The Food and Drug Administration (FDA) on June 15 ended the emergency-use authorization (EUA) for hydroxychloroquine and the closely related chloroquine for the CCP virus, commonly known as the novel coronavirus.
The agency reversed its authorization after being asked to do so by Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority (BARDA).
Based on recent trials, scientists at the FDA believe hydroxychloroquine and chloroquine, also known as HCQ and CQ, “are unlikely to produce an antiviral effect.”
“Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated and recent data from a randomized controlled trial assessing probability of negative conversion showed no difference between HCQ and standard of care alone,” Denise Hinton, the FDA’s chief scientist, wrote in a letter (pdf) to Disbrow.
It is no longer reasonable to believe that hydroxychloroquine and chloroquine may be effective in treating COVID-19, Hinton said.
The authorization only applied to doses donated to the National Strategic Stockpile, the Association of American Physicians and Surgeons said in a statement, restricting the use of those doses to patients in hospitals.
Rescinding the order “means that the supply of the drug stuck in the stockpile is now free from the EUA’s restrictions, once it is released into the consumer supply chain,” it added.
Clinical trials, more rigorous than observational studies, are underway in the UK, the United States, and in other countries testing the efficacy and safety of hydroxychloroquine and chloroquine.
The drugs were approved decades ago for use against ailments including malaria. They were used early during the pandemic in treatment of patients with the CCP virus, and doctors around the world said they worked against the disease.
The use of the drugs became a political issue when they were endorsed by President Donald Trump. Some of his critics quickly made hyperbolic claims and later circulated observational studies indicating the drugs aren’t effective against COVID-19.
One such study was retracted earlier this month after researchers admitted they couldn’t vouch for the data used.
While some studies have pointed to a lack of effectiveness in certain dosages and certain populations, others, including ones conducted in France and the United States, indicate the drug might be effective in some cases, especially when combined with azithromycin, an antibiotic, and zinc.
Indian researchers said last month that testing showed that health care workers who took hydroxychloroquine as a preventative medicine were less likely to get the CCP virus.
Trump took the drug as a prophylactic for two weeks and would take it again if he thought he was exposed, stated White House press secretary Kayleigh McEnany.
The FDA issued the authorization in March, but the next month it warned against using the drugs outside of hospitals or clinical trials because of side effects including heart issues.
BARDA, an office inside the Department of Health and Human Services, has had a large impact on policy concerning hydroxychloroquine.
Dr. Rick Bright, who headed the office, initially requested the emergency-use authorization, but later filed a whistleblower complaint alleging concerns he put forth about the drug were downplayed or ignored.
“We want to make sure that the drugs we consider are safe and effective. Many of these reports we had are anecdotal evidence,” Bright told lawmakers in May.
Disbrow replaced Bright after the doctor was shifted to the National Institutes of Health.