Drug Shortage Reports Emphasize Continuing Problems

In early June 2024, FDA and the US Pharmacopeial Convention (USP) both published reports on drug shortages as of the end of 2023. The Center for Drug Evaluation and Research at FDA published its 11th annual report to Congress on drug shortages on June 6, 2024, in which the agency stated it had worked with manufacturers to prevent 236 drug shortages in 2023 (1). According to FDA, drug shortages decreased from 251 in 2011 to 55 in 2023.

“Although the number of new drug shortages has declined since 2011, shortages continue to pose a real challenge to public health, particularly when the shortage involves a critical drug, such as those used to treat cancer, to provide parenteral nutrition, or to address other serious medical conditions,” the agency stated in the Executive Summary of the report.” In the past calendar year, FDA has seen manufacturers in the United States and abroad continue to experience quality issues as well as struggle with capacity constraints. Additionally, as demand increased for numerous drugs over the last several years as a result of the COVID-19 pandemic, the flu season, and the respiratory virus season, FDA has seen further strain on drug availability and the pharmaceutical supply chain.”

The USP report released on June 4, 2024, USP Annual Drug Shortages Report: Economic Factors Underpin 2023 Shortages, includes drug shortage trends up to the end of 2023 in the US (2). These trends were based on use of USP’s Medicine Supply Man tool, which uses artificial intelligence and predictive analytics to predict supply chain risks. One such trend found by USP is that shortages are lasting more than three years compared to two years in 2020. Shortages are also impacting a variety of therapeutic classes with 53% being new generic sterile injectable drugs.

According to the USP report, the supply of a medicine is at risk when one or more of the following factors are in play: low prices, complexity of manufacture, geographic concentration, and quality problems. Drugs with lower prices had an increased discontinuation rate of 40% in 2023 for one year. Sterile injectable drugs that were in shortage were almost 8.5 times lower in price than those not in shortage.

Sterile injectables also have a higher manufacturing complexity, making them even more vulnerable to shortages. Antibiotics, which sometimes require separate dedicated facilities, and APIs that require complex chemical synthesis are also at risk.

Limited locations for API and finished dosage production also contribute to shortages according to USP, but it is quality concerns that can plague manufacturers the most. When regulators discover quality problems at facility inspections or a recall must be made, manufacturers must inform regulators of the possibility of a shortage that may result from these quality control actions. “Quality comes at a price,” said Vimala Raghavendran, vice president for Informatics Product Development at USP, in a press release (3). “The economics of generic drugs often leave manufacturers with razor-thin margins, making it challenging to prioritize investment in modern machinery or to elevate standards of quality. Without sufficient profitability, the cycle of innovation and improvement becomes difficult to sustain.”

“As we navigate the complex landscape of drug shortages, it is paramount to shift the market into a stable state,” said Anthony Lakavage, senior vice-president for Global External Affairs at USP. “Economic pressures, especially the very low prices that generics manufacturers recover for many medicines, along with contracts that are frequently broken, have left our generic medicine supply chain fragile. Unexpected shocks can break the system and disrupt the supply of quality medicines. This worrisome trajectory leads to more frequent drug shortages, prolonged scarcity, and more people at risk of not getting the medicines they need, when they need them.”

References

1. FDA. Report to Congress. Drug Shortages CY 2023. June 2024. https://www.fda.gov/media/179156/download
2. USP. USP Annual Drug Shortages Report: Economic Factors Underpin 2023 Shortages. USP.org. June 2024.
3. USP. U.S. Drug Shortages Reach Decade-high and Last Longer. Press Release, June 4, 2024. https://www.usp.org/news/us-drug-shortages-reach-decade-high-and-last-longer