FDA barred from regulating COVID-19 lab testing

WASHINGTON — The Trump administration this week blocked the Food and Drug Administration from regulating a broad swath of laboratory tests, including for the coronavirus, in a move strongly opposed by the agency.

The new policy stunned many health experts and laboratories because of its timing, several months into a pandemic. Some public health experts warned the shift could result in unreliable coronavirus tests on the market, potentially worsening the testing crisis that has dogged the United States if more people get erroneous results. They argued the change is unlikely to solve current testing problems, which at this point are largely due to shortages of supplies such as swabs and chemical reagents.

But supporters cheered the change as long overdue, saying it could help get new and more innovative tests to market more quickly. They said that the FDA review process sharply slowed testing at the beginning of the pandemic and that the new policy could ensure such bottlenecks don’t recur.

Administration officials said the decision, announced Wednesday on the website of the Department of Health and Human Services, was made for legal reasons. They said the FDA lacks the authority to regulate laboratory developed tests — a significant part of the market. The agency, they said, can only obtain that through a formal rulemaking process or legislation; those options are unlikely to occur any time soon. The officials spoke on the condition of anonymity to freely discuss the decision.

The change in policy came as a surprise to many at the FDA and was a point of intense disagreement between HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn. Tensions have been rising between the two men for weeks, according to several people familiar with the situation who spoke on the condition of anonymity because they did not have clearance to talk about it. Hahn vociferously opposed the change, arguing the agency has the authority to regulate laboratory developed tests during a public health emergency like the current pandemic, the individuals said.

An FDA spokeswoman declined to comment and referred questions to HHS.

The episode is the latest in which health agencies have been undercut by political overseers. On Wednesday, for example, President Donald Trump blamed the FDA for not yet authorizing the emergency use of convalescent plasma, a promising but unproven treatment. “You have lot of people over there that don’t want to rush things. They want to do it after Nov. 3,” he said in a White House press briefing.

But administration officials who defended the change said it was based on the law, not politics, and that it emanated from HHS as part of a review of the department’s COVID-19 response. They said it was consistent with administration efforts to reduce unnecessary regulation.

“It’s safe to say this fits squarely into the ‘lessons learned’ category of the department’s response to COVID,” said Brian Harrison, Azar’s chief of staff.

FDA supporters said the agency has followed the same practice during previous public health emergencies, including the H1N1 pandemic in 2009 and the Zika outbreak in 2015 and 2016. They stressed that it is critical during health emergencies to make sure tests are accurate and not fraudulent.

“It’s safe to say this fits squarely into the ‘lessons learned’ category of the department’s response.” Brian Harrison, chief of staff, Health and Human Services