President Donald Trump with FDA Commissioner Stephen Hahn and White House Coronavirus Coordinator Debbie Birx
Source: AP Photo
President Donald Trump created confusion during a White House briefing when he mistakenly said the U.S. Food and Drug Administration had granted approval to a more than 80-year-old malaria medicine to treat the new coronavirus.
The medicine, chloroquine, also available in another form as hydroxychloroquine, is approved in the U.S. to treat malaria, lupus erythematosus and rheumatoid arthritis. Teva Pharmaceutical Industries Ltd. and Mylan NV are among the companies that manufacture the medicine.
Neither form of the drug is approved in the U.S. for COVID-19, the disease caused by the novel coronavirus.
There are no approved therapies to treat COVID-19. The disease has infected nearly 240,000 people worldwide and has killed almost 10,000, according to Johns Hopkins University's Center for Systems Science and Engineering.
But at his March 19 briefing, Trump incorrectly said the FDA had cleared the use of hydroxychloroquine and chloroquine for COVID-19.
"We're going to be able to make that drug available almost immediately," Trump told reporters. "They've gone through the approval process. It's been approved. They did it. They took it down from many months to immediate."
"Normally, the FDA would take a long time to approve something like that," he added. "It was approved very, very quickly."
In the U.S., doctors can prescribe a marketed medicine for other indications not approved by the FDA — a practice known as off-label prescribing — unless the drug is restricted for safety or other concerns.
Hydroxychloroquine is being studied for COVID-19 in at least one trial of 24 patients in France, where 75% of the study participants had positive results after six days of treatment, versus 10% in the control group.
Bayer AG said it was donating 3 million tablets of its chloroquine product, Resochin, to treat COVID-19.
Bayer's product, however, is not approved in the U.S. for any indication. In a March 19 statement, the company said it was seeking an emergency use authorization from the FDA to permit Resochin's use in the U.S.
Mylan said it has restarted production of hydroxychloroquine tablets at its West Virginia facility and expects to be able to supply its product by mid-April. Mylan said it would ramp up manufacturing to provide as many as 50 million tablets.
Trump also initially said Gilead Sciences Inc.'s experimental drug remdesivir had been "out" and "approved," but then corrected himself, saying it was "very close to approved."
Remdesivir is being tested in at least five COVID-19 trials, but Gilead is far from submitting an application to the FDA to market the medicine for COVID-19.
In a statement to S&P Global Market Intelligence, Gilead said it was "working with urgency to respond to the pressing need for an effective treatment for COVID-19."
"We are in discussions with regulatory agencies, including FDA, to determine the most appropriate pathway for approval of remdesivir in the event that the data are positive," Gilead said.
Gilead has been providing remdesivir to COVID-19 patients under the FDA's compassionate use program, also known as expanded access, which permits people with immediately life-threatening conditions or serious diseases to obtain access to an experimental medicine outside of clinical testing when no comparable alternative is available. The FDA said 250 U.S. patients have been granted access to the drug.
FDA Commissioner Stephen Hahn and other federal officials.
After Trump spoke, FDA Commissioner Stephen Hahn made clear that remdesivir was "going through the normal process" at the agency.
While Hahn said the FDA was "looking at everything coming across our desks as possible treatment options for coronavirus," he noted that "we want to make sure it's done well and right for the American people."
For chloroquine and hydroxychloroquine, Hahn said the FDA would be taking a closer look to see if "an expanded use approach to that could be done to see if that actually benefits patients."
Hahn emphasized, however, that examination would be done "in a large, pragmatic clinical trial to answer the question that needs to be asked and answered."
Hahn did not state that the drugs were not approved.
Michael Carome, director of health research at the consumer advocacy group Public Citizen, said Trump's statements at the March 19 briefing about the malaria drug and remdesivir "only raise false hopes and sow confusion."
Carome called on Trump to let "qualified public health experts take the lead in truthfully informing the public about our government's response to the pandemic."
The evening before the briefing, Hahn revealed that the spread of COVID-19 has caused the FDA to postpone its manufacturing facility inspections in the U.S. — a step taken to protect the safety of the agency's employees.
The FDA had already halted its foreign inspections for the time being.
"I want to assure the American public that we have full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate," Hahn said in a March 18 statement.