FDA Still Restricting COVID-19 Testing

April 23, 2020

The agency is delaying deployment of serological testing with more red tape. When will this end? Action Alert!

The FDA is blocking COVID-19 testing at point-of-care facilities such as doctors’ offices and clinics, and instead insisting that, in many cases, they be performed at “high complexity labs,” of which there are only a very few nationwide. This is yet another unfortunate example of the FDA’s complete lack of flexibility during the COVID-19 pandemic. This agency needs to stop getting in the way of widespread testing with excessive red tape.

We detailed a few weeks ago how the FDA and CDC bungled the deployment of widespread testing at the outset of the pandemic. When Secretary Alex Azar declared a public health emergency, new rules kicked in that made it harder for labs and hospitals to develop their own COVID-19 diagnostic tests. Labs needed to receive an Emergency Use Authorization (EUA)—in essence, pre-approval—from the FDA to deploy COVID-19 tests. It was only later that the agency released a policy that allowed companies to develop and offer these tests while they awaited approval of the EUA so as not to waste any more valuable time.

The FDA’s policy included serological tests, which measure the amount of antibodies present in the blood when the body is responding to a specific infection such as COVID-19. The benefit of serological tests is that they are simple to conduct and give rapid results, sometimes in 15 minutes. The RT-PCR tests that are meant to detect viral DNA can take hours to days. There have been issues with the accuracy of the tests being deployed in the US. This is certainly problematic, but does not diminish the importance of widespread testing. South Korea used a similar RT-PCR test that is used in the US, yet large scale testing is widely regarded as a key pillar of South Korea’s successful and rapid response to the pandemic.

The FDA’s policy allowed companies to begin offering serological tests, both in labs and at point of care, while waiting for the FDA’s approval of the EUA as long as certain conditions were met.

In subsequent statements, however, the FDA hit serological tests with more red tape. The FDA policy mentioned above, the agency explains, was silent about the status of these tests under the Clinical Laboratory Improvements Act (CLIA). CLIA requires that “high complexity” tests be performed in high complexity labs unless the test is waived. The FDA further states that all tests offered under the new policies are high complexity by default until or unless they are deemed otherwise through an EUA or general FDA review process.

The point is this: serological tests developed to be used by healthcare workers at point of care can only be performed in high complexity labs. Only after an EUA for a point of care serological test is approved by the FDA can the test be conducted outside of a high complexity lab.

Almost at every turn, the federal government is putting its incompetence and costly commitment to bureaucracy on full display. The FDA and other government health agencies are making it harder to get COVID-19 testing at locations where it would be most beneficial and convenient. The first at-home test was finally approved by the FDA weeks after companies were ready to offer them but destroyed samples they had collected due to FDA intimidation. The agency is blocking distillers and compounders from making hand sanitizer during a shortage. The FDA is also blocking us from learning about the benefits of natural medicine to deal with the pandemic. This is damaging to public health even in normal circumstances, much less a pandemic. This agency must be reined in.

Action Alert! Write to the FDA and Congress, telling them to stop blocking access to serological tests. Please send your message immediately.

39 responses to “FDA Still Restricting COVID-19 Testing”

  1. Cathy Kaech says:

    make the test available…None of the numbers matter, until we know how many people have already had this virus and have the antibodies.

  2. Jessica Rollins says:

    Stop blocking access to serological tests.

  3. Cheryl Grillmeier says:

    The FDA and Congress must stop blocking access to serological tests.

  4. Charlotte Fremaux says:

    The government and the FDA have failed us. The level of corruption and cronyism is appalling.

  5. Charlotte Fremaux says:

    Once again the FDA has failed to move quickly and think outside of the box. Corruption and cronyism prevents creative thinking and flexibility.

  6. It’s sad that it only changes when it affects THEIR family. God help us al.I think they are clearing out more room for Social Security monies.

  7. Beth Darlington says:

    Please stop blocking access to serological tests immediately. We cannot afford delays.

  8. Betty R Young says:

    This needs to stop now.

  9. Dale Whigham says:

    FDA&CONGRESS,stop blocking access to serological tests.

  10. Rickey McClunie says:

    Another example of ‘absolutely (and immorally) non-present’ regard for the lives of the American people, only regard for power, his and his family’s money, and those who bow to him. That is so clearly evident of the Trump administration, which (indeed) is nothing new for the GOP, Trump is simply a bolder, unapologetic version of the great majority of GOP members (a proven fact – despite their attempts to paint “those across the aisle” as the nation’s problem). His “In-your-face & let the chips fall where they may, because I am not responsible, it’s the Democrats’ fault, especially the black man who preceded me in office” manner of ‘so-called’ governing (endorsed by the GOP) is destroying American lives, literally. A recent PBS “Frontline” telecast submitted the same proof to America, last night, also. The FDA’s purpose is to ensure the safety and protection of American lives against foreign and domestic enemies (food and drugs that pose potential and proven threats to our health) through ethical/honest/stringent testing, but the GOP and Trump have made it their mission to pervert its purpose and function.

    • Mark says:

      The FDA was a criminal organization long before Trump came to office. Once you get your TDS medicated into remission, look up vagus nerve stimulation and side effects. I’ve worked for medical companies and I know that most of the devices on the market have never undergone clinical trials. The FDA just charges protection money if you can convince them your device is essentially similar to devices already on the market. In the case of the VNS, in one man it kept stopping his heart. Even though everyone knew it was possible, he was unable to sue the mfg. Why? Because the FDA approval granted the company immunity. When a journalist probed the FDA for pertinent info, they covered it up. The info became out of reach of even an FOIA request. The FDA needs to come under congressional oversight and the revolving door between Big Pharma and FDA needs to be closed. Permanently.

  11. Jo Ann Mikulencak says:

    Stop blocking access to serological tests! Stop with the Red Tape! Stop the negative press about the benefits of natural medicine!

  12. Russ Wilson says:

    I have what is called Covid 19 toes. Which is now one of the signs / indicators of Asymptomatic CV19. I’ve notified my health care provider and they won’t test. ??? Just told me to shelter in place for a week.

    One would think they would want me tested?? Until these test are done on a wider basis. The numbers are not a realistic indicator of the true infection rate.

  13. Elizabeth Roberts says:

    Until we have a vaccine against Covid-19, the key to releasing the lock down is testing. If this administration is so anxious to lift the stay in place order, why are they dragging their feet in obtaining reliable testing? This makes no sense unless there is something going on behind the scenes.

  14. Patricia Chambers says:

    The FDA has been complacent for decades. They’re one of the most horrible departments we have in power currently. Just look at all the side effects of major main-prescribed pharma.

  15. james grapek says:

    It is time for widespread testing. You cannot hide behind unsupported claims any longer. The Stanford study shows a very low mortality rate for this virus — not worthy of further restrictions. We know what you are doing. WWG1WWA.

  16. Emily Willoughby says:

    While I truly appreciate the safety that the FDA provides, sometimes some changes must be made in order to speed up the development and testing of new products. I am not advocating for no safety, especially not to any human volunteers, but we do need to safely accelerate the testing process.

  17. John Nichols says:

    The FDA needs to have it’s hand smacked. Keep out of the Big Business of public safety and allow unbiased scientists make policy!
    When greedy drug companies are now feeding their biased x-employees into the leadership of the FDA, it is not to be trusted

  18. There NEEDS to be testing done so this virus can be controled

  19. Raleen says:

    Their actions are Dangerous and We The People need to expose Anti-Life Consciousness they have. It will be brought to the Light that Country could be leading the way .Instead USA number one in Deaths. Let the Growups be in charge. This will change In the future for the better we are all in this together. Wake up from the Mother.

  20. Rossen Vassilev Jr. says:

    Stop blocking access to serological tests. They are key to fighting Covid-19.

  21. Carmen Blakely says:

    Congress and the Treason Administration have lost their collective minds. WHY would you block access to serological tests that could stop the coronavirus? You are all a pack of mindless, heartless idiots. RESIGN – ALL OF YOU! You don’t do your jobs, you only kiss the huge ass of the Traitor-In-Charge. Trump is a cancer – there is no cure for him. LOCK HIS ASS UP & THROW AWAY THE KEY!

    • Mark says:

      If Hillary didn’t goto prison, there’s no way he should. What’s with you TDS patients? You think he made the FDA corrupt? Um no, look back at how many FDA directors have been appointed from Big Pharma and then later returned to it. THAT is the problem, the FDA is corrupt. Close the revolving door and MAYBE we could drain the swamp.

  22. Pamela Sheridan says:

    We need COVID19 testing now to try to slow this pandemic. No time for red tape interference!

  23. Steven Rosenberg says:

    Bb

  24. Robert Meyer says:

    America will not start to open until there is legitimate testing for everyone.

  25. Judy Nuber says:

    Please get rid of unnecessary red tape to help the American people fight this disease.

  26. CD says:

    When this pandemic is over, all government employees who have abused their power should be thrown out on their ass along with the biggest ass in the White House. In all my years living in the Washington area, this is the worst group of people on the hill who insist they work FOR the American people. Their greed pushes their deeds.

  27. Bill Tally says:

    Vote on Nov 3rd to get rid of this administration Turd! We need competence and leadership to address this and future pandemics!

    • Mark says:

      Another TDS patient. The FDA does whatever Big Pharma wants regardless of WHO sits in the big chair. The healthcare racket is so lucrative that nothing short of an economic collapse is going to change the status quo.

  28. Mary says:

    I think that if we observe these actions we can tell that the FDA is our enemy. Why beg them for anything? Instead, we should act as free people do and just take care of things ourselves.

  29. Susan Welsford says:

    The U.S. has no idea how many coronavirus cases we have because the FDA continues to gaslight by restricting testing.

  30. Marlena Alo says:

    Please stop blocking access to serological tests for COVID-19. We don’t have knowledge about this virus and what can be deemed as help toward combating this, may be the answer. Too many have died, would you please have an open mind and let them try.

    Thank you

  31. No namw says:

    If it’s blocking it from coming to us that’s a façade because they said they want to make us take it so it’s like trying to make the people hungry for it when reality it’s not good for us which I thought it was now it’s dangerous and a lot of people didn’t take any vaccines in the past most of us did for measles and all the others and there are still people that did not however what can I tell you God knows if I should take this or not but I will let other people take it first because I’m not gonna be no guinea pig I have to stay alive for my parents and I don’t take chances on risking my life for stupid things like this No one knows what to believe anymore because it’s always fake news they tempt you and tell you oh this is we’re holding it back from you so that we make his hungry for it and then we want it and then we get sick so that’s the trick of holding it back from us

  32. Leona Bochantin says:

    Stop standing in the way of testing for the virus, if we are ever to get back to some normalcy, we have to have testing.

  33. YOU LET THIS HAPPEN AND WEREN’T PREPARED, THAT’S YOUR JOB, LETS GET WITH THE PROGRAM YOUR PAID TO DO. I’M SITTING HOME AND CAN’T WORK AS AN LMT WHO CONTRACTS W/ DIRECT INSURANCE PROVIDERS FOR THEIR CLIENTS CARE. I CARE, DO YOU?

  34. Donna Rader says:

    stop blocking access to serological tests

  35. Cindy Black says:

    Need tests…..to the Nth degree!!!!

  36. Mark says:

    Look people, including TDS patients, the FDA has been corrupt for a long time. Our current president has very little say in it. With a revolving door between Big Pharma and FDA “leadership” corruption is almost endemic. We have people like Gates and his lapdog, Fauci pushing dangerous vaccines and you rail against Trump? Look, channel your howling at the moon into productive action. Petition to make the revolving door ILLEGAL.Big Pharma pays off people on both sides so I doubt anything will come of it but at least you can take decisive action instead of blaming someone who had nothing to do with how degenerate the FDA has become. BTW, do you honestly think there would even be a worldwide pandemic had the Chinese Communist Party hacks not lied and covered up what was going on? The scale of coverup rivals Chernobyl. This is Beijing’s Reactor 4 only this time the fallout is global.

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