FDA authorizes US states to approve their own coronavirus tests

President Donald Trump said he was refraining from ordering sweeping public quarantines or lockdowns for the time being, even as some state and local officials acted to impose their own restrictions.

President Donald Trump with the Coronavirus Task Force hold a press briefing in Washington (photo credit: REUTERS)
President Donald Trump with the Coronavirus Task Force hold a press briefing in Washington
(photo credit: REUTERS)

The US Food and Drug Administration on Monday took a step toward speeding the development of coronavirus test kits, agreeing a regulatory change to give states the ability to approve tests developed in laboratories in the states, an administration official said.

The regulatory relief came as President Donald Trump attempts to accelerate the availability of testing for the pandemic as the virus spreads deeper into the United States.

"The purpose is to achieve more rapid testing capacity in the United States," said the official, who spoke to Reuters on condition of anonymity.

The new policy gives states the option to take responsibility for tests developed and used by laboratories in their states, similar to the action the FDA granted last week to the New York state Department of Health, the official said.

"States can set up a system in which they take responsibility for authorizing such tests and laboratories won't engage with the FDA," the official said.

"Basically it's just giving power to the states to control this process. The FDA will not be involved in the process. The states will take over the approval process. This is getting rid of bureaucratic red tape that will allow for the approval to be much quicker than would normally take place," the official said.

 The White House issued new US coronavirus guidelines on Monday warning Americans to limit social gatherings to 10 or fewer people and urging restaurants, bars and other public venues to close in states where community transmission of the virus exists.

But President Donald Trump said he was refraining from ordering sweeping public quarantines or lockdowns for the time being, even as some state and local officials acted to impose their own mandatory restrictions on eateries, movie theaters and other places of leisure in a bid to contain the respiratory virus.

"We're recommending things," Trump told a White House news conference. "We haven't gone to that step yet" of ordering a lockdown. "That could happen, but we haven't gone there yet."

Trump also said a nationwide curfew was not under consideration at this point, and he disagreed with the notion of postponing primary elections.

New guidelines recommend for anyone feeling ill, any elderly person, and anyone with underlying health conditions to stay home. In addition anyone living with someone diagnosed with the coronavirus must also be quarantined at home. 

While the number of known coronavirus infections and deaths in the United States paled in comparison to hot spots of the global pandemic, such as China, Italy or Iran, the tally of confirmed US cases has multiplied quickly over the past few weeks, surpassing 4,000.

At least 74 people have died of the virus, as of Monday, according to Johns Hopkins University and public health agencies, with the hardest-hit state, Washington, accounting for the bulk of those fatalities.

Dr. Deborah Birx, the White House coronavirus response coordinator, said health officials are relying on members of the millennial generation - those in their 20s to 40s, and representing the largest living adult cohort - to alter their social behavior for the good of the public.

"Why do I think the millennial are the key?" Birx asked rhetorically at the briefing. "Because they're the ones that are out and about, and they're the most likely to be in social gatherings, and they're the most likely to be the least symptomatic."

Release of the latest 15-day guidance from the US Centers for Disease Control and Prevention (CDC) came as state and local government officials pleaded with the Trump administration to mount a coordinated national response to the coronavirus pandemic, as millions of workers and students hunkered down at home to slow the spread of the outbreak.

The unprecedented wave of closures and restrictions, which began to accelerate last week, took on fresh urgency as New Jersey "strongly discouraged" all non-essential and non-emergency travel between 8 p.m. and 5 a.m., starting on Monday.

And officials in six San Francisco Bay Area counties on Monday ordered residents to stay at home for all but the most crucial outings until April 7.

In the US capital, a deeply divided Senate was considering a multibillion-dollar emergency spending bill requiring sick leave for some workers and expanded unemployment compensation, while the Supreme Court postponed oral arguments for the first time in over a century.

The states of New Jersey, New York and Connecticut struck a regional agreement to close all movie theaters, casinos and gyms as of 8 p.m. Monday (0000 GMT). Restaurants and bars in the three states -- where more than 22 million people live - will serve takeout and delivery only.

Michigan and Maryland have taken similar measures.

Some 64,000 US schools were closed in at least 33 states, including in the nation's two biggest public school systems - New York City and Los Angeles. School closures nationwide were disrupting instruction for at least 32.5 million students, according to Education Week.

School districts are trying to find a way to provide meals and create lessons plans for the millions of students who are forced to stay home.

State restrictions on restaurants and places of leisure, while in line with expert advice to slow spread of the virus through "social distancing," will hit many lower-paid workers in the service industry.