FDA tries to mitigate damage done by Trump's push for speedy approval of antibody tests
He's a menace! 
https://www.dailykos.com/stories/2020/5/4/1942590/-FDA-tries-to-mitigate-damage-done-by-Trump-s-push-for-speedy-approval-of-antibody-tests
FDA tries to mitigate damage done by Trump's push for speedy approval of antibody tests
Kerry Eleveld
Daily Kos Staff
Monday May 04, 2020 · 5:55 PM EDT
In the midst of a pandemic, flooding a market with faulty antibody tests is a pretty much a worst-case scenario. Any errant results leave the recipients operating with the false impression that perhaps they have achieved immunity and can carry on with their work absent the worry of getting infected or infecting others. Or a false negative might convince someone who actually is immune that they must continue with a strict social distancing regimen. In other words, faulty tests in a marketplace foster a ton of misinformation that threatens public health and could even prove deadly.
But thanks to Donald Trump's insistence that regulators ease rules in order to get coronavirus tests to market more quickly, more than 100 antibody tests are now being sold that haven't met any standard for being effective, according to Politico. But on Monday, the Food and Drug Administration (FDA) announced it would retroactively impose a process for emergency use applications that companies must submit within 10 days after first bringing their products to market.
When the FDA first relaxed the regulations on antibody tests back in mid-March, the agency itself acknowledged the risks of failing to regulate the products in any way. "Inaccurate diagnoses during a pandemic can impair prevention efforts and delay appropriate treatment for sick patients," the FDA stated, urging companies to "take all necessary steps" to ensure the accuracy of their tests. The policy, however, tasked companies entirely with validating their own tests.
The stricter FDA policy change came after the chair of the House Oversight Economic and Consumer Policy Subcommittee announced a congressional investigation of the policy, writes Politico. Last week, the American Medical Association also urged the Department of Health and Human Services to restrict who can administer the tests to medical professionals after doubts have grown about the accuracy of some tests. Some companies have also made false claims about their tests being FDA-approved or appropriate for at-home use, which was never part of the FDA guidelines.
According to FDA Commissioner Stephen Hahn, close to half of the companies with an antibody test on the market are now seeking appropriate authorization through the updated policy.
But confusion in the marketplace was bound to be the result of Trump and his allies pushing to get a bunch of unproven tests on the market as part of their reckless push to reopen the economy.
= new reply since forum marked as read
