On-label vs. off-label | BrightSci


so you went to the doctor and the doctor
said no more jumping or maybe they just gave you a prescription but if you’re an
American there’s a greater than a one in five chance that you’ve just been
prescribed that drug off-label what does off-label mean well if the FDA
has approved the drug you’re using for your specific condition then it’s on
label if it’s approved the drug for condition a but you’re using it for
condition B then it’s off level why would you prescribe something off-label
in the first place let’s talk about drugs every drug that is legal to use in
the United States gone through an approval process via the FDA the Food
and Drug Administration but it’s thankfully not the case that drug
companies can just rock up to the FDA and say hi guys we’ve got a great new
drug we want to put on the market and you should have proved it for everything
it currently takes about 12 years for a drug to go from conception to shelf and
that includes an average of three and a half years of lab testing before the
drug company can even apply to the FDA for approval to test in humans there are
then three phases of human trials phase one using healthy volunteers fairs two
using patient volunteers and phase three a larger scale study using patients at
clinics and hospitals and only then can the company submit the drug to the FDA
for final approval if final approval is granted the drug
becomes legal for physicians to prescribe but and it’s big but the drug
has only technically been approved for the conditions for which it has been
tested those phase two and phase three studies we mentioned yes they form the
basis of a drugs approved uses medication comes with a label and a
packaging insert what to tell you the drugs approved indications or on label
uses that is what the FDA has said they think the drug is good for so if a
person has a sprained their ankle and then swollen and it hurts and they take
ibuprofen for it that’s a non label use off-label use is when you use a drug in
spite of the fact that it hasn’t technically been studied for your
condition or for your age group off-label use also covers when you make
up a drug in a different formulation like in liquid form for people who can’t
swallow pills now there’s nothing necessarily wrong with off-label use of
drugs over-the-counter medications are used off-label all the time but it does
come with some extra risks because there haven’t actually been any studies done
to say that the drug works for your condition or doesn’t actually make it
worse in the long run but if you for example have a condition which doesn’t
get a lot of research funding and the drug that you’re prescribed has been
to alleviate some of the symptoms that you’re experiencing might as well give
it a whirl that’s the theory anyway but while off-label prescribing is fine
with the FDA off-label marketing is not off-label marketing is when a company
has a drug which is approved for use in condition a but then they start telling
people that hey you can also use it for condition Bane it’s really good for that
too off-label marketing is illegal but that doesn’t stop drug companies even
paying tens or hundreds of millions of dollars in fines doesn’t stop them
off-label marketing is such a money spinner that the risks are generally
worth the rewards the thing is the drug approval process is necessarily long and
involved and expensive so drug companies figure well if the drugs already
approved and itthere may as well get as much money out of it as we can this is
the first in a series on drugs thanks as always to my patrons for their support
and if anyone would like to suggest an episode topic you can do so down in the
comments oh and if you liked this video and want to see more you should hit the
subscribe button and also ring that bell see you next time

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5 thoughts on “On-label vs. off-label | BrightSci

  1. How about marketing to patients (as in the US) vs marketing to GPs (as in the UK) of prescription drugs, since you kind of touched on the vicinity with your comment about marketing off label being illegal in the US?

  2. Thankfully, research for a new use is far quicker than research for an entirely new drug. You really only need Phase II and III. How about a video on refeeding syndrome? We've both had cats who undertook a Hero's Journey, and apparently it's dangerous to start feeding them normally from the moment they get home.

  3. Hey, this channel is great, nobody else is explaining socially relevant scientific concepts like this. I see this was posted 4 months ago but I hope you haven't given up on this channel!

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