January 28, 2025 • 22 mins
Join us as we explore the fascinating world of medications in this episode of Deep Dive! From the rigorous regulations behind prescription drugs to the murky waters of nutraceuticals and the rising interest in CBD, we break down what you need to know to navigate the world of health products. Learn about the pathways that bring drugs to market, the safeguards of clinical trials, and how patients and professionals alike contribute to medical advancements. Empower yourself with the knowledge to make informed health decisions—because understanding your medications is key to better health!
Mark as Played
Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:00):
All right, let's dive into the world of medications.
(00:03):
Today, we're tackling the differences
between over-the-counter and prescription drugs
here in the US.
Sounds good.
You know, a lot of listeners want
to untangle that whole web of regulations and approvals
and especially figure out where things
like nutraceuticals fit in.
Yeah.
Oh, and CBD.
Everyone wants to know about CBD these days.
Of course.
Plus, we've got some great questions
(00:25):
about things like 505b2, pathways, and NDAs.
Oh, wow.
Getting specific.
Right.
It gets pretty complex.
Luckily, we've got you here to help us break it all down.
Happy to be here.
Let's start with something that might surprise people.
OK.
I'm intrigued.
Did you know that some of the stuff we eat
is technically considered a drug?
Wait a minute.
I thought we were talking about medications, not
(00:46):
my grocery list.
I know, right?
It's all about the intended use.
OK.
So take baking soda, for example.
OK, yeah, baking soda.
You can use it in baking, of course,
but it's also marketed as a heartburn remedy.
Oh, right, right.
Because it's used for medicinal purposes,
boom, it falls under the FDA's regulations
for over-the-counter drugs.
So the same thing could be a food and a drug,
depending on how you're using it.
(01:07):
Exactly.
That's pretty wild.
It seems like there must be a ton of rules
to keep everything straight.
Oh, there are, definitely.
The main source is the Code of Federal Regulations, or CFR,
specifically Title 21.
It's basically a giant encyclopedia
for anything and everything related to food and drugs.
Different sections are dedicated to specific types of products,
(01:30):
so it gets very detailed.
Got it.
CFR, Title 21.
So whether we're talking about a simple antacid
or a really powerful prescription painkiller,
there have to be some baseline quality standards, right?
Absolutely.
Both OTC and prescription drugs have
to meet something called current good manufacturing
practices, or CGMPs for short.
(01:52):
CGMPs.
Is that just a fancy way of saying,
keep your kitchen clean?
That's actually a great analogy.
Oh, OK.
CGMPs basically ensure that all drugs,
doesn't matter if you pick them up off the shelf
or needed a prescription, they're all
made with that same level of care,
that same focus on safety.
Think of it as a guarantee that your medications have
(02:15):
been made in a really clean, really controlled environment
following all those strict quality standards.
So CGMPs are like the universal hygiene rule,
no matter what you're cooking up, so to speak.
Exactly.
But then obviously, prescription drugs
have to go through a much more intense approval process.
Why is that?
Well, it really comes down to the potential risks
(02:37):
and benefits.
Prescription drugs are often much stronger.
They can have some pretty serious side effects.
So the FDA, the Food and Drug Administration,
they have a much stricter approval process.
Got to make sure everything is safe and effective.
If that makes sense.
So walk me through it.
What does a company have to do to get a brand new prescription
drug approved?
All right, so they have to submit what's
(02:57):
called a new drug application or an NDA to the FDA.
This is not just some quick form they fill out.
It's massive.
Really?
Oh, yeah.
It's a huge document that details literally everything
about the drug, everything from its chemical structure
to the results of years of clinical trials.
(03:17):
Years.
Wow.
So they're really put through the wringer, these drugs.
For sure.
The FDA wants to see data on everything.
How the drug works in the body, how effective
it is at treating the condition it's meant for, any side
effects, how it's made, the whole nine yards.
So they don't just look at whether the drug works.
They really weigh the benefits against the risks.
(03:38):
Exactly.
They want to make absolutely sure that it's
safe for people to use.
So the FDA is like a gatekeeper, making
sure only safe and effective drugs make it to the market.
That's a great way to put it.
But drug development is a global thing, right?
Yeah.
Do other countries have similar processes?
Definitely.
And that's where the International Council
for Harmonization comes in.
Or ICH.
ICH, got it.
They bring together regulatory authorities
(04:00):
and pharmaceutical companies from all around the world
to basically develop guidelines for good clinical practice.
So the ICH is making sure there's
some consistency in how drugs are developed and evaluated
across different countries.
Yep, that's the goal.
Sounds like a win for global public health.
I think so, too.
OK, so prescription drugs, we got that covered.
(04:21):
Let's move on to over-the-counter drugs.
Right.
Are those also subject to all this FDA scrutiny?
Oh, absolutely.
You might be able to buy them without a prescription,
but OTC drugs still go through a pretty
rindious FDA approval process.
Really?
Yep.
The FDA has to be confident that they're safe enough for people
to use on their own.
(04:42):
So it's not just a free for all out there?
Not at all.
There's still a lot of oversight.
Got to make sure what ends up on drugstore shelves
is safe for everyone.
But there must be some unique things
about OTC drug regulation.
Oh, there are, definitely.
I mean, we talked about intended use being important.
Does that come into play here, too?
Totally.
Remember that baking soda example?
It's a great illustration of how things
(05:03):
can get a bit blurry between food and drugs.
Right, right.
So what else is unique about OTC drugs?
Well, another interesting thing is the tamper evident packaging
requirement.
You mean like that seal you have to break before you
can open a bottle of pills?
Exactly.
I've always wondered about that.
Well, unfortunately, it was implemented
after some pretty tragic situations where
(05:25):
OTC meds were tampered with.
Oh, wow.
So it's a super important safety measure
to make sure what you're buying is actually what it says it is.
Yeah, that's a sobering reminder about how important
those regulations are.
Speaking of things that can get a little tricky,
let's talk about nutraceuticals.
Where do those fit into all of this?
That's a great question.
(05:46):
And this is where things get even more complex,
especially when it comes to your question about CBD.
Oh, yeah, CBD.
Everyone's talking about it.
All right, let's unpack this a bit.
First things first, remind me what exactly
are nutraceuticals?
Think of them as products that are derived from food sources.
But they're making claims about additional health benefits.
(06:07):
Things like fishmill capsules, probiotics,
certain herbal extracts, they often fall into this category.
So they're kind of in that gray area between food and drugs.
Yeah.
But they're regulated, right?
Yes, but the regulations are usually a bit less strict
than those for actual drugs.
Neutraceuticals usually fall under dietary supplement
(06:27):
regulations, which means they don't
have to go through that same intense FDA approval process
as OTC or prescription drugs.
So less evidence is required, but there's also
less oversight.
Exactly.
That sounds like it could be a bit of a double-edged sword
for consumers.
It definitely can be.
Now, brings the CBD, since that's
what everyone wants to know about.
It often gets marketed as a nutraceutical, right?
(06:50):
It does.
So where does it fit into this regulatory puzzle?
Is it a drug?
Is it a supplement?
Is it both?
Is it neither?
Well, the legal status of CBD is still evolving, to be honest,
especially when it comes to making health claims.
On one hand, you've got the FDA who
has approved a CBD-derived drug for epilepsy.
But that doesn't mean all CBD is automatically
(07:12):
considered a drug.
So once specific CBD medication is approved,
but that doesn't extend to all CBD.
Exactly.
OK, got it.
And here's where it gets even more complex.
Oh, boy.
Some companies are marketing CBD as a nutraceutical,
as a dietary supplement.
But the FDA has been cracking down
on companies that are making, let's say, unsubstantiated
(07:35):
health claims about CBD.
So it's like a regulatory tug of war.
The FDA is recognizing the medical potential of CBD
in some cases, but they're also trying to keep companies
from making false claims.
It's exactly that.
It's a hot topic, lots of gray areas,
and the regulations are constantly evolving.
It sounds murky, even for someone
who follows this stuff closely.
It is.
It is.
And it's important for people to stay informed
(07:55):
and be really cautious about those claims
companies are making about CBD products.
Good advice.
Now, I know our listener also asked about 505b2 applications
in NEDAs.
Oh, yeah, those are important ones.
They can apparently speed up drug development.
They're key for getting new and generic drugs
to market more quickly.
Before we jump into those, though,
let's take a step back.
(08:16):
Why do we even need these alternative pathways?
Yeah.
Isn't the standard NDA process enough?
Well, the standard NDA process is super rigorous
and for good reason, but it can also be really time
consuming and expensive.
These alternative pathways offer a way to streamline things,
especially for certain types of drugs, particularly those that
(08:39):
build on existing knowledge or ones that have already been
proven safe and effective.
So they're kind of like shortcuts,
but not in a way that's going to compromise
safety or effectiveness, right?
Exactly.
You still have to go through a thorough FDA review,
but companies can leverage existing data,
and that can seriously speed up the approval process.
OK, I like the sound of that.
(09:00):
Let's dive into 505b2 first.
What's the deal with this one?
Think of it as a kind of middle ground between a full NDA
and an ADA.
It's for drugs that are similar to ones that are already
approved but have some key differences,
like a new formulation, a different dosage,
or a new use for an existing drug.
So instead of starting totally from scratch,
(09:21):
companies can build on what's already out there.
Exactly.
It's much more efficient.
That makes a lot of sense.
Could you give me an example?
Sure.
Let's say a company wants to make a new extended release
version of a drug that already exists.
They could use the 505b2 pathway.
They can rely on some of the data
that was used to approve the original drug.
(09:43):
So it's like a remix, taking a proven hit
and tweaking it for a new purpose
or maybe just delivering it better.
That's a great way to put it.
What about NDAs?
Where do those come in?
NDAs are abbreviated new drug applications.
That's the pathway for generic drugs.
Generic drugs, the heroes of affordable medication.
You got it.
So how do NDAs help?
It's all about bioequivalence.
(10:04):
Bioequivalence?
OK, that's another one for the acronym Bingo Card.
What does that mean?
It means that the generic drug works in your body
the exact same way as the brand name drug.
Same active ingredient, same dosage.
And it delivers the same amount of the drug
to your bloodstream over time.
So it's like a generic brand of cereal maybe?
Exactly.
Different packaging, but the stuff inside
(10:26):
is essentially the same.
Yep, that's the idea.
Generic drug manufacturers, they don't
have to repeat all those really expensive clinical trials
that were done for the original brand name drug.
They just have to prove that their version is bioequivalent.
Makes sense.
It streamlines the whole process, which
helps make meds more affordable.
And that's a good thing.
Absolutely.
(10:47):
NDAs play a crucial role in making sure everyone
can access affordable medications.
All right, so we've covered TGMPs, NDAs, 505B2s, NDAs.
My head's spinning a bit, but in a good way.
It's a lot to take in for sure.
It's fascinating to see how these medications actually
get to us.
It is a pretty complex world.
(11:07):
Before we move on, I want to touch on something
we mentioned earlier, those gray areas,
especially with nutraceuticals.
Let's say something is being marketed
as a superfood with all these amazing health benefits.
How can our listeners tell if it's really safe and effective?
What questions should they be asking?
That's a fantastic question, and it's something everyone
(11:29):
should be thinking about.
So where do we even start?
Well, we'll dive deeper into all of that
in the next part of our deep dive.
Sounds good.
We'll be right back after short break.
Yeah, it really is a jungle out there,
especially with all these wellness products.
They make all sorts of claims.
And remember, nutraceuticals, they're
not subject to the same level of scrutiny as actual drugs.
(11:52):
So a healthy dose of skepticism is never a bad thing.
OK, so how can our listeners be saddy consumers when
it comes to these products?
What are some red flags to look out for?
I'd say one of the biggest red flags
is any product that claims to cure or treat
(12:12):
a specific disease.
That's a huge no-no, unless it's been approved by the FDA
as a drug.
So if something says it can cure diabetes or eliminate
arthritis, that's a problem.
Yeah, run the other way.
Got it.
Those are the kinds of claims that should
make you really suspicious.
Remember, if it sounds too good to be true, it probably is.
(12:33):
Yeah, good advice.
Right.
What about claims that are a little more subtle?
Like, what if a supplement says it supports immune health
or promotes relaxation?
Those are definitely trickier, because they're often
vague enough to avoid making specific medical claims.
But even with those, you really got to look for evidence.
(12:55):
What kind of evidence should people be looking for?
Ideally, you want to see if those claims are backed up
by scientific research.
Look for studies that have been published in reputable journals.
And be careful about testimonials or anecdotes.
They're not the same as solid scientific evidence.
So don't just take the company's word for it.
Exactly.
Do your own research.
Look for information from sources that are independent,
(13:19):
like the National Institutes of Health website.
They have great information on dietary supplements
that's actually evidence-based.
Now, when it comes to CBD specifically,
since the regulations are still kind of up in the air,
what's your advice?
I'd say proceed with caution.
The FDA has been sending out warning letters
to companies making claims about CBD that aren't backed up.
(13:42):
So be wary of those products making big promises.
So like, if a CBD product claims to cure everything
from insomnia to cancer, that's a red flag.
Huge red flag.
You really want to stick to products from companies
are reputable, companies that are open about their
manufacturing process, where they get their CBD from.
Right.
And if you're thinking about using CBD for a specific health
(14:05):
condition, it's always best to talk to your doctor first.
That's good advice.
I think it's easy to forget that even though these things are
marketed as natural or plant-based,
they could still have powerful effects.
They could interact with other medications.
Definitely.
So it's always better to be safe than sorry.
Exactly.
And consult with a health care professional.
For sure.
(14:25):
Speaking of being cautious, I want
to circle back to the drug approval process for a minute.
OK.
We've talked about NDAs, 505B2s, and ADAs.
But none of those actually guarantee
that a drug will get to market, right?
That's right.
Even after going through all of that,
a drug still needs to get approval from the FDA.
Right.
The review process is very thorough,
(14:48):
and they won't hesitate to reject an application
if they have concerns about safety or effectiveness.
So it's not just a rubber stamp.
The FDA really does their homework.
Absolutely.
And even after a drug is approved,
they keep monitoring it.
Oh, wow.
It's called post-marketing surveillance.
OK.
They can either really pull a drug off the market
if there are new safety concerns.
(15:08):
So it's not just a one-time check.
They're keeping an eye on things even after a drug is
available to everyone.
Yep.
That's how seriously they take their role
in protecting public health.
And that's reassuring.
It is.
Well, it sounds like the FDA has a pretty big job.
They do.
And a crucial one.
For sure.
But we've been talking a lot about regulations
and processes.
Yeah.
Let's bring it back to something a little more personal.
(15:30):
OK.
Knowing all of this about drug regulation,
how should our listeners approach their own health care
decisions?
That's a great question.
What questions should they be asking their doctor
or pharmacist about their medications?
I think the most important thing is to be really involved
in your health care.
OK.
Don't be afraid to ask questions,
(15:52):
even if they seem basic.
So no question is too silly.
Exactly.
You have the right to understand your medications,
how they work.
Ask your doctor or pharmacist about things
like potential side effects.
Are there any interactions with other meds you might be taking?
What to do if you miss a dose?
Things like that.
That's a great list.
Yeah.
(16:12):
It reminds me of something we talked about earlier.
The importance of looking beyond the marketing
and doing your own research.
Oh, absolutely.
Right.
Don't just take everything at face value.
Yeah.
Dig a little deeper.
Ask those questions.
And be an informed consumer.
Knowledge is power, especially when it comes to your health.
Couldn't agree more.
Well, this has been a fascinating trip
(16:33):
through the world of medications, that's for sure.
It has.
But before we wrap up, I want to touch on one last thing.
OK.
We've been talking about the US this whole time.
Right.
But drug regulations are different in other countries,
right?
Oh, absolutely.
What might be an OTC drug here could require a prescription
somewhere else.
Oh, wow.
And the approval processes can be completely different too.
(16:54):
So if you're traveling with medications,
yeah.
It's a good idea to check the rules of the country
you're going to.
Always a good idea to be prepared and avoid
any surprises at the border.
Good advice.
Right.
Well, listener, I hope you feel a lot more equipped
to navigate the world of medications now.
Me too.
It's definitely complex.
But even understanding the basics
(17:16):
can really help you make good decisions about your health.
Exactly.
And remember, if you ever have questions
about your medications, don't hesitate
to talk to your doctor or pharmacist.
Oh, absolutely.
They're great resources.
They are.
They're your partners in this.
Couldn't said it better myself.
Thanks for joining us for this deep dive
into the world of medications.
(17:36):
It's been a pleasure.
We've covered so much in this deep dive.
We have.
From those really strict regulations
on prescription drugs to nutraceuticals and CBD.
But there's one more piece I want to look at.
OK.
The human side of things.
Ah, you're talking about clinical trials.
That's a big one.
Yeah.
We've mentioned them here and there.
Right.
But I think it's worth taking a closer look at what actually
(17:59):
happens in a clinical trial.
Yeah, definitely.
After all, these trials involve real people.
Right.
Who are volunteering to test new medications.
Absolutely.
It's a big deal.
It is.
Yeah.
Clinical trials are these carefully designed studies.
OK.
That help researchers figure out whether a new drug or treatment
is safe and effective.
And they involve human volunteers
(18:20):
who are very closely monitored.
So it's kind of like a real life laboratory.
Yeah.
But with people instead of test tubes.
Exactly.
And just like in a lab experiment,
there are different phases for clinical trials.
So break it down for me.
What are the different phases?
All right.
So the first phase, phase one, focuses mainly on safety.
OK.
Researchers are trying to see how the drug is absorbed
(18:42):
by the body, how it's broken down, how it's eliminated,
and what doses are safe.
So they start with a small group of people
and basically see if it's toxic.
Basically, yeah.
What happens if it passes that first test?
Then it moves on to phase two.
OK.
And that's where the focus shifts to effectiveness.
They want to see if the drug actually works
(19:04):
for what it's supposed to treat.
So in phase two, they're finding out if it actually
lives up to the hype.
Exactly.
And they'll still gather more safety data to any side effects,
things like that.
So if the results from phase two are promising, then what?
Then it goes to phase three.
OK.
That's the biggest phase, the most rigorous.
OK.
And it involves a lot more people, often
(19:25):
at multiple different locations.
So they're taking the show on the road,
testing it out in the real world.
That's a great way to put it.
So what happens in phase three?
They're often comparing the new drug
to the standard treatment or a placebo
to see how well it works.
It's the final test before a company can even
apply for FDA approval.
(19:45):
That makes sense.
But all this testing with people,
it's got to be super controlled.
There are ethical concerns?
Oh, absolutely.
There are strict ethical guidelines and regulations
in place to protect people in the trials.
OK, good.
It's called good clinical practice.
Good clinical practice.
Or GCP.
GCP, another acronym.
I know, right?
But I'm guessing this is a good thing.
(20:07):
It is a very good thing.
OK.
Think of it as the rule book for running these trials ethically.
Got it.
It covers everything.
Wow.
From getting informed consent to making sure the data is
accurate to ensuring everyone is safe.
So GCP is kind of like a guardian,
making sure everything is done the right way,
that people's rights and safety are protected.
(20:28):
Exactly.
OK, that makes me feel better.
Yeah, ethical considerations are super important.
And people can always back out of a trial.
Right, absolutely.
It's completely voluntary.
OK, good.
People can leave at any time for any reason.
Got it.
Oh.
Well, listener, I hope this gives you
a better understanding of the role clinical trials play
in bringing new meds to market.
It's super important.
(20:49):
It's complex.
Yeah.
But there are a lot of safeguards in place
to make sure everything is safe and effective.
Right.
And it wouldn't be possible without the people who
volunteer for these trials.
Absolutely not.
They're incredibly important.
So if you're interested in learning more
about clinical trials, maybe even participating in one,
talk to your doctor.
(21:09):
Or check out the National Institutes of Health website.
Yeah, that's a great resource.
That's a great reminder that we can all
play a part in moving medical science forward.
For sure.
Well, that wraps up our deep dive
into the world of medications.
It does.
We covered a lot, from the regulations for prescription
drugs to the details of nutraceuticals
and the crucial role of clinical trials.
(21:31):
It's been quite a journey.
We hope you learned some valuable things today.
You too.
And feel more confident navigating
the world of medications.
Yeah.
Remember, knowledge is power when it comes to your health.
Absolutely.
So keep asking questions, keep learning,
and keep talking to your health care providers.
Those are great takeaways.
And if you ever have more questions about drug regulation,
(21:52):
you know where to find us.
We'll be here for your next deep dive.
Until then, stay curious and stay well.
Bye, everyone.
All right, let's dive into the world of medications.
(00:03):
Today, we're tackling the differences
between over-the-counter and prescription drugs
here in the US.
Sounds good.
You know, a lot of listeners want
to untangle that whole web of regulations and approvals
and especially figure out where things
like nutraceuticals fit in.
Yeah.
Oh, and CBD.
Everyone wants to know about CBD these days.
Of course.
Plus, we've got some great questions
(00:25):
about things like 505b2, pathways, and NDAs.
Oh, wow.
Getting specific.
Right.
It gets pretty complex.
Luckily, we've got you here to help us break it all down.
Happy to be here.
Let's start with something that might surprise people.
OK.
I'm intrigued.
Did you know that some of the stuff we eat
is technically considered a drug?
Wait a minute.
I thought we were talking about medications, not
(00:46):
my grocery list.
I know, right?
It's all about the intended use.
OK.
So take baking soda, for example.
OK, yeah, baking soda.
You can use it in baking, of course,
but it's also marketed as a heartburn remedy.
Oh, right, right.
Because it's used for medicinal purposes,
boom, it falls under the FDA's regulations
for over-the-counter drugs.
So the same thing could be a food and a drug,
depending on how you're using it.
(01:07):
Exactly.
That's pretty wild.
It seems like there must be a ton of rules
to keep everything straight.
Oh, there are, definitely.
The main source is the Code of Federal Regulations, or CFR,
specifically Title 21.
It's basically a giant encyclopedia
for anything and everything related to food and drugs.
Different sections are dedicated to specific types of products,
(01:30):
so it gets very detailed.
Got it.
CFR, Title 21.
So whether we're talking about a simple antacid
or a really powerful prescription painkiller,
there have to be some baseline quality standards, right?
Absolutely.
Both OTC and prescription drugs have
to meet something called current good manufacturing
practices, or CGMPs for short.
(01:52):
CGMPs.
Is that just a fancy way of saying,
keep your kitchen clean?
That's actually a great analogy.
Oh, OK.
CGMPs basically ensure that all drugs,
doesn't matter if you pick them up off the shelf
or needed a prescription, they're all
made with that same level of care,
that same focus on safety.
Think of it as a guarantee that your medications have
(02:15):
been made in a really clean, really controlled environment
following all those strict quality standards.
So CGMPs are like the universal hygiene rule,
no matter what you're cooking up, so to speak.
Exactly.
But then obviously, prescription drugs
have to go through a much more intense approval process.
Why is that?
Well, it really comes down to the potential risks
(02:37):
and benefits.
Prescription drugs are often much stronger.
They can have some pretty serious side effects.
So the FDA, the Food and Drug Administration,
they have a much stricter approval process.
Got to make sure everything is safe and effective.
If that makes sense.
So walk me through it.
What does a company have to do to get a brand new prescription
drug approved?
All right, so they have to submit what's
(02:57):
called a new drug application or an NDA to the FDA.
This is not just some quick form they fill out.
It's massive.
Really?
Oh, yeah.
It's a huge document that details literally everything
about the drug, everything from its chemical structure
to the results of years of clinical trials.
(03:17):
Years.
Wow.
So they're really put through the wringer, these drugs.
For sure.
The FDA wants to see data on everything.
How the drug works in the body, how effective
it is at treating the condition it's meant for, any side
effects, how it's made, the whole nine yards.
So they don't just look at whether the drug works.
They really weigh the benefits against the risks.
(03:38):
Exactly.
They want to make absolutely sure that it's
safe for people to use.
So the FDA is like a gatekeeper, making
sure only safe and effective drugs make it to the market.
That's a great way to put it.
But drug development is a global thing, right?
Yeah.
Do other countries have similar processes?
Definitely.
And that's where the International Council
for Harmonization comes in.
Or ICH.
ICH, got it.
They bring together regulatory authorities
(04:00):
and pharmaceutical companies from all around the world
to basically develop guidelines for good clinical practice.
So the ICH is making sure there's
some consistency in how drugs are developed and evaluated
across different countries.
Yep, that's the goal.
Sounds like a win for global public health.
I think so, too.
OK, so prescription drugs, we got that covered.
(04:21):
Let's move on to over-the-counter drugs.
Right.
Are those also subject to all this FDA scrutiny?
Oh, absolutely.
You might be able to buy them without a prescription,
but OTC drugs still go through a pretty
rindious FDA approval process.
Really?
Yep.
The FDA has to be confident that they're safe enough for people
to use on their own.
(04:42):
So it's not just a free for all out there?
Not at all.
There's still a lot of oversight.
Got to make sure what ends up on drugstore shelves
is safe for everyone.
But there must be some unique things
about OTC drug regulation.
Oh, there are, definitely.
I mean, we talked about intended use being important.
Does that come into play here, too?
Totally.
Remember that baking soda example?
It's a great illustration of how things
(05:03):
can get a bit blurry between food and drugs.
Right, right.
So what else is unique about OTC drugs?
Well, another interesting thing is the tamper evident packaging
requirement.
You mean like that seal you have to break before you
can open a bottle of pills?
Exactly.
I've always wondered about that.
Well, unfortunately, it was implemented
after some pretty tragic situations where
(05:25):
OTC meds were tampered with.
Oh, wow.
So it's a super important safety measure
to make sure what you're buying is actually what it says it is.
Yeah, that's a sobering reminder about how important
those regulations are.
Speaking of things that can get a little tricky,
let's talk about nutraceuticals.
Where do those fit into all of this?
That's a great question.
(05:46):
And this is where things get even more complex,
especially when it comes to your question about CBD.
Oh, yeah, CBD.
Everyone's talking about it.
All right, let's unpack this a bit.
First things first, remind me what exactly
are nutraceuticals?
Think of them as products that are derived from food sources.
But they're making claims about additional health benefits.
(06:07):
Things like fishmill capsules, probiotics,
certain herbal extracts, they often fall into this category.
So they're kind of in that gray area between food and drugs.
Yeah.
But they're regulated, right?
Yes, but the regulations are usually a bit less strict
than those for actual drugs.
Neutraceuticals usually fall under dietary supplement
(06:27):
regulations, which means they don't
have to go through that same intense FDA approval process
as OTC or prescription drugs.
So less evidence is required, but there's also
less oversight.
Exactly.
That sounds like it could be a bit of a double-edged sword
for consumers.
It definitely can be.
Now, brings the CBD, since that's
what everyone wants to know about.
It often gets marketed as a nutraceutical, right?
(06:50):
It does.
So where does it fit into this regulatory puzzle?
Is it a drug?
Is it a supplement?
Is it both?
Is it neither?
Well, the legal status of CBD is still evolving, to be honest,
especially when it comes to making health claims.
On one hand, you've got the FDA who
has approved a CBD-derived drug for epilepsy.
But that doesn't mean all CBD is automatically
(07:12):
considered a drug.
So once specific CBD medication is approved,
but that doesn't extend to all CBD.
Exactly.
OK, got it.
And here's where it gets even more complex.
Oh, boy.
Some companies are marketing CBD as a nutraceutical,
as a dietary supplement.
But the FDA has been cracking down
on companies that are making, let's say, unsubstantiated
(07:35):
health claims about CBD.
So it's like a regulatory tug of war.
The FDA is recognizing the medical potential of CBD
in some cases, but they're also trying to keep companies
from making false claims.
It's exactly that.
It's a hot topic, lots of gray areas,
and the regulations are constantly evolving.
It sounds murky, even for someone
who follows this stuff closely.
It is.
It is.
And it's important for people to stay informed
(07:55):
and be really cautious about those claims
companies are making about CBD products.
Good advice.
Now, I know our listener also asked about 505b2 applications
in NEDAs.
Oh, yeah, those are important ones.
They can apparently speed up drug development.
They're key for getting new and generic drugs
to market more quickly.
Before we jump into those, though,
let's take a step back.
(08:16):
Why do we even need these alternative pathways?
Yeah.
Isn't the standard NDA process enough?
Well, the standard NDA process is super rigorous
and for good reason, but it can also be really time
consuming and expensive.
These alternative pathways offer a way to streamline things,
especially for certain types of drugs, particularly those that
(08:39):
build on existing knowledge or ones that have already been
proven safe and effective.
So they're kind of like shortcuts,
but not in a way that's going to compromise
safety or effectiveness, right?
Exactly.
You still have to go through a thorough FDA review,
but companies can leverage existing data,
and that can seriously speed up the approval process.
OK, I like the sound of that.
(09:00):
Let's dive into 505b2 first.
What's the deal with this one?
Think of it as a kind of middle ground between a full NDA
and an ADA.
It's for drugs that are similar to ones that are already
approved but have some key differences,
like a new formulation, a different dosage,
or a new use for an existing drug.
So instead of starting totally from scratch,
(09:21):
companies can build on what's already out there.
Exactly.
It's much more efficient.
That makes a lot of sense.
Could you give me an example?
Sure.
Let's say a company wants to make a new extended release
version of a drug that already exists.
They could use the 505b2 pathway.
They can rely on some of the data
that was used to approve the original drug.
(09:43):
So it's like a remix, taking a proven hit
and tweaking it for a new purpose
or maybe just delivering it better.
That's a great way to put it.
What about NDAs?
Where do those come in?
NDAs are abbreviated new drug applications.
That's the pathway for generic drugs.
Generic drugs, the heroes of affordable medication.
You got it.
So how do NDAs help?
It's all about bioequivalence.
(10:04):
Bioequivalence?
OK, that's another one for the acronym Bingo Card.
What does that mean?
It means that the generic drug works in your body
the exact same way as the brand name drug.
Same active ingredient, same dosage.
And it delivers the same amount of the drug
to your bloodstream over time.
So it's like a generic brand of cereal maybe?
Exactly.
Different packaging, but the stuff inside
(10:26):
is essentially the same.
Yep, that's the idea.
Generic drug manufacturers, they don't
have to repeat all those really expensive clinical trials
that were done for the original brand name drug.
They just have to prove that their version is bioequivalent.
Makes sense.
It streamlines the whole process, which
helps make meds more affordable.
And that's a good thing.
Absolutely.
(10:47):
NDAs play a crucial role in making sure everyone
can access affordable medications.
All right, so we've covered TGMPs, NDAs, 505B2s, NDAs.
My head's spinning a bit, but in a good way.
It's a lot to take in for sure.
It's fascinating to see how these medications actually
get to us.
It is a pretty complex world.
(11:07):
Before we move on, I want to touch on something
we mentioned earlier, those gray areas,
especially with nutraceuticals.
Let's say something is being marketed
as a superfood with all these amazing health benefits.
How can our listeners tell if it's really safe and effective?
What questions should they be asking?
That's a fantastic question, and it's something everyone
(11:29):
should be thinking about.
So where do we even start?
Well, we'll dive deeper into all of that
in the next part of our deep dive.
Sounds good.
We'll be right back after short break.
Yeah, it really is a jungle out there,
especially with all these wellness products.
They make all sorts of claims.
And remember, nutraceuticals, they're
not subject to the same level of scrutiny as actual drugs.
(11:52):
So a healthy dose of skepticism is never a bad thing.
OK, so how can our listeners be saddy consumers when
it comes to these products?
What are some red flags to look out for?
I'd say one of the biggest red flags
is any product that claims to cure or treat
(12:12):
a specific disease.
That's a huge no-no, unless it's been approved by the FDA
as a drug.
So if something says it can cure diabetes or eliminate
arthritis, that's a problem.
Yeah, run the other way.
Got it.
Those are the kinds of claims that should
make you really suspicious.
Remember, if it sounds too good to be true, it probably is.
(12:33):
Yeah, good advice.
Right.
What about claims that are a little more subtle?
Like, what if a supplement says it supports immune health
or promotes relaxation?
Those are definitely trickier, because they're often
vague enough to avoid making specific medical claims.
But even with those, you really got to look for evidence.
(12:55):
What kind of evidence should people be looking for?
Ideally, you want to see if those claims are backed up
by scientific research.
Look for studies that have been published in reputable journals.
And be careful about testimonials or anecdotes.
They're not the same as solid scientific evidence.
So don't just take the company's word for it.
Exactly.
Do your own research.
Look for information from sources that are independent,
(13:19):
like the National Institutes of Health website.
They have great information on dietary supplements
that's actually evidence-based.
Now, when it comes to CBD specifically,
since the regulations are still kind of up in the air,
what's your advice?
I'd say proceed with caution.
The FDA has been sending out warning letters
to companies making claims about CBD that aren't backed up.
(13:42):
So be wary of those products making big promises.
So like, if a CBD product claims to cure everything
from insomnia to cancer, that's a red flag.
Huge red flag.
You really want to stick to products from companies
are reputable, companies that are open about their
manufacturing process, where they get their CBD from.
Right.
And if you're thinking about using CBD for a specific health
(14:05):
condition, it's always best to talk to your doctor first.
That's good advice.
I think it's easy to forget that even though these things are
marketed as natural or plant-based,
they could still have powerful effects.
They could interact with other medications.
Definitely.
So it's always better to be safe than sorry.
Exactly.
And consult with a health care professional.
For sure.
(14:25):
Speaking of being cautious, I want
to circle back to the drug approval process for a minute.
OK.
We've talked about NDAs, 505B2s, and ADAs.
But none of those actually guarantee
that a drug will get to market, right?
That's right.
Even after going through all of that,
a drug still needs to get approval from the FDA.
Right.
The review process is very thorough,
(14:48):
and they won't hesitate to reject an application
if they have concerns about safety or effectiveness.
So it's not just a rubber stamp.
The FDA really does their homework.
Absolutely.
And even after a drug is approved,
they keep monitoring it.
Oh, wow.
It's called post-marketing surveillance.
OK.
They can either really pull a drug off the market
if there are new safety concerns.
(15:08):
So it's not just a one-time check.
They're keeping an eye on things even after a drug is
available to everyone.
Yep.
That's how seriously they take their role
in protecting public health.
And that's reassuring.
It is.
Well, it sounds like the FDA has a pretty big job.
They do.
And a crucial one.
For sure.
But we've been talking a lot about regulations
and processes.
Yeah.
Let's bring it back to something a little more personal.
(15:30):
OK.
Knowing all of this about drug regulation,
how should our listeners approach their own health care
decisions?
That's a great question.
What questions should they be asking their doctor
or pharmacist about their medications?
I think the most important thing is to be really involved
in your health care.
OK.
Don't be afraid to ask questions,
(15:52):
even if they seem basic.
So no question is too silly.
Exactly.
You have the right to understand your medications,
how they work.
Ask your doctor or pharmacist about things
like potential side effects.
Are there any interactions with other meds you might be taking?
What to do if you miss a dose?
Things like that.
That's a great list.
Yeah.
(16:12):
It reminds me of something we talked about earlier.
The importance of looking beyond the marketing
and doing your own research.
Oh, absolutely.
Right.
Don't just take everything at face value.
Yeah.
Dig a little deeper.
Ask those questions.
And be an informed consumer.
Knowledge is power, especially when it comes to your health.
Couldn't agree more.
Well, this has been a fascinating trip
(16:33):
through the world of medications, that's for sure.
It has.
But before we wrap up, I want to touch on one last thing.
OK.
We've been talking about the US this whole time.
Right.
But drug regulations are different in other countries,
right?
Oh, absolutely.
What might be an OTC drug here could require a prescription
somewhere else.
Oh, wow.
And the approval processes can be completely different too.
(16:54):
So if you're traveling with medications,
yeah.
It's a good idea to check the rules of the country
you're going to.
Always a good idea to be prepared and avoid
any surprises at the border.
Good advice.
Right.
Well, listener, I hope you feel a lot more equipped
to navigate the world of medications now.
Me too.
It's definitely complex.
But even understanding the basics
(17:16):
can really help you make good decisions about your health.
Exactly.
And remember, if you ever have questions
about your medications, don't hesitate
to talk to your doctor or pharmacist.
Oh, absolutely.
They're great resources.
They are.
They're your partners in this.
Couldn't said it better myself.
Thanks for joining us for this deep dive
into the world of medications.
(17:36):
It's been a pleasure.
We've covered so much in this deep dive.
We have.
From those really strict regulations
on prescription drugs to nutraceuticals and CBD.
But there's one more piece I want to look at.
OK.
The human side of things.
Ah, you're talking about clinical trials.
That's a big one.
Yeah.
We've mentioned them here and there.
Right.
But I think it's worth taking a closer look at what actually
(17:59):
happens in a clinical trial.
Yeah, definitely.
After all, these trials involve real people.
Right.
Who are volunteering to test new medications.
Absolutely.
It's a big deal.
It is.
Yeah.
Clinical trials are these carefully designed studies.
OK.
That help researchers figure out whether a new drug or treatment
is safe and effective.
And they involve human volunteers
(18:20):
who are very closely monitored.
So it's kind of like a real life laboratory.
Yeah.
But with people instead of test tubes.
Exactly.
And just like in a lab experiment,
there are different phases for clinical trials.
So break it down for me.
What are the different phases?
All right.
So the first phase, phase one, focuses mainly on safety.
OK.
Researchers are trying to see how the drug is absorbed
(18:42):
by the body, how it's broken down, how it's eliminated,
and what doses are safe.
So they start with a small group of people
and basically see if it's toxic.
Basically, yeah.
What happens if it passes that first test?
Then it moves on to phase two.
OK.
And that's where the focus shifts to effectiveness.
They want to see if the drug actually works
(19:04):
for what it's supposed to treat.
So in phase two, they're finding out if it actually
lives up to the hype.
Exactly.
And they'll still gather more safety data to any side effects,
things like that.
So if the results from phase two are promising, then what?
Then it goes to phase three.
OK.
That's the biggest phase, the most rigorous.
OK.
And it involves a lot more people, often
(19:25):
at multiple different locations.
So they're taking the show on the road,
testing it out in the real world.
That's a great way to put it.
So what happens in phase three?
They're often comparing the new drug
to the standard treatment or a placebo
to see how well it works.
It's the final test before a company can even
apply for FDA approval.
(19:45):
That makes sense.
But all this testing with people,
it's got to be super controlled.
There are ethical concerns?
Oh, absolutely.
There are strict ethical guidelines and regulations
in place to protect people in the trials.
OK, good.
It's called good clinical practice.
Good clinical practice.
Or GCP.
GCP, another acronym.
I know, right?
But I'm guessing this is a good thing.
(20:07):
It is a very good thing.
OK.
Think of it as the rule book for running these trials ethically.
Got it.
It covers everything.
Wow.
From getting informed consent to making sure the data is
accurate to ensuring everyone is safe.
So GCP is kind of like a guardian,
making sure everything is done the right way,
that people's rights and safety are protected.
(20:28):
Exactly.
OK, that makes me feel better.
Yeah, ethical considerations are super important.
And people can always back out of a trial.
Right, absolutely.
It's completely voluntary.
OK, good.
People can leave at any time for any reason.
Got it.
Oh.
Well, listener, I hope this gives you
a better understanding of the role clinical trials play
in bringing new meds to market.
It's super important.
(20:49):
It's complex.
Yeah.
But there are a lot of safeguards in place
to make sure everything is safe and effective.
Right.
And it wouldn't be possible without the people who
volunteer for these trials.
Absolutely not.
They're incredibly important.
So if you're interested in learning more
about clinical trials, maybe even participating in one,
talk to your doctor.
(21:09):
Or check out the National Institutes of Health website.
Yeah, that's a great resource.
That's a great reminder that we can all
play a part in moving medical science forward.
For sure.
Well, that wraps up our deep dive
into the world of medications.
It does.
We covered a lot, from the regulations for prescription
drugs to the details of nutraceuticals
and the crucial role of clinical trials.
(21:31):
It's been quite a journey.
We hope you learned some valuable things today.
You too.
And feel more confident navigating
the world of medications.
Yeah.
Remember, knowledge is power when it comes to your health.
Absolutely.
So keep asking questions, keep learning,
and keep talking to your health care providers.
Those are great takeaways.
And if you ever have more questions about drug regulation,
(21:52):
you know where to find us.
We'll be here for your next deep dive.
Until then, stay curious and stay well.
Bye, everyone.
Popular Podcasts
Crime Junkie
Does hearing about a true crime case always leave you scouring the internet for the truth behind the story? Dive into your next mystery with Crime Junkie. Every Monday, join your host Ashley Flowers as she unravels all the details of infamous and underreported true crime cases with her best friend Brit Prawat. From cold cases to missing persons and heroes in our community who seek justice, Crime Junkie is your destination for theories and stories you won’t hear anywhere else. Whether you're a seasoned true crime enthusiast or new to the genre, you'll find yourself on the edge of your seat awaiting a new episode every Monday. If you can never get enough true crime... Congratulations, you’ve found your people. Follow to join a community of Crime Junkies! Crime Junkie is presented by audiochuck Media Company.
24/7 News: The Latest
The latest news in 4 minutes updated every hour, every day.
Stuff You Should Know
If you've ever wanted to know about champagne, satanism, the Stonewall Uprising, chaos theory, LSD, El Nino, true crime and Rosa Parks, then look no further. Josh and Chuck have you covered.