T
he quality standards for approval of drugs sold in the United States are uniform,
whether they are for generic or brand-name drugs. "Since generic drugs generally sell
for less than brand-name drugs, many people falsely believe that generics must be infe-
rior to brand-name products," says Doug Sporn, Director of FDA's Office of Generic
Drugs. "Generic drugs contain exactly the same active ingredients as the brand-name
drug and are just as safe and effective."

FDA Ensures
Equivalence of Generic Drugs
Page 2
Despite the strict standards
imposed by the FDA for approval of
generic drugs, and their enforce-
ment of these standards, a number of
misconceptions about generic drugs
persist (See "Myths and Facts about
Generics" to the right).
New drugs, like other new prod-
ucts, are developed under patent
protection. The patent protects the
investment in the drug's develop-
ment 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 expire, manufac-
turers can apply to the FDA to sell
generic versions.
"Much of FDA's review of generic
drugs and brand name drugs is the
same," Sporn explains (See "Same
FDA Requirements for Brand-Name
and Generic Drugs" below). There
are eight major parts to the FDA's
review of a firm's application to sell a
generic drug:
* There must be an FDA-approved
brand-name drug that is the
"same" as the proposed generic.
The generic must have the same
active ingredient or ingredients
and the same labeled strength as
this reference product. It must
have the same dosage form-
tablets, patches and liquids are
examples of dosage forms. It must
Myths and Facts about
Generic Drugs
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 sta-
bility 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 counter-
parts.
MYTH:
Brand-name drugs are made in
modern manufacturing facilities, and
generics are often made in substan-
dard facilities.
FACT:
FDA won't permit drugs to be
made in substandard facilities. FDA
conducts about 3,500 inspections a
year to ensure standards are met.
Generic firms have facilities compara-
ble 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 reac-
tions and has found no difference in the
rates between generic and brand-name
drugs.
Same FDA Requirements for Brand-Name and
Generic Drugs
 
 
 
 
 
 
.
Page 3
be administered the same way, for
example, swallowed as a pill or
given as an injection.
* The manufacturer must show the
generic drug is "bioequivalent" to
the brand-name drug (See "What
Is Bioequivalence?" below).
* The generic drug's labeling must
contain information that is essen-
tially the same as that of the
approved drug.
* The firm must fully document the
generic drug's chemistry, manufac-
turing steps, and quality control
measures. Each step of the process
must be detailed for FDA review.
* The firm must assure the FDA that
the raw materials and the finished
product meet USP specifications, if
these have been set. The USP, or
U.S. Pharmacopoeia, is the non-
profit, scientific body chartered by
Congress to set standards for drug
purity in this countr y.
* The firm must show that its generic
drug is stable under extremes of
heat and humidity before it can be
sold. Once on the market, the firm
must continue to monitor the
drug's stability. The firm must
show that the container and its clo-
sure system won't interact with the
drug. Firms making sterile drugs
must submit sterility assurance data
and data showing microbiologic
integrity of these products.
* The firm must provide a full
description of the facilities it uses
to manufacture, process, test, pack-

age, label and control the drug. It

Reprinted August 2002 from: FDA Center for Drug Evaluation and Research Special Report  Printed September 1999. This article originally appeared in the September 1999 From Test Tube to Patient: Improving Health Through Human Drugs

 

must certify that it complies with
federal regulations about current
good manufacturing practices and
undergo FDA inspection of the
manufacturing facility to assure
compliance.
* Before FDA approves a generic
drug, it usually conducts a prod-
uct-specific inspection at the pro-
posed manufacturing site to make
sure the firm is capable of meeting
its application commitments and to
ensure the firm can manufacture
the product consistently.
"Generic competition helps keep
the cost of drugs down," Sporn says.
"It also encourages the research-
based drug companies to keep find-
ing newer and better medicines that
have patent protection."
When retired federal auditor Stuart
Addison goes to the pharmacy in
Margate, Fla., he has the pharmacist
fill his prescriptions with generic
drugs. "My motivation is to keep
the prices down," Addison said, not-
ing that his insurance plan helps pay
for his prescriptions. "My pocket-
book isn't directly affected; but, in
the long run, I'm helping keep
insurance premiums down." Generic
drugs save consumers an estimated
$8 to $10 billion a year at retail
pharmacies (according to the
Congressional Budget Office). Even
more billions are saved when hospi-
tals use generics.
"FDA-approved generic drugs are
bioequivalent and therapeutically
equivalent to their brand-name coun-
terparts," says Sporn. "People can
use them with total confidence."
What Is Bioequivalence?