House Democrats: FDA not doing enough to regulate antibody tests


House Democrats said Friday that the Food and Drug Administration (FDA) is not taking strong enough action to monitor the massive influx of new coronavirus antibody tests on the market, products that can help determine how and when to reopen the economy. 

A memo from staffers on the House Oversight Committee to the panel’s members reveals the preliminary findings of the committee’s investigation into antibody testing and warns that a lack of regulation over antibody tests could put people’s health at risk.

“FDA’s policy, which it stated was intended to ‘make it easier’ for tests to go to market, has allowed serological antibody tests without any substantive review,” staffers wrote in the memo. “FDA is not yet able to assess the reliability of any serological antibody tests on the market.” 

The FDA began allowing developers to sell their antibody tests to the public without prior review in March on the condition that they vow to validate their products and notify the agency when the reviews are complete.

The administration has defended its policy, saying it provides “flexibility.”

“We have told manufacturers that in order to market in the U.S., they have to validate their test,” FDA Administrator Stephen Hahn said at a White House press briefing Friday. “They have to let those people know … that the tests were not authorized by the FDA.”

Hahn added that the FDA is working with the Centers for Disease Control and Prevention and the National Cancer Institute to validate tests sent to the department, and will provide “as much information as we possibly can” about their effectiveness. 

The availability of antibody tests is one prong in the White House’s plan to reopen the economy. However, health officials have warned that the presence of antibodies does not necessarily translate to immunity for the coronavirus.

“There’s an assumption, a reasonable assumption, that when you have an antibody that you are protected against reinfection, but that has not been proven for this particular virus,” Anthony Fauci, the nation’s top infectious disease expert, said earlier this week.

Democrats wrote in the memo that the FDA has not yet taken legal action against companies that falsely market tests as approved by the agency and that the oversight panel will continue investigating the antibody tests.

Tags Anthony Fauci antibody Coronavirus Food and Drug Administration Immunology
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