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To: Jim Noble

RE: Hydroxychloroquine is an FDA-approved drug already.

Not really. FDA’s stance is this -— Hydroxychloroquine has shown some promise against the coronavirus in a very small French study, but it is not federally approved to treat the COVID-19 because no official studies have been conducted to determine whether it’s both safe and effective for those sick patients.

SEE HERE:

https://www.modernhealthcare.com/politics-policy/trump-wrongly-claims-fda-approved-covid-19-drug

(EXCERPT)

But FDA Commissioner Dr. Stephen Hahn walked back Trump’s remarks minutes later, clarifying that the FDA will conduct a clinical trial to determine whether chloroquine is a safe and effective coronavirus treatment and at what dosage.

“That’s a drug that the president has directed us to take a closer look at,” Hahn said. “We want to do that in the setting of a clinical trial, a large pragmatic clinical trial to actually gather that information and answer the question that needs to be answered.”


61 posted on 03/22/2020 9:13:53 AM PDT by SeekAndFind (look at Michigan, it will)
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To: SeekAndFind

There is much in print.
However Faci walked it back at the last press conference & said he was sorry his words had been interpreted that way. Millions of does are on the way to NY. Why would that be if they were not going to be used.


69 posted on 03/22/2020 9:16:16 AM PDT by JayGalt (You can't teach a donkey how to tap dance. Nemo me impune lacessit!)
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To: SeekAndFind
RE: Hydroxychloroquine is an FDA-approved drug already. Not really

Yes really.

You continue to mix up "approval" with "adding an indication".

Any doctor can prescribe any approved drug. No doctor can prescribe an unapproved drug.

The reason everyone is prescribing hydroxychloroquine and most patients are on it is BECAUSE it is an approved drug.

The FDA does not "approve" drugs to treat specific diseases. They issue a declaration that a drug has been PROVEN "safe and effective" for a specific disease, this process is codified in statutory law and NOBODY can deviate from it without a change in the law.

85 posted on 03/22/2020 9:32:03 AM PDT by Jim Noble (There is nothing racist in stating plainly what most people already know)
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