals and reviews that have the potential to mitigate shortages.2
Addressing drug shortages requires a multifaceted approach that combines policy innovation, strategic investments, and professional advocacy. A critical solution involves bolstering the domestic production of APIs.6 Utilizing programs such as the EB-5 Immigrant Investor Program to fund US-based manufacturing facilities can reduce reliance on foreign suppliers by encouraging investment in US-based companies and jobs.7 This would increase resilience by keeping manufacturing onshore and avoiding international supply chain risks.
State and federal legislative initiatives also have a significant role to play. Programs such as California’s CalRx initiative, which seeks to lower costs and ensure consistent supply, provide a valuable model for federal expansion. Initially, California is partnering with a nonprofit manufacturer to produce low-cost insulin.8 Market uptake is uncertain; California can mandate its product be used by programs such as the state’s Medicaid program but not others.8
Policy makers can address the systemic issues that drive shortages and stabilize generic drug availability by replicating such initiatives nationally and focusing on generic, shortage-prone drugs. For example, the Affordable Drug Manufacturing Act of 2023 proposes government-backed production of essential generics to address persistent shortages and reduce costs.9 These legislative efforts can create a framework for sustainable drug manufacturing while ensuring fair pricing and equitable access.
A variety of efforts will be important in resolving drug shortages. Pharmacist advocacy is indispensable. Pharmacists can highlight their operational challenges by engaging with policy makers and advocating for reforms such as improved manufacturer communication and streamlined FDA processes during shortages. The voices of those on the front lines are indispensable to crafting effective policies.
REFERENCES
2. McLaughlin M, Kotis D, Thomson K, et al. Effects on patient care caused by drug shortages: a survey. J Manag Care Pharm. 2013;19(9):783-788. doi:10.18553/jmcp.2013.19.9.783
3. Ammar MA, Tran LJ, McGill B, et al. Pharmacists leadership in a medication shortage response: illustrative examples from a health system response to the COVID-19 crisis. J Am Coll Clin Pharm. 2021;4(9):1134-1143. doi:10.1002/jac5.1443
4. Beuriot J, Crunenberg R. Influence of drug shortages on the well-being at work of pharmacists practicing in community pharmacies. Explor Res Clin Soc Pharm. 2024;15:100471. doi:10.1016/j.rcsop.2024.100471
6. Muzzio FJ, Gupton BF, Ferri JK, Gurvich VJ. Overcoming global risk to the pharmaceutical supply chain for the United States: achieving pharmaceutical independence by reshoring manufacturing capacity and capability. June 18, 2024. Accessed January 16, 2025. https://nipte.org/wp-content/uploads/2024/06/Overcoming-Global-Risk-to-the-Pharmaceutical-Supply-Chain_061824.pdf
