FDA Cracks Down on Unauthorized and Counterfeit COVID-19 Diagnostic Tests

The National Law Review reports

As the COVID-19 public health emergency drags into its third year, we continue to keep track of efforts by the Food and Drug Administration (FDA) to combat fraud in the form of fake cures, counterfeit diagnostic tests, and other products claiming to prevent, treat, or detect infection by SARS-CoV-2 that are marketed without required FDA authorization. Our previous posts (see here and here) provided updates on joint and separate efforts by FDA and the U.S. Federal Trade Commission (FTC) throughout the pandemic to detect and eliminate these illegal products. In this post, we focus on FDA’s recent enforcement activities concerning COVID-19 diagnostic tests and the agency’s increasingly aggressive pursuit of entities offering counterfeit or unauthorized tests.

From one perspective, FDA appears to have pumped the brakes on enforcement activities relating to COVID-19 tests. Although the agency issued 15 Warning Letters to companies offering unauthorized tests between January 1 and July 31 of 2021, only two such letters issued since August 1, 2021 appear in FDA’s Warning Letter database. However, FDA’s device recall database tells a completely different story and serves as a striking reminder that such letters are not the only metric to consider when it comes to the agency’s enforcement powers.

Notably, since August 1, 2021, companies initiated 40 recalls for COVID-19 test products classified under product codes QLT, QKP, QJR, and QKO. By comparison, companies initiated a total of 89 recalls for products in the same device classifications when we look back over the course of the entire pandemic (i.e., starting in March 2020). Furthermore, FDA has designated 17 of the 40 recalls commenced since August 1, 2021 as Class 1 recalls (the highest risk classification for a recall of an FDA-regulated product), whereas only 23 recalls for these same product codes have been designated as Class 1 since the start of the pandemic. The fact that just over 40% of the recalls for COVID-19 tests were initiated in the past nine months and that almost half of those recalls are Class 1 illustrates FDA’s zeal to root out poor quality and unauthorized tests from the U.S. marketplace. Indeed, most of the Class 1 recall descriptions state that the diagnostic test products are being removed from the market because they did not receive authorization from FDA.