FDA saw uptick in drug shortages in 2022

Although the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) worked to prevent 222 drug shortages in 2022, both CDER and CBER reported a total of 49 new drug shortages during the calendar year, according to the agency’s report to Congress.

While not as high as the peak of 251 drug shortages seen in 2011, the 49 new drug shortages in 2022 is an increase from 41 drug shortages 2021 and 43 drug shortages in 2020, FDA said.

“Because drug shortages can pose a significant public health threat that can delay, and in some cases even deny, critically needed care for patients, drug shortages remain a top priority for FDA,” the agency wrote in its executive summary of the report. FDA recently released draft guidance outlining steps manufacturers of certain drug and biological products should take when notifying the agency of manufacturing shortages under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act). (RELATED: Manufacturers seek clarity on FDA’s drug shortage notification guidance, Regulatory Focus 6 June 2023)

FDA said 150 manufacturers sent notifications for 1,293 potential drug and biological product shortages in 2022. They noted manufacturers are adhering to notification requirements more often than in previous years, and more manufacturers are notifying the agency about potential shortages annually.

“These early notifications give FDA additional time to work with manufacturers and other stakeholders to identify ways to maintain treatment options and prevent a shortage,” they wrote.

Despite a decrease in the number of new drug shortages over the last several years, ongoing drug shortages have remained high. The report noted 86 ongoing drug shortages in 2022 compared to 83 ongoing shortages in 2021 and 86 ongoing shortages in 2020. Some disruptions to the medical product supply chain that arose from the COVID-19 pandemic continued into 2022 and contributed to some shortages of drug products, the agency noted.

“In the past 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, as well as an earlier than typical flu and respiratory virus season, FDA has seen additional strain on the pharmaceutical supply chain,” they said.

When FDA acts to prevent and address drug shortages, they use “a range of available tools,” such as regulatory flexibility and discretion, they said. In 2022, FDA reported 87 instances of regulatory flexibility and discretion across 76 products for situations ranging from identifying new sources of medically-necessary drugs to alleviate a shortage to granting third-party oversight of manufacturing processes for a product with quality issues. The agency also expedited the review of 80 abbreviated new drug applications and 70 supplements of abbreviated new drug applications in 2022.

During 2022, FDA used quality management maturity (QMM) practices to address drug shortages, and CDER is working towards building a QMM program, the report noted. The agency also highlighted its work in collaboration with the US Department of Health & Human Services to expedite production of a combination smallpox and mpox vaccine after an outbreak of mpox in the United States.

Future work in addressing drug shortages includes gaining better insight into the supply chain and improving supply chain resiliency, FDA said.

“Based on FDA’s experience to date and the data on drug shortages presented in this report, the Agency believes that the requirements related to early notification of interruptions and discontinuances in manufacturing and FDA’s own actions are helping to reduce the threat and impact of drug shortages,” the agency said. “FDA will continue to prioritize its efforts on this important public health issue, working to ensure the availability of necessary drugs and biological products for the American public, including adequate supplies of drugs needed to treat patients with COVID-19 and other respiratory illnesses.

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FDA saw uptick in drug shortages in 2022

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