Rep. Raja Krishnamoorthi, D-Ill., chairman of a House panel investigating whether COVID-19 antibody tests work, accused the FDA on Tuesday of stonewalling in developing information about antibody test kits that went on the market before the FDA validated their claims.
There is an enormous interest in developing antibody tests to see if people had COVID-19, even if they did not show symptoms.
These antibody, or serology tests, are not used to diagnose if a person has the infection. Antibody blood tests could determine if a person had and recovered from COVID-19. Scientists have suggested that people with COVID-19 antibodies are immune from the disease.
In a letter to FDA Commissioner Stephen Hahn sent Tuesday, Krishnamoorthi said officials in Hahn’s agency failed “to respond to our outstanding requests for information in furtherance of our investigation” into FDA “policies governing serological testing for coronavirus.”
Krishnamoorthi said in the letter, “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.”
Krishnamoorthi’s panel last week released a report that found the coronavirus antibody tests on the market “face unanswered scientific questions of utility and accuracy.”
The report also found the FDA did not review any coronavirus “rapid” antibody test kits before they went on the market, and a “lack of enforcement by FDA has allowed manufacturers to make fraudulent claims about their efficacy.”
The FDA “failed to police the coronavirus serological antibody test market,” the report concluded.
The report cited research on antibody tests conducted by the University of California, San Francisco; the University of California, Berkeley; and the Chan Zuckerberg Biohub that found “that 11 of 14 serology tests that were analyzed did not deliver consistently reliable results.”
On Tuesday, Krishnamoorthi’s panel sent letters to four companies making or distributing tests that did not pass the muster of the University of California researchers.
The companies were told 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.”
The companies were asked to produce, by May 11, data to show their tests were effective.
The FDA was asked to pledge, by May 6, to revise its policy to require serological test makers apply to the FDA for approval before selling to the public. The FDA was urged to use its enforcement tools “on bad actors” and “pull ineffective serological tests from the market.”
Krishnamoorthi represents the north suburban 8th Congressional District. He is the chairman of the subcommittee on economic and consumer policy, part of the Committee on Oversight and Reform, the principal oversight committee of the House.