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Generic Viagra Facts
Have you ever wondered how the drugstore brand of ibuprofen can really
be the same as Advil when it costs half the price? Or why there isn't
an inexpensive generic version of your medicine on the market? If so,
read on for the facts about generic drugs.
- If generic drugs are
just as good as brand-name drugs, why do they cost less?
It is cheaper to make and sell generic drugs, so these savings
are reflected in a lower price. Unlike the manufacturers of brand-name
products, the makers of generic drugs don't incur the costs of research
and development, marketing, and advertising. Since drug manufacturers
have begun advertising directly to consumers, this has become a huge
cost of doing business that is passed along to the consumer in the form
of higher priced brand-name drugs. As for quality, the U.S. Food and
Drug Administration (FDA) ensures that generic drugs are equivalent
to brand-name drugs. By "equivalent," the FDA means that generics
must contain the same active ingredients that work the same way in the
body to deliver their medicinal effects.
- Why aren't all prescription drugs available
in a generic version?
When a company develops a new drug and begins to usher it through
the regulatory process required for FDA approval, a patent on that unique
chemical formulation is issued for 17 years. Generic medicines cannot
be manufactured and sold until the patent on the original drug has expired.
Some drug formulas are patent-protected for longer periods because several
different chemical combinations or processes are used - and patented
- for one medication. In other cases, it may seem that a drug is on
the market for only a few years before the generic is available. This
is usually because the original testing and trial period required by
the FDA may have taken many years, so by the time the drug is approved,
there are only a few years left on the patent.
- Are generic drugs tested as rigorously as the
brand-name versions?
Yes and no. They are tested rigorously to make sure their performance
and ingredients meet the FDA's standards for equivalency. Scientists
from the FDA will sometimes visit the laboratories of the company that
has applied to manufacture a generic drug to check the purity of the
ingredients and the quality of the processing. But the generic drug
does not have to be tested by the clinical trial process applied to
the original drug. In order to be considered a generic version, the
compound must behave chemically identical to the brand-name, which was
already subjected to years of testing. It must be labeled, however,
with the same information as the original drug, including cautionary
data and side effect disclosures.
- What about the companies that make generic drugs?
Are they as reputable as the original pharmaceutical companies?
That's a common apprehension. In fact, very often the same pharmaceutical
company that developed the brand-name drug releases a generic version
when the patent expires. Other companies specialize in manufacturing
generic drugs. Many drugs are difficult to formulate, even when the
amounts and processes of the active ingredients have already been established.
In fact, the reason some brand-name drugs never become available as
generics is that they are too complicated or costly to manufacture.
- How can I know when a generic prescription drug
is an option?
You may have to take the initiative with your physician and ask
if the prescription can be written to permit filling with a generic
equivalent. The pharmacist can only supply the generic, if there is
one, when the doctor indicates that option. Managed healthcare programs
are encouraging providers to prescribe generics because they are less
expensive, but some doctors (and patients) are still inclined to opt
for the higher priced brand-name pharmaceuticals. In general, you will
be charged a higher copay for brand-name drugs than for generic equivalents,
and depending upon your pharmacy benefits plan, you might even have
to pay out-of-pocket expenses for brand-name medicines.
- Are there reasons to stick with a brand-name
drug even if there is a generic on the market?
There can be reasons why a generic may not be suitable for you.
Remember, the FDA regulates the equivalency of active ingredients in
generic drugs. But there are also tiny amounts of inactive ingredients,
components of the drug that give it bulk or help it conform to a desired
shape or color. For certain people these inactive ingredients may not
always be inert, meaning they may have an unanticipated effect. For
example, suppose you're allergic to wheat: if a drug has some added
fiber to help it pass through the gastrointestinal system quickly, that
fiber doesn't affect how the drug works on your arthritis pain. However,
if the bulking agent is wheat fiber, you may experience a slight allergic
reaction to that medication. If you have a specific allergy, you should
ask your pharmacist about the ingredients in your medicine and remind
your doctor of your allergies. There are sometimes several generic options
for a drug, with slightly different inactive ingredients, so there may
be one that is right for you.
Like every aspect of health care, in monitoring your use of medications-generic
or brand name-it is crucial that you know the facts and that you act as
an advocate for your own best interests.
Sources:
Abbreviated new drug application (ANDA) process for generic drugs.
Center for Drug Evaluation and Research (CDER). Available at: http://www.fda.gov/cder/regulatory/applications/anda.htm
An inside look at generic pharmaceuticals. Mylan
Institute of Pharmacy. Available at: http://jbdc.vwh.net/mylanweb/overview/inside_generics.htm
FDA approval process for generic medications. Teri
Wagner, PharmD, Stadtlanders Pharmacy. Available at: http://www.stadtlander.com/general/generics.html
FDA ensures equivalence of generic drugs. FDA
Consumer, special report, January 1995. The Food and Drug Administration
Web site. Available at: http://www.fda.gov/fdac/special/newdrug/generic.html
Generic drugs. Merck Manual Home Edition.
Available at: http://www.merck.com/pubs/mmanual_home/sec2/12.htm
Generic drugs: saving money at the pharmacy.
April 1998, Federal Trade Commission Web site. Available at: http://www.ftc.gov/bcp/conline/pubs/health/generic.htm
More info on generics from the FDA. Available
at: http://www.fda.gov/cder/handbook/bioequiv.htm and www.fda.gov/cder/handbook/andabox.htm
Therapeutic equivalence of generic drugs. Response to
national Association of Boards of Pharmacy. Available at: http://www.fda.gov/cder/news/ntiletter.htm
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