>> So, this is what I think is fun. And I was going to bring
>> Commercials? >> A journal ad for you.
Oh, I love the Yaz commercial, I should have done that.
>> I know. Gotta go.
Gotta go. That's my favorite commercial of all
time. [LAUGH] So, what is drug promotion.
So a drug is anything [LAUGH] that you have to consider a drug is anything that
can mitigate, cure, treat, prevent. A, an illness or a disease in an animal
or a human. >> If I'm Cialis, I have a bathtub.
>> Well that's, I know. [LAUGH] Right, and if you are, if you
are. If you are the.
>> [LAUGH] All I can think of is the nut cereal, because that's what my son
calls it. Honey Nut Cheerios.
And do you guys ever see the Honey Nut Cheerios, how we lower your cholesterol?
>> Yeah. >> That got a warning letter.
>> Thank goodness. >> It got a warning letter.
Because that is acting as, well, you know, you think the cereal's not a drug.
But the cereal is saying I help prevent, I help reduce your cholesterol.
So, it is saying that it now treats. And because it treats, it is now a drug,
and it has violated the way that you can promote, because it doesn't have
substantial evidence to say that, and it received a warning letter.
And with a warning letter, it goes to the CEO of the company, and there's all these
financial things of what you have to bring back and pay.
And, and DA's office begin investigations for you guys, once, once a warning letter
has gone out, it gets pretty. [CROSSTALK]
>> So the honeybee was sorry. [LAUGH]
>> So the what? >> The honeybee was sorry.
>> The honeybee was sorry. [LAUGH] For multiple reasons.
But anyway, drug promotion is any way you want to get your drug out there.
Any information that you want to get out to the public, out to a physician, out to
anybody about your drug, that ends up relating to being, and that is drug
promotion. >> But what if I have you guys go to
the doctors' offices and you see those little leave behind pamphlet things
stacked all over? >> Oh yeah, that's promotion.
>> That's just educational. That's how, how come that's promotional?
It's educational. >> Oh no, but you're giving education
about a drug. And because you're giving education about
a drug, then that is promotion. You are trying to figure out a way to
increase the, to increase the knowledge about your drug, increase the use about
your drug, increase how people will differentiate your drug from someone
else. Or increase the knowledge of how you
would pay for your drug. Any of those classifications is a drug.
>> But what if it just says that I work on erectile dysfunction?
And it doesn't say a brand name? >> Well, if you work on erectile
dysfunction and it has a bathtub, everybody knows that the bathtub is
Cialis, so that is talking about your product.
So it all depends. And those are all the intricacies of the
labeling and of drug promotion. So when you look at it.
Whenever you look at a product, this is actually from the FDA website, by the
way. To teach people how, what, what are the
requirements for drug labeling. You always have to have the drug name.
And the generic name. And the generic name now actually has to
be half the size. And you have to mention on any one page
that you have and in running text at least one page in the same size, and
there's all these different rules about that.
You have to say what the indication is. You always have to say what the
indication is. So, there it is.
Prescription medication, it helps you with allergies.
You always have to say what side-effects happen with a drug.
And it has to be in comparable prominence, or equally representative of
what the good things are. You have to balance.
You have to tell me the good things, you have to tell me the bad things.
>> Can't I make the font half the size so you can't read it?
>> Well then that would be a little misleading, now wouldn't it.
so here it is. And then you have to tell them how to
report side effects and those are the main types of things that you need.
You have to give them balance. So.
That's the fun kind of thing about promotion, if you do it well.
I like investigating the different things and figuring out all the, the, rules of
what you can and can't do. but that's, that's what is interesting
about it. And there's, the so when you look at all
of that there's, there's ways to balance it, and, and there's ways to communicate
all of that data. And when you do not do it appropriately,
then it results in well love notes. If the FDA wants to, I'll show you this
one first. Oh, there, if the FDA wants to just
kindly tell you that. Or a untitled letter is what they call it
when you need to change something, but it's sent just to you, or a warning
letter. So, those happen any time you try to
communicate any information about your product that makes it that you can use
your product in a larger patient population.
Then you'd been approved. So if you say that you can be used in
pediatrics when pediatrics haven't been specifically studied.
If you say that you can be used in depression, as opposed to saying oh, what
are types of, oh I'll just do diabetes. You can be used in diabetes instead of
type one diabetes. Those are expanding your indication, so
you can't say that. If you don't give all of the risks of
your product, and don't present it then that is a violation.
And you haven't shown the information appropriately.
So, in essence what you're having to show is everything to a physician or a
healthcare provider, in order for them to be able to make a balanced decision.
About whether or not to use the product. And when you are talking to a patient,
you're supposed to be, if it goes through an intermediary like a physician or, it's
a little bit different. But in essence what you're having to do
is to give them the same type of information.
They need to know the positive things of what's going to happen and they need to
know the negative things. >> Katie what if I
>> So they can balance that. >> What if I'm a doctor at a dinner
program that's paid by Norvartis, and maybe I, I understate the side effects.
Can I, as a licensed practicing physician, be held accountable?
>> Yes. So the question is, is if you can be in
trouble when you are speaking on behalf of a pharmaceutical company, according to
the FDA, anybody that is acting as an agent of the company.
Now, an agent of the company is a pharmaceutical rep, who actually pays, is
paid to promote the product. an agent of the company is someone in
medical affairs like Kelly who is setting up the phase three trials.
agent of the company is someone in-house who's actually in research and
development. An agent of the company is an
investigator, who is running the trials. An agent of the company is a speaker when
they are there speaking for the company. If they are speaking about that product,
and they do not communicate all of the side effects that they're supposed to and
the way that they're supposed to do it, then they can be held liable.
Just, and get a warning letter from the FDA.
Just like they can get a warning letter, if they do not enroll the patients
appropriately. Into their trial.
So it is something that does actually effect the pharmaceutical company as much
as any person who helps to speak on their behalf.