The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Development course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug development. In this course you will learn the different stages of clinical development as well as the regulatory including but not limited to, an Investigational New Drug Application (IND), New Drug Application (NDA), and product labeling. Additionally you will learn how to Incorporate study design methods for consideration in the design of clinical protocols to assess safety, tolerability, and efficacy in multiple therapeutic areas. In this course you will learn the different phases of clinical development: * Phase 1 or early stage clinical trial are conducted primarily to determine how the new drug works in humans, its safety profile and to predict its dosage range. It typically involves between 30 and 100 healthy volunteers. * Phase 2 or Proof of Concept POC studies test for efficacy as well as safety and side effects in a group of between 30 to 200 hundred patients with the disease for which the new drug is being developed. * Phase 3 or late stage clinical development involve much larger group of patients, between a few hundred to thousands, depending on the indication, which will help determine if the new drug can be considered both safe and effective. It will involve control groups using placebo and/or current treatment as a comparison. * Product registration and approval process after a drug is considered safe and effective from Phase 3 trials, it must be authorized in each individual country before it can be marketed. All data generated about the small molecule or biologic is collected and submitted to the regulatory authorities in the US at the FDA, Food and Drug Administration FDA, in Europe the EMA or European Medicines Agency, Japan Ministry of Health and other countries which may require their own national approvals. This course is intended as part 2 of a series: Drug Discovery (https://www.coursera.org/learn/drug-discovery), Drug Development and Drug Commercialization (https://www.coursera.org/learn/drug-commercialization). We would highly recommend that you take the courses in order since it will give you a better understanding on how a drug is discovered in the lab before being tested in clinical trials and then launched in the market place.
New Drug Application, Filing, Product Labeling V
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Del curso dictado por University of California San Diego
Drug Development
183 calificaciones
De la lección
New Drug Application, Filing, Product Labeling, Kelly Hogan, Pharm.D.
Conoce a los instructores
Williams S. Ettouati, Pharm.D.Director, Industrial Relations & Development; Health Sciences Associate Clinical Professor, N.S.
Skaggs School of Pharmacy and Pharmaceutical Sciences
Joseph D. MaAssociate Professor of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Sciences
>> 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.
And really, does it matter? This, this is just of July 2012.
So, there's even more settlement. So, one of the things that you see is the
behaviors of what happens. There is accountability.
And remember I said that the attorneys generals begin looking at the effects and
what's going on. So, a major event happened in 2004, when
Depakote had been, being talked to, to physicians about how to use it with
seizures. Right?
>> That's right. >> Neurontin.
This is the Neurontin case, and that was actually how the Medical Affairs
Department was communicating data. It wasn't even sales reps.
It was how they were talking to medical >> was it me?
>> The medical affairs department. Not you, I know you weren't at the
company. >> No, it was me.
It was my part of the company. >> But it was your, your part of the
company. Or physicians, how they talk to
physicians at advisory boards. And that resulted in a 500, 460, but in
essence almost $500 million settlement. Now, since then, the settlements are
getting typically a bit larger. The largest settlement to date is over $3
billion dollars. B, billion.
for GSK, that they settled in recently. and those behaviours, one of the things
to keep in mind, what GSK got in trouble for was some of the stuff that their
medical department was doing or, their ad boards that they were doing.
You know, what their sales reps were doing in 2001.
So, the stuff that goes on leads, [LAUGH], so you really have to think
ethically, what is going on and what are the appropriate decisions to be made?
And they're being held accountable, pharmaceutical companies are being held
accountable. Now, you can be also very cynical and say
yeah, but then they develop the marketing and their strategies in order to account
for that, so they can write the check. So it depends on how cynical you want to
be, but if you look at a settlement of that, $3 billion?
Most drugs don't really bring in $3 billion.
>> Mm-hm. >> Over the two billion that we already
had to sell in order to get the drug to market, right?
I mean there's not a lot of blockbuster drugs anymore out there.
And so that's something to really kind of keep in mind.
And the FDA is asking for assistance and help in trying to really kind of tag and
recognize when, when inappropriate kind of marketing is taking place, so that
they can use these.
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