FDA “removes barrier” for hydroxychloroquine use

Health and Human Services Secretary Alex Azar clarified the FDA’s action on hydroxychloroquine on Monday saying it “removes the barrier” for people thinking it could only be used in a hospital setting.

He was responding to questions from reporters at a White House media appearance with President Donald Trump after the FDA announced its decision to withdraw its emergency use recommendation for hydroxychloroquine to treat COVID-19.

Chloroquine, an anti-malarial drug, and hydroxychloroquine, a related compound normally used to treat arthritis, are being extensively studied around the world for COVID-19 treatment.

After reviewing new information from large clinical trials the agency concluded that the suggested dosing regimens “are unlikely to produce an antiviral effect,” FDA chief scientist Denise Hinton said in a letter announcing the decision.

“They took the emergency use authorization off. At this point it’s just like any other approved drug in the United States. They may be used in hospitals, they may be used as out-patient, at home, all subject to a doctor’s prescription,” Azar explained.

“In fact the FDA’s removal of the authorization takes away what has been a significant misunderstanding by many that made people think that somehow it could only be used in a hospital setting,” he said.

 “If a doctor wants to prescribe [it] working with a patient, they may do that for any purpose they want to do. This removes the barrier,” he noted.

 “So, it actually uncomplicated it in a way,” said Trump.

Azar described the media interpretation of the FDA’s letter as inaccurate.

“With the FDA finding that they don’t see enough data to support hospital-based use, for those who are the most extreme cases of patients who have been hospitalized, they took that restriction off. They took the Emergency Use Authorization off,” he said.

Although the FDA stated its data in the hospital setting was not supportive, “We continue to study in out-patient settings, as well as preventative. That data is not yet in,” he noted. 

The president told reporters that only U.S. agencies have failed to grasp the benefit of hydroxychloroquine in fighting coronavirus. He noted that other countries had provided great reports on the effectiveness of the 50-year-old drug for COVID-19 treatment.

“A lot of the data that has come out that was more negative was people who were quite ill in the hospital,” he said.

 Epidemiologists in Greece consider chloroquine effective, especially in the early stages of COVID-19. It has been administered to hospitalized patients in combination with the antibiotic azithromycin.

Greek scientists are conducting clinical trials with a “calm and distant approach,” refusing to be drawn into the fraught, politicized debate which is impacting studies in several other countries.

Spanish researchers found that the use of hydroxychloroquine on a group of COVID-19 patients on dialysis was associated with a lower rate of death. Lead author J. Emilio Sánchez-Álvarez, MD, of Hospital Universitario de Cabueñes in Gijón, Spain, and his colleagues noted “the significance of this last finding requires studies in a larger number of patients.” The study was published on May 1, 2020, in Nefrologia.

Hundreds of trials testing hydroxychloroquine or chloroquine as interventions for COVID-19 are still underway. One U.S. study is examining whether hydroxychloroquine in combination with azithromycin can prevent hospitalization and death from COVID-19.