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Generic Medications - The Truth Behind The Myths
by Richard Clement
These days the subject of generic medications troubles many "anxious about our
health government minds". Generic drugs are unsafe, not helpful as brand names
for your diseases, they are made in unauthorized facilities ect. Is this the
truth or is it just an attempt to favor some American drug manufacturers and pharmacies.
Drug products sold in the United States are approved by the FDA whether they are
brand name or generic. "Most people believe that if something costs more, it has
to be better quality. In the case of generic drugs, this is not true," says Gary
Buehler, Director of FDA's Office of Generic Drugs. "The standards for quality
are the same for brand name and generic products."
Health professionals and consumers can be assured that FDA approved generic
drugs have met the same rigid standards as the innovator drug. To gain FDA
approval, a generic drug must:
 contain the same active ingredients as the innovator drug (inactive ingredients may vary)
be identical in strength, dosage form, and route of administration
have the same use indications
be bioequivalent
meet the same batch requirements for identity, strength, purity, and quality
be manufactured under the same strict standards of FDA's good manufacturing
practice regulations required for innovator products.
So we can make the conclusion that: The Generic Drug is a drug which is
bioequivalent to a brand name drug with respect to pharmacokinetic and
pharmacodynamic properties.
Generic medicines must contain the same active ingredient at the same strength
as the "innovator" brand, be bioequivalent, and are required to meet the same
pharmacopoeial requirements for the preparation. By extension, therefore,
generics are identical in dose, strength, route of administration, safety,
efficacy, and intended use. Thus, in some cases, the "generic" product is
actually the brand product but inside a different box.
The principal reason for the reduced cost of generic medicines is that these are
manufactured by smaller pharmaceutical companies which do not invest in research
and development into new drugs. The significant research and development costs
incurred by the large pharmaceutical companies in bringing a new drug to the
market is often cited as the reason for the high cost of new agents - they wish
to recover these costs before the patent expires. Other reason for high prices
is that every year pharmaceutical companies spend billions to market their products.
When a pharmaceutical company first markets a drug, it is usually under a patent
that only allows the pharmaceutical company that developed the drug to sell it.
This allows the company to recoup the cost of developing that particular drug.
It will frequently cost millions of dollars to develop and test a new drug
before it is approved for use.
After the patent on a drug expires, any pharmaceutical company can manufacture
and sell that drug. Since the drug has already been tested and approved, the cost
of simply manufacturing the drug will be a fraction of the original cost of testing
and developing that particular drug.
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