Drug shortages continue to increase

For the report, USP analyzed data from FDA and the Center for Drug Evaluation and Research to identify drug shortages in the United States.

Overall, USP found that the number of drug shortages in the United States has increased over the last decade. In December 2023, there were 125 FDA-monitored drug shortages, compared to 82 shortages in December 2014. 

Among the 125 shortages at the end of 2023, 34 were new shortages. Several types of drugs were part of these new shortages, including oncology drugs, psychiatric drugs, gastroenterology drugs, and more. Of these drugs, more than half (53%) were generic sterile injectables, while 32% were solid oral drugs.

According to USP, the average duration of drug shortages has also increased year-over-year. As of December 2023, the average drug shortage duration was 1,202 days, or over three years. Compared to 2020, the average duration of drug shortages increased by almost a full year. 

Of the 125 drugs in shortage at the end of 2023, 27 had been in shortages for more than five years, and six had been in shortage for over 10 years. "Increased durations of drug shortages should be concerning as they impact patient care, prolonging or hindering access to drugs," USP wrote.

According to USP, "Market forces, particularly pricing, play a significant role in drug shortages." In 2023, more than half of the injectable medications in shortage cost less than $5, and almost one-third cost less than $2. In addition, 66% of solid oral medications in shortage were $3 or less.

These low prices also contributed to an increasing number of product discontinuations. Between 2022 and 2023, product discontinuations increased by 40%, going from 100 in 2022 to 140 in 2023. This was the highest rate of product discontinuations since 2019.

What's causing these shortages?

According to USP, thin profit margins are often the cause of drug shortages. "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," said Anthony Lakavage, the organization's SVP for global external affairs.

Aside from low profits, poor quality control at some companies can also contribute to drug shortages. For example, USP found that facilities that made drugs in short supply were more likely to be required by FDA inspectors to fix a problem.

However, the companies required to fix problems made up less than 1% of the total production volume for drugs in shortage. In comparison, companies that were told voluntary changes were needed made up almost 40% of production volume for drugs in shortage.

Efforts by FDA to resume regular inspections after the COVID-19 pandemic have also added to drug shortages. In fiscal year 2021, FDA conducted 7,147 onsite domestic inspections and 186 foreign inspections. In 2023, this increased to 13,305 domestic inspections and 2,716 foreign inspections.

Because of this increased surveillance, FDA inspectors are more likely to identify manufacturing issues that cause companies to slow or halt their production until the problems are corrected. For example, FDA prevented Intas Pharma, a key chemotherapy supplier based in India, from distributing some medicines in the United States after finding serious issues at one of its plants.

According to STAT+, there is also some controversy around group purchasing organizations, which act as intermediaries for hospitals, clinics, surgery centers, and more. Low-ball contracting by these organizations is often said to contribute to shortages, since companies are hesitant to agree to prices that will yield insufficient margins.

Currently, the U.S. Federal Trade Commission is investigating the extent to which group purchasing organizations and wholesalers may be contributing to ongoing drug shortages. The agency is also investigating whether these organizations are using their market power to influence drug pricing and availability at healthcare facilities.

So far, experts have made several suggestions on how to reduce drug shortages. For example, the Brookings Institution has recommended the U.S. government provide manufacturers with incentives to upgrade their facilities and encourage hospitals to create buffer inventories to prevent sudden shortages.

The U.S. Senate Finance Committee also recently drafted a bipartisan bill to mitigate drug shortages. Under the bill, Medicare would pay bonuses to hospitals and physicians for using contracting practices that ensure an adequate supply of drugs. Drugs at the highest risk, such as generic sterile injectables and infused medications, would be targeted first. (Silverman, STAT+ [subscription required], 6/4; U.S. Pharmacopeia report, accessed 6/12)

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