Trump pushes FDA limits in rush for coronavirus medicines
President Donald Trump is pushing the Food and Drug Administration to speed up approval of antiviral therapies that could combat the coronavirus, despite warnings that untested treatments could harm Americans infected with COVID-19.
In the short-term, Trump has directed the FDA to “slash red tape like nobody’s ever done before” in order to make treatments already approved for other uses available for COVID-19 patients.
Trump said that hydroxychloroquine and chloroquine, an antiviral therapy used to treat malaria, and remdesivir, an Ebola drug, were among those that would be available as potential coronavirus treatments in short order.
“We have to remove every barrier. There were a lot of barriers that were unnecessary,” Trump told reporters at a press briefing on Friday. “For the FDA to act the way they acted with this kind of speed, it’s incredible.”
While Trump also asked the FDA to expedite trials on new therapies, he acknowledged that untested experimental treatments could “do destruction” to patients.
“When you go with a brand new drug, you don’t know if that’s going to happen,” Trump said.
Trump has already faced pushback, both from large pharmaceutical firms and laboratory scientists, over his effort to rush vaccines and therapies to market.
Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases and a member of the White House coronavirus task force who has warned Trump of the potential harm rushed medicines could inflict, was not present at the FDA announcement on Thursday.
Stephen Hahn, commissioner of the Food and Drug Administration, said that drugs like remdesivir are “going through the normal process,” but will be made available for “compassionate use,” allowing doctors to have emergency access to the drugs if requested.
He said that allowing COVID-19 patients the “right to try” would provide the FDA with additional data on the effectiveness of the drugs against coronavirus, potentially speeding up its release to the public.
“FDA’s responsibility to the American people is to ensure products are safe and effective,” said Hahn. “We’re trying to provide them the regulatory flexibility but also the scientific oversight.”
Remdesivir, from drug maker Gilead Sciences, is an antiviral drug that is already being tested in China and in the United States to treat COVID-19.
According to the National Institutes of Health, the drug “was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS),” other coronaviruses that, like COVID-19, attack the respiratory system.
Hahn noted that the treatments would likely not be available for broad use for several months, and repeated guidance from the National Institutes of Health is that approval of a vaccine is likely 12 months away.
“One thing that was really important is to provide hope,” Hahn said, recalling his experience as a cancer doctor. “I have great hope for how we’re going to come out of this situation. What’s also important is not to provide false hope, but to provide hope as a doctor.”
Research published in the journal Nature said chloroquine “appears to be the drug of choice for large-scale use due to its availability, proven safety record, and a relatively low cost.”
“A recent case report showed that treatment with remdesivir improved the clinical condition of the first patient infected by SARS-CoV-2 in the United States, and a phase III clinical trial of remdesivir against SARS-CoV-2 was launched in Wuhan on February 4, 2020,” researchers documented in Nature.
Public health officials in China, Australia and France are also testing chloroquine.
This story was originally published March 19, 2020 at 12:25 PM with the headline "Trump pushes FDA limits in rush for coronavirus medicines."
