The coronavirus outbreak has turned diagnostic testing into a political football. In a March 4 news conference, U.S. President Donald Trump blamed Obama administration policies for the shortage of coronavirus test kits -- an assertion that was contradicted by lab medicine experts.
In the news conference, Trump claimed that the Obama administration "made a decision on testing that turned out to be very detrimental to what we're doing." Trump claimed that his administration overturned the decision to enable testing to take place in a "more accurate and rapid fashion."
The problem is that no one appears to know what decision Trump was referring to, according to a March 5 article in the New York Times. Obama administration officials and health experts didn't know of any policy changes that would have affected how the U.S. Food and Drug Administration (FDA) approved diagnostic tests that would be useful during the coronavirus outbreak, the Times reported.
The Trump administration has come under fire for its response to coronavirus, particularly with respect to the slow rollout of coronavirus testing to lab facilities in the field. In the first weeks of the outbreak, the only approved coronavirus test was from the U.S. Centers for Disease Control and Prevention (CDC), and that test required labs to send samples to CDC headquarters for processing.
Since then, the CDC and the FDA have taken steps to make diagnostic testing for coronavirus more accessible to labs in field. The CDC broadened its criteria for which patients could be given the test after a facility in California said the agency declined its request to test a patient who later turned out to be infected with the coronavirus.
For its part, the FDA has waived its requirement that labs receive an emergency use authorization (EUA) from the FDA before using their own diagnostic tests on patients suspected of having COVID-19, the respiratory disease caused by coronavirus infection. The FDA is hosting a virtual town hall on March 6 to discuss the new guidance.
Some observers speculated that Trump was referring to FDA and CDC policies in his March 4 news conference. But the New York Times article quoted a spokesperson for the Association of Public Health Laboratories as stating that while there had been discussions about tightening rules on laboratory-developed tests, nothing had come to fruition during Obama's term in office. The official was not aware of any other rules or policies that had changed how labs were regulated.
But at least one commentator has been unafraid to lay the blame for slow coronavirus response on government regulation. Writing for the conservative website City Journal Online, Dr. Roger Klein, PhD, maintained that excessive government regulation of the lab medicine sector has played a part in the sluggish response to the coronavirus outbreak.
Klein pointed out that, while the CDC restricted testing to its own lab, officials in China were able to publish the sequence of the coronavirus in mid-January, which resulted in the World Health Organization using a "freely available German procedure" to create a test kit, with 250,000 kits shipped to 159 labs around the world. In China, the government by February 23 had approved 10 test kits, with the capacity to perform 1.65 million tests per week -- compared with 472 tests performed by the U.S. government as of March 2, Klein wrote.
"The FDA's regulation of laboratory tests has been a longstanding concern," Klein wrote. "With coronavirus testing, the FDA's abandonment of enforcement discretion may have proved deadly."