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FDA Seeks To Expand Treatment For Coronavirus As Part Of White House Response

Mar 19, 2020
Originally published on March 19, 2020 4:02 pm

Updated at 3:37 p.m. ET

The Food and Drug Administration is trying to clear the way to expand the types of medicines or treatments available during the coronavirus pandemic, President Trump said Thursday.

Early trials have begun for a prospective coronavirus vaccine, and the FDA also is working to permit patients to have access to medicines approved for use in other countries or for other uses.

FDA Commissioner Stephen Hahn stressed that the agency is moving as quickly as it can while still following protocol to ensure safety standards are met.

The White House briefing comes as the administration continues to ramp up its response to the virus, including providing economic relief and mobilizing the Federal Emergency Management Agency. Trump met with governors about their needs.

Trump also said Thursday that he would support the prospect of the government taking an equity stake in companies as part of a big stimulus for the economy.

The particulars are being negotiated in Congress as part of another bill that could lead to hundreds of billions or $1 trillion in cash or other support for individual Americans, small business and big companies.

Trump's answer on Thursday suggested that he would be open to a situation in which the government might buy a percentage of the stock of a big company in order to provide it with equity to continue operating through the economic shock associated with the pandemic.

Trump said the amount of spending would depend on the virus.

If social distancing and the clinical response could stop the coronavirus "in its tracks," about $1 trillion would be "plenty," the president said. If that won't do, more negotiations might be required.

FDA fast track

FDA officials want to expand the treatments available during the pandemic in a way that's both fast and responsible, Trump said, so that authorities can monitor what works as soon as practical.

"Immediately — like, as fast as we can get it," the president said.

Trump said the measures he announced on Thursday could be a "game-changer," but "maybe not."

Hahn, of the FDA, said he wanted to assure Americans that the agency would work as fast as it could to broaden access to new medicines and treatment but that it remained bound by its mission to ensure that those products would be safe.

"We are looking at everything that's coming across our desks as treatment options for coronavirus," Hahn said. "We need to make sure this sea of treatments will get the right drug to the right patient at the right dosage at the right time."

One first step in the short term, Hahn said, is to examine medications already in use for other purposes.

Doctors will look at an anti-malaria drug, for example, to see how it might be applied to coronavirus sufferers, he said. Another option might be to take blood from patients who've recovered from a coronavirus infection and inject it into sick patients to help their immune response.

Hahn said the FDA's work would be a "continuous process" and might take three to six months. A vaccine might not be complete for about a year.

Overall, it was not clear on Thursday that beyond officials' emphasis on doing lots of assessments quickly, when the work that has begun would start to pay off at significant scale.

"This is an unprecedented situation," Hahn said. "This is a really significant time."

More testing

Dr. Deborah Birx, the White House's coronavirus coordinator, told reporters in the same briefing that she recognized that the number of coronavirus cases in the United States would likely continue to rise as more tests become available and it takes less time to process them.

The number of infections has topped 10,000, as of Thursday afternoon, according to the latest reports.

Birx said the rate of positive results is between 10 and 11%, meaning that about 90% of people receiving tests don't have the coronavirus.

Even so, a more robust testing regime likely will reveal more cases, officials said.

Conference with governors

Trump traveled from the White House to the Federal Emergency Management Agency on Thursday. He spoke with a group of governors about the need to be able to care for what is expected to be a wave of people needing treatment for the respiratory disease caused by the coronavirus.

FEMA is accustomed to responding when natural disasters like hurricanes and tornadoes overwhelm local resources, but the scope and scale of the coronavirus pandemic presents huge logistical challenges.

Georgia's Republican Gov. Brian Kemp told Trump to "leave the directives for the National Guard with the governors."

Responded Trump: "That's done. I like it."

Kemp also asked Trump to consider maintaining staff at a military base used for quarantining cruise ship passengers in order to handle people from the metro Atlanta area.

Louisiana's Democratic Gov. John Bel Edwards said he was worried that his state's medical facilities would be overwhelmed in a week. Edwards said the state would like to be able to send some patients to a hospital run by the Department of Veterans Affairs.

Trump said he would work to approve that quickly.

Vice President Pence urged governors to place orders for N95 masks after a new change to liability laws made it possible for hospitals to use industrial masks, normally targeted for construction sites.

Pence also told governors that a survey was being done to determine the supply of ventilators. Birx, the response coordinator, urged them to ensure that coronavirus test results are reported centrally so that supplies can be surged to the right areas.

Nebraska's Republican Gov. Pete Ricketts said he was concerned about the supply of reagents for processing tests.

Ricketts also said there was an urgent need for "pop-up alternative day care," especially for first responders and health care workers. He asked Trump for assistance with streamlining the process of clearing day care workers.

"We need a waiver from the fingerprint requirement to be able to do that quickly," he said.

Ricketts also asked that the Education Department relax "free appropriate education" requirements because recent guidelines created concerns. He said some school attorneys have told teachers they cannot teach because they could be sued under those "appropriate education" requirements.

Massachusetts Democratic Gov. Charlie Baker said his state has put in orders for personal protective equipment supplies, as Trump had previously directed. But he suggested the federal government was crowding out other buyers.

"On three big orders, we lost to the feds," Baker said, asking Trump to look into the issue.

Maryland's Republican Gov. Larry Hogan said the federal government should give at least half of stimulus aid funding to the states, saying that state government could get money out faster to where it's needed.

Pressure for results

Trump is under pressure to show that his administration has the situation in hand as Americans see their day-to-day lives dramatically change.

Schools are closed, people are heeding warnings to stay away from others, and many have lost their income as the economy has been shocked to a near-halt.

Meanwhile, Trump's administration is negotiating with Congress on a new package of aid to help people and businesses through the huge economic losses from the crisis. It will be the third round of aid in two months. Trump signed the second package into law Wednesday night.

But the virus is making it hard for lawmakers to do their work.

On Wednesday evening, two congressmen said they had tested positive for the virus, and others who had met with them — including Rep. Steve Scalise, the No. 2 Republican in the House — said they would self-quarantine, to be safe.

No decision on Olympics, Trump says

Trump acknowledged at the White House that Japanese Prime Minister Shinzo Abe discussed the upcoming Summer Olympics, set to occur in Tokyo, in a call with world leaders earlier this week.

Abe hasn't decide whether to cancel the games, Trump said, but "we'd live with his decision if he does."

Trump was asked on Thursday when he thought life would get back to normal.

"I hope very soon," he said. "We'll see. This is uncharted territory."

: 3/19/20

A previous version of this story incorrectly said President Trump signed the latest coronavirus aid package into law on Tuesday. It was signed Wednesday.

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