Discussing the “off-label” use of hydroxychloroquine and chloroquine for Covid-19, the commissioner of the US Food and Drug Administration this weekend said his agency does not “regulate the practice of medicine.”
FDA Commissioner Dr. Stephen Hahn made the comments in an open letter published on the FDA’s website Friday and tweeted out by Hahn Sunday.
The letter was titled “Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic,” but it focused heavily on unproven drugs touted by President Trump for coronavirus.
“The drugs hydroxychloroquine and chloroquine have received particular attention,” Hahn wrote in the letter. The medications are FDA-approved for some conditions, such as malaria, but they’re not approved to prevent or treat Covid-19. Like other drugs, they can still be prescribed off-label.
In April, however, the FDA warned against using the drugs to treat coronavirus outside of hospitals or clinical trials, pointing to the risk of severe heart problems or death. Even so, Trump earlier this month claimed he was taking daily doses of hydroxychloroquine to prevent infection.
In his letter, Hahn said many physicians have “prescribed these drugs for patients with Covid-19 based on an individual assessment of the potential benefits versus the risks for an individual patient.”
“The agency neither endorses individual prescribing decisions nor prohibits physicians from prescribing medications,” Hahn wrote. “We do not regulate the practice of medicine.”
Still, his letter pointed to the potential risks of hydroxychloroquine and chloroquine. “It is important that patients and health care providers understand the known side effects of these drugs, including serious and potentially life-threatening heart rhythm problems as noted in a recent Drug Safety Communication,” Hahn wrote, pointing to the FDA’s earlier warning.
But he said patients who have been prescribed the drugs for approved reasons, like lupus, should understand that “the FDA’s approval means the agency has determined them to be safe and effective for those conditions.”
Hahn appeared to defend a limited emergency use authorization that the FDA issued for the two drugs in late March. The authorization was narrow in scope, applying only to hospitalized Covid-19 patients and only to drugs donated to the Strategic National Stockpile.
“This decision was based on evaluation of the EUA criteria and the scientific evidence available at that time. We continue to look at the data on hydroxychloroquine and chloroquine and we will make future determinations on these products based on available evidence including ongoing clinical studies,” Hahn said in the letter.
The emergency use authorization, or EUA, made it easier for pills donated to the national stockpile to be distributed to coronavirus patients. “We also knew it was important to help ensure a stable supply of the drugs for patients with lupus and rheumatoid arthritis given the increased demand,” Hahn said.
In an interview with CNN this week, Hahn denied political pressure at the FDA. But the agency has had to issue a number of high-profile walk-backs and revisions during the pandemic.
“Some of the science and data aren’t perfect in emergency situations,” he said. “You make the best with the information you have at hand.”