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- Food and Drug Administration regulations in place since 2004 require labaratories to get an Emergency Use Authorization from the agency to use diagnostic tests and medical treatments that haven't gone through the typical clearance process.
- The policy was intended to speed up the process, but researchers reported significant delays between seeking an application and getting approval and these regulations played a role in that.
- The FDA has since changed the regulations to allow labs to start utilizing tests before receiving clearance.
Accusations about the responsible party behind the United States’ struggle to accelerate coronavirus testing have come from every which way and the blame has fallen, often inaccurately, on the shoulders of different public officials.
In a March 13 tweet, President Donald Trump said the Centers for Disease Control and Prevention studied its testing system for decades but wasn’t prepared for a large scale pandemic, an issue that was complicated by policy changes made by former President Barack Obama.
U.S. Sen. Chuck Schumer, D-N.Y., retweeted Trump’s remark and added his own comment: "Trump is once again trying to blame the previous administration for the number of tests available. This is his #DailyLie."
U.S. Rep. Dan Crenshaw, R-Houston, retweeted Schumer’s remark and said: "It’s not Obama’s fault and it’s not Trump’s fault. We have stringent FDA regulations, long in place, that created barriers to the private industry creating a test quickly."
PolitiFact looked at a different Trump claim blaming Obama for a lack of testing and rated it False. We also looked at a Mostly False claim from Democrat Joe Biden about the Trump administration rejecting tests from the World Health Organization (they were never offered). Trump also inaccurately stated that any individual who wants to be tested for the coronavirus can get a test — we rated that statement Pants on Fire.
We wanted to dig deeper into Crenshaw’s claim, which attributes the delays in the availability of widespread testing to Food and Drug Administration regulations.
Justin Discigil, spokesman for Crenshaw, pointed to articles from ProPublica, the New Yorker, The Atlantic and the Washington Post, all of which highlighted the role FDA regulations played here.
He added: "Just to be clear – nowhere did we say that these regulations were the sole/only reason for the testing issue, we said that they created barriers."
A timeline of events
The first confirmed case of COVID-19 in the United States came at the end of January, when a man in Washington state developed symptoms after returning from a trip to Wuhan.
One month later, federal health officials at the Centers for Disease Control and Prevention said it was inevitable that the U.S. would experience a spread of the virus and urged people to take precautions.
In these early days of the virus, tests were not widely distributed to local and state laboratories. Instead, testing for the new coronavirus was conducted almost entirely by the CDC — samples collected at the local level were sent to the agency.
Initial test kits developed by the CDC for use in local and state labs were flawed and produced inaccurate results in some labs, meaning they couldn’t be distributed. As the agency worked to correct the tests, health officials turned to the FDA.
The U.S. Association of Public Health Laboratories submitted a letter asking the agency to use "enforcement discretion" and authorize local and state labs to develop and use their own tests.
During a public health emergency, labs and drug manufacturers must seek an Emergency Use Authorization from the FDA to use diagnostic tests and medical treatments that have not gone through the typical clearance process — to share them faster in the emergency.
(These authorizations were begun in 2004 under President George W. Bush.)
For laboratory-developed tests, like the ones in question, FDA policy has stated that they cannot be used in clinical diagnoses without the FDA’s approval during an emergency.
One doctor in a Seattle lab described the process for getting an Emergency Use Authorization from the FDA and said the agency asked for a level of testing that didn’t make sense in the context of an emergency, according to a GQ profile.
A doctor in North Carolina told NBC News that she had developed a test using the World Health Organization’s protocol but had yet to receive the use authorization from the FDA, putting the state "way behind" in its ability to test patients.
On Feb. 29, the FDA announced a change in the process: Labs would still need to seek the agency’s approval for their tests, but the labs could begin testing while waiting for the official green light.
On March 16, (three days after Crenshaw made his claim) the FDA announced another change to its policies and put state officials in charge of coronavirus tests developed by laboratories in their states, meaning labs would engage with state officials and not the FDA. It also removes the requirement for these labs to apply for an Emergency Use Authorization for their tests.
The changes also expand which labs and manufacturers are included in FDA guidelines and which kinds of tests can be developed.
"We believe the unprecedented policy set forth in today’s updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories," reads a release from the agency.
After the changes
After the FDA announced changes to its policies, Labcorps and Quest Diagnostics both announced plans to start testing for the new coronavirus, crediting changes in federal policy with their ability to do so.
"We applaud the FDA for providing the flexibility for innovative, quality lab developed tests to be brought to patients and providers quickly to advance effective response to the coronavirus outbreak," said Steve Rusckowski, chairman and chief executive officer of Quest Diagnostics, in a statement.
But even as state and local authorities move to ramp up testing, the number of available tests is still lacking.
In Austin, for example, there is still a gap between available test kids and demand for testing, as officials prioritize testing for health care workers, people living in nursing homes and people at high risk for complications from the virus.
Crenshaw said in a tweet that longstanding FDA regulations "created barriers to the private industry creating a test quickly" for the coronavirus.
Crenshaw’s statement is accurate. FDA procedures adopted in 2004 meant laboratories had to seek the agency’s approval before developing and using tests in communities, a policy many health care officials have said prevented the country from taking early action in response to the novel coronavirus.
It is important to keep in mind that other factors have contributed to the low levels of testing for the virus, beyond the FDA regulations.
But Crenshaw’s statement is accurate. We rate it True.
Tweet, Dan Crenshaw, March 13, 2020
Email interview with Crenshaw spokesman Justin Discigil, March 18, 2020
Food and Drug Administration, Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics, Feb. 29, 2020
Food and Drug Administration, Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics, March 16, 2020
PolitiFact, Trump wrongly blames Obama for limits on coronavirus testing, March 6, 2020
PolitiFact, Biden falsely says Trump administration rejected WHO coronavirus test kits (that were never offered), March 16, 2020
PolitiFact, Donald Trump falsely says WHO coronavirus test 'was a bad test,’ March 17, 2020
PolitiFact, Donald Trump’s wrong claim that ‘anybody’ can get tested for coronavirus, March 11, 2020
New York Times, ‘It’s Just Everywhere Already’: How Delays in Testing Set Back the U.S. Coronavirus Response, March 10, 2020
Austin American-Statesman, City health officials increase testing capacity, but still short test kits, March 18, 2020
Washington Post, DIY nasal swabs, drive-thrus and labs in overdrive: Americans are desperate for more coronavirus testing, March 17, 2020
The Atlantic, The 4 Key Reasons the U.S. Is So Behind on Coronavirus Testing, March 13, 2020
Washington Post, How U.S. coronavirus testing stalled: Flawed tests, red tape and resistance to using the millions of tests produced by the WHO, March 16, 2020
New Yorker, What went wrong with coronavirus testing in the U.S., March 16, 2020
ProPublica, The FDA Is Forcing the CDC to Waste Time Double Testing Some Coronavirus Cases, March 12, 2020
Reuters, Mixed messages, test delays hamper U.S. coronavirus response, Feb. 27, 2020
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