GENERIC DRUGS
"Since generic drugs generally sell for
less than brand name drugs, many people falsely believe that
generics must be inferior to brand-name products. Generic
drugs contain exactly the same active ingredients as the brand-name
drugs and are just as safe and effective."
Doug Sporn, Director
FDA Office of Generic Drugs
Generic Drugs, Are They As Good as Brand-Names?
Medical Author: Melissa Stoppler, M.D.
Medical Editor: Barbara K. Hecht, Ph.D.
"Almost half of all prescriptions today
in the US are filled with generic drugs. Still, I am often
asked if generic drugs are really as good as their brand-name
counterparts. After all, goes the reasoning, don’t you
get what you pay for?
Generic drugs are copies of brand-name drugs
that have exactly the same dosage, intended use, effects,
side effects, route of administration, risks, safety, and
strength as the original drug. In other words, their pharmacological
effects are exactly the same as those of their brand-name
counterparts.
Many people become concerned because generic
drugs are often substantially cheaper than the brand-name
versions. They wonder if the quality and effectiveness have
been compromised to make the less expensive products. The
FDA (U.S. Food and Drug Administration) requires that generic
drugs be as safe and effective as brand-name drugs.
Actually, generic drugs are only cheaper because
the manufacturers have not had the expenses of developing
and marketing a new drug. When a company brings a new drug
onto the market, the firm has already spent substantial money
on research, development, marketing and promotion of the drug.
A patent is granted that gives the company that developed
the drug an exclusive right to sell the drug as long as the
patent is in effect.
As the patent nears expiration, manufacturers
can apply to the FDA for permission to make and sell generic
versions of the drug. Without the startup costs for development
of the drug, other companies can afford to make and sell it
more cheaply. When multiple companies begin producing and
selling a drug, the competition among them can also drive
the price down even further.
So there’s no truth in the myths that
generic drugs are manufactured in poorer-quality facilities
or are inferior in quality to brand-name drugs. The FDA applies
the same standards for all drug manufacturing facilities,
and many companies manufacture both brand-name and generic
drugs. In fact, the FDA estimates that 50% of generic drug
production is by brand-name companies.
Another common misbelief is that generic drugs
take longer to work. The FDA requires that generic drugs work
as fast and as effectively as the original brand-name products.
Sometimes, generic versions of a drug have
different colors, flavors, or combinations of inactive ingredients
than the original medications. Trademark laws in the United
States do not allow the generic drugs to look exactly like
the brand-name preparation, but the active ingredients must
be the same in both preparations, ensuring that both have
the same medicinal effects.
Resource: Office of Generic
Drugs, Center for Drug Evaluation and Research, U.S. Food
and Drug Administration (FDA), 5600 Fishers Lane, Rockville
MD 20857.
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