transcript:
15 Jun: White House: Remarks by President Trump in Roundtable Discussion on Fighting for America’s Seniors
THE PRESIDENT: I’d like to ask Alex, maybe, to discuss that.
SECRETARY AZAR: Sure. So just to clarify: Your statement there, I don’t think, was quite accurate in what the FDA’s action was. The FDA, at the request of BARDA, which is an agency within HHS, withdrew an Emergency Use Authorization for a product that we had acquired into the National Stockpile by donation from Bayer of hydroxy- — of chloroquine that was manufactured in Pakistan. And the EUA — the Emergency Use Authorization — was restricted for hospital use — in-patient hospital use of the product, 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.
At this point, hydroxychloroquine and chloroquine are just like any other approved drug in the United States. They may be used in hospital, they may be used in out-patient, they may be used at home — all subject to a doctor’s prescription. In fact, the FDA’s removal of the EUA takes away what had been a significant misunderstanding by many that had made people think that somehow it could only be used in a hospital setting. And we’ve tried to make that clear throughout.
It’s a drug. It’s approved in the United States. Has been for decades. If a doctor wishes to prescribe it, working with a patient, they may prescribe it for any purpose that they wish to do so. And this actually removes a potential barrier to that.
THE PRESIDENT: So it actually un-complicates it —
SECRETARY AZAR: It does.
THE PRESIDENT: — in a way. And I think that’s probably — your question was a very inaccurately stated question.
Q No, I didn’t mean to — I didn’t mean to pose it inaccurately. I believe what it said specifically was that it’s no longer reasonable to consider it an appropriate treatment.
SECRETARY AZAR: Only in the hospital. It said the data in the hospital setting was not supported. We continue to study in out-patient settings, as well as preventive. That data is not yet in.
Q Are you suggesting that data in the hospital setting is not something you would take seriously?
SECRETARY AZAR: No, that’s why the FDA acted. It was that they looked at the data and they removed the Emergency Use Authorization for hospital-setting use of the chloroquine that was the Bayer product that had been donated from Pakistan...
https://www.whitehouse.gov/briefings-statements/remarks-president-trump-roundtable-discussion-fighting-americas-seniors/
16 Jun: Livemint: Press Trust of India: Doctors can still prescribe HCQ to patients, says US health Secretary
Doctors can still prescribe anti-malarial drug hydroxychloroquine to patients, US Health Secretary Alex Azar said, hours after the FDA withdrew the emergency use authorisation of chloroquine and HCQ in the treatment of COVID 19 patients...
“At this point, hydroxychloroquine (HCQ) and chloroquine are just like any other approved drug in the United States. They may be used in hospital, they may be used in out-patient, they may be used at home, all subject to a doctor’s prescription,” Azar said.
“In fact, the FDA’s removal of the Emergency Use Authorization takes away what had been a significant misunderstanding by many that had made people think that somehow it could only be used in a hospital setting, and we’ve tried to make that clear throughout,” he said in response to a question.
During a White House media appearance with President Donald Trump, Azar asserted that HCQ was approved in the United States.
“If a doctor wishes to prescribe it, working with a patient, they may prescribe it for any purpose that they wish to do so. And, this (FDA’s decision) actually removes a potential barrier to them,” the health secretary said...
Azar described the media interpretation of 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 hospitalised, they took that restriction off. They took the Emergency Use Authorization off,” he said.
Azar asserted that FDA said 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 added.
https://www.livemint.com/news/world/doctors-can-still-prescribe-hcq-to-patients-says-us-health-secretary-11592273755247.html