— President Trump, remarks at a roundtable with airline executives, March 4
“This was a very big move. It was something that we had to do and we did it very quickly. And now we have tremendous flexibility. Many, many more sites. Many, many more people. And you couldn’t have had that under the Obama rule, and we ended that rule very quickly.”
— Trump, additional remarks at the same meeting
When things get tough in the Trump administration, the president has a default position — blame Barack Obama.
The administration has been under fire for its failure to quickly expand testing for coronavirus across the United States; the Centers for Disease Control and Prevention had distributed flawed tests to state and local health departments. The lack of tests, compared with countries like South Korea that have tested tens of thousands of people, has meant the possible spread of the virus in the United States may be hidden.
Trump suggested the problem instead was an “Obama rule” on testing that his administration had recently overturned. But this is completely wrong. Let’s explore.
This is a fact check that turns out to be about a complex and technical issue that had attracted little attention outside trade press and a small community of experts. But the quick answer is there was no Obama rule, simply “guidance" that was never acted on because Congress stepped in and decided it would craft the necessary legislation, according to experts we consulted. The Trump administration, in fact, has been working with Congress on such legislation.
The question revolves around something called laboratory developed tests (LDTs). These are generally described as in vitro (such as in a test tube) diagnostic tests designed, manufactured and used within a single laboratory. The Food and Drug Administration, under a 1976 law, regulates medical devices, but generally did not regulate LDTs even though it claimed the authority to do so.
But FDA officials began to believe that a hands-off approach was no longer appropriate, especially in an age when overnight shipping and the Internet make it possible for a single lab to have customers across the country and even around the globe. Some genetics tests, for instance, claim to predict how someone might respond to certain medications. In addition, LDTs were being manufactured with components that the FDA said are not legally marketed for clinical use.
In 2014, the FDA released “draft guidance” making the case for phasing in regulations over a period of years. The document can still be found on the FDA website, where every page is labeled: “Contains Nonbinding Recommendations Draft — Not for Implementation.”
There was immediate blowback from across the medical community, generating more than 300 sets of comments. There was a 2015 public workshop and endless meetings and conferences with affected parties. The Obama administration then withdrew the proposed framework in November 2016. Just before Obama departed office, the FDA issued a discussion paper that summarized the feedback. “The synthesis does not represent the formal position of FDA, nor is it enforceable,” the FDA said.
In effect, the FDA punted, leaving the problem in Congress’s hands. Later that year, after Trump took office, a House committee inserted language in an appropriations bill that made it clear Congress would take the lead. In 2018, Trump’s then-FDA commissioner, Scott Gottlieb, issued a statement calling for a narrow approach that focuses on just about 10 percent of laboratory developed tests — such as ones marketed direct to consumers or used at home.
Trump’s remarks mystified experts who had been closely following the LDT debate. “We aren’t sure what rule is being referenced,” said Michelle M. Forman, a spokeswoman for the Association of Public Health Laboratories. “To our knowledge, there were some discussions about laboratory-developed test rules but nothing was ever put into place. So we are not aware of anything that changed how LDTs are regulated.”
In a public health emergency declared by the Department of Health and Human Services, such as in the case of the coronavirus, hospitals and labs are expected to get FDA permission to use their own LDTs. The FDA can make exceptions under an “emergency use authorization" (EUA), under which LDT developers can go ahead but also submit information about their tests to help FDA understand how well they work.
During the outbreak of the Zika virus in 2016, for instance, the FDA sent letters to two laboratories and two Texas hospitals, saying they appeared to have developed tests without submitting requests for an EUA. But the issue was quickly resolved — in one case the FDA had misunderstood language on a lab’s website — and the hospitals said that the FDA had not asked them to discontinue use of the tests.
On Feb. 29, a month after the HHS emergency declaration, the FDA expanded its EUA policy to allow more labs to apply for approval to conduct covid-19 testing. For instance, Quest Diagnostics announced it would launch a new test that would be available by March 9. The company said it would submit for FDA review an EUA within 15 days of clinical testing. The service would test respiratory specimens collected in hospitals and doctor’s offices.
But such an option was always possible for the Trump administration and was never prevented by anything put in place by Obama. Indeed, the discussion draft of the legislation, known as the Verifying Accurate Leading-edge IVCT Development (VALID) Act, would continue to allow in vitro clinical tests to be authorized for use in an emergency under the use of EUAs.
An FDA spokesperson noted the 2014 draft guidance and insisted: “Under the previous administration, the FDA required all labs to receive an EUA prior to patient testing during a declared public health emergency. The action we took this past Saturday enables certain qualified labs to immediately use tests they developed and validated in order to achieve more rapid testing capacity in the U.S. and shows that we are flexible during this public health emergency.”
An HHS spokesperson acknowledged that the 2014 draft guidance was not finalized and that requiring an EUA prior to patient testing during public health emergencies “is not reflected in any written policy, but FDA did send letters for in vitro diagnostic testing without an EUA,” such as during the Zika outbreak. “FDA was concerned that because of the public health emergency, it was even more important to ensure that all tests have EUAs, because of concern about false negatives.”
The HHS spokesperson added that it was “a reasonable assumption by labs, based on the previous administration’s behavior, that they would be met with regulatory action," arguing that “the draft guidance spoke to the previous administration’s regulatory perspective even if it was not finalized.”
We sought an explanation from the White House but did not get a response.
The Pinocchio Test
Trump is looking for scapegoats to excuse his administration’s sluggish efforts to expand testing. But he cannot blame Obama. There was no “Obama rule,” just draft guidance that never took effect and was withdrawn before Trump took office. If there was confusion by labs, the administration could have easily taken the action on EUAs sooner than it did. The Trump administration’s efforts to work with Congress on draft legislation on LDTs certainly made clear how it viewed the issue.
Trump earns Four Pinocchios.
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