When the topic of Brand vs. Generic medications came up with a Wal-Mart pharmacist, I started researching. I
just saw an updated special on Fox News in December 2008 about "Alternative" Generics that are wrecking havoc with people's
lives - it said some of these "alternatives" are making people sicker by adding more and more fillers and additives; which
causes the active ingredient to be less effective.
This is just crazy - the SAME company can let their
patent expire and then turn around file to sell a generic drug then sell to us the consumers, both the brand AND the generic...interesting.
Here
is some information about the differences:
What are generic drugs?
A generic drug is a version of
a brand drug. According to the U.S. Food and Drug Administration (FDA), compared to the brand drug, a generic:
- is chemically the same
- works the same in the body
- is just as safe and effective
- meets the same standards set by the FDA
- often costs much less.
There are two forms of generic substitution:
- A generic equivalent is made with the same active ingredient at
the same dosage as the brand medication. You can expect the same results as with the brand counterpart.
- A generic alternative works like a brand drug and may be used to
treat the same condition. But the chemicals in a generic alternative differ from the brand drug or its generic equivalent.
So, overall results may be somewhat different.
Important: Your pharmacist can usually substitute a generic
equivalent for its brand counterpart without a new prescription from your doctor. But only your doctor can determine whether
a generic alternative is right for you and must prescribe the medication.
Bioequivalence,
however, does not mean that generic drugs are exactly the same as their innovator product counterparts, as chemical differences
do exist.
Some doctors and patients emphatically believe
that certain generic drugs are not as effective as the products they are meant to replace (ie. Prozac, Oxycontin), and consumers
would undoubtedly benefit from more clinical studies done on drug by drug basis.
Generic drugs look different
from brand-name drugs. This is because trademark laws do not allow generics to look exactly like brand-name drugs.
Colors, flavors, and other inactive ingredients may be different.
Quote:
These differences may cause slightly different effects. Some brand-name drugs may be more
easily absorbed by the body. Brand-name drugs may cause fewer or weaker side effects. |
Never assume that a medicine looks different just because
it is generic. Double check with the pharmacist that you have the correct medicine before you leave the pharmacy.
Why
do generics typically cost less than brand medications?
When a brand drug first becomes available, the manufacturer
usually receives a patent. This patent protects their investment in the new drug by keeping other companies from copying and
producing it for several years.
When a patent expires, other manufacturers can produce a generic version of the drug
– and the cost goes down. On average, a generic drug costs 30 to 80 percent less than its brand counterpart.
The generic version works like the brand-name drug in dosage, strength, performance and use,
and must meet the same quality and safety standards.
All generic drugs must be reviewedand approved by FDA.
Why do generic drugs look different than brand
drugs?
Trademark laws require that a generic
drug look different than a drug already on the market. So, a generic equivalent will be a different size, shape and/or color
than the brand drug.
Although the active ingredient in a generic equivalent is always
the same as the brand counterpart, the generic may have different inactive ingredients, such as a coating or flavoring.
In addition, since more than one manufacturer may produce a generic equivalent for the
same brand drug, generics can vary based on which supplier or suppliers your pharmacy uses.
Bioequivalence,
however, does not mean that generic drugs are exactly the same as their innovator product counterparts, as chemical differences
do exist.
Some doctors and patients emphatically believe that certain
generic drugs are not as effective as the products they are meant to replace (ie. Prozac, Oxycontin), and consumers would
undoubtedly benefit from more clinical studies done on drug by drug basis.
For more reading visit:
U.S. FDA CDER Home PageOffice of Generic Drugs Home Page
Here's another way of thinking about it; alittle easier to comprehend than
the medical jargon they have on the FDA website:
In the United States, the Food and Drug Administration (FDA) requires
that all drugs, whether a brand name drug or a generic drug, meet standards of safety, strength, purity and effectiveness
A
drug may be chemically exact but not bioequivalent.
In other words, two different products
of the same drug may not get into the body in exactly the same way.
Bioequivalence depends on how the drug is formulated
and how it is absorbed and eliminated by the body.
Other ingredients can affect the absorption of the drug. These
include starch fillers, gum-like substances and other products which allow a drug to be formulated into a pill or capsule.
Factors such as a person's age, body mass, kidney, liver and intestinal function can also affect the
absorption of the drug by the body.
The human body is always changing, and factors such as diet, metabolic rate and hormones can affect how a drug acts in the body.
For
the most part, these changes are not cause for alarm, but it is important to realize that a person may try the same brand
or generic medication and have a different experience at different times.
However, in most instances, the generic
and brand name drugs are both working in the body.
To summarize, generic drugs, if they have been approved by the FDA,
are as safe and effective as the brand name product.
Wow I wonder how true this is? This is from drugs.com:
Why you sometimes have problems with Generic Drugs
Some people have disagreed with me when I explained about the
20% plus or minus difference that the FDA allows for generic drugs, some have insisted this was only for the inactive ingredients.
I have done some more research on this
subject, and NO! the 20% difference IS NOTjust limited to the inactive ingredients.
Here's
an article with some information, and the name of the law that allows this:
http://counsellingresource.com/medic.../generics.html
Are There Any Differences Between Generics and Brand-Name Drugs?
...it
should be noted that current regulations permit a variation of up to 20% either way in the bioavailability
of the active ingredient.
(See this Food and Drug Law Institute overview of the Hatch-Waxman
Act of 1999.)
In one study (Borgheini 2003), a 31% variation was found in the blood plasma levels of a particular
medication after a patient switched from a branded to a generic product.
(Why does this happen? It may be accounted
for by differences in the manufacturing process yielding different particle sizes that are absorbed at different rates, as
well as other factors.)
So yes, this gives them a leeway of 40% on manufacturing these drugs,
they can be significantly different than their name brand counterparts, and
in some cases the effect can mean a drug doesn't work at all, or may have too much of the active ingredient,
resulting in serious effects or even fatalities!
Here's the overview of the law in question that allows these differences:
http://www.fdli.org/pubs/Journal%20Online/54_2/art2.pdf
For some of you, I know this will be a relief as you can now know
for sure that if a generic seems to work different, it is not all in your head. Simply said, poor quality control and poor
testing, means poorly made drugs from some companies.