Who was responsible for deciding the CDC would produce all COVID-19 tests instead of immediately opening up test production to the private sector?

Question

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?

Answer 1

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.

Answer 2

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.

Answer 3

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.