COVID-19 had an Impact on Drug Supply

In 2021, regulators at the FDA’s Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research worked with manufacturers to prevent 317 drug shortages, according to a new report issued by the agency. Last year, the number of new drug shortages was 41, compared with a peak of 251 in 2011.

Regulatory officials said 2021 was a challenging year for shortages, with manufacturers in the United States and abroad struggling with both quality issues and capacity constraints.

The FDA continues to work closely with manufacturers to mitigate and prevent shortages as the COVID-19 situation evolves, an FDA spokesperson said. In 2021, the FDA expedited the review of 274 submissions and prioritized 29 inspections to address drug shortages.

The agency is currently focusing its shortage efforts on the drugs used in the hospital intensive care unit setting for patients on ventilators, including sedatives, opioid analgesics, neuromuscular blocking agents, vasopressors, anticoagulants, dialysis agents, antibiotics, beta-2 agonist inhalers, and intravenous fluids.

One such case involved cisatracurium, a drug that is used for patients on mechanical ventilators and went into shortage due to the increase in hospitalized patients early in the pandemic. Additional manufacturers were approved under expedited assessment and the shortage was able to be resolved in July 2021.

Additionally, the FDA issued 15 enforcement discretion decisions to increase supplies of the bronchodilator albuterol, oxygen, the anesthetic propofol and other critically needed medications.
“One urgent request covering the distribution of industrial grade oxygen for medical use due to significant shortages in Texas and increased demand due to COVID-19, was considered and approved in less than eight hours on the condition that oxygen distributors met several key quality and safety conditions, including testing for impurities prior to distribution and immediately reporting any serious adverse events,” the spokesperson said.

The Food and Drug Administration Safety and Innovation Act (FDASIA) enacted in 2012 gave regulators new authority to address drug shortages and ensure quality in the global drug supply chain. It required manufacturers to notify the FDA about discontinuation of manufacturing or a temporary interruption that could impact supply.

Additionally, the CARES Act, signed into law on March 27, 2020, to help ease the economic impact of the COVID-19 pandemic provided additional authority to the FDA in this area, including allowing the agency to prioritize and expedite reviews and inspections that could help ease or prevent shortages.

Agency officials believe the requirements related to early notification of interruptions and discontinuances in manufacturing and the FDA’s own actions are helping to reduce the impact of drug shortages.