I'm disappointed by #FDA Commissioner Hahn's response to a question about my subcommittee's investigation into the major flaws in the Administration's handling of coronavirus serology testing and the fact that the FDA doesn't know whether the tests currently on the market work.
Commissioner Hahn didn’t deny my subcommittee’s staff findings that the FDA hasn’t been validating the effectiveness of serological tests for COVID-19; it’s just taking the word of the test-makers that they validated their test and are following FDA rules. oversight.house.gov/sites/democrat…
The FDA isn’t even asking serological test-makers for validation data or documents to support their claims: it's just accepting those claims at face value and allowing companies to sell their products. Because of this failed policy, there are bogus COVID-19 tests on the market.
Commissioner Hahn has characterized the antibody tests the FDA has failed to review as “self-validated.” Given the presence of so many faulty tests on the market, it might be more fitting to describe them as “unregulated” and that is a serious problem.
The National Cancer Institute voluntary review program is designed for failure, because there is no plan for FDA to review tests it doesn’t receive. Junk test-makers won’t voluntarily give their tests to the government to reveal they don't work; they'll just keep selling them.
Hahn said FDA provided “flexibility” in the marketing of serological tests, but that’s just a euphemism for “laissez-faire.” “Flexibility” has allowed junk tests to flood the markets, sacrificing quality and reliability for the sake of free market access.
There’s still time to fix this. Commissioner Hahn and the FDA can require test-makers to submit data and tests to review, crack down on the bad actors, get junk tests off the market, and ensure only effective tests are used to fight COVID-19. The FDA needs to act now.
Not only do the tests need to work, doctors and patients need to know how to use them effectively to fight COVID-19. The CDC must put out guidance ASAP about if and when antibody tests should be used, and what to do with the results. Not doing so will risk more lives.
