How FDA Red Tape Prevented Widespread Coronavirus Testing

April 7, 2020

The FDA needs to stop blocking progress on COVID-19. Action Alert!

Countries like South Korea and Singapore that have (so far) successfully hampered transmission of COVID-19 have tested widely for the virus. South Korea had its first confirmed case on the same day as the US, on January 20. Health officials there relied on a test based on the World Health Organization (WHO) technical guidelines published at the beginning of the outbreak and immediately allowed the private sector to process samples. They quickly mobilized to test 20,000 people a day. South Korea is a model of an effective and decisive response to a critical situation; the FDA and CDC’s response demonstrate the effects of cumbersome bureaucracy.

The US, led by the CDC and the FDA, decided not to use the WHO test, but rather to develop their own test—a test that turned out to be flawed, wasting precious time in the first weeks of the outbreak. This and FDA regulatory barriers delayed widescale testing, which is one of the main reasons the rate of infection in the US is so high.

US lags behind many other countries in testing its population.

The FDA shares much of the blame for the lack of an effective US response to the pandemic. Laboratory developed tests are generally not subject to FDA pre-approval. But when Health and Human Resources 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.

According to former FDA officials, in previous outbreaks EUAs could be obtained in a matter of days; but during this outbreak, the application process reportedly became so complicated it took weeks to receive the authorization. Initially, labs were not allowed to begin testing until they got approval from the FDA, even if the lab had confirmed internally that the test worked. The FDA later relaxed this requirement, allowing certain accredited labs to begin testing as they awaited approval for an EUA—but not before weeks had passed when hospitals and labs were not able to use accessible COVID-19 tests.

Some companies had developed at-home tests developed in accordance with accredited labs. Just days after these tests became available and samples started coming in, the FDA announced that it had not approved any at-home COVID-19 tests. This prompted companies marketing the tests to pause their distribution and, worse yet, to destroy the samples they had already collected to comply with FDA bureaucracy. The at-home test kits used inner-cheek swabs, saliva, and throat swabs to collect samples, rather than the nasopharyngeal swabs of the back of the throat that are widely used—though the companies stated that the labs they were working with met federal standards for demonstrating the accuracy of the tests. The FDA insists, however, that its emergency guidelines for coronavirus testing do not apply to at-home tests, including self-collection of samples to be sent to a clinical laboratory.

The FDA is also holding up test kits from overseas: at least one South Korean firm, which is churning out 400,000 test kits a week, has been shipping the kits around the world, including to individual states in the US and private labs. The one remaining obstacle is FDA approval: according to one Korean CEO, “The biggest hurdle when it comes to the United States is getting the FDA approval.”

When the FDA rightly caught flak for its commitment to onerous and superfluous regulations during a public health emergency, the agency released a statement touting its “unprecedented flexibility” in allowing labs to develop and offer COVID-19 tests.

The testing capacity in the US is starting to increase. There are two kinds of tests available. The most common is the polymerase chain reaction test which uses a nasopharyngeal swab. There are multiple versions of the same test that have been approved with slight variations—for example, different tests target different sets of genes withing the COVID-19 virus. The other type of test is a serological test, which uses blood samples to detect antibodies the body produces to fight the virus.

Even with increased capacity to test, regulations are still preventing widescale testing on par with other countries.

If ever there was a time for flexibility, it would be now, in the midst of a pandemic that could infect 40-70% of the world’s population this year. While we certainly do not want to open the door for fraudulent tests that do not give reliable results, companies should be allowed to innovate and create solutions where the federal government has failed so miserably at nearly every turn to meet the demand for tests during this pandemic.

Action Alert! Tell the FDA to stop blocking innovation in coronavirus testing. Please send your message immediately. 

73 responses to “How FDA Red Tape Prevented Widespread Coronavirus Testing”

  1. freepornpics says:

    I wish mankind victory over disease

  2. Teresia Erna LaFleur says:

    Lead, follow, or get out of the way.

  3. Marvin Feil says:

    Remember thalidomide? If not look it up.

  4. Karl Hamann says:

    Stop blocking innovation in cv-19 testing!

  5. Sarah Staats says:

    If you don’t have the requisite expertise in-house, please find it and apply it.

  6. Penelope Z Andrews says:

    To: FDA

    Please stop blocking innovation in corona virus testing.

  7. Cynthia Ortiz says:

    STOP BLOCKING INOVATION IN CORONA VIRUS TESTING!

  8. Al says:

    Dear FDA:

    Fast, reliable, affordable testing is key to creating a manageable plan, both for health and the economy. Please be an ally and not an obstacle! Testing is needed to manage the patient load, track the true rate of spread of the disease–with random testing done periodically, and create a way for non-infected people to return to work.

    Please fast track tests and cut any un-necessary steps.

    Al C.
    Oregon

  9. Anna says:

    Trump/s FDA doesn’t approve coronavirus tests because they want to avoid showing the true number of infected people.

  10. Perhaps the upper management of the CDC should be charged with “Reckless Endangerment”.

  11. Fred Flickinger says:

    It’s hard to believe that our narcissistic Health Care and Pharmaceutical Czars led by the FDA consider themselves flexible or even an all effective for our population. Why did they wait and also at the same time hamper private labs? I’m sure it was to line the pockets of some special interest groups company who obviously didn’t have a solution when we the people really needed it. So much for a free market and competition!

  12. Thomas A Braun says:

    Why don’t we call a Ace of Spades what it is! The rules allowed LabCorp and Quest to maintain a lock on blood testing for their financial benefit. They make in excess of 1.3 Billion dollars per year in profit!

  13. Marcy Gordon says:

    Please stop blocking innovation in coronavirus testing!

  14. Mark Goodman says:

    Thanks for reading my letter.

  15. Alex Pummer says:

    it looks like we do not need any enemy, we could kill us self, but I hope that , the agency will correct it ASAP

  16. Tom Grigsby says:

    Please promote testing for anyone with symptoms!!!

    More testing allows citizens make better decisions about themselves and others for how to take care of their basic needs during quarantine.

    Please allow any COVID-19 testing in the USA that has been proven to be viable.
    It appears that the FDA is more concerned about creating economic benefits for patronizing companies.

    Thank you for your considerations.

    Tom Grigsby, Major, USA (R)

  17. Don Pew says:

    WTF!? It’s like we are being overseen by a cluster hump of morons!

  18. MJ Coons says:

    Cut the red tape and catch up with Iceland. What good is the FDA but a hindrance to progress and the ‘good old boys club’?

  19. Brenda says:

    While we need some quality control, the FDA is a government leviathan that has out lived it’s shelf life. It presents a dangerous public health risk. It should be shut down immediately in the name of saving lives. All of it’s rules, regulations and protocols should be trashed for the safety of all.

  20. Susan Talarico says:

    How do you expect to control this virus when you don’t have any where near enough tests to test the people that need it ??

  21. Susan Fehl Erickson says:

    Please take leadership in catalyzing the FDA to show more flexibility in its guidelines for developing widespread and available test kits for COVID 19. In this global crisis, it is literally the difference between life and death.

  22. ROBERT G KOCH says:

    THE FDA, NOW MORE THAN EVER, NEEDS TO STOP THE BUREAUCRATIC NONSENSE
    AND DO WHAT’S RIGHT FOR THE PEOPLE. THE CORRUPTION MUST STOP NOW AND
    ALLOW DECENCY AND ETHICS TO PREVAIL.

  23. David Wolter says:

    When a snowstorm hits, the government job is to remove snow, not approve snowplow designs. When a pandemic strikes the government job is to test for the illness, not slow down the approval of testing kits.

  24. Stefan C Taylor says:

    Censoring facts about the CoVid-19 pandemic is not helping at all!!! In fact, it is stupid!!! ALL the facts should be released. It is better to know than to be kept in the dark wondering about what is true and what is false. There is too much false information being disseminated now, much of it from the Federal Administration, which should know better!!!

  25. Carolyn Cassetty says:

    Please stop holding up testing for the Corona virus just because you can. People are dying and you keep putting up road block after road block for tests that have already been proven to work. Just give blanket approval for established labs to make these tests available. And before the next pandemic hits you need to revise your rules for emergency situations such as this.

  26. Dr. Maria dC Rodriguez says:

    Let’s use the test developed by S. Korea. We need as many tests as possible so that we can truly know the facts and overcome this health crisis ASAP.

  27. Our FDA and CDC have been criminally negligent and irresponsible for allowing the Covid-19 virus to spread all across America, by interfering with and blocking testing prior to developing a Covid-19 test that did not work. This level of criminal incompetence demonstrates that the leadership of the FDA and the CDC wanted the Covid-19 virus to spread across the United States and infect as many people as possible before conducting any tests. All those responsible for this act of treason will be held liable in this life and eternity. This is an act of Biological Terrorism on Humanity. The Covid-19 virus was developed at Fort Detrick prior to being transferred to other Biological Warfare labs and eventually to the Biological Warfare lab in Wuhan China. Who ever authorized Biological Warfare labs to proliferate around the globe will be held liable for all eternity under God Almighty’s gudgement. These people have declared Biological Warfare upon Humanity in the form of Covid -19 and 5G. Let the Tribunals begin!!!

  28. Marlene says:

    If not now when? I’m all for the principles of scientific method. I expect that any testing and/or medications for coronavirus must be effective and safe. Assuming that criteria can be met I’m supportive of cutting any unnecessary red tape from the FDA.

  29. Jill Sanoff says:

    Quick, safe + reliable! A novel idea under novel but deadly conditions.

  30. Priscilla Martinez says:

    We need to test, test, test….

  31. William Grosh says:

    Received “Bad Gateway” response from FDA petition.

    • Ila Kimata says:

      Hi William,

      Please send more details to [email protected] and we’ll be happy to look into this. Please include the type of browser you’re using, whether you’ve been able to submit a petition in the past, if you’re having any connectivity issues, or any other pertinent information. Thank you!

  32. GILLES MARIN says:

    Greed and power games have corrupted the whole upper branches of out government. Time for a clean up!!!

  33. Jessica Rollins says:

    Stop blocking innovation in coronavirus testing.

  34. Ms. Lee West says:

    Really Iceland can and has tested 80,000 people and we have only tested about 5,000.00, what is wrong with you people? Get on it and cut the red tape and the greed to come up with your own test. Regulations are killing people and that is crazy stupid.

  35. Abid Hussain says:

    Please STOP the red tape and let the private companies develop innovative test procedures for COVID-19

  36. Barbara says:

    We need more testing. Stop blocking methods labs can use.

  37. Sarah S Broomfield says:

    We MUST start widespread testing of all the people!

  38. hiroko I says:

    Stop blocking innovation in coronavirus testing.

  39. Bonnoie Yohe says:

    FDA is to protect Americans right? So, get busy and STOP blocking any innovation in coronavirus testing. It is absolutely possible to be flexible and at the same time protect us from fraudulent tests. PLEASE!

  40. Rossen Vassilev Jr. says:

    Please stop blocking innovation in coronavirus testing.

  41. Andrew Jacobson says:

    Where to start? There are many things that don’t add up when it comes to this CV crisis. First is the numbers do not add up. 350,000 people die each day in the world. As of April 7th 2020 there have been less than 90,000 deaths from CV in nearly 100 days, about 900 deaths per day average. The flu virus on a bad year kill on average 1780 deaths per day. We have never had lock downs for diseases that are twice as bad. Why are we having them now?

    Then there is the fact that of those who died in Italy the average age was roughly 80 years old and over half of those who died had 3 or more other serious health issues. In fact experts concluded that 88% of those who died either died of other causes or would have died of other causes in the very near future.

    Then there is the letter sent by the CDC to all US hospitals stating that it does not matter if someone who died was tested or not, if you suspect that CV was a contributing factor that should be listed as the primary cause of death. So why would they want these numbers inflated?

    If you ask someone who has been to NYC metro hospitals, they will tell you that they are empty. How can that be if we are in such a dire crisis? So what is really going on here?

    In conclusion it seems to me that the government is using this crisis to blame it on the economic collapse which started with inter-bank lending rates spiking causing credit to freeze up back in September. This way the people will not be looking to blame the government or the banks for this collapse. It also looks like Big Pharma is using this crisis to usher in mandatory vaccinations for everyone. There are possibly more reasons that these shenanigans are being orchestrated by government and the news media. All I really know is that the lock down is a farce.

  42. David M. Scheer, D.C. says:

    Would you PLEASE get around to doing some coronavirus testing, for gods sake?!? We are ‘supposed’ to be the “technologically-greatest” country in he world—-but ha!…with respect to COVID-19, we’re like ‘little kids’. Who’s running this show?!? Oh yeah…I forgot…bonehead trump, who determines what “you folks” do. And moron trump shouldn’t be ‘running’ ANYTHING….much less this biggest pandemic the world has ever seen!

    Get your act together an get some testing done…O.K.?!?

  43. Nan Anderson says:

    Stop blocking the public’s access to testing.

  44. Billie Wolf says:

    I am surprised to find this kind of information on the ANH site. The CDC “CRP test” has NEVER been medically validated as a diagnostic tool and is CLEARLY creating “FALSE POSITIVES”. If you look at the CDC and WHO sites, they actually admit it:

    From “CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel” [1]:

    “Detection of viral RNA may not indicate the presence of infectious virus or that 2019-nCoV is the causative agent for clinical symptoms.”

    Translation: A positive test doesn’t guarantee that the COVID virus is causing infection at all. And, ahem, reading between the lines, maybe the COVID virus might not be in the patient’s body at all, either.

    From the World Health Organization (WHO): “Coronavirus disease (COVID-19) technical guidance: Laboratory testing for 2019-nCoV in humans” [2]:

    “Several assays that detect the 2019-nCoV have been and are currently under development, both in-house and commercially. Some assays may detect only the novel virus [COVID] and some may also detect other strains (e.g. SARS-CoV) that are genetically similar.”

    Translation: Some PCR tests register positive for types of coronavirus that have nothing to do with COVID—including plain old coronas that cause nothing more than a cold.

    The WHO document adds this little piece: “Protocol use limitations: Optional clinical specimens for testing has [have] not yet been validated.”

    Translation: We’re not sure which tissue samples to take from the patient, in order for the test to have any validity.

    From the FDA: “LabCorp COVID-19RT-PCR test EUA Summary: ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARYCOVID-19 RT-PCR TEST (LABORATORY CORPORATION OF AMERICA)” [3]:

    “…The SARS-CoV-2RNA [COVID virus] is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status…THE AGENT DETECTED MAY NOT BE THE DEFINITE CAUSE OF DISEASE (CAPS are mine). Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.”

    Translation: On the one hand, we claim the test can “generally” detect the presence of the COVID virus in a patient. But we admit that “the agent detected” on the test, by which we mean COVID, “may not be the definite cause of disease.” We also admit that, unless the patient has an acute infection, we can’t find COVID. Therefore, the idea of “asymptomatic patients” confirmed by the test is nonsense. And even though a positive test for COVID may not indicate the actual cause of disease, all positive tests must be reported—and they will be counted as “COVID cases.” Regardless.

    From a manufacturer of PCR test kit elements, Creative Diagnostics, “SARS-CoV-2 Coronavirus Multiplex RT-qPCR Kit” [4]:

    “Regulatory status: For research use only, not for use in diagnostic procedures.”

    Translation: Don’t use the test result alone to diagnose infection or disease. Oops.

    “non-specific interference of Influenza A Virus (H1N1), Influenza B Virus (Yamagata), Respiratory Syncytial Virus (type B), Respiratory Adenovirus (type 3, type 7), Parainfluenza Virus (type 2), Mycoplasma Pneumoniae, Chlamydia Pneumoniae, etc.”

    Translation: Although this company states the test can detect COVID, it also states the test can read FALSELY positive if the patient has one of a number of other irrelevant viruses in his body. What is the test proving, then? Who knows? Flip a coin.

    “Application Qualitative”

    Translation: This clearly means the test is not suited to detect how much virus is in the patient’s body. I’ll cover how important this admission is in a minute.

    “The detection result of this product is only for clinical reference, and it should not be used as the only evidence for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms/signs, history, other laboratory tests and treatment responses. The detection results should not be directly used as the evidence for clinical diagnosis, and are only for the reference of clinicians.”

    Translation: Don’t use the test as the exclusive basis for diagnosing a person with COVID. And yet, this is exactly what health authorities are doing all over the world. All positive tests must be reported to government agencies, and they are counted as COVID cases.”

    Those quotes, from official government and testing sources, torpedo the whole “scientific” basis of the test.

    Note: ALL these [false] POSITIVES must be “reported to authorities” and will undoubtedly be added to the FAKE numbers the thoroughly corrupt Centers for “Death” Control and WHO are trying to terrorize the public with. These organizations are OWNED and OPERATED by the Globalist Central Banks and their minions. This is well documented. This is the most amazing coincidence in history or the Central Banks are using “COVID” as a cover for the global economic collapse they created. The collapse was coming no matter what but the Globalists did need a scapegoat; what could be more perfect than a “pandemic”? It’s martial law lock-down without the guns pointed at our heads.

    I will say, I do believe there is something out there. I believe it is a bio-weapon because “gain-of-function” has been detected by independent scientists. MORE of these INVALID “TESTS” by the CDC and WHO are only going to further inflame fear and panic in the public and absolutely CRUSH what little is left of the GLOBAL ECONOMY.

  45. Deborah Richerso says:

    FDA officials, You have no conscience or shame and it has been known historically that that is the way it has always been in your agency. You are a disgrace especially when compared to other countries who allow new & modern innovations, inventions, etc. over the decades. Corruption to the max. I hope this latest ‘boondoggle’ will be what it takes to ‘hold you feet to the fire’ to make your agency accountable.

  46. winston says:

    The inefficiencies of this administration is killing American people!

  47. Maryellen Redish says:

    The patients need whatever help there is IMMEDIATELY. Otherwise, they will probably die.

  48. Todd Campbell says:

    I’m one of the people who had Covid-19 symptoms, but could not be tested due to the shortage of test kits in the U.S. Please get your act together FDA! Peoples’ lives depend on it!

  49. Gary Ritzke says:

    Everyone in the FDA you should be put on notice that you should be tried and jailed for being so stupid during this trying time. You remind me of the WHO that is worthless and lied in the first place you are just as bad. Your should be held accountable for the deaths at your hands, to me you are just as bad as China.

  50. Peter B Harwood says:

    The FDA is holding up test kits from overseas: at least one South Korean firm, which is churning out 400,000 test kits a week, has been shipping the kits around the world, including to individual states in the US and private labs. The one remaining obstacle is FDA approval: according to one Korean CEO, “The biggest hurdle when it comes to the United States is getting the FDA approval.”

    If ever there was a time for flexibility, it would be now, in the midst of a pandemic that could infect 40-70% of the world’s population this year. While we certainly do not want to open the door for fraudulent tests that do not give reliable results, companies should be allowed to innovate and create solutions where the federal government has failed so miserably at nearly every turn to meet the demand for tests during this pandemic

    Stop blocking innovation in coronavirus testing.

  51. Drina Brooke says:

    If the US government is even half serious about containing this virus instead of shooing is into our corners and breaking the economy, they will bring in hospital ships to every major city instead of frightening us all about overwhelmed hospitals, they will have face masks available in multiples for every individual human being in the USA, rubber gloves for all, pay the bath tissue industry to step up production, stop projecting frightening figures based on almost no testing, and have tests and restests available by voluntary freewill for every single person in the USA. The lack of the above is deeply unethical, even criminal, and should be punished by a court of law. If they do not prove good intention in action, then they also are proving that various agendas are afoot, and they may not be pretty. We have every right to form class action lawsuits nationwide, and we should. Such lawful suits are orderly, peaceful, legal, and anyone claiming immunity is installing an unconstitutional gag order which lawyers can and will override, as will any competent, rational judge capable of sitting on the bench with his sanity intact.

  52. Jon says:

    YOU AND YOUR ORGANIZATION ARE “TARES” IF YOU WANT NATIONAL TESTING FOR THIS FAKE VIRUS. A VIRUS CANNOT BE TRANSMITTED IN THE MANNER SUGGESTED.

  53. jR Blank says:

    Stop preventing wide-scale testing

  54. Elizabeth G. Hung says:

    Kick trumpers out of the FDA

  55. Linda says:

    What the heck is going on? You have titles and authority now get the job done.

  56. Georgia Couch says:

    We need millions more covid 19 tests

  57. carrol grady says:

    It is unforgiveable that we were not prepared ahead of time with tests, or else willing to use tests from another country.

  58. LAW says:

    FDA you are responsible for the unchecked spread of coronavirus. You need to approve innovative ways to test this virus immediately.

  59. Mirko says:

    FDA never did what they were made to do, many pharmacy vitamins or prescribe medication have dangerous side effects. Other product like vitamins are not FDA approved which mins the FDA is Government pad having large salary for doing NOTHING.
    Thats why most American people do not trust American health system run by Corporates.
    No wander the American people lost trust in any Government control systems.Democrats were making lots of promises but never kept it. Lotsof words bat no dids.

  60. Stephanie Hammond says:

    We must make tests available to our citizens, now!

  61. Mine says:

    Please cut the red tape and allow testing of all sick patients in our country. Or else, you and the Trump administration will be blamed for the death of so many US citizens and rightly so.

  62. Sharisa Cherry says:

    PLEASE stop blocking innovation in coronavirus testing!

  63. J B says:

    Lead Trump out of the White House. He has blood on his hands. HE DOES NOT CARE; GET THAT THROUGH YOUR HEADS. He speaks only to the Stock Market

  64. George Baschiera says:

    Stop Immediately blocking coronavirus testing.!!THE FDA needs to support the Public and not the pharmaceuticals, and get out of the way with useless and harmful, un needed n-95 mask requirements, and stop attacking organics, natural medicine and cures, and not let WHO, CDC, Bill Gates , and NIH hamper and derail the known natural cures and medicines off of patents that already cure and ameliorate CCP pandemic now.

  65. Susan Mullins says:

    Not being able to test people who are suspicious they might have a virus and might infect others is MUCH worse than keeping a lid on your own questionable ability and power. WHAT DO YOU HOMICIDAL AND SUICIDAL BUREAUCRATS THINK YOU ARE ACCOMPLISHING? DO YOU TRULY HATE AMERICANS SO MUCH ??

  66. OSCAR O BARROZO RODRIGUEZ says:

    How can I be sure that “the home test” are validated?

  67. Please help the citizens by not blocking innovations in coronavirus testing.

  68. Cynthia K Lee says:

    Let’s step up and help our people! Get the tests out there and use them!

  69. Carol Berkeley says:

    Stop blocking innovation in coronavirus testing

  70. Meg Titus says:

    We all need to be tested……………….please get them out there ASAP

  71. Anne says:

    45, Denial will NOT solve the problem!

  72. Again, proof that anything that the government has control of turns out to be a disaster. The private specter does a much better job dealing with almost any issue than those run by government agencies. The FDA has proven how useless they have been for so many years. We need a better, updated, organization to take over.

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