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Generic
Drugs: What Everyone
Should Know
(NAPS)—An estimated half of all prescriptions in the
United States are filled with generic drugs. These products carry
all the medicinal qualities (and side effects) of their brand-name
counterparts, but generics tend to have one additional benefit:
lower cost.
According to the U.S. Food and Drug Administration (FDA), a generic
drug is a copy that is identical to a brand-name drug in dosage,
safety, strength, how it is taken, quality, performance and intended
use. New drugs, like other new products, are developed under patent
protection. The patent protects the investment—including research,
development, marketing and promotion—by giving the company the sole
right to sell the drug while the patent is in effect. When patents
or other periods of exclusivity on brand-name drugs are near
expiration, manufacturers can apply to the FDA to sell generic
versions. As those manufacturers don’t have the same development
costs, they can sell their product at substantial discounts. Also,
there is greater
competition and less advertising, which keeps the price down. For
example, in the 1950s, when the analgesic acetaminophen was
developed, it was only available under its brand name—Tylenol.
Today, acetaminophen can be found in many other pain relief products,
including generic and store-brand versions.
“FDA-approved generic drugs are bioequivalent and therapeutically
equivalent to their brand name counterparts,” says Gary Buehler,
director of FDA’s Office of Generic Drugs. “People can use them with
total confidence.”
Both brand-name and generic drug facilities must meet standards of
good manufacturing processes. The FDA conducts about 3,500
inspections each year 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.
To learn more about generic drugs, contact your physician,
pharmacist or insurance company. Or visit the FDA Web site at
www.fda.gov/cder/ogd/index.htm.
Consumer Education:
Generic Drugs
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Date created: August 2, 2004; Updated August 17, 2005 |
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