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To: lulu16; PA Engineer
I believe you will find that the FDA regulations with regard to off-label use are extremely squishy, and as long as they are not advertising or promoting a drug for off-label use, and as long as the use of the drug cannot cause a worse medical outcome that some other treatment [including non-treatment] doctors can pretty much prescribe off label and get away with it.

I think all of the criteria allowing an MD to escape from prosecution under 21 CFR [The part of the Code of Federal Regulations concerning FDA regulation of off-use, clinical trials, drug promotion, marketing, etc, etc.] are pretty well satisfied by antiviral drugs used in treating Ebola patients.

Anyway, unlike 0bama's mythical foot-choppers, every Doc I've ever known would be willing to do anything they could possibly do to save a patient, and damn the regulations.

Does it work? Only one way to really find out...

45 posted on 10/11/2014 4:50:12 PM PDT by FredZarguna (His first name is 'Unarmed,' and his given middle name is 'Teenager.')
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To: FredZarguna
I believe you will find that the FDA regulations with regard to off-label use are extremely squishy, and as long as they are not advertising or promoting a drug for off-label use, and as long as the use of the drug cannot cause a worse medical outcome that some other treatment [including non-treatment] doctors can pretty much prescribe off label and get away with it.

I agree, however the last two years have been particularly chilling to drug companies and doctors alike. First hand experience, their message is getting out and having an effect. Enforcement is happening in both prescription writing as well as medical lecture audits.
54 posted on 10/11/2014 5:27:52 PM PDT by PA Engineer (Liberate America from the Occupation Media.)
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