FDA Is Examining Foreign Factories That Make US Drugs Less, Even as More Inspections Find Issues

The Food and Drug Administration (FDA) has not been inspecting drug manufacturing facilities as often as it did before the COVID-19 pandemic, and the inspections they do perform are leading to more citations, a new report warns.

An article in Health Affairs by researchers from Duke University and the University of Maryland, “observed steep declines” in the numbers of inspections the FDA conducted. 

However, despite the dip in the number of inspections, the authors say that “citations rose dramatically,” even though every facility is given notice that an inspection is coming, the experts continue.

These citations mean that “there is an unsatisfactory level of compliance with current good manufacturing practices,” and that action needs to be taken to remedy this.

When the pandemic began, the FDA said they would be decreasing the amount of inspections they would conduct, saying that it would concentrate on “mission-critical inspections” that were deemed to have the most public health benefit. 

Inspections for non-mission-critical global manufacturing sites, as well as non-prioritized domestic sites, didn’t resume until 2022. According to the study authors, more than two thirds of the sites that produce active ingredients in drugs that are distributed in the United States are located outside of the country. 

In 2019, the study found that the FDA conducted 954 inspections of foreign sites, and 738 domestic sites. In 2022, the authors found that the number of domestic inspections had fallen by 35%, foreign inspections had fallen by almost 80%, and that the FDA did not inspect any sites in China or India between April 2020 and March 2021.

The authors cite a tragedy from 2008 as a reason these foreign inspections are so important. In 2008, contaminated blood thinner from a factory in China was found to be responsible for 81 U.S.deaths. The contaminated drug, called heparin, caused severe and deadly allergic reactions. 

This year, 65 children in Uzbekistan died because of contaminated cough syrup, which was found to contain toxic ingredients that are used in cleaners and car antifreeze. 

However, in 2016, a report from the Government Accountability Office found that a third of the 3,000 foreign drug manufacturers whose products are distributed in the U.S. had never been inspected by the FDA.