FDA Site Inspections Decreased During Pandemic. Questions Continue about Drug Quality.

The COVID-19 pandemic impacted the FDA’s ability to properly inspect facilities that manufacture prescription drugs, which could have impacted drug quality, suggests a new paper in the December 2023 issue of Health Economics. Even now after the public health emergency has lifted, the authors said concerns about drug quality remain as regulators work through their backlog of inspections, especially in foreign facilities.

Prescription drug manufacturing outside the United States plays a critical role in the U.S. supply of medications, with India, China and Italy playing a lead role in manufacturing active ingredients.

During the COVID-19 public health emergency, the FDA prioritized critical domestic inspections in low-risk areas. This decreased the overall number of inspections done by the regulatory agency. But regulators monitored imports for safety issues and asking for records.

The U.S. Department of Health and Human Services officially declared the end of the public health emergency in May 2023. By then, the FDA had resumed non-prioritized inspections both in the United States and in other countries.

Emily A. Cuddy, Ph.D.

In this study, researchers wanted to look at the impact and outcomes of the decreased FDA inspections during the pandemic. Led by Emily A. Cuddy, Ph.D., assistance professor of economics at Duke University, they assessed data on inspections by the FDA Office of Regulatory Affairs from 2012 to 2022. Researchers assessed preapproval and postapproval inspections, surveillance, and for-cause inspections.

Cuddy and her coauthors aggregated inspection observations to the monthly level and also aggregated inspections to five areas: China, Europe, India, Latin America and America. They then created a measure of intensity of the resource deployed and reported on the average number of inspector days per month per region. They also reviewed “official action indicated,” or citations for deficient findings, from those inspections.

Researchers found that the before the COVID-19 pandemic, the number of foreign inspections was rising. For the full year 2012, there were 648 foreign inspections and 1,392 inspections in the United States. For the full year 2019, foreign inspections rose to 954 while U.S inspections decreased to 738.

During the public health emergency, FDA inspections decreased significantly and had not yet returned to pre-pandemic numbers by 2022. In 2022, total annual inspections were down by 79% and U.S. inspections were down by about 35%. About 70% of inspections during the pandemic were reinspections of facilities with deficiencies from previous inspections. Additionally, between April 2020 and March 2021, no inspections were conducted of facilities in China or India.

At the same time, the authors note the costs for inspections increased during the pandemic. They suggest that the FDA’s choice of which facilities to inspect was a key cost driver. “As FDA leaders prioritized certain inspections, the resources required to conduct those inspections also changed.”

While the number of inspections has gone down since the start of COVID-19, the time spent by inspectors has increase, from between five to eight days before 2020 to between seven and 15 days by 2022. Additionally, during this time, deficient findings increased, with facilities inspected during the pandemic were “nearly twice as likely to have had a history of objectionable conditions or practices than those that were not inspected.”

The authors suggested that delaying inspections could impact the quality of prescription drugs, exposing U.S. consumers to lower-quality products. Even now after the public health emergency has lifted, the authors said concerns about drug quality remain.

The authors provided policy recommendations going forward for inspecting facilities and maintaining the quality of prescription drugs. These include:

• Increasing the investigator workforce;
• Prioritizing foreign inspections;
• Increasing international cooperation for ensuring quality;
• Spreading the drug quality assurance burden to intermediaries; and
• Increasing patients’ awareness of drug quality.