Well, welcome back to another episode of Your
Mom on Drugs. We are so happy to have you here.
My name is Josh, the son. and i'm jennifer the
mom yes the mom on drugs professor of pharmacy
or former professor of pharmacy now retired and
i have roped her into doing many podcast episodes
to keep her and my mind sharp uh so this is number
15 that we're doing today and it's an interesting
topic it's one that came to my radar um, via
a friend of mine, we're going to do it on pharmaceutical
manufacturing, which I promise is more interesting
than it sounds because it's essentially where
do drugs come from? Um, I had a friend who went
to a party one time and this was around the buzz
when, um, things like semaglutides or semaglutides,
um, things like Wegovi, um, Ozempic were really
in the buzz. They probably still are. Um, and
She was talking about it, and this guy that she
was talking to was like, oh, I know a guy who
can get you some, almost like a drug dealer.
And she said yes. And so she got these drugs
from this guy, and she took them in a way that
is not recommended by the mechanism that is laid
out by the companies. And if you could go back
in our catalog and look at our episode on GLP
-1 agonists, and you'll understand why. taking
it all at once is not a good idea. But I was
so amazed at one, that you could get these things
just at a party. And then two, the willingness
to take them because they were cheaper. And three,
it just made me think, man, where do drugs come
from? And why is it so important to really know
where your drugs are coming from and how they're
being manufactured? So I turned to my mom on
drugs and I said, We should do this episode and
I would really love for you to educate me and
our listeners on the drug manufacturing process.
So Dr. Seltzer, would you like to go into an
overview of where drugs come from? Okay. Yes,
I'd love to. I by no means am an expert on the
topic, but I definitely have known about it by
being a pharmacist and then diving into this
gave me a lot more information. And we're going
to compare. pharmaceutical manufacturing versus
compound pharmacies, which is a little bit, they're
two different entities. So let me start out with
pharmaceutical manufacturing. So the pharmaceutical
industry is referring to the area of business
that's devoted to the design and development
and manufacture of chemical products that are
used in diagnosing and treating disease, disability,
or some other dysfunction, or they can improve
function. And pharmaceutical manufacturing is
incorporated into that pharmaceutical industry.
Pharmaceutical companies can be public or private.
And one of the key differences between pharmaceutical
companies is that they may create either basic
pharmaceuticals or they can create biopharmaceuticals.
Regular pharmaceuticals are products that come
from chemicals and synthetic compounds, whereas
bio... biopharmaceuticals are biologics that
are derived from living material and they can
be a whole host of things such as the vaccines,
therapeutic proteins, blood and blood components,
tissues, and they are larger molecules and more
complex to make. And the regular pharmaceutical
products are more, are easier to chemically synthesize.
We're not going to spend, we're not going to,
go through a whole host of like the differences
between pharmaceuticals and biopharmaceuticals
but i just wanted the our audience to know that
that that the pharmaceutical manufacturing industry
is is large yeah so if you're making something
like um ibuprofen versus you're making something
like you know plasma you know or i guess you
can't make plasma but you can definitely process
it in a way then you have different areas and
what you're doing that That makes a lot of sense.
Some of the monoclonal antibody type medications
that are available, like Prolia, I have to take
it for osteoporosis. So it's going to be a little
bit more of a complicated medication and obviously
more expensive because of that mechanism. Okay.
That makes a lot of sense. Pharmaceutical manufacturing
is part, like I said, of the pharmaceutical industry,
and it's responsible for manufacturing medicinal
drugs in both small quantities as well as in
larger quantities. One of the key... focuses
of the pharmaceutical manufacturing industry
is stringent safety and quality regulatory standards.
So that really sets them apart from compounding
pharmacies, which we'll get to in just a few
moments. A pharmaceutical manufacturing plant
makes active pharmaceutical ingredients, and
it also can assemble active ingredients into
a final product. So that all encompasses pharmaceutical
manufacturing. Yeah. For our listeners, can you
let them know what an active ingredient is? Active
ingredients are going to be the thing in a medication
that's going to do the work. So the ibuprofen
in your Advil, the active ingredient in Eliquis,
which is a blood thinner. Rosuvastatin and Crestor,
those active ingredients are the ones that are
going to cause your cholesterol to lower or your
blood pressure to lower or your blood to be thin.
There are inactive ingredients in those agents
as well too that may help to bind them together
or to solubilize them. But those are not the
ones that are going to, those parts of the tablet
or the capsule are not the... part of that agent
that causes the actual activity. That makes sense.
It's like when I drink a cup of coffee, there's
a lot of things in a cup of coffee that could
help make it the color brown, maybe promote its
acidity, but the active ingredient caffeine is
what's giving me that sense of being alert and
lack of being tired. Yes. Okay. Yes. We're going
to talk about this a little bit more. This will
become a little clearer once we get into compounding
pharmacies, but pharmaceutical manufacturing
companies are typically what we call a 503b outsourcing
facility. So they are manufacturing medications.
They can be sterile medications or intravenous
products and subcutaneous products, as well as
oral, topical. sublingual, all of those types
of products, they make them in larger amounts.
And the pharmaceutical manufacturing companies
are registered with the Food and Drug Administration,
our United States Food and Drug Administration.
Interestingly, when you think about it, they
make these large bulk supplies of medications.
There's no specific patient prescription that
is assigned to that order. They distribute these
medications to pharmacies, warehouses, physician's
offices, and then the prescription comes so that
the agent can be dispensed at that point. Interesting.
So the provider, either the doctor or medical
professional, will essentially be the go -between
between the pharmaceutical manufacturer who sends
that drug out, and then you have the patient
who then will need a prescription for that drug,
and then based on the evidence or the... expertise
of that medical practitioner, then they will
be given that drug. That's correct. Okay. That's
correct. The pharmaceutical manufacturing process
is very involved. There are really five key stages
to it, but they're Each one of them is involved.
They're broken down into research and development.
And in research and development, the nickname
of it is R &D. People may have heard R &D. That's
where the scientists are going to develop new
drugs. They're going to contest. conduct testing.
Maybe they develop a new dosage form. And they
are also going to be performing clinical trials,
animal studies on these agents to make sure they're
safe and effective. So that can take a number
of months, years, depending on what the agent
is. The formulation step is the next stage in
the pharmaceutical manufacturing process. And
so this is where investigators are or employees
of the pharmaceutical company are trying to figure
out how to combine the drug's active ingredients
with other raw materials to make it an effective
product as well as a stable one. In the third
step or the third stage, we have production.
So you've got the medications being manufactured
in bulk and you are following specific guidelines
and quality assurance, quality control measures.
to make sure that these agents are manufactured
consistently and that they will all be very comparable.
Quality control is the fourth stage in the pharmaceutical
manufacturing process. Again, you're looking
that every single stage goes into rigorous testing
to ensure that it is... quality and has efficacy
and safety. So you can't bypass those steps.
They are all steps to make sure that then the
FDA can put their stamp of approval on that particular
medication when it gets approved. And then the
fifth stage is packaging and distribution. So
you've got research and development, formulation,
production, quality control, and packaging and
distribution. Okay. Yeah. I mean, I think it's
amazing how you said all those steps in like
a minute or two, but like you said, this can
be a decade long process depending on the drug.
I think especially let's gloss over stage, like
the step one, which is just making sure that
it's safe. We've talked about clinical trials
a lot on this podcast, but phase one, phase two,
phase three, like phase one is just making sure
that it's safe in animals and just making sure
that when you give it. to an organism that there's
no adverse effects. And then obviously you work
yourself up to humans to make sure there's an
appropriate dose. And then you make sure it does
what you say it's going to do. And that can take
time. I mean, it can take years sometimes. Scientists
aren't cheap. You know, like you have to hire
them for multiple years and then you have to
get the patient population to be able to test
them. So this is a very involved process in every
step of the way. And again, this is all to get
FDA approval, correct? Right. Because obviously
there are drugs out there. We call them supplements.
Essentially, they can be sold into the market
and they can make claims, but they're not backed
up by the FDA. So there's obviously a lot of
people making claims. But this whole process
to make sure, are you actually backing up what
you're really saying? And this is a relatively
new concept, especially in the 20th century,
which is kind of crazy to me. And we're going
to talk about some of those examples. But the
idea that you actually have to show what you
actually mean is actually it is it's such a new
and actually a wonderful thing that we do. And
it obviously means that these drugs can be very
expensive. But by all these steps, not just the
safety in the clinical trials, but also making
sure that. Your manufacturing processes are super
controlled. When you say that you're getting
10 milligrams of acetaminophen, you really know
that you're getting 10 milligrams of acetaminophen
rather than this huge ballpark figure. So just
want to let people know, even though these steps
kind of seem like a cookbook, this can literally
take years. Each step, yes. Because I worked
for a college of pharmacy, I don't know if our
audience realizes that Schools of pharmacy, schools
of medicine have researchers that work on developing
new medications or new dosage forms. And so there
were scientists that worked within the College
of Pharmacy that had relationships with pharmaceutical
manufacturers to help them with that process.
And you have that all over the country and stuff.
I mean, they've got their own internal scientists,
but they do work with colleges as well, too,
universities as well, too. Pharmaceutical development
process, as Josh mentioned, is very involved.
So the purpose of pharmaceutical development
is to design a quality drug product that uses
a manufacturing process that provides consistent
drug process performance. And the environment
in where it's being processed is stable. And
the therapeutic objective is also stable. So
each step. there are quality assurance and quality
control measures. And so you want to make sure
that you've got scientific, sound scientific
principles used throughout the process, that
you have studies that you're depending on that
are showing relevant and positive results. That
means not only does the active ingredient work,
but... Is the product stable in the dosage form
that you've decided to create as well too? So
that's also part of the study process. Is it
safe? Can you replicate this medication without
a lot of variability between the different individual
tablets or capsules or intravenous solutions?
That's all part of this quality assurance, quality
control. pharmaceutical development process which
can take like josh said a long time so yeah you
might have seen on one of your drug bottles like
expired by and they have a date in which the
drug it's not technically despires but it loses
its potency and its ability to actually you know
to guarantee to do what it's meant to do um and
they actually you know stress test it they'll
put it under conditions quote unquote like you
know increased temperature increased pressure
and like, because you have to think about it.
These drugs are going everywhere. They're not
just going to be in the laboratory. They're going
to be here in Texas where it's hot and muggy.
They're going to your mailbox, your mailbox.
So like you want a drug that if it's getting
shipped to you or to your pharmacy, that it'll
survive that plane or truck ride across the country,
you know, to your place. And then it can be guaranteed
to work. So they have to do these tests there
too. So there's a lot of like guarantees that
a lot of these. drugs are trying to deliver and
they have to go through, like my mom said, stringent
testing to make sure that they're actually done.
Right. So in order to get a medication approved
by the United States Food and Drug Administration.
A pharmaceutical company or an individual, but
most likely a pharmaceutical company, needs to
submit what we call a new drug application. They're
very involved applications. They include clinical
trial data, animal data, stability data. It is
the document that needs to be submitted. to propose
to the FDA that you have a medication that you
think that they should approve. And the goals
of the new drug application are to determine
whether a drug is safe and effective in its proposed
use. So you will notice that on the package insert
that there may be like one or two indications.
That's because they've gone through this rigorous
assessment process. Now, I know you'll come back
at me and say, well, my doctor is giving me this
drug for X. How about this? I'm getting an antidepressant
to treat my migraine headaches and it's not listed
on the package insert as an indication, but after
drugs are approved, there can be some clinical
trials and there's some off -label uses as well
too, but we're really not talking about that
right now. I mean, we could even talk about,
I mean, that's essentially how things like. ozembek
and way govi were that's true for me right it's
like they were they were a type two diabetes
drug. Right. And then they figured out, oh, we
can actually use this for weight loss. Right.
And so you could, they're prescribed under different
names. I'm trying to remember the name for. Ozempic
is the diabetes medication and Wagovi is the
weight loss. Exact same drug, but they just have
a different name. They're a little bit different
dosages, but yeah, they're, yeah. So it's the
same chemical compound. Yes. Yes. We find out,
I mean, Viagra is the same as well, you know.
Or, yeah. Or finasteride. Finasteride is a great
example as well, too. It's FDA, although I think
it carries the both indications, but it was originally
created for enlarged prostate in men. And then
it was determined that it can also help with
hair growth. Yeah, amazing. So, yeah. So you
were looking for it to be safe and effective
as well as whether the benefits outweigh the
risks. Now, most medications are going to have
an adverse effect associated with it, but can
we tolerate them for the most part? You want
to make sure too, when you're going through this
new drug application process, that the drug's
proposed labeling is appropriate, that it's not
labeled in a way that's misleading or false.
And then also the labeling has to tell you what's
in the medication. So that's important as well.
I read that 25 % of all drug recalls were due
to mislabeling. So essentially they didn't. claim
to have what they said that they did on the label
yeah so yeah labels can foods can be that way
as well too so yeah and then you want to make
sure also the this is the third uh The third
purpose of the new drug application is to make
sure that the methods that were used in drug
manufacturing and the controls that were used
to maintain the drug's quality are adequate and
they preserve the drug's identity, its strength,
and its quality as well as its purity. So it's
a very involved process. So when you get a medication
that is approved by the FDA, it has been through
a lot of rigorous testing. So you can have some
assurance that what they say the medication is
going to do, it's actually going to do. Other
things that are incorporated into the new drug
application are United States laws and regulations,
as well as policies and procedures. It's all
part of making sure that the drug is safe, effective,
and therapeutic. It's going to do what it says
it's going to do. Someone might say, why on earth
would you need to do this? And, you know, Josh
mentioned that this process of determining safety
and efficacy of medications is not that old.
It's really not. It's not even 100 years old.
In 1938, before 1938, we had what was called,
pardon me. Before 1938, we had what was called
the Pure Food and Drug Act, and it was created
in 1906, and it was approved by and signed into
effect by President Theodore Roosevelt. And the
target for that... That Pure Food and Drug Act
was primarily misbranding and adulteration, which
means that it could either be labeled incorrectly
for its use or it contains something that it
shouldn't contain for the efficacy that it was
proposed to have. Can I do an anecdote on that?
Of course you can. I can't remember the book
off the top of my head, but there was an author
who wrote this book basically. thanking everybody
in the supply chain for his cup of coffee and
it ended up being hundreds of people long because
there's just so many people involved with your
cup of coffee when you purchase it from a store
but one of the stories that he told was like
when coffee was just getting popular and it was
getting this huge demand i think in the 19th
century um people would be selling these coffee
beans But they would like fill them with other
things to basically bulk up the bean. Like it
would be like sawdust and sometimes even like
animal droppings to make it look like the color.
And like if you give people an inch, they'll
take a mile to make a buck because, you know,
we're all trying to make money out here. But
it's amazing what people will do just to trick
people into thinking they have this product and
obviously to sell it for cheaper. And so I'm
sure that this act was in response to things
like that. It was like, if I'm going to buy a
coffee bean, I want to make sure that it's an
actual full, robust coffee bean rather than coffee
being mixed with these other things that I don't
want. Absolutely. Absolutely. So in 1938, we
developed an updated version of that Pure Food
and Drug Act. And the reason that that happened
was Again, this Federal Food, Drug, and Cosmetic
Act of 1938, it's a series of laws that authorize
the FDA to oversee and regulate the production,
sale, and distribution of food, drugs, medical
devices, and cosmetics. So it goes over all of
those agents. And it protects the general population,
again, from adulteration and misbranding. So
you're wanting to make sure that what you get
in your medication is what's really there. that
this happened was that there was a mass poisoning
event in 1937. So there was an antibiotic called
sulfanilamide, and it was in tablet and powder
form, and it was used largely for pediatric infections
childhood you know ear infections maybe sinusitis
or whatever and stuff so stress and they treated
streptococcal infections a strep throat and things
like that so In June of that year, 1937, there
was a salesperson from the company that was making
the sulfanilamide that said that there had had
a greater demand for a liquid formulation of
sulfanilamide. If you've ever had a child and
trying to get the drug down them, the liquid
formulation is going to be better because they
can't swallow tablets early on. So they had a
researcher in their company figure out that the
sulfanilamide would dissolve in ethylene glycol.
And so they tested it for flavor, appearance,
and fragrance, and it all passed all of their
tests. They neglected, though, to test it for
toxicity. And so 100 people, I believe it was
over 100 people died in, I think it was 15 states,
because what... What diethylene glycol is, is
antifreeze. And it ends up having significant
damage to a person's body. It can cause kidney
failure. It can cause some brain effects. It
can cause coma. It can cause... you know, things
less serious than a coma, drowsiness, headaches,
but it can ultimately lead to death. So they
have over 600 bottles of this stuff that's been
distributed out into the United States. And so
they didn't have cell phones, computers back
then. So they have the Food and Drug Administration
as well as the employees of this company. going
out and seizing these bottles that they created
so no other people would die they had to go to
hotel rooms um mountain cabins because it was
just it was everywhere and stuff so this this
caused this act to start to this this federal
food drug and cosmetic act to be developed um
so that was an important thing um to to note
and stuff so but that that doesn't that doesn't
That wasn't necessarily enough. And as time went
on, so we've got more of a safety kind of aspect
of. drug inspection going on with this federal
food drug and cosmetic act but in 1962 we had
an additional amendment created called the kefauver
harris amendment and this was created in response
to there was a well i'm sure a lot of people
have heard of the thalidomide disaster thalidomide
was an agent it was actually created in germany
if i'm not mistaken and it was created the The
key indication was for insomnia, so I believe
it helped with sleep, but it also helped with
morning sickness in pregnant women. So it was
given to a lot of women in other countries, and
I believe that there were physicians in our...
in our country that did get some samples of it.
But we had a woman who was a researcher, a clinical
scientist who was not willing to put the stamp
of approval on this medication in the United
States because she didn't feel like there were
enough data. And she blocked it from coming into
the United States because this medication caused
significant birth defects and deaths in babies.
So it was not safe to use in pregnant women and
stuff. So with that came the development of this
Kefauver -Harris Amendment, which then made drugs
not only had to be proven safe, but they also
had to be proven effective. So we do see that
nowadays in our research process for new medications
as well. What a concept to actually prove that
something is safe and effective. I know. And
as we outlined earlier, like all the mechanisms
to do so and to think that, a company could just
be like, does it taste good? Does it smell good?
Can people tolerate it? And to not have to jump
to the hoops. And I would like to remind people,
we're going to get into compounding in a minute,
but also to talk about in the supplement space,
which we've talked about a lot. That's essentially
where we are. We're actually stuck in 1937 in
the supplement space where you can essentially
say, does it taste good? Does it claim to do
the same to do? No, but you can believe me if
you want to. So you essentially in the supplement
space, you have pre -1937 regulations. And then
with things that are regulated by the FDA, they're
more modern. I'm not saying that the FDA is perfect.
I'm not saying that pharmaceutical companies
are perfect. But when you compare the two alternatives,
one is clearly superior than the other. And it
would be much better if there was more tightly
regulated stuff so that we always knew what we
were getting so that some of these, you know,
side effects are not hidden by pharmaceutical
companies. And we should just all know what we're
taking and that it's safe and effective. And
the risks associated with it. Correct. Yeah.
And interestingly, too, when I was in pharmacy
school back in the late 70s, early 80s, and in
that time period, and maybe it was, oh, maybe
it was 2000 or so. where pharmaceutical manufacturing
companies ramped up the number of medications
that were created per year. Maybe it was before
that, but when I was in the late 70s, early 80s,
you may have gotten one new medication a month.
So as a pharmacist, you could know a lot about
all of the new medications that were created
per year. Well, now, I mean, you can have...
50, 100 new medications per year. And it's very
hard to keep up with the new ones. Plus, you
know, you've got more regulations and you're
trying to regulate more medications, more new
drug applications and all the paperwork as well,
too. So one of the things, again, this goes along
with pharmaceutical development. This is standard
for the manufacturing process in pharmaceutical
companies. It may also be standard in other businesses
that have to manufacture things as well too.
And they're called good manufacturing practices.
So complex pharmaceutical dosage forms, they
have many steps in the production of them. And
we've talked about those. And so every step has
to be done correctly. And you've got appropriate
testing after each step because you're ensuring
the quality of the final product. The quality
is built into every single step in the... process
of creating this product. You can't develop the
quality at the end in post -testing after the
product is already put together, because then
all you can do is say, this one's not doing great,
or you just have to reject the whole batch after
you've spent a lot of money creating this agent.
So it's very important to have these steps in
place. And I'm not going to go through all the
steps, but it does involve having the right people
working for you, having the right facility to
develop these medications and produce these medications,
having the right documents filed and available
to you to make sure that you've got the right.
You've got the right temperature to cook this
particular medication or the right temperature
in which to store it, all that kind of data.
Also that their lab surfaces are clean, that
things are properly ventilated. Yes. Their glassware
is heated to a certain degree so that it becomes
aseptic. I think a great analogy to all this
is like if you were eating at a restaurant, what
would you want the kitchen to look like? And
would you want it to look like your kitchen at
home? Then maybe you don't clean as much. Well,
with my mom, you definitely want her kitchen.
She's definitely an FDA approved kitchen. But
if you go to the back and you see ingredients
mixing with each other, you see people not washing
their hands in between meals, like you're going
to be a little skeptical about the meal that
you're about to eat. And I think the same thing
should be applied when you're thinking about
taking drugs is that I'll talk a little bit in
a minute about generic drugs versus brand name
drugs. At the end of the day, yeah, the place
where the thing is made can make or break everything,
even if you've done all the clinical trials and
you've proven that this thing works. But if then
your manufacturing processes are sloppy, then
all that work is gone and done in vain. Right.
And drugs are continued to be assessed even after
they're approved when they initially get. approved
and prescribed for the patient population. Data
are still collected about those medications looking
primarily for any weird adverse effects that
did not show up in the clinical trials because
you didn't have enough of a patient population
to find them. So yeah, there's still assessment
being done after it even goes onto the marketplace.
Yeah, that's a really good point. A lot of people
have issues with how much their medications cost.
But it is very expensive to make a brand name
medication. In 2019, the pharmaceutical industry
spent $83 billion just on research and development.
83 billion on research and development. And that
was up from 38 billion in 2000, and it was only
5 billion in 1980. So we have ramped up our ability
to assess and evaluate medications, but it comes
at a cost. 59 new drugs were developed in 2018,
and that was an increase of 60 % compared to
the decade of 2000. The cost estimates... are
going to include not only the laboratory research
and the clinical trials on the successful agents,
but they also include the laboratory research
and clinical trials on non -successful agents.
And I know people might think, that's so unfair.
The pharmaceutical manufacturer is taking their
time and their resources that they don't get
paid for with their flops to make those agents
that work. And they have to recoup their costs
for that some way or they just couldn't stay
in business. The third area in which costs are
included in an estimate of how much a drug is
made is what we call capital costs. And those
are the costs for the pharmaceutical company.
pharmaceutical company that if they could have
been doing something else instead of making this
particular medication and getting some revenue
from it, that gets factored into that as well
too. They call that a foregone investment. So
you've got these three estimates, these three
estimates that are built into the cost of a medication.
There was an economic evaluation study that was
done. They looked at both public and proprietary
sources, and it showed that the mean cost to
develop a new drug from 2000 to 2018, this is
the cost to develop the drug, was $173 million.
But that cost increased to $516 million if you
added in the cost of failures, and it increased
to $800 million. $80 million if you included
the cost of failures as well as those capital
costs. It's almost a billion dollars per drug.
And so if there are 59 new drugs developed, that's
around $59 billion that you're spending, hoping
to recoup your cost. But it seems like the juice
is worth the squeeze, depending on the pharmaceutical
company. Right. And so you're like thinking,
well, you know, Those pharmaceutical companies
make a lot of money, and they do. In 2023, the
United States pharmaceutical companies generated
$318 billion in domestic revenue. That's not
net revenue. That's total revenue. So they have
got to subtract out the cost of those medications,
the employee salaries, the rent on their facility.
They're still going to obviously generate a profit.
That's that's what capitalism is, you know, and
stuff. So we need that. But it's like but there's
a cost to getting a good medication that there
is an estimate that we will that these pharmaceutical
companies in the United States will generate
a revenue of over one trillion dollars by the
year 2030. Drugs, everything costs more and they're
just they're investigating more new medications
to make as well, too. Yeah. Also, I mean, I know
we're hitting a lot on these GLP -1 agonists,
but those obviously took off between 2022 to
now. And a lot of the revenue from places like
Novo Nordisk and Eli Lilly, that's a lot of the
profits from their R &D department. And I think
it's very similar to like a record label for
musicians or for any venture capital firm. 95
% of the individuals or companies that you invest
in are going to flop. you just you if anybody
could predict the future you know please be my
guest but investment is a risky business because
you're just trying to predict the marketplace
and what the marketplace wants um and so record
label 95 of artists do not yield a return on
the record labels but then you have your sabrina
carpenters you have your perry styles you have
you have your dochis and these are artists who
obviously blow up and you then continue to invest
in those artists But you always kind of have
a quote -unquote R &D department at your label,
and you're figuring out what's going on. So a
lot of these companies, even though they make
a lot of money, there's a lot of risk associated.
But also to hedge their bets against that risk,
they've negotiated with the United States government
that they have a 10 -year basically patent on
any drug that they create because it's such a
large investment. They're like, hey, we spent
a lot of money on this drug. We would like to
be free from competition for at least 10 years.
And so that's just the deal that we've struck
up with these large pharmaceutical companies.
Because if you think about it, let's say you
put a billion dollars into making a drug and
then you release it, it becomes wildly successful.
Another pharmaceutical company can just come
copy your recipe without doing any of the work
and then sell it for a lower price. And then
you would immediately go out of business because
you have no way to recoup your investment. So
we've kind of had this wiggle room. of this 10
-year period. And then after that 10 -year period,
we've granted this access to quote -unquote generic
drugs. And actually generic drugs are given like
a six -month category where they're like, if
you get approval for that, you can sell your
generic for six months and then you're open to
competition as well. Because I didn't know this,
but when a company releases their information
on their drug, their patent, all they have to
do is release the chemical formula. They don't
have to release any of their way that it's made.
It's like Coca -Cola. It's like, hey, we'll tell
you what's in Coca -Cola, but we won't tell you
the ratios. We won't tell you where we got the
sugar. We don't tell you all the processes to
get there. And as anyone has known, we're from
Texas, and so we go to HEB, and they have their
simulated Coke there. But it doesn't taste like
Coca -Cola. It's similar, but it's not the same.
And generics are the same way. And if anyone
is interested in generics and understanding where
they come from, I highly recommend going to listen
to Peter Attia's The Drive podcast number 71.
I think her name is Catherine Navarro. And they
go into a deep dive of why not all generics are
equivalent to the FDA approved drug for reasons
that we will kind of skip over because I think
it would take way too much time and then go into
a lot more detail. But there's a really interesting
story that I'll just get into. Like one of our
former presidents, George W. Bush, felt compelled
to give cheap medications to Africa because they
were struggling with the AIDS crisis epidemic
at the time. But these drugs are really expensive.
And so he we signed this act called PEPFAR, which
is essentially it signed this deal of like. If
we can make pharmaceutical manufacturing companies
in other countries who can produce drugs for
cheaper, places like China, places like India,
then we can essentially buy these drugs for cheaper
from the American taxpayer and we can fund some
of this aid to send it over to Africa. And so
by that logic, we were able to give FDA approval
to some of these manufacturing plants in places
like India and China, which opened up generic
drugs. especially AIDS related drugs to Africa.
And then we were like, well, wait a minute. If
we are selling, giving these drugs to Africa,
why can't we give them to the United States citizens?
So we then opened up selling these drugs to United
States citizens, which obviously you can buy
a brand name drug for cheaper because you can
manufacture it in a country where manufacturing
costs are low. That sounds great in theory. And
this is where I'll stop after this last sentence.
But the United States does not have. jurisdiction,
especially the FDA, does not have the ability
to go over and inspect these facilities. And
based on some investigative journalists and some
really intrepid FDA employees who do go over
to inspect some of these manufacturing, it is
awful. Like the conditions at which some of these
generics are made, they do not receive an FDA
approval for these manufacturing facilities.
And the mechanisms that my mom talked about earlier,
the good manufacturing processes are not. in
place and so i would caution anybody listening
to this podcast when you buy a generic go to
your pharmacist or ask somebody who works at
the pharmacy where is this manufactured and you
should be able to get the name of that pharmacy
or the manufacturing facility and go to their
website and if they have not received an fda
approval either through a voluntary process or
via the state working with the federal government
I would be very hesitant to take that generic
because it is not getting the same stamp of approval
as we've alluded to earlier. I don't know if
you have anything to add about my generic statement,
but just be cautious. No, I think you covered
that fairly well. The only thing I might say
is that you talked about Coca -Cola. Coca -Cola
is not patented. It is a trade secret, which
is very different. And so then they don't ever
have to reveal their way to make Coca -Cola unlike
a patent. And if I'm not mistaken, patents...
I think they can be longer than 10 years, but
they may be 20. But part of that is the development
process. So by the time they finally get to market
it, they may have only about 10 years left on
their patent and stuff, something like that,
I think. So just a couple of other small points
I wanted to make about the research and development
spending, because it is a lot of the money that's
spent to develop a drug. Things that influence
that are, The anticipated lifetime global revenues
from a new drug. So they're thinking about how
long in the life of this drug are we going to
make money worldwide? That's one factor. How
much is it going to cost us to develop this new
drug? That's another aspect of the research and
development spending. And then what policies
and programs? influence the supply and demand
of prescribing this particular medication. Because
you think if you spend all this money on a medication
and you end up with having 50 patients in the
whole world for it, it is not going to be lucrative.
So they've got people that think, forward -thinking
people, that think about that as they're anticipating
whether or not to market this drug. Again, I
talked about the fact that I talked about the
stages of the pharmaceutical manufacturing process.
The areas that are covered by research and development
spending include the invention of the medication,
the development and the clinical trials and the
FDA applications, something that's called incremental
innovation. So you may need to tweak your product
along the way to maintain your patent. product
differentiation how do you make it different
than somebody else's as well as safety monitoring
that's a really good point i think this would
be a great time to pivot to compounding because
like essentially this is the downside of capitalism
is that every company obviously is out there
to make money and large pharmaceutical companies
make it by something called the economy of scale
so like you can make I always think about it
like cookies in an oven. Like you can turn your
oven on and you can put one piece of cookie dough
in that oven. It'll make one cookie. But you
could also put 30 pieces of cookie dough and
it'll make 30 cookies. So someone selling 30
cookies versus one cookie, you can sell 30 cookies
for cheaper. It took you the same amount of energy
to make 30 cookies than one cookie. And so pharmaceutical
companies and any company who makes something
in large bulk, uses this idea of economy of scale.
You usually put a certain amount of energy in
to make more of that product. You can sell that
product for cheaper to a lot of people. But if
I was selling a cookie that had peanut butter
chips in it and somebody had a peanut butter
allergy or peanut allergy, that person is out
of cookies. They have no luck. So they're relying
on somebody coming along to make a batch of cookies
without peanut butter chips. I only make peanut
butter chip cookies. So they're relying on a
compound cookie maker to come along. and make
a peanut -free cookie. That's going to be more
expensive for that compound cookie maker, which
is why I think it would be good to transition
into talking about the benefits of compound pharmacies,
but then also why it might not always be the
best option. Okay, great. So we will transition.
That's a great transition into compounding pharmacies.
And I'm sure everybody is aware. Actually, every
pharmacy can compound. If you go to a pharmacy
and they add water to the powder and turn it
into a liquid suspension, that's compounding.
But anyway, so let me give you a more official
definition of compounding. It is defined by the
Drug Quality and Security Act of 2013 as it's
the combining, admixing, diluting. pooling, reconstituting
or otherwise altering of a drug or bulk drug
substance to create a drug. It starts with a
bulk substance and it is combined with excipients
to form a final product. Compounding pharmacies,
this is very different than our pharmaceutical
manufacturing companies. Compounding pharmacies
are not regulated by the Food and Drug Administration.
They are instead regulated by individual state
boards of pharmacy. And so the compounding regulations
are going to vary by state. Let me give you a
little tiny bit of history as far as compounding
is concerned. Compounding, if you've ever been
to a... I grew up in Virginia and I loved going
to Williamsburg. And so they have apothecary
shops, you know, the little drawers and they
would have all their little ingredients in the
drawers, mortars and pestles. You know, the compounding
was the primary way that medications were produced
until the early 20th century when large scale
pharmaceutical manufacturing companies came into
existence. And we have a decreased reliance on
compounding now. But there has been a recent
resurgence in compounding in the last couple
of decades because people have become more focused
on personalized medical care. I think about it
specifically with men and women's health. hormone
replacement therapy was a big one, pain management,
hospice care, dermatology, oncology, even veterinary
care. Almost all veterinary products are, well,
not all, but a lot of veterinary products are
compounded. There really is a lack of regulation
and oversight for the development of compounded
medications. So when you're in a compounding
pharmacy, you get a unique prescription for that
particular patient, but you're not replicating
it for other patients. Now, you may replicate
it if that patient comes back for that same prescription,
or maybe this particular physician uses this.
recipe, per se, for this compounded medication
in different patients. But it's not regulated.
You don't have all those quality control steps
for a compounding pharmacy. So there sometimes
can be concerns about whether you could have,
should there be concerns about patients being
exposed to medications that are not subject to
these rigorous uh, quality control standards.
Yeah. Let's, let's give an example of that. Let's
say that you like taking Tylenol or acetaminophen
via pill form. Okay. And I hate it. I hate swallowing.
It's the worst in the world. So I have, I go
to a compound pharmacy, I have them crush it
up and then I have them dissolve it. And let's
say, what would you say? Diethylene glycol? Yeah.
Diethylene glycol. Let's say I just really, I
love the flavor of that for some reason. And
so I have them dissolve it in that. And then
I just take it that way. Now, that seems fine.
But at the end of the day, I don't know how Tylenol
interacts with diethylene glycol and or the safety
consideration of consuming that. So the idea
that you just add it to something else sounds
quite benign. But then that pharmacy. Can't make
that and then sell it to my mom. He's like, oh,
we actually have this liquid version that we
think would be great. It's like, no, each of
these has to be tailor -made based on the patient's
request. Right. You can't compound something
that is commercially available. And realize,
too, what's being compounded is being compounded
with FDA approved. FDA -approved ingredients.
I mean, the excipients, the active ingredient,
those parts are regulated, but the actual thing
coming together doesn't go through those good
manufacturing processes that a pharmaceutical
company does. Who can compound, you might say?
Well, you know, your pharmacist can do it as
well as anybody that's under the supervision
of a licensed pharmacist. So they may have technicians
or they can have pharmacy interns, pharmacy students
that work with pharmacists can also compound
and physicians can also compound in their offices
as well, too, if they've got there. There are
there are. continuing education processes. You
need to keep up to date with how to compound.
So there are definitely classes that need to
be taken to be able to continue to be compounding
more complex medications other than adding a
liquid to a powder that's already inside of a
bottle. Why on earth do we need a compounded
medication? Why do we need compounded medications?
Well, We talked about it. You're going to provide
a therapeutic agent for something that's not
commercially available. So it's something that
you can't get anywhere else. Or it could be that
you need a particular dosage form. Let's say
you need Prilosec, which is for ulcers in a suppository
form. I don't think it comes that way. I don't
know if it could. It can be. Why not? So something
that doesn't come. that particular way, you can
create that. Or the other thing too, that you
could see a lot of in a pharmacy is as kiddos
can't swallow pills. So there would be a lot
of different ways to try to make a medication
in a liquid form so a kiddo could take it. Or
like Joshua mentioned, if a particular FDA approved
medication has an ingredient in it to which a
patient is allergic, you can recreate it, leaving
that weird inactive ingredient excipient out
of it because they happen to be allergic to FDA
or food, whatever, the FDC dye number three or
whatever and stuff. And then you can also compound
medications for which there is either a drug
shortage or an FDA drug discontinuation. Remember,
a compounding prescription is originated by a
prescription. From a physician for a specific
patient. And then the pharmacist or the person
who's going to compound it makes it. That's very
different than the pharmaceutical manufacturer.
Remember, they were not specific for a particular
patient. They're a 503B facility. And compounding
pharmacies are 503A facilities. Yeah. So 503A,
patient -specific. 503B. much more being able
to make an economy of scale. It's for the general
population as long as well as those big giant
pharmaceutical manufacturing plants. And the
pharmaceutical manufacturing companies that manufacture
those agents, they end up in the pharmacy, a
compounding pharmacy. I'm going to get into this
right now. Let me just say this and then I'll
add that thought I was just going to say. So
how common is it? how common is medication compounding?
It's really difficult to determine the number
of drugs that are compounded and the number of
compounders due to the lack of federal reporting
requirements. Really, like I said, almost, you
could say almost 100 % of pharmacies can be compounders
because they can add liquid to a powder. But
specifically the more complex compounding pharmacies,
it's estimated that about 7 ,500 of 56 ,000 US
pharmacies, so about 13 % specialize in compounding
services. And it's interesting to note that a
lot of compounded prescriptions will not be covered
by your insurance. That's just because they don't
have the, they haven't been regulated. So insurance
companies will, and it's not all insurance companies,
but it may be more difficult to get it paid for
by an insurance company. About one to 3 % of
prescriptions written in the United States are
compounded prescriptions. So there's not that
many, but there's still a fair number. Although
we don't have good manufacturing practices in
place for compounding pharmacies, there are requirements
that are set by the state boards of pharmacy.
You need to have a specific area in your pharmacy
that's dedicated for compounding. It has to be
clean. It has to have a good counter area, good
lighting to be able to. to keep it separate from
the other part of the pharmacy. You have to have
the right equipment, the right supplies, the
right ingredients, the right, you need either
water or alcohol, depending on whether or not
the particular agent will dissolve in water or
alcohol. You need to keep records. Even though
it's not FDA approved, you still need to keep
records and record keeping for these compounded
agents. And there are still policies and procedures
to follow. set by the state to to make sure that
you do use certain uh safety measures standard
operating procedures that you do it the same
way every time and that you have quality assurance
and control in those as well too um so yeah so
unlike um so joshua mentioned earlier that with
a pharmaceutical manufacturing medication, after
it goes through the whole process, it ends up
with an expiration date. And an expiration date,
when you get to that expiration date on a medication,
it means that 10 % of the efficacy of the medication
has been lost. Well, we don't set expiration
dates with compound. pharmacy medications, but
we set beyond use dates. And these dates are
assigned to guide the patient for appropriate
use as well as storage. The beyond use dates
allow the product enough time to be used appropriately
without it being able to be stored for long time
periods and degrade and lose its potency. There
are actual standards for setting these beyond
use dates. It depends on the dosage form. If
it's an oral preparation containing water versus
a limit liquid or semi -solid, like a topical
or mucosal agent versus a preparation containing
no water. Preparations that contain no water
can have a longer beyond use date up to six months,
whereas those agents that are Oral preparations
that contain water, like the reconstituted antibiotic,
only has a 14 -day beyond use date. Your beyond
use date cannot be greater than the expiration
date of the active ingredient that's used to
make that medication. So if you happen to be
low on an ampicillin... I don't even know if
they prescribe impicillin anymore, but suspension
that needs to be reconstituted. You have to set
the beyond use date on what the bottle says rather
than the actual 14 days. You always need to make
sure that you dispense your medication in a container
that protects from light and moisture. And typical,
you can really compound most everything. You
can compound solutions. You can compound suspensions,
which are two -phase systems that have finely
divided solids that are dispersed in the liquid
vehicle. You can do emulsions, which are two
-phase systems that have two what they call immiscible
liquids. Then you shake them up. I think we need
to slow down because I don't think a lot of people
know these terms. And we need to give examples.
Okay. So a solution is going to be just like
if you add water to a – Well, it may just come
as a solution. We don't know if you're going
to make it. Well, just, I mean, think of sugar
water as a solution. Okay. So you have a solid,
which is the sugar, and then you have the water,
which is the liquid. You stir it around. You
make sure it's nice and evenly mixed. You now
have a two phase solution where you have solids
mixed with liquids and you can probably no longer
see the solid anymore because it's mixed in and
it tastes delicious. Yes. There you go. A suspension
is going to be your. uh antibiotic that you've
got the powder in the bottom of the bottle you
add the water you shake it up it gets dispensed
and dispersed within the water you can still
see it i know i'm like i'm shaking my hand i'm
just i'm i'm mixing up my suspension right now
it's like i think orange juice is a great example
because you you have the pulp with the rest of
the juice and so you can still see the pulp that's
inside and it's not mixed evenly like you would
see in sugar water Okay. Emulsions. Best example
of an emulsion. Again, we're talking about two
liquids that don't mix together. Oil and water,
salad dressing, mayonnaise. Milk actually is
an emulsion. You've got the milk droplets that,
and there are drugs that like that as well too.
We should say that oil and water is not a good
emulsion because they separate. Right. But you
can add an emulsifier, which is a thing that
will bind the water and the oil. together. Help
them stay clumped together. Yes. So you can make
capsules. You can make tablet triturates. You're
like, what on earth is that? They actually have
little molds that you can add the medication
to and it will solidify and it can become a sublingual
tablet. So that's how they make those. What is
it? What is a sublingual tablet? Sublingual tablets
are those tablets that you put under your tongue
and then they melt and you don't have to swallow
them. Oh, fun. Sometimes I have a medication
that I take for migraines. So sometimes migraines
can make you feel nauseated and you don't feel
like drinking water. So things like that might
be sublingual. Or if it's a cancer patient, sometimes
they can't swallow very well. So you can give
them medications under their tongue. So a sublingual
tablet. Another thing that can be... made in
a compounding pharmacy are things that we call
trochies or lozenges or lollipops. Trochies are,
again, agents that you can put in your mouth.
It's kind of like a mint. Yeah, I meant that
you can suck on that will get the medication
into your systemic circulation. Same thing with
the lozenge that you can suck on it and lollipops
as well too. They do make lollipops for pain
management and cancer patients. You can get some
FDA approved and there may be others that you
can make in a compounding pharmacy. Ointments,
creams, and paste. They were the bane of my existence
in pharmacy school. Like making them? Making
them. Yes, you had to make them. Because you
needed to make them smooth. And they'd always
pick these nasty ingredients that you had to
make. Because it was mainly there for dermatologic
issues like psoriasis or eczema. You had to mix
things together. And you had a spatula. You had
to make them smooth and mixed in completely in
there. So you didn't see any evidence left of
the ingredient to which. that was being added
to the base. And so that was a common thing.
Gels, suppositories, there's definitely molds
and you can make suppositories as well too. Powders.
And then I used to, I made powder papers. You're
like, what on earth is a powder paper? They were
really cool, but you had, you have to have the
writing, you have to have the right equipment.
You had to have a balance. And so you had to
have these little powder papers, you put them
on the balance, you would. either get a supply
from a manufacturer that was just raw powdered
medication, or you could grind it up in a mortar
and pestle. You would then weigh it out on the
balance and then you put it into the powdered
paper and then you folded these powder papers
in a particular way and they went into these
little boxes and stuff. So for patients that
can't swallow pills, but they could potentially
be mixed up in their water or juice, it was another
way to give medications as well too. So that's
it as far as, you know, so again, really, I've
never actually worked in a full -fledged compounding
pharmacy, so I can't give you a lot of examples
of what they do. I do know that there was a...
compounding pharmacy in san antonio that was
known for making veterinary medications so they
had all these amazing flavors to add to the medications
that dogs and cats would like so it was like
it was really cool so yeah yeah it seems to be
a really nice addition for the personalized aspect
of medicine like in just in case you have an
allergy to a certain type of medicine but you
still need to take it then somebody can find
a way to personalize it for you. I know there's
a difference between non -sterile and sterile
compound pharmacies where one is needing to be
a lot more stringent in their safety procedures.
I believe there was that case with the NECC.
I don't know if we're going to talk about the
New England Compounding Center. So this is actually
the reason that the new compounding law was enacted.
So in 2012, there was something called the NECC,
called the New England Compounding Center, and
they were making steroid injections. And unfortunately,
they were made in non -sterile conditions and
they got contaminated with basically a fungus
that caused fungal meningitis. And we should
let people know that what fungal meningitis is,
if you've never heard of meningitis. Itis means
inflammation. Menin means meninges, which is
kind of like part of your nervous system. And
it essentially gets into your brain. So essentially,
these injections went into the bloodstream, crossed
the blood -brain barrier, and then infected over
700 people. And about 60 -something of them died
from these injections. And this basically propelled
Congress to say, hey, we need some more. tighter
regulations on the compound pharmacy, especially
on the sterile side when you're actually injecting
things into people's bodies rather than making
things like mints or lollipops. And so the risk
of something being compounded is that it can
be made at a place, like my mom said, in a place
that's not FDA approved. And we mentioned before
there are two types of compounding pharmacies.
They get 503A designation or 503B designation.
503A designation means you're making very personalized
doses for people. The NECC was a 503B compounding
pharmacy where essentially they were making large
batches of a substance like this steroid injection.
And what a 503B is meant to do is kind of be
a filler anytime there's a supply shortage of
a certain type of drugs. If there's a larger
demand for something like a steroid, or in the
case of COVID, monoclonal antibodies or vaccines,
you can essentially have these 503B pharmacies
come in and say, hey, we will fill the gap where
the supply is being limited at the moment. Because
maybe they could get a source of the drug from
somewhere else that's not the main manufacturer.
So that sounds great in theory. But unfortunately,
if these pharmacies, very similar to like the
generic drugs I mentioned, don't have that FDA
approval or an FDA auditor hasn't come by and
inspected their facility, you're kind of taking
their word that they are doing best practices.
And depending on the state and how often that
state audits these facilities, you're relying
on these facilities to be clean. and safe. And
unfortunately, this place wasn't. And that's
one of the downsides with having these 503B pharmacies.
But luckily now, it's not mandatory, but these
pharmacies can now voluntarily work with the
FDA. They can go across state lines and say,
hey, we want you to come and approve us. So,
which is what I strongly recommend if you are
getting your drugs from a compounding pharmacy.
And this can be a lot of different things. We've
talked a lot about GLP -1 agonists on this episode,
but there are a lot of wellness companies out
there. Some of them you might've heard of on
commercials, things like Noom, HIMS, HERS, and
they are offering semaglutide or terzepatide
injections at a lower price than what a company
like Novo Nordisk or Eli Lilly is offering. And
the reason they're able to do that is they partner
with larger compound pharmacies to make these
at a lower price. Some of these facilities have
been approved by the FDA. They work with the
FDA to get that stamp of approval that they're
doing all the things that a large manufacturing
facility would do. But a lot of them are not.
And a lot of them are actually using semaglutide
mixed with another base. Something like a sodium
salt that will mix in a solution that's slightly
different than the original formula. It's almost
kind of like having Coca -Cola mixed with aspartame
instead of stevia, for example. They might be
the same thing, but consuming 12 Diet Cokes a
day could be different if you have 12 parts aspartame,
12 parts stevia. You just don't know if you've
never done the clinical trial. Just a word of
caution for anybody who is getting any of these
cheaper alternatives is to really do your due
diligence and figure out where these things are
being made, where they're being sourced, just
like you would do with your food. Because you
are putting these things in your body and you
want to make sure that they've gone through the
same stringent testing as a lot of these other
FDA approved drugs have done. So just wanted
to give the delineation between a 503A and a
503B and the risk. and benefits to either of
those. You know, as far as, so when we're, what
I've been talking as far as compounding pharmacies
this morning is primarily the non -sterile compounding
dosage forms. You can do sterile compounding
as well, too, but when you do sterile compounding,
you need a hood. It's got to be ventilated in
a particular way. You have to gown, glove. You're
making a sterile product, so it's a very different
type. I did an internship in a pharmacy, and
also hospital pharmacies have sterile hoods to
make. intravenous preparations and stuff. So
they've got guidelines around those as well too.
But when you think about a compounding pharmacy,
you think maybe more of the non -sterile compounding
parts rather than the sterile compounding parts.
But they can be made in a compounding pharmacy
as well too. So again, they're going to have
regulations. And again, although they may not
be regulated by the Food and Drug Administration,
they are regulated by the state boards of pharmacies.
So they can't get away with everything. things
can happen like in that new england compound
i can only imagine in texas where we live they
probably check them once and then they just let
them do whatever they want um because we do not
like regulating people down here and then but
in a place like new york or california there
might be more stringent regulations and i think
It's not good or bad, but I think the thing that
I always want to get across on an episode like
this is that you have a choice between cost versus
safety. And I think a lot of times, if you think
about any activity that you do, if you want to
be more safe, it's going to be more costly, whether
in terms of your money or your time. If you want
to walk outside without tripping, you will tie
your shoes. That's going to take a certain amount
of time. Or shoes with laces, right? But if you
don't tie your shoes, It doesn't mean that you
are going to trip, but there is a higher likelihood
that you will trip because you will step on your
shoes. So I think in this episode, we wanted
to really get across it like there's no evildoers
here. It's just everyone is responding to incentives.
And if I was a company and I could get out of
paying a billion dollars to develop a drug and
I could just, you know, sell it and compound
it, heck, I would do that. And if I didn't have
to be regulated as hard, heck yes, let's do that.
But at the end of the day, if I was an ethical
person, I would want to think I'd still want
to guarantee that my customer is getting the
same health benefit as a normal drug. And unfortunately,
I think relying on somebody's goodwill to do
the right thing sounds very nice. But this is
why we have government. We have government and
regulation so that everyone has these best practices.
Not because we want to chastise people, but we
want to be guaranteed being given the same thing.
If I was in Oregon versus I was in Ohio. And
I think that type of consistency just gives you
a nice peace of mind. So then whenever you walk
into a drugstore and you see a generic versus
a brand name, or if you go to a compound pharmacy,
that you can have a relative confidence that
a lot of these things are going to be similar
rather than think, oh my gosh, what am I getting
today? Similar to when you buy a piece of meat
somewhere, you want to make sure that. It's actually
cow that I'm buying rather than antelope. So
I think the consistency is what we want for our
customers. And I know that I want as someone
who takes pharmaceuticals. I would probably beg
to differ. I think that the Texas State Board
of Pharmacy does do some regulation in their
pharmacies. but there are a lot of pharmacies
in the state of Texas. So, I mean, they may,
but they, they were always assessing, you know,
pharmacists and pharmacies to make sure that
they're doing appropriate things. Do they go
out and inspect? They do. We have like officers
here. There's a board of pharmacy. Yeah, there
are. So yeah. Now again, and how they, because
there's paperwork that pharmacies have to submit
to, to the. board of pharmacy and then they've
got monitoring systems for narcotics and things
like that and so things can be flagged i think
that you know that that that they might find
uh concerning right and they'll look at things
i guess i'm just saying people can just lie on
their paperwork uh they yes but when you're talking
about actual counts of medications and and stuff
i you know yeah i mean i'm sure yes they Anybody
can get by with something. But, you know, they
do. I'm just saying that they do their best to
regulate. I'm not saying that they're not doing
their best. I'm just saying is like sometimes
you're just hampered by the laws within your
state. Right. So for example, even the FDA is
like the FDA is wonderful. They are incredibly
underfunded for the amount of demand. Like the
pharmaceutical industry is a multibillion dollar
industry. And the fact that our FDA. is not funded
to the degree to be able to regulate an industry
like that like that seems wrong to me like i
think at the end of the day we would want a lot
of these officers the same with the epa is like
i don't want people dumping their waste into
rivers and so i want officers out there to be
able to prevent things like that happening but
if we're not going to fund the proper law enforcement
officers to police these things and they can
only rely on getting paperwork into these offices.
I'm not saying this is the case. We should probably
look more into it. But if I can't literally walk
into somebody's facility and see what they're
doing at a random day, just like we do with kitchens,
we'll have the health officer for the city. We'll
just walk into a restaurant and then give them
a grade. I don't see why we can't do that for
a compound pharmacy or even a 503B pharmacy.
Just walk in. All right. You're getting audited
today. Right. And that seems very reasonable.
And I'm not sure that they don't do it that way.
Okay. Yeah. One last point. Well, two last points
I wanted to make. So we talked about how much
money is generated from pharmaceutical manufacturing
industry. So the 503A compounding pharmacies.
are projected to grow from $4 .47 billion in
2024 to $8 billion in 2034. So they make a substantially
lower amount of money than the pharmaceutical
manufacturing company, but that's still... A
chunk of change, you know, when you think about
it. It's about double. Yeah. In 30 years. 30
years. So, yeah. Well, no, in 10 years. 2024
to 2034. For some reason, I thought we were in
2004. We're in 2025, actually. So, yeah. So,
let me just remind you again, the differences
between a pharmacy compounding. institution and
a manufacturing or pharmaceutical manufacturing
company. Remember, the compounding pharmacy is
patient specific. It's regulated by the state
boards of pharmacy. You don't have to have clinical
trials to determine the safety and efficacy of
that particular compound you're making. You don't
have to submit a new drug application, but you
do have to use good compounding practices. You
need to assign a beyond use date. and you are
exempt from the FDA labeling requirements. Whereas
a manufacturing company is not patient -specific,
but they're regulated by the FDA, there are clinical
trials involved as well as submitting a new drug
application. They have to follow good manufacturing
processes. They assign expiration dates, and
they do follow FDA labeling requirements. So
I think we can see differences between both.
We can see utility in both. And I think Josh
offered just some, just, you know, just have
some, just be aware, you know, if you sense something
could be maybe not correct, you know, or maybe
a little off or whatever, just to ask questions.
Yeah. If this stuff is not documented, that's
a bit concerning. I can even see from the compounding
side, especially on the 503A, why a lot of that
FDA stuff would not be required because essentially
it's just your personal relationship with your
pharmacist. Like there's no company involved.
I mean, obviously they get the chemical from
the manufacturer itself. Which has gone through
all of the rigorous. But at the end of the day,
if they're going to personalize it, it's like,
okay, the liability is now on you, the individual,
because you've gone this route. and then this
compound pharmacist is now taking this route
as well so i could see why you know you wouldn't
want to be too strict around that because at
the end of the day it's such a small scale um
especially with developing things like therapeutics
like you said for cancer patients and maybe even
novel medications for you know like hey we don't
know if this drug works we're kind of at the
end of our rope here we want to try this thing
so let's compound a new treatment for this hospital,
for this specific patient so that they can do
this. And there are definitely rules or regulations
they have to follow. It's not just like carte
blanche, do whatever you want. It's just different
and not as rigorous as the manufacturing practices
for a pharmaceutical company. That's what I have.
All right. Well, I think, man, this has been
such a deep dive into this. And I think... One
thing that I've really learned a lot is the history
of drug regulation in this country and just how
a lot of times we operated on good faith, that
people were just kind of giving you what they
said they were going to give you. And it took
a couple of unfortunately bad historical examples
to remind us that the grass isn't always that
green. And even though it can be quite annoying
and quite frustrating and quite expensive to
go through the process to make sure that something
is safe and effective, it might actually be worth
it in the end. But I would really like to see
the generic space and the compound space catch
up to the standards that we set at the FDA. I
would just love to see the FDA get more funding
so that it can... actually almost like train
a lot of these other folks in those practices
or even supply grants for some of these places
to have the necessary safety equipment. Because
I'm sure for a compound pharmacy, it's got to
be really expensive to have all of these extra
vent hoods and, you know. If you were compounding
sterile products, yes. And at the end of the
day, we want to have a country and a world where
a lot of these medications are safe and effective.
And I think another just a last point to make,
too, is that I know our medications can be expensive
and, you know, biopharmaceutical medications
cost a lot more. And it depends on whether or
not you have health insurance and what kind of
health insurance you have. But when you look
and again, pharmaceutical companies, there are
parts of them, I'm sure, that are not completely
ethical. But. It takes a long time for one medication
to get designed all the way from the idea all
the way through the whole new drug application,
clinical trials, production, and packaging. And
it can take a decade. And that pharmaceutical
company is not making any money on that medication
at all during that time period. So they have
to have a way to be able to... generate revenue
from that effort. And that's why they have all
those people assigned, assess how well is this
drug going to be used, how many people are going
to use it, for how long, to help them figure
out how to price it, and then how long the patent
lasts and all that stuff. That's really well
said. And you can also imagine the perverse incentive,
which obviously has happened where pharmaceutical
companies have bribed members of the FDA or they
fudged the numbers on their data. or they've
hid side effects because you have this 10 -year
gamble and you really want it to work. And it's
your goal as a company, unfortunately, to deliver
money to your shareholders and things like that
rather than the public good. But I always want
to stress too, even though that's bad and we
try to catch the bad actors, the alternative
is to not get rid of it. It's to make it better.
I think a lot of people think like, well, the
FDA is corrupt. It's done these corrupt things.
I'm just going to buy supplements from now on.
It's like, no, it's like they don't have to do
anything. There's no FDA member to bribe. They
can just go out and sell it on Amazon and you
have no idea what you're getting. So I would
really encourage people, even if you're frustrated
with the process, is to engage with the process
and make it better. Because as you've seen from
1937 to 2025. how much better the process has
gotten. And even though we do have instances
where some of this stuff slips through, most
drugs from the FDA are safe and effective and
we're getting better as years go along. So we
hope that you've learned something today. Well
said. Yeah. Well, this has been a great episode
and I've learned a lot. And so I hope that you
have too. And I hope you ask questions at your
local pharmacy and also give them a high five.
So this has been another episode of Your Mom
on Drugs. My name is Josh, the son. And I'm Jennifer
the Mama. And we'll see you next time. Thank
you. Bye.