Washington, D.C. -Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer Policy, sent a letter to the Food and Drug Administration (FDA) pressing for compliance in the Subcommittee’s investigation into the agency’s policies governing serological testing for coronavirus.
“With many plans to reopen the economy requiring the availability of consistently reliable serological testing, we need your answers now, while there is still time to fix shortfalls in FDA policy," wrote Krishnamoorthi. “It is FDA’s job to protect the public health. Abdicating that responsibility and trusting private industry to regulate itself is unacceptable."
On April 24, 2020, Subcommittee Chair Krishnamoorthi released a staff memo with preliminary findings showing wide gaps in the Trump Administration’s handling of serological testing based on a briefing with senior officials from the FDA, Centers for Disease Control and Prevention (CDC), and Department of Health and Human Services (HHS).
When asked about the Subcommittee’s staff memo during the April 24 White House Coronavirus Task Force press briefing, FDA Commissioner stated the following:
“So, under our policy, we provided flexibility. What we’ve told manufacturers is that in order to market in the U.S., they have to validate their tests, they have to tell us that they validated their test, and then in the package insert they have to let people know-end users, labs, etc.-that those tests were not authorized by the FDA. We’ve authorized four, as I mentioned, more are in the pipeline. And these tests that have come in without any information to us, but have been self-validated, as I mentioned at the podium a couple days ago, we are working with the National Cancer Institute, as well as CDC, to perform our own validation of the tests that have been sent to us. So, we’ll provide as much information as we possibly can. And there is transparency on our website about those tests, and also the tests that we have authorized."
Researchers confirmed the Subcommittee’s concern that FDA’s lax policies are permitting a flood of fraudulent tests onto the market. The research-conducted by the University of California, San Francisco; the University of California, Berkeley; and the Chan Zuckerberg Biohub-found that 11 of 14 serology tests that were analyzed did not deliver consistently reliable results.
The Subcommittee also sent letters to four companies-UCP Biosciences, Inc., BioMedomics, Inc., Epitope Diagnostics, Inc., and Premier Biotech, Inc.-that manufacture or distribute tests that the University of California researchers found did not deliver consistently reliable results, seeking information about their interactions with FDA and data supporting claims about the accuracy of their tests.
“The Subcommittee is concerned that FDA is not conducting substantive review of serological tests that it has allowed on the market and that those tests may not meet a reasonable standard of accuracy," added Krishnamoorthi.
