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Generic Medications - The Truth Behind The Myths
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 unautorised facilities ect . Is this the truth or is it
just an attempt to favour 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 manufacturered 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.
So despite the strict standards imposed by the FDA for approval
of generic drugs, and their enforcement of these standards, a
number of misconceptions about generic drugs persist that we
must disprove:
MYTH: Generics take longer to act in the body.
FACT: The firm seeking to sell a generic drug must show
that its drug delivers the same amount of active ingredient in
the same timeframe as the original product.
MYTH: Generics are not as potent as brand-name drugs.
FACT: FDA requires generics to have the same quality,
strength, purity, and stability as brand-name drugs.
MYTH: Generics are not as safe as brand-name drugs.
FACT: FDA requires that all drugs be safe and effective
and that their benefits outweigh their risks. Since generics use
the same active ingredients and are shown to work the same way
in the body, they have the same risk-benefit profile as their
brand-name counterparts.
MYTH: Brand-name drugs are made in modern manufacturing
facilities, and generics are often made in substandard
facilities.
FACT: FDA won't permit drugs to be made in substandard
facilities. FDA conducts about 3,500 inspections a year in all
firms to ensure standards are met. Generic firms have facilities
comparable to those of brand-name firms. In fact, brand-name
firms account for an estimated 50 percent of generic drug
production. They frequently make copies of their own or other
brand-name drugs but sell them without the brand name.
MYTH: Generic drugs are likely to cause more side effects.
FACT: There is no evidence of this. FDA monitors reports
of adverse drug reactions and has found no difference in the
rates between generic and brand-name drugs.
And finally what we can conclude is that the only "unsafe and
unhealthy" thing about generics is the financial loss for the
big pharmaceutical companies that want to protect their monopol
on our health,despite the necessity of some low income
households for effective medical care.
We believe that it takes knowledge & understanding to make wise
decisions about the prescription meds that we take. In today's
society we are bombarded with huge amounts of confusing
information about our health and the prescription drugs that are
available. In an effort to clear some of this confusion we
strive to provide you with as much information as possible
concerning your health and prescription drugs. So if you can
afford to buy brand name medications ,you can help yourself
visiting our site http://
www.alto-infotech.com/generic-drugs.html ,where we hope
that you will find all the drug information that you seek to get
rid of your diseases.
About the author:
None
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