ONCE AGAIN, TRUMP EARNS FOUR PINOCCHIO’S

This is Trump’s personal BADGE OF HIS PRESIDENCY

Trump once again falsely tried to use Obama as his scapegoat

When things get tough in the Trump administration, the president has his own personal default position: “Just blame Barack Obama.”

The Trump administration has been under fire for its failure to quickly expand testing for the coronavirus across the United States; the Centers for Disease Control and Prevention had distributed defective test kits to multiple state and local health departments. The lack of the proper test kits, compared with countries like South Korea that have tested tens of thousands of people, has meant that the spread of the virus in the United States may be larger and completely hidden.

Trump has suggested the problem instead was an “Obama rule” on testing that Trump’s administration had recently overturned. But as usual, Trump is completely wrong.

This is exactly what President Trump said: 

“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. That was a decision we disagreed with. I don’t think we would have made it, but for some reason it was made. But we’ve undone that decision.  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.”

This turns out to be about a complex and technical issue that had attracted little attention outside the trade press and a small community of experts. But the quick answer is. There was no Obama rule, there was  simply “guidance" that was never acted on because Congress stepped in and decided it would provide the necessary legislation.  According to experts that were consulted. The Trump administration, has in fact, been working with Congress on such legislation.  However, as usual, they were late in doing anything that would fix the issue.

The question revolves around something called laboratory developed tests (LDTs). These are generally described as diagnostic tests designed, manufactured and used within a single laboratory.

In 2014, the FDA released “draft guidance” making the case for phasing in regulations over a period of years.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 today on the FDA website, where every page is labeled as: “Contains Nonbinding Recommendations Draft — Not for Implementation.”

There was immediate blowback from across the medical community to Trump's statement, generating more than 300 sets of negative comments against Trump’s comments.

Just before Obama departed office in 2018, 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 had punted the issue, 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 that 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 only about 10% of laboratory developed tests.  These are the tests that are marketed directly to consumers for use at home.

Trump’s remarks mystifies the 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 (HHS) 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 can also submit information about their tests to help FDA understand how well they work.

On Feb. 29, just 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 it was never prevented by anything put in place by President Obama. Indeed, the discussion draft of the legislation, known as the Verifying Accurate Leading-edge IVCT Development (VALID) Act, would continue to allow clinical tests to be authorized for use in an emergency.

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.”

The Washington Post  sought an explanation from the White House but as usual, they did not get a response.

Trump is continuing to look for more scapegoats to excuse his administration’s very slow efforts to expand virus testing.

However, he cannot blame President Obama. There was no “Obama rule,” just some drafted guidance that never took effect and was withdrawn even before Trump took office.

If there was confusion by labs, the Trump administration could have easily taken the action on the emergency use authorizations (EUA’s) sooner than it did. The Trump administration’s lame efforts to work with Congress on draft legislation on LDTs certainly made clear how they viewed the issue.

Trump as usual has earned himself Four Pinocchio’s for the hundredth time, since he took office.

Copyright G. Ater 2020