VP Pence: FDA approving 'off-label' use for hydroxychloroquine to help coronavirus patients
Dr. Oz asks Vice President Mike Pence what the U.S. is doing to accelerate clinical coronavirus trials and if the administration plans to approve 'off-label' use of hydroxychloroquine medication
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Vice President Mike Pence said Tuesday that “the FDA [Food and Drug Administration] is approving off-label use for the [anti-malarial drug] hydroxychloroquine right now" to help coronavirus patients.
Pence made the comment during Fox News’ virtual coronavirus town hall in response to a question from Dr. Mehmet Oz about the drug, which has shown encouraging signs in small, early tests. A similar drug, Chloroquine has also showed positive signs.
Dr. Oz noted that “the FDA appropriately desires randomized critical trials for proof to guide the medical community,” but asked the vice president how the clinical trials can be accelerated “while also satisfying the demand from physicians, front-line doctors, who want to use these pills for their patients and themselves?”
In response, Pence said, “The good news is, the chloroquine medication, we actually deployed in the state of New York resources to be able to be administered to the people.”
New York has reported more than 25,600 confirmed coronavirus cases and 210 deaths, the most in the U.S., according to data compiled by Fox News.
“Doctors can prescribe that medication, which as you know is a perfectly legal and approved malaria medication," Pence told Dr. Oz, "but doctors can now prescribe chloroquine for that off-label purpose of dealing with the symptoms of coronavirus. We are making that clear across the country."
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Preliminary studies sparked intense interest after President Trump tweeted that hydroxychloroquine plus an antibiotic could be “one of the biggest game changers in the history of medicine” and should “be put in use immediately.” The president cited a French study that gave the combination to six patients.
Some French doctors and politicians want to expand hydroxychloroquine’s use as well. However, scientists say major studies are needed to prove the drugs are safe and effective against coronavirus.
During a news conference on Sunday, New York Gov. Andrew Cuomo announced that the state has acquired 70,000 doses of hydroxychloroquine, 10,000 doses of the antibiotic zithromax and 750,000 doses of chloroquine, with trials set to start Tuesday.
“The president’s very optimistic, he’s very hopeful that some of these anecdotal results that we’ve seen around the country will prove out to be true,” Pence said on Tuesday. “I want to assure you, there is no barrier to access the chloroquine in this country. We’re working to add to that supply even as we speak.”
He went on to say that the Trump administration is working with companies that produce vast amounts of chloroquine, adding that at the same time “we are engaging in a clinical trial while we make this broadly available for off-label use. Because we do want to take the opportunity, we are doing that in New York state, to study the results of this so that we can better understand the impact going forward.”
Dr. Oz also asked Pence if he would “take these pills” if he felt sick.
“I would follow the advice of my physician and I would recommend that approach to every single American,” the vice president said in response.
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Several studies are currently underway to see if hydroxychloroquine can prevent people exposed to the virus from getting sick or reduce the severity of the symptoms if they contract the new coronavirus.
Fox News' James Rogers, Victor Garcia and the Associated Press contributed to this report.
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