FDA commissioner on fast-track testing, treatment amid COVID-19 pandemic
Dr. Stephen Hahn, FDA commissioner joins ‘America’s Newsroom.’
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Dr. Stephen Hahn, the head of the Food and Drug Administration (FDA), said the agency is pushing forward "very aggressively” with the testing of potential therapies and treatments for the novel coronavirus.
“It's really important to stress that there are no FDA-approved therapies for COVID-19," discussed on “America’s Newsroom” on Wednesday, " but what we're talking about is expediting, getting potentially positive therapies, therapies that could help out into hospitals, to doctors' hands."
Also on Wednesday, the FDA announced a new program geared at expediting the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while also supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this new virus.
“This is great news for the American people in terms of the partnership between the private sector and government,” Hahn, who has been working closely with the Trump administration to find medicines effective in fighting the coronavirus, said.
“For the last four to six weeks we stood up a group to actually look at the acceleration of potential therapies, treatments for coronavirus starting with agents that actually specifically treat the virus and also something called convalescent plasma, where we are looking at again gathering these antibodies to give to people who are sick to treat them,” he explained.
Hahn added, “We’re streamlining all processes to make sure that we can get the applications that come to us into the treatment arena and the hospitals as quickly as possible.”
Host Sandra Smith brought up an article from The Washington Post titled “FDA authorizes widespread use of unproven drugs to treat coronavirus, saying possible benefit outweighs risk.”
She noted that there is “a lot of criticism of the FDA possibly going too quickly with some of these treatments and potentially not looking at all the risks involved and rather looking at just trying to get fast help.”
The Washington Post article said, “There have been only a few, small anecdotal studies showing a possible benefit of the drugs, hydroxychloroquine and chloroquine, to relieve the acute respiratory symptoms of covid-19 and clear the virus from infected patients.”
“Health experts warn the drugs’ well-known side effects could become commonplace with wide use. In particular, they say, patients with existing heart problems or taking certain drugs, such as anti-depressants that affect heart rhythm, are at risk of a fatal episode,” the article continued. “Experts recommend screening before the drugs are prescribed to prevent drug-related deaths.”
Smith asked Hahn on Wednesday if he is “seeing the benefits outweigh the potential risks of exposing people to these treatments?”
In response, Hahn said that an emergency-use authorization was implemented “for entry of hydroxychloroquine and chloroquine into the system,” noting that “we did not approve it for the use of treatment of COVID-19.”
“But what this allowed us to do is have donated drugs to come into the system. That drug will be allocated for clinical trials, where we'll be able to ask the question about whether these drugs work,” he explained. “That's the best way to get the data and the science for us to tell Americans whether this is the right drug for them.”
He went on to note that Americans can also obtain such a drug from their doctor, who can explain the "risks and benefits."
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“We have not taken a stance ... on whether doctors should prescribe it,” he continued. “We're providing facts and information about the risks and benefits. It is and should be a doctor/patient decision.”
Fox News’ Brie Stimson and The Associated Press contributed to this report.
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