| Myths and Facts about Generic Drugs
Generic drugs may be defined as a counterpart to
branded drug sharing the same quality, strength, safety, dosage
etc..the only difference between the two lies in their price and
looks. The generic drugs are identified by their chemical name.
Once the patent on brand name drugs has expired, the FDA allows
manufacturers other than the original developer to create a bioequivalent
of the brand name drug and make it available to the public.
Generic drugs are alike or bioequivalent to branded product in safety, strength dosage form. People can use them with total confidence. Generic drugs are also chemically identical to their branded products they are typically sold at substantial discounts from the branded price.
Generic drugs are the term for prescription drugs that are the same as brand-name drugs. As with any new type of product, most brand-name prescription drugs are developed under a patent. This patent serves to protect a drug firm's investment in developing the drug by giving the company the sole right to sell the drug while the patent is in effect.
Thus, generic versions of that drug may be sold by competing drug companies only after the patent expires-which is about 17 years after the original drug was discovered. Because competition enters the picture when a patent expires, generic drugs usually sell for less than the brand-name product from the original manufacturer.
The fact that generics generally sell for less has led many people to believe that generics are in some way inferior to brand-name products. That's not true; generic drugs contain exactly the same active ingredients and safe and effective as branded drug. Generic drugs help keep the cost of drugs down. It encourages the research based drug companies to keep finding newer and better medicines that have patent protection.
Myths and Facts related to Generic Drugs:
|
Myth |
Fact |
|
Food and Drug Administration permit
a law to ignore safety and effectiveness requirements
for generic drugs while branded drugs fulfill these
tests. |
Generic manufacturers have to perform
their own tests to verify that the active ingredients
in their products are safe and effective. But branded
products have been already verified all the tests that's
why there is no need to test all again, but generic
drugs must go through scientific testing to prove that
they work same as branded product do. |
Generic
drugs just won't do same job as brand-name drugs. |
To
get FDA approval it is necessary that generic drugs
must be bioequivalent to their branded products. It
means that the generics must contain the same active
ingredients and strength as branded product.
FDA on Generic
Drugs
|
|
Generic drugs are not as powerful
as brand-name drugs. |
Generic
drug manufacturers have to ensure that their products
are of the same quality, strength, purity, and stability
as the brand-name products.
|
|
Generics take longer to act in the
body. |
In
seeking FDA approval for their products, generic makers
must submit evidence that their drugs delivers the same
amount of active ingredient in the same time frame as
the Branded product and also have same quality, strength,
purity, and stability as the brand-name products. |
Generics
products are made by less reliable manufacturers therefore
these drugs are cheaper than branded drugs. |
Many
of the generic drugs approved by the FDA are manufactured
by companies that also make brand name drugs. The manufacturing
process of all drugs is strictly regulated by the FDA
and the same standards are met by all manufacturers.
|
|
Generics are not as safe as brand-name
drugs. |
FDA
requires that all drug products be safe and effective.
Since generics use the same active ingredients as their
brand-name counterparts and work the same way in the
body, generics are as safe and effective as their brand-name
equivalents. |
|
FDA requires that brand-name manufacturers
test new drugs in thousands of patients, but it lets
generic firms get by with tests in only 20 to 30 healthy
volunteers. |
Generic
drugs are duplicate copy of branded product which is
already tested so there is no need to test it on thousands
of patients. Generic manufacturers need only prove to
FDA that their drug reacts as same way in the body as
the original version. |
|
Generic manufacturers only have to
prove that the active ingredients in their products
get to the bloodstream. That doesn't mean that their
products are used by the body in the same way. |
When
the same amount of the active ingredients of the generic
products gets into the bloodstream at the same rate
as the brand-name products, there is no scientific reason
to believe that the effects of the two drugs will differ.
|
|
Most drugs are tested by healthy
young volunteers, yet 25 percent of all prescription
drugs are taken by the elderly who don't respond the
same to drugs. |
While
the elderly may often absorb and process drugs differently
than younger people, there is no proof that drugs will
perform differently in them. Further, it isn't fair
to force already weakened or disabled patients to give
blood samples and face the other discomforts of bioequivalence
testing. Further, such patients cannot be used in bioequivalence
testing because they are virtually always taking other
drugs concurrently. |
Brand-name
drugs are made in new facilities, while generics drugs
are often made in poor facilities. That's why, generics
are usually inferior. |
It
is the responsibility of FDA doesn't allow drugs which
are manufactured in imperfect facilities. FDA is also
responsible to check quality of product. FDA officials
inspect more than 5,000 drug plants a year to ensure
that standards are met. Generic firms have state-of-the-art
plants that compare favorably with those of brand-name
firms. |
|
Generic drugs have more negative
side effects than brand-name drugs. |
There
is no proof of this. FDA monitors reports from doctors
and others of adverse drug reactions and has found no
difference in the rates of adverse reactions between
generic and brand-name drugs. |
|
FDA-approved generic drugs are bioequivalent and
therapeutically equivalent to their brand-name counterparts, People
can use them with total confidence.
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