There was no Obama-era rule limiting people from developing coronavirus tests as Trump falsely claimed.
Donald Trump and his officials are falsely asserting that they've accelerated coronavirus testing by easing a restrictive policy introduced by the Obama administration.
Trump also appeared to suggest that people with the infectious disease should go to work as long as they feel OK, advice that defies the warnings of his health officials that such people shouldn't leave their homes unless they need care.
TRUMP: "The Obama administration made a decision on testing that turned out to be very detrimental to what we're doing. And we undid that decision a few days ago so that the testing can take place in a much more accurate and rapid fashion."
MIKE PENCE: "The last administration asserted FDA jurisdiction over testing and the development of tests like this. ... The president changed that on Saturday so that now, as I spoke to several governors this morning, the states now have the ability to actually conduct the coronavirus test in state labs, university laboratories."
TRUMP: "This was a very big move. And it was a — 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." — remarks Wednesday.
The facts: It's not true that an Obama-era rule limited laboratories run by companies, universities, and hospitals from developing and running tests for the coronavirus during an emergency. No such regulation existed.
The Trump administration's action Saturday only undid a policy that its own Food and Drug Administration put in place. The new action lets labs develop and use coronavirus diagnostic tests before the agency reviews them. Previously, the FDA had only authorized use of a government test developed by the Centers for Disease Control and Prevention.
Under a 2004 federal law, the FDA has wide power to authorize drugs, tests, and other therapies during emergencies. That means no legal authority was hindering the Trump administration when it earlier decided to limit testing to public health labs using the CDC test.
"All they did was reverse a policy that they themselves set," said Dr. Joshua Sharfstein, an FDA official during the Obama administration who is now a vice dean at Johns Hopkins-Bloomberg School of Public Health.
Former FDA testing employees said that during public health emergencies the agency tended to increase its scrutiny and require diagnostic labs to seek authorization before launching their tests. But they said that was not a binding policy and it preceded the Obama era.
Trump and Pence appeared to be referring, in part, to draft FDA guidance circulated during the Obama administration in 2014 that called for tighter regulation of so-called laboratory-developed tests, a market traditionally not overseen by the agency. That nonbinding guidance cited a need for accurate and reliable tests to help consumers make better health care decisions. But that guidance, which did not pertain to public health emergencies such as the coronavirus, never went into effect.
The virus has infected more than 90,000 people worldwide and killed more than 3,100. But the United States has trailed other countries in rolling out tests because of problems with its test kits.
In January, the CDC said it had developed a test kit and sent it to state and big city public health labs so they could test more people. But most of the kits proved to be faulty, providing inconclusive results to test samples that should have tested positive.
Trump, on the coronavirus: "A lot of people will have this, and it's very mild. They will get better very rapidly. They don't even see a doctor ... So, if we have thousands or hundreds of thousands of people that get better just by, you know, sitting around and even going to work — some of them go to work, but they get better." – Fox interview Wednesday night.
TRUMP: "I NEVER said people that are feeling sick should go to work. This is just more Fake News." — tweet Thursday.
THE FACTS: His wording was imprecise but seemed to suggest that people with COVID-19 can go to work if they have minor symptoms, contradicting the guidance of his federal health officials. Regardless of how sick people may or may not feel, people are advised to stay home.
The CDC states that people with confirmed or suspected COVID-19 who do not need hospitalization should restrict their activities and "stay home except to get medical care."
"Do not go to work, school or public areas," it states.