The shortage of many medicines in the U.S. remains a ‘systemic’ problem, a new analysis finds

STAT News – Tuesday, June 9, 2027
By Ed Silverman

The number of prescription drug shortages in the U.S. fell by 23% last year, marking the second consecutive year of declines and the lowest level since 2017, according to a new analysis that otherwise found troubling signs about medicines that are in short supply.

For instance, the average drug shortage lasted 5.3 years, exceeding the 4.3 years seen in 2024 and greatly outpacing the average two-year shortage experienced in 2019. Moreover, nearly two-thirds of out-of-stock medicines were in short supply for more than three years, and 39% were unavailable for more than five years.

Meanwhile, the 75 drugs that were in short supply last year spanned 130 therapeutic categories, indicating that shortages affected a wide range of diseases and patient populations, according to the analysis by U.S. Pharmacopeia, an independent organization that develops standards for medicines.

At first glance, the numbers do appear conflicting and suggest some progress, but the overall trends are troubling, said Matthew Christian, director of supply chain insights at the organization. “The problems we have are systemic. They are not resolved and they are not new. They’re old and not going away.”

The findings arrive as persistent shortages have sometimes hobbled the health care system across the U.S. A growing number of hospitals, doctors, and patients regularly encounter difficulties trying to obtain a variety of drugs. The report found that shortages were most notable among pediatric meds, cancer treatments, and anesthetics, among others.

The issue has been blamed on various factors. As an example, the report cited rising product discontinuations, which can be blamed on formulation changes or portfolio consolidation. But drugmakers typically stop producing medicines due to low profit margins or a lack of incentives to remain in or enter a market, USP explained.

The numbers last year were striking. Discontinuations rose to 170 from 106 in 2024, which was a 60% year-over-year increase that reversed a decline seen between 2023 and 2024. This was also the largest number of discontinued medicines recorded since December 2019, when there were 155 discontinuations, the report noted.

Pricing underscores the problem. The analysis found that 65% of discontinued oral solid medicines — such as pills and tablets — were priced below $1 a unit. And their median price fell by 78% — from $1.80 in 2024 to 40 cents last year. The upshot was that the share of discontinued medicines priced below $1 rose to 65% from 46%.

For injectable drugs that were discontinued, 35% were priced below $15 per unit, which was a 19% rise in the share of discontinued injectable medicines priced at that level compared to 2024. The “findings suggest that very low prices may be closely associated with a higher likelihood of discontinuation,” the report stated.

Consider that, among the 12 oral solid drug products in shortage, 83% were priced below $6 per unit, with 42% priced below $2 per unit and 25% priced below $1 per unit, according to the analysis. Among the 51 injectable drugs in shortage, 73% were priced below $15 per unit, with 47% priced below $5 a unit. Injectables are also more complex to manufacture.

Here is another way to illustrate the point: The average price of a generic injectable that was not in short supply was $169, or 8.5 times higher than the $20 price for a generic injectable product in shortage last year. For generic oral solid drugs, the average price was $8 for products not in shortage, compared to $3 for products in shortage, the report stated.

Beyond sometimes low profits that prompt manufacturers to abandon a market, poor quality control at some companies also contributes to shortages. In some cases, the U.S. Food and Drug Administration prevents a company from distributing medicines until facilities and procedures are revamped.

From 2021 to 2025, the analysis found facilities manufacturing drugs that were in short supply were more likely to receive the FDA’s most serious inspection finding than facilities that were producing drugs not in short supply. When this occurs, the FDA may withhold approvals or certificates needed to export medicines.

This is particularly true for generic drugmakers, which operate in an ecosystem that prizes efficiency but also the lowest possible prices, the report noted. The companies need to avoid adverse FDA inspections, but at the same time, are pressured to maintain low prices, which can constrain the ability to invest in greater quality production.

U.S. Pharmacopeia used its report to highlight a related issue — the growing concern about the concentration of production of both key ingredients and finished medicines in other countries. Beyond the potential for disruptions to supply chains for any one medicine, this is increasingly seen as a vital national security issue.

Among the 75 drugs in short supply last year, 33 — 44% — rely on at least one key starting material that is produced exclusively in a single country. Six drugs for which shortages existed depend entirely on such materials from one country — four injectable medicines sourced solely from China and two oral medicines sourced from India.

The analysis found a similar pattern for active pharmaceutical ingredients. Of the 75 drugs in short supply last year, the European Union was the primary supplier for 15 of those medicines — more than 50% of those sorts of ingredients were sourced from the EU. India was found to be the primary supplier for seven drugs for which shortages existed.

Meanwhile, the U.S. last year made 21% of all oral solid drugs and 58% of those in shortage. By comparison, India produced 63% of all oral solid drugs and only 23% of those in short supply. The U.S. made 47% of all injectables, but 57% of those in short supply, while the EU produced 20% of all injectables but only 5% of those in shortage. India produced 16% of all injectable volume and 26% of the injectable volume in shortage.

Christian noted that 2% of finished medicines and 8% of active pharmaceutical ingredients are produced by China for U.S. patients. But China makes 41% of key starting materials that find their way to U.S. patients. “As you go further upstream,” he said, “the national security risk is significantly higher.”

Another telltale sign is a drug master file, which is a document submitted to the FDA to provide confidential detailed information about manufacturing and processes. For this reason, Christian called these a “leading indicator” of where drugs will be produced in the future, and at the end of 2024, he noted that China had the largest share of new filings.

The problem facing the U.S., therefore, is that the increased reliance on China will make supplies increasingly vulnerable to trade wars, tariff policies, and also natural disasters. “Their influence over the medical supply chain for U.S. patients,” Christian explained, “will continue to grow over time.”

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