FactCheck.org considers Trumps claim that he inherited a broken CDC system to be 'misleading', and has given a long description of why they made that ruling. It effectively boils down to the claim that the CDC was never intended to be the sole producer of tests. Instead they claim that the CDC was always intended to work with third parties and private sector to support the production of tests and other resources if a pandemic happened, and that the delays with testing was due to the CDC not allowing private sector agencies to build tests originally.

If it's true that the intent of the CDC was to support/regulate private sector test development, and that the CDC failed to do that, then the next question is why didn't it? Why did the CDC not immediately open up production of tests to the private sector and support and vet those tests as factcheck.org claims was the original design intent?

Is there a specific individual or group of individuals who had the ability to decide to open up testing to private sector and failed to do it? Was Trump or the white house in any way responsible for this decision to not open up testing to the private sector?

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    Equally relevant was who decided to design a brand new test instead of using the existing and proven WHO test – divibisan Apr 3 '20 at 2:01
  • A through reading of the FactCheck.org article gives a good review on the sequence of events, however, does not assign "blame" for the failure to expand the providers of COVID-19 diagnostic testing. Is that assignment of responsibility what this question is seeking? – BobE Apr 3 '20 at 15:14
  • @divibisan actually FactCheck addressed that one. Basically the WHO test was designed for poorer countries with limited medical infrastructure, and as such was designed to be cheap to produce but potentially limited. For that reason most most first world nations decided to produce their own test, with a focus on either higher accuracy or more rapid testing, instead of cost. Many nations made that decision, so presumably it's not as insane as it's depicted. The faulty tests were also due to materials, not design, so using the WHO test wouldn't have prevented the USA from having bad tests – dsollen Apr 3 '20 at 17:52
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    Could you provide a citation on: 'WHO test was rejected because it was cheap and inaccurate' I realize that's not exactly what you said, but that is the implication. Now if the WHO test was inaccurate, what was it compared to? Can you provide a citation (say in the Dec/Jan time frame) that establishes that the WHO test was less accurate than... what??) - Please recall that even the February CDC test had reagent failures. – BobE Apr 3 '20 at 18:47
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    @dsollen Yes and no. The specific issue with faulty kits may have been directly caused by a manufacturing and testing issue with the 3rd set of primers, but it was a flaw in the design of the protocol that led to this disrupting testing so severely. An updated protocol from the CDC solved the issue by skipping those faulty probes, but the protocol should have been designed for simplicity and robustness. – divibisan Apr 3 '20 at 18:58

Is there a specific individual or group of individuals who had the ability to decide to open up testing to private sector and failed to do it?

That would be the FDA (emphasis mine):

The Food and Drug Administration requires an onerous approval process to bring any test to market. Once the FDA granted "emergency use authorization" to the Centers for Disease Control and Prevention to distribute and conduct the coronavirus test that it had developed, the CDC took control of distributing and administering tests while the private sector and foreign-developed tests were kept out of the process during the crucial weeks between when the virus was first identified in December and when it started rapidly spreading among the American public. The obstacles to private-sector action are only now being lifted.

"Emergency use authorization" is a scaled-down approval process that requires fewer criteria to be met to speed a test or treatment to market when time is of the essence. But even a more streamlined process didn't allow tests developed abroad and distributed by the World Health Organization to make the grade. According to White House officials, the WHO test was meant for research purposes and didn't meet American quality control standards amid concern about incorrect results. Yet other countries have been using the test, suggesting our federal government let the prefect be the enemy of the good.

As a result of the CDC's being the sole organization to make and distribute the authorized test kits, the agency needed to strictly ration distribution. Because of the tight supply, the CDC initially set very restrictive criteria on testing individuals. To make matters significantly worse, by mid-February, the CDC had learned that many of its tests, for all the supposed focus on quality control, were inconclusive because of a flaw in one of its components and needed to be fixed. Meanwhile, no competing manufacturers were ready to meet the increasing demand.

The FDA should have sought to ameliorate the domestic shortage of test kits by granting authorization for tests already in use in other countries. However, the FDA doesn't simply grant reciprocal approval of drugs or tests approved in other countries — they must go through an FDA approval process.

In this country, many public health labs, private-sector organizations and universities grew anxious to develop their own tests. Yet the CDC warned them not to do their own testing without first getting the emergency use authorization from the FDA, a cumbersome process that discouraged many from acting.

So maybe it's the fault of the FDA and the CDC, but the FDA and its associated red tape definitely played a critical role in this.

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    good information, but that is only half the problem. As I understand it once a test was designed the CDC was still producing all the tests in house. Who could have authorized third parties to produce tests in the manner designed by the CDC? IE who could have told others to start putting tests together using the instructions CDC provides once CDC came up with them? was that also the FDA? – dsollen Apr 3 '20 at 19:11
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    The private sector can do what it wants. It normally isn't told to make things, except maybe in certain circumstances. As far as whether the private sector is allowed to sell what it makes and, consequently, whether it is used by the public, the media I've seen on it (such as this article) makes it sound like it's the ultimately the FDA's decision. – user29681 Apr 3 '20 at 19:19
  • @dsollen: yeah, that seems to be essence of your/the question, if we want to pin down the blame on one particular agency (of the two). I suggest you go and edit your question to make it much more clear what you're asking, as users who want to answer it shouldn't have to read every comment under every answer... – Fizz Apr 3 '20 at 20:19

Shorter answer: The Departments of the CDC, FDA, and HHS all are under the direction and guidance of the Trump administration. Failures of any one of these departments is the direct responsibility of the President. Parsing which department is most responsible for failure to immediately mobilize and deploy mass testing, while interesting, is an exercise in searching for a scapegoat.

  • Something I can agree with, i.e. that the question is fairly poorly framed, so a real answer has to be mostly a frame challenge. – Fizz Apr 3 '20 at 20:15
  • Identifying failures is maybe premature, but is crucial in at least attempting to prevent similar failures in the future. – Jeff Lambert Apr 9 '20 at 12:35

The head of the CDC is Robert Redfield, who was appointed by Trump (a fact left out of the Wikipedia page, for some reason) in March of 2018. He is a noted virologist, but like many of Trump's appointees was not chosen from the public sector. His background is almost entirely in clinical research in the private sector or the military, and thus he has little experience with public administration, epidemiology, or public health more generally. It's reasonable to assume that his appointment was politically motivated: while he is an established expert in the study and treatment of HIV/AIDS, he is lionized by Christian conservatives for openly holding that the best defense against the transmission of HIV is sexual abstinence before marriage, instead of practical tactics like providing free condoms, and maintained close ties with anti-gay and anti-HIV activists up until the time of his appointment to the CDC.

The idea that Trump inherited a 'broken' CDC is hard to justify considering that his own appointed head was in power for nearly two years before COVID-19 arrived on the scene. What seems more likely is that Redfield — though perhaps an adequate leader for the CDC in normal times — was unprepared and ill-equipped to lead the center through a burgeoning crisis. While there is no way currently to know what happened in internal CDC discussions and communications with the White House — that will require Freedom of Information requests for documents, assuming that the White House doesn't decide to classify them and hide them away — it is safe to make a couple of assumptions.

First, it's apparent that Redfield was doing what he knew how to do, not what his position called for. Redfield is a clinician and academic researcher who spent his life developing tests and vaccines for viral infections. The slow creation and distribution of tests in the US is due in large measure to the fact that Redfield decided the CDC would develop it's own test, a more expansive test that would detect a wide range of SARS-like illnesses, not just the coronavirus behind COVID-19. This developed test proved to have clinical flaws and had to be reworked, adding to the delay in distribution. A more experienced public health official would likely have abandoned this research-driven approach for something more practical and rapid, such as the testing kits already available in other nations.

Second, as an overtly political appointee, we can assume that Redfield was inclined to follow the White House narrative on the disease, unlike more seasoned epidemiologists (like Dr Fauci) who would be inclined stand up against such narratives and cling to scientific facts and projections. Since Trump's narrative through most of February and March minimized the dangers and impact of COVID-19, it's understandable that Redfield might have resisted the urge to rock the political boat by stepping up production of testing kits or ensuring that private-sector companies had the FDA clearance to do so on their own. Redfield's inexperience with the functioning of government bureaucracy may have led him to miss or underestimate the complexity of coordinating this kind of massive undertaking.

We can choose whether we want to place the blame for this failure with Redfield as the direct CDC leader or with Trump as the person who appointed him to office. I suppose we could even place it with Alex Azar, the Secretary of Heath and Human Services, whose job it would be to act as a bridge between the White House and the CDC. But in any case, the responsibility falls squarely on an administration that prizes political favors over competence and experience.

For parts of this, I drew on this Politco article from February 26, early in the spread of the pandemic.

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    I think this answer is fairly factual, but the actual problem is that those decisions like approving foreign tests [or not] were entirely made at the FDA. I'm not sure if the CDC could have told the FDA, we're gonna use a foreign test, period. There is a specific law [pre]authorization just for CDC-developed tests. Everything else required FDA's approval. Somewhat related skeptics.stackexchange.com/questions/46070/… – Fizz Apr 3 '20 at 7:21
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    @Fizz: I'd have to look into the actual delegation of powers, but the FDA's purview is product safety. I cannot imagine a case in which the CDC (whose purview is public health) tells the FDA that it needs a test for a looming public health crisis and the FDA says 'no'. Notice how quickly the FDA wrote up emergency rule exemptions once the White House started taking cover-19 seriously. I mean, it doesn't help that we've been through five FDA heads since Trump took office (two appointed and three acting), but still... – Ted Wrigley Apr 3 '20 at 7:37
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    too much speculation for my taste, still did not downvote since I see no better answer. – NoSenseEtAl Apr 3 '20 at 17:14
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    @NoSenseEtAl: the only speculation is about motivations; everything else is factual. And short of documentation about internal discussions, speculation on motivations is all we can do. – Ted Wrigley Apr 3 '20 at 17:29
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    @TedWrigley I appreciate your attempts at bringing facts into it. I really do. But for answers it's best if we can leave as much speculation as possible. This keeps our site completely factual based. Questions that ask for speculation and the internal motivations of people are off-topic. It is only fair if we hold answers to the same standard. – user29681 Apr 3 '20 at 18:48

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