FDA on fast track to approve COVID-19 drugs

March 20, 2020

At a recent White House Coronavirus Task Force meeting, President Trump said he was pushing the Food and Drug Administration (FDA) to eliminate barriers to using the antimalarial drug, hydroxychloroquine, to treat COVID-19 infections.

"It's been around for a long time, so we know if things don't go as planned it's not going to kill anybody," Trump said of the drug, which is also used to treat arthritis symptoms in some patients. An unpublished, small, non-randomized trial based on French COVID-19 patients shows the drug has promise against the virus.

But FDA Commissioner Steve Hahn, MD, struck a more cautious tone during the press conference. He said he did not know how effective the treatment would be and urged caution when looking at therapeutics for the novel coronavirus.

"Let me make one thing clear. The FDA's responsibility to the American people is to ensure that products are safe and effective," said Hahn. Of using hydroxychloroquine, Hahn said, "We want to do that in the setting of a clinical trial, a large, pragmatic clinical trial to actually gather that information."

But Trump said red tape surrounding therapies for coronavirus would be cut dramatically in the coming days.

"Therapies are something we can move on much faster [than a vaccine]," said Trump, who also said the FDA would be allowing the compassionate use of remdesivir, an antiviral originally used for Ebola treatment that's been studied in Chinese coronavirus patients. Last month, the National Institutes of Health launched a trial of remdesivir in COVID-19 patients at the University of Nebraska Medical Center (UNMC) in Omaha.

Trump also said he was directing the FDA to look at treatments being used in Europe and Japan and extrapolate good results in those regions to American patients.

Hahn said the FDA would look into "convalescent plasma" taken from recovered COVID-19 patients as a possible treatment, based on antibody therapy.

Amesh Adalja, MD, of the Johns Hopkins University Center for Health Security, said hydroxychloroquine has been well-studied, and has both antiviral and anti-inflammatory properties.

"It's an important tool we have to study and make sure we get good data on good coronavirus patients and what the impact is," he told CIDRAP News. But he cautioned that there is limited availability of the drug, and many patients with rheumatoid arthritis rely on it. He also worried the sudden interest in the drug could cause supply chain issues.

Trump also said he spoke with New York Governor Andrew Cuomo last night about hydroxychloroquine, and said the governor was excited to try the medication. New York has been one of the hardest hit states, but also one of the states that's effectively ramped up testing.

Overnight, Cuomo tweeted that the state tested 7,500 samples for coronavirus, finding 1,769 new positive cases. The state's total is now 4,152, including 2,469 cases in New York City alone.

"Remember: We know that as more people are tested we will find more cases," Cuomo cautioned on Twitter.  Cuomo also signed an executive order mandating that 75% of the non-essential workforce must work from home.

By early afternoon the US case count had surged past 10,000 cases to 11,274 cases, per the Johns Hopkins University tracker. White House Coronavirus Response Coordinator, Deborah Birx, MD, said that about 50% of US cases are in 10 counties, primarily in Washington, California, and New York. Global cases are at 246, 275.

Health officials in King County, Washington—the first US county to be hit hard with the coronavirus—warned that rapid widespread community transmission could happen. Washington state has reported 1,026 cases and 68 deaths, according to the New York Times coronavirus tracker. Thirty-five of those deaths occurred in patients or visitors to the Life Care Center, a long-term care facility in Kirkland, Washington.

There have been 169 deaths total in the United States.

Also, two lawmakers, Reps. Mario Diaz-Balart (R-FL) and Ben McAdams (D-Utah), said they both tested positive for COVID-19 and were in self-quarantine, becoming the first members of Congress to test positive for the coronavirus. The Washington Post reported at least three additional members of Congress would be self-quarantining because they had been in close contact with Diaz-Balart and McAdams.

Meanwhile, the State Department this afternoon announced a level 4 travel advisory, urging all Americans abroad to return home immediately or be prepared to remain abroad indefinitely. Americans were also instructed to avoid all international travel. A level 4 warning is the highest given by the department.

CIDRAP has the story.

More COVID-19 coverage HERE.