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Medical Forum / General / Pharmacy / February 2004

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Flonase, Allegra, etc not OTC? Why?

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Peter - 05 Feb 2004 19:07 GMT
Why are medicines like allegra, flonase, and the like available by
prescription only?

It appears quite ridiculus to me that is actually illegal to buy safe
medicines like those without a prescription.  It's hard not to laugh
about the silliness of it.  What is the punishment by the governemt
for purchasing them without prescription?  Fines, jail time, or
something else?  If  the matter was ever to be brought to the supreme
court, they'd rule this law as unconstitutional (which is clearly the
case).

-Peter
James Pinkerton - 06 Feb 2004 02:02 GMT
Much of the reason is the drug companies do not want to sell the drugs
without a prescription. They figure they can make more money by charging the
high prices they can get for them being prescription only and not available
as a generic..  I have a Rx for Allegra but even with insurance co-pay it
costs me about thirty dollars for thirty tablets.  I switched myself to
generic Claritin.  I get it from Dollar General store and it cost $2.50 for
ten tablets!  Works just as well or better than Allegra.

The FDA is protecting drug company profits, not your health with regard to
the medication that you mentioned.

> Why are medicines like allegra, flonase, and the like available by
> prescription only?
[quoted text clipped - 8 lines]
>
> -Peter
Nigel - 06 Feb 2004 04:31 GMT
> Much of the reason is the drug companies do not want to sell the drugs
> without a prescription. They figure they can make more money by
[quoted text clipped - 4 lines]
> General store and it cost $2.50 for ten tablets!  Works just as well
> or better than Allegra.

Could you please explain:

1.        How drug companies make more money by having a drug available by
prescription only, and
2.        How being prescription only prevents generic competition.
James Pinkerton - 06 Feb 2004 06:31 GMT
> Could you please explain:

> 1.    How drug companies make more money by having a drug available by
prescription only, and

One thing since it is Rx only the consumer will think it is better (which it
might be and pay more money for it) than a cheaper product that is not
prescribed by a doctor. Also insurance companies and the government doesn't
generally pay for none Rx medication.  Not that many people would have paid
four bucks a piece for Prilosec capsules and most certainly can't afford to
pay the cash price of all the expensive AIDS medication.  The government is
paying for most of it.  After all, if a doctor prescribes it, it must be
better than a plain old medication available without a prescription.Who
wants to visit a doctor and be told to just take aspirin and drink lots of
water for a cold.  Seems like you have wasted time and money. Since it is Rx
only a team of sales people can desend like locus on the doctors and educate
them that the Rx product is better than its rivals.  Note how the company
that made Claritin never pushed the FDA for it to be made available without
a Rx.  Once  the patent on Claritin expired and generic companies could make
it and undercut the price of the brand name, the Schering Corporation was
all for its being made available to the consumer without a Rx.  Then they
cut the price but still keeping it higher than a pure generic like Dollar
General distributes.  They know that many consumers will pay more for the
brand name even though the drug is available as a generic.

> 2.    How being prescription only prevents generic competition.  It does
not.  However many drugs become available without a Rx once the patent runs
out and generic companies can start making it.  Look at Prilosec for an
example.  Also Tagamet and Pepsid and  Monistat Vaginal Cream.  They all
required a Rx when they had patent protection but suddenly were safe enough
to sell without seeing a doctor after they became available generically.
Wayne Alan Simon - 06 Feb 2004 07:18 GMT
for the same reason its illegal to download free music over the internet.
Patent laws and corporate profits, (sometimes greed especially when it goes
against the public health, and I'm sure music therapy is in the best
interest  of the public health).
Nigel - 06 Feb 2004 14:15 GMT
> for the same reason its illegal to download free music over the
> internet. Patent laws and corporate profits, (sometimes greed
> especially when it goes against the public health, and I'm sure music
> therapy is in the best interest  of the public health).

You have lost me here.  What question are you answering?
Nigel - 06 Feb 2004 14:14 GMT
>> Could you please explain:
>
[quoted text clipped - 23 lines]
> know that many consumers will pay more for the brand name even though
> the drug is available as a generic.

You have not explained how the drug company makes more money by having a
product available only by prescription.  Let me help your thinking on
this.
1.        How does the price change,
2.        How do unit sales change,
3.        How do manufacturing costs change,
4.        How do distribution costs change,
5.        How do liability costs change,
6.        How do regulatory costs change, and
7.        How do sales costs change.
Actual numbers and examples would be very helpful here.

>> 2.    How being prescription only prevents generic competition.  It
>> does
[quoted text clipped - 4 lines]
> were safe enough to sell without seeing a doctor after they became
> available generically.

I take it then you are retracting the point you made in your first post:

"They figure they can make more money by charging the
high prices they can get for them being prescription only and not
available
as a generic."

which implies that there is no generic competition because it is
prescription.
James Pinkerton - 06 Feb 2004 19:41 GMT
Yes. The reason there is no generic competition is because the source
company will not license a generic firm to produce it. At first,
medications under patent are only be available from one source, the original
company that discovered it.  If the company had to sell it at low cost they
would probably just shelf the product and not bother.   Some companies are
not very keen on selling AIDS drugs at a low cost to undeveloped African
nations that can not afford American drug prices.

> I take it then you are retracting the point you made in your first post:
>
[quoted text clipped - 4 lines]
> which implies that there is no generic competition because it is
> prescription

Sorry for the grammar.  "not available as a generic" is not a result of them
being prescription only, just the result of patent laws such as protect
works of art like music..
Peter - 08 Feb 2004 21:19 GMT
It has kinda gotten off the topic of my inquiry.  Does anyone know
what the punishment for purchasing medicines such  allegra, flonase,
or nasonex without a prescription?  I agree meds that are  otc have
additional market pressures that will drive the price down faster.
However, my point and questions were relating to the silliness of the
law.  It's not like these can be dangeruous or have large potential
for abuse.  There are already plenty such things otc that do almost
fit these categories (afrin, asprin, tylonal, alcohol etc).

Are there any cases on record of someone going to jail for illegal
purchasing of allergy medicine?  If so, the government is overstepping
is bounds (acting unconstitutionally) because it has no such
legitimate authority to create or enforce such ridiculus laws.

-Peter

> Yes. The reason there is no generic competition is because the source
> company will not license a generic firm to produce it. At first,
[quoted text clipped - 16 lines]
> being prescription only, just the result of patent laws such as protect
> works of art like music..
Nigel - 08 Feb 2004 23:07 GMT
> It has kinda gotten off the topic of my inquiry.  Does anyone know
> what the punishment for purchasing medicines such  allegra, flonase,
[quoted text clipped - 11 lines]
>
> -Peter

I'm sorry that your question(s) got lost in the discussion.  Let me parse
your question into a few items then answer each part.

1.        Why are some drugs prescription only,
2.        Why do some get changed from prescription to otc,
3.        What are the penalties for buying/selling prescription only
drugs, and
4.        Are drug controls constitutional?

In answering, I will assume you are in the USA, as laws vary.

1.        Generally, new drugs are available by prescription only.  The
approvals are based on controlled, supervised studies.  In the real
world, the use of the drug will vary greatly from the trial protocols.  
For safety sake then, it is considered prudent to keep the patient under
supervision.  This is best accomplished by requiring them to attend a
health professional regularly.  By requiring a prescription, this can be
enforced.

2.        Over a period of time, the post marketing surveillance may
indicate that a drug is sufficiently safe that the general public can
self select and self medicate with little need for ongoing professional
supervision.  See www.fda.gov/opacom/factsheets/justthefacts/9meder.pdf

3.        Typically for a non-narcotic drug, the purchaser will not be
charged with a crime, but keep in mind that the law is written to cover
any drug, not just narcotics.  In fact, the seller may not be charged
either.  However, for the seller, there will likely be professional
consequences, ranging from a reprimand to revocation of license to
practice.  So to the seller, is it worth risking your livlihood for a few
quick bucks.

4.        You may want to read the entire constitution, I think it and
the declaration of independance are two of the greatest documents.  In
particular, look at Article 1, section 8, clause 18, Article 3, section
2, and Article 6 section 2 for your answers - the government is empowered
to pass and enforce laws.

You also raise the rather interesting question should drugs be regulated
at all?  A libertarian would tell you that it is none of the government's
business.  And that a prudent consumer would look for professional advice
before starting any medical treatment, but it is always the individual's
choice.  A more practical minded libertarian would remind you that all
the healthcare professionals are working for you, and that you need to be
a good consumer when buying anything including healthcare.

For more information about prescription and otc drugs, look at the fda
website at www.fda.gov
Jonathan Smith - 10 Feb 2004 17:18 GMT
> > Could you please explain:
>  
[quoted text clipped - 4 lines]
> might be and pay more money for it) than a cheaper product that is not
> prescribed by a doctor.

New technologies tend to be better than old technologies.  New
technologies in medicine have less data regarding safety in general
use.  New technologies are therefor restricted to a more controlled
distribution system (the prescriptive distribution) until such time
that enough safety data are available to allow "self medication."

> Also insurance companies and the government doesn't
> generally pay for none Rx medication.  

Medicaid pays for some, but not all, OTCs.  But this isn't really the
point.  Sales of OTCs are revenues to the producers so the issue isn't
reimbursement but rather price and market size.

> Not that many people would have paid
> four bucks a piece for Prilosec capsules

Can you show me where the willingness to pay study is that says this?

> and most certainly can't afford to
> pay the cash price of all the expensive AIDS medication.  The government is
> paying for most of it.  

In the US, private insurers pay for most drugs.  Medicare at this time
does not pay for outpatient drugs as a general rule.  Medicaid does,
but it represents less than 10% of the total.

> After all, if a doctor prescribes it, it must be
> better than a plain old medication available without a prescription.

You are welcome to use OTCs if you prefer and believe them to be as
good as prescribed medications.  I for one think Ceclor is a bit
better than...monistat? for upper respiratory conditions.

> Who
> wants to visit a doctor and be told to just take aspirin and drink lots of
> water for a cold.  

Who wants to go to a doctor.

> Seems like you have wasted time and money. Since it is Rx
> only a team of sales people can desend like locus on the doctors and educate
[quoted text clipped - 3 lines]
> it and undercut the price of the brand name, the Schering Corporation was
> all for its being made available to the consumer without a Rx.  

OTC Claritin was an initiative undertaken by insurers.  You need to
get your facts right to make your examples supportive of your dribble.

> Then they
> cut the price but still keeping it higher than a pure generic like Dollar
> General distributes.  

And you have a problem with this because?

> They know that many consumers will pay more for the
> brand name even though the drug is available as a generic.

Giving consumers choices is BAD?

Seems you still haven't answered the question - how do drug companies
make more money from prescription drugs than OTCs?

> > 2.    How being prescription only prevents generic competition.  It does
> not.  

Oh - OK - so your second premise was wrong from the start.  Let's see
how much further you wantr to paint yourself into the untenbale
corner.

>However many drugs become available without a Rx once the patent runs
> out and generic companies can start making it.  

Do they now.   Considering Rx to OTC switch is driven by time on
market as is patent expiry, you observed a correlation and inferred
causality.  Shame on you.

> Look at Prilosec for an
> example.  

OK - now what?  Both brand and generic went OTC in September and the
brand share is - 20%  Smart move.

> Also Tagamet and Pepsid and  Monistat Vaginal Cream.  They all
> required a Rx when they had patent protection but suddenly were safe enough
> to sell without seeing a doctor after they became available generically.

Gee - how about that.  Had nothing to do with the fact that after 10
years as a prescription product the safety was well established - and
that the effective patent life on these medications is about - no,
don't say it, 10 years.

Let's see about some other drugs and determine if it's safety or
patent expiry that drives OTC switching.

Adalat
Amoxil
Buspar
Calan
Cardizem
Ceftin
Coumadin
Estrace
Glucophage
Prozac
Vasotec

All generic - not a one OTC.  Hmmmm.  seems it must be safety.

js
 
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