Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) wrote to Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., today regarding the agency’s work to determine the accuracy of COVID-19 diagnostic and serological tests.
“Public health experts have consistently called for increased access to reliable diagnostic testing to improve treatment, surveillance, contact tracing, and containment efforts," the Committee leaders wrote to Commissioner Hahn. “While many diagnostic tests have been authorized to come onto the market under an Emergency Use Authorization (EUA), questions remain about [FDA’s] oversight of these tests and their reliability. As we continue to take the necessary steps to improve access to testing, it is imperative that Americans and their health care providers have the utmost confidence in diagnostic tests. We write to you today to inquire about FDA’s work to determine the accuracy and sensitivity of these tests."
FDA issued guidance on Feb. 29, 2020, on how it would evaluate EUA requests for molecular diagnostic tests used to detect the coronavirus that causes COVID-19. Since that time, FDA has issued more than 170 EUAs for diagnostic testing products. While most diagnostic tests might typically undergo large patient studies prior to approval to determine accuracy, those authorized under an EUA are required to undergo a much smaller clinical testing sample.
“While no diagnostic test will ever be 100 percent accurate, these lower standards for determining reliability in diagnostic tests could affect our understanding of COVID-19’s spread within a community and across the United States," the Committee leaders continued. “As outbreaks continue to arise, patients, health care providers, and public health officials must be able to quickly test and trace the path of the disease."
The Committee leaders also raised questions regarding the reliability of rapid point-of-care diagnostic tests that can provide test results in 5 to 30 minutes, which some community settings and workplaces have indicated that they are using, or plan to use, as they take steps to reopen. One study found that the rapid point-of-care test the White House uses to test all visitors to the Oval Office could have a false-negative rate as high as 48 percent. FDA has reportedly received 106 adverse event reports about the rapid test used by the White House, which is just one of many COVID-19 tests on the market under an EUA.
In their letter, the members raised similar concerns about serological tests, which are used to determine the presence of antibodies to the coronavirus. In March, citing the relative simplicity of serological tests, FDA allowed some serological tests to be used without first receiving an EUA, under certain conditions. As a result, a flood of unauthorized tests, which were later found to provide unreliable results, inundated the market. While FDA has since revised its guidance on serological tests, requiring developers to request an EUA, dozens of unreliable and unauthorized tests remain on the market.
“While we are pleased that FDA is finally evaluating these tests under its May 4 revised guidance and is also publicly listing tests that should no longer be distributed, we believe FDA should do more to protect the safety and health of the American people," the Committee leaders wrote.
In order to better understand FDA’s actions to date and the reliability of tests currently on the market, the Committee leaders requested answers to a series of questions by July 27, 2020, including:
* Describe the post-market actions FDA is taking to evaluate the reliability of COVID-19 in vitro diagnostic tests, including serology tests.
* Identify which commercial test developers FDA has requested provide additional data or conduct post-marketing studies of tests authorized by an EUA.
* Describe the EUA status of serology tests that remain on the market.
* Describe the authorities or tools FDA may use to enforce compliance with the agency’s emergency use authorities for diagnostic tests, including a description of the actions FDA is taking or intends to take in a series of examples listed in the letter.
