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Can The President Override The FDA In Emergencies?
Canada Free Press ^ | O3/23/20 | Kelly O'Connell

Posted on 03/23/2020 11:59:01 AM PDT by Sean_Anthony

President Trump, in an epic crisis, must quickly determine if an already approved drug is available

”I want a new drug,” said Huey Lewis. But Americans increasingly demand an older medicine, Hydroxychloroquine, while coronavirus enfeebles victims across America. ‘Chloroquine’ is one of the oldest and best-known anti-malarial drugs and appears effective against COVID-19. President Trump advocates chloroquine. Since the drug is US Food and Drug Administration approved for humans, and effective in China, why not offer it to Americans? Because it is not approved for use outside malaria. Wait. What?!!


TOPICS: Government; Health/Medicine; Politics; Society
KEYWORDS: coronavirus; fda; pandemic; presidenttrump
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1 posted on 03/23/2020 11:59:01 AM PDT by Sean_Anthony
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To: Sean_Anthony

Are U kidding? He’s the CEO. He would be risking accusations; but he gets those anyway.


2 posted on 03/23/2020 12:00:47 PM PDT by Migraine (hi)
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To: Sean_Anthony

Who reports to who?
The FDA reports to the POTUS.


3 posted on 03/23/2020 12:02:33 PM PDT by BuffaloJack ("Security does not exist in nature. Everything has risk." Henry Savage)
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To: Sean_Anthony

It’s being used, starting Tuesday in NY.


4 posted on 03/23/2020 12:06:43 PM PDT by AU72
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To: Sean_Anthony

My PCP ordered it for me “in case” last week as I live n a small barrier island. ( in US). Off label use is legal...


5 posted on 03/23/2020 12:08:50 PM PDT by R.I.chopper
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To: Sean_Anthony
The amount of confusion on this issue seems nearly unlimited.

Doctors in the USA have the legal right to prescribe any FDA approved drug for any purpose. Doctors do not need the FDA's permission to prescribe one of the anti-malarial drugs in combination with an azithromycin.

Of course doctors use their professional knowledge, and rely on research results from other doctors and scientists, and their choice of medication is based on their knowledge, experience, and inputs from other clinicians. Right now there are very encouraging results from a small clinical study run by some of the foremost virologists in France, along with other studies from China and elsewhere.

Doctors fighting COVID-19 infections are very likely to be using an anti-malarial in combination with azithromycin for patients that have serious cases. That strategy has already become the standard of care in some other countries.

6 posted on 03/23/2020 12:08:56 PM PDT by freeandfreezing
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To: Sean_Anthony

These agencies don’t answer to anybody,they are fiefdoms


7 posted on 03/23/2020 12:14:21 PM PDT by ballplayer (By)
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To: Sean_Anthony

the medicine is available for any American physician wishing to prescribe it for this new Virus or any other condition for which the doctor believes the medicine will help


8 posted on 03/23/2020 12:17:26 PM PDT by faithhopecharity ("Politicians are not born, they are excreted." Marcus Tullius Cicero (106 to 43 BCE))
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To: Sean_Anthony

I bet if nancy or chuck, or anyone in the upper tiers of our government, got the coronavirus they would have no problem getting ‘Chloroquine’ and of course the other one Zpack.


9 posted on 03/23/2020 12:19:34 PM PDT by Leep (Everyday is Trump Day!)
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To: freeandfreezing
Doctors fighting COVID-19 infections are very likely to be using an anti-malarial in combination with azithromycin for patients that have serious cases. That strategy has already become the standard of care in some other countries.

I agree. I'd love to see rolling compiled data on how these patients, particularly American ones, have responded. The scripts are tracked, the patients' progress is tracked, so let's put those together and see the "anecdotal" results.
10 posted on 03/23/2020 12:25:26 PM PDT by mmichaels1970
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To: ballplayer
These agencies don’t answer to anybody,they are fiefdoms

Not when a Democrat is president, then they are his or her personal property and can be used for political purposes or to enrich family "foundations" without any consequences at all.

11 posted on 03/23/2020 12:30:38 PM PDT by Steely Tom ([Seth Rich] == [the Democrats' John Dean])
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To: Leep
People are walking out of the hospitals and will be in droves next 7-10 days because of this therapy. On the ground this is turning into a seasonal flu nothing burger. You get sick, doc calls in this cocktail, you stay home, catch up on Netflix and in 3-5 days you are back to work. Sure some 85 year old with lung disease or a 32 year old on chemo, may die. But they were going to anyway this year, of the flu or a cold.

But the MSM will only report number\deaths\charts\graphs. They want Biden and student loan forgiveness,etc. and totalitarianism. Won't work,Trump is handling it, he's Churchill right now.

12 posted on 03/23/2020 12:33:56 PM PDT by pburgh01 (Negan all the MSM)
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To: Sean_Anthony

He can. But the doctors will probably stick to what the FDA says and not incur the additional liability.


13 posted on 03/23/2020 12:34:45 PM PDT by discostu (I know that's a bummer baby, but it's got precious little to do with me)
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To: Sean_Anthony

Can blog stumps override spam in emergency spam shortages?


14 posted on 03/23/2020 12:35:37 PM PDT by Larry Lucido
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To: Sean_Anthony; All

An elected official better be able to override non-elected bureaucrats.


15 posted on 03/23/2020 12:35:41 PM PDT by Amendment10
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To: discostu

So your wife is in the ICU, struggling to breathe, you suggest an off label approved therapy which you personally sign off on and the doctor will still refuse to prescribe with almost 0% malpractice liability.. Umm not likely doomer. Doomer logic = Everything is doom, no saving from the doom, we are doomed, economy doomed, no cure doomed.

16 posted on 03/23/2020 12:39:44 PM PDT by pburgh01 (Negan all the MSM)
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To: Sean_Anthony

Of course


17 posted on 03/23/2020 12:47:17 PM PDT by DesertRhino (Dog is man's best friend, and moslems hate dogs. Add that up. ....)
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To: Sean_Anthony

Problem solved, just have the Doctor report the patient has malaria, and administer the medication.


18 posted on 03/23/2020 12:51:55 PM PDT by cabbieguy ("I suppose it will all make sense when we grow up"can't be counted)
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To: freeandfreezing
You are correct...well stated.

The author of the article is misinformed and providing bad info. FYI:

When a doctor prescribes an FDA approved for an illness that is not the illness the drug was approved for, then this "off label." Here's a link that explains "off label".

Off Label

In addition to "off label", there are 3 more categories that should be explained: Investigational Drugs; Expanded Access (Compassionate use); and Right to Try.

Links below explain.

Investigational Drugs

Expanded Access

Right to Try

19 posted on 03/23/2020 12:53:09 PM PDT by FtrPilot
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To: pburgh01

I see you’ve never argued with a doctor before. They are NOT covered on malpractice just because I insisted. Not without a killer paper trail, including a medical power of attorney. And even then, you can still sue and the process of going through the suit, even if they win, will cost the doctor a ton of money. Nothing doom about it. I’ve seen doctors refuse to go off the script before. I never said anything was doomed. I just pointed out that doctors do not like going against FDA recommendations. Mostly because their malpractice insurance company usually denies coverage when they do and things go wrong. That’s the world we live in.


20 posted on 03/23/2020 12:56:10 PM PDT by discostu (I know that's a bummer baby, but it's got precious little to do with me)
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