Educating Groups Influencing Generic Drug Use

FACTS ABOUT
GENERIC DRUGS
Today, nearly 8 in 10 prescriptions filled in the U.S. are for generic drugs.

GENERIC

SAME QUALITY &

BRAND

PERFORMANCE

FDA requires generic drugs to have the same active ingredient, strength,
dosage form, and route of administration as the brand-name drug.
The generic manufacturer must prove its drug is the same (bioequivalent) as
the brand-name drug.
All manufacturing, packaging, and testing sites must pass the same quality
standards as those of brand-name drugs.
Many generic drugs are made in the same manufacturing plants as the
brand-name drugs.

ALL FDA-APPROVED GENERIC DRUGS

MUST BE EQUIVALENT TO THE BRAND-NAME DRUG.
Any generic drug modeled after a single, brand
name drug must perform approximately the same
in the body as the brand name drug. There will
always be a slight, but not medically important,
level of natural variability just as there is for one
batch of brand name drug compared to the next
batch of brand name product.
This amount of difference would be expected and
acceptable, whether for one batch of brand name
drug tested against another batch of the same
brand, or for a generic tested against a brand
name drug.

80-85%
LESS
Average cost of a generic drug
vs. its brand-name counterpart

$$$

$

$$$

$

In 2010 alone, the use of FDA-approved
generics saved $158 billion.

$3 billion saved every week!
Sun

Mon

Tues

Wed

Thurs

Fri

Sat

THE LOWER PRICE

DOESN’T MEAN INFERIOR.

$

$$$

Generic manufacturers are able to sell their products for lower
prices because they are not required to repeat the costly
clinical trials of new drugs and generally do not pay for costly
advertising, marketing, and promotion  In addition, multiple
generic companies apply to FDA to approve a generic for the
same brand name drugs. Multiple generic companies are
often approved to market a single product. Competition in the
market place, often results in lower prices.

FDA MONITORS ADVERSE EVENTS

REPORTS FOR GENERIC DRUGS.
The monitoring of adverse events for all drug products,
including generic drugs, is one aspect of the overall FDA
effort to evaluate the safety of drugs after approval. Many
times, reports of adverse events describe a known
reaction to the active drug ingredient.
Reports are monitored and investigated, when appropriate.
Investigations may lead to changes in how a product is used
or manufactured.

FDA IS ACTIVELY ENGAGED IN
MAKING GENERIC DRUGS SAFER.
FDA is aware that there are reports that some people may experience an undesired
effect when switching from a brand name drug to a generic formulation or from
one generic drug to another generic drug. FDA wants to understand what may
cause problems with certain formulations if, in fact, they are linked to specific
generic products.
FDA is encouraging the generic industry to investigate whether, and under what
circumstances, such problems occur. The Agency does not have the resources to
perform independent clinical studies and lacks the regulatory authority to require
industry to conduct such studies. FDA will continue to investigate these reports to
ensure that it has all the facts about these treatment failures and will make
recommendations to healthcare professionals and the public if the need arises.

Davit et al. Comparing generic and innovator drugs:
a review of 12 years of bioequivalence data from the United States Food and Drug Administration.
Ann Pharmacother. 2009;43(10):1583-97.
1

Arthritis
Morning
1 Tablet 400 mg

Creating a drug costs lots of money.
Since generic drug makers do not
develop a drug from scratch, the
costs to bring the drug to market
are less. But they must show that
their product performs in
the same way as
the brand-name
drug. All generic
drugs are
approved
by FDA.

xxxx (Example)

WHY ARE GENERIC DRUGS
LESS EXPENSIVE?

What do I use
it for?

FACT

When do I
take it?

No. Generic drugs
work in the same way
and in the same
amount of time as
brand-name drugs.

Your medication guide should be kept with
you and up to date. List your prescription
and over-the-counter medicines as well as
your dietary supplements.

How much do
I take?

DO GENERIC
DRUGS TAKE
LONGER TO WORK
IN THE BODY?

Name of my
medicine

FACT

FACTS

ABOUT
GENERIC
DRUGS
U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES
Food and Drug Administration

1-888-INFO-FDA • www.fda.gov

FOOD AND DRUG
ADMINISTRATION

FACT

WHAT ARE GENERIC DRUGS?

FACT

A generic drug is the same as a
brand-name drug in:
• dosage
• safety
• strength
• quality
• the way it works
• the way it is taken
• the way it should be used
FACT

ARE GENERIC DRUGS AS
SAFE AS BRAND-NAME
DRUGS?
Yes. The FDA
says that
all drugs
must work
well and be safe. Generic drugs
use the same active ingredients as
brand-name drugs and work the same
way. So they have the same risks and
benefits as the brand-name drugs.

FACT

ARE GENERIC DRUGS AS STRONG
AS BRAND-NAME DRUGS?
Yes. FDA requires generic
drugs must be as:
• high quality
• strong
• pure, and
• stable
as brand-name drugs

ARE BRAND-NAME DRUGS MADE IN
BETTER FACTORIES THAN GENERIC
DRUGS?

FACT

No. When new drugs are first
made they have drug patents.
Most drug
patents are
protected for
17 years. The
patent
protects the
company that made the drug first.
The patent doesn’t allow anyone
else to make and sell the drug.
When the patent expires, other drug
companies can start selling the
generic version of the drug. But,
first, they must test the drug and
the FDA must approve it.

No. All
factories
must
meet the
same high
standards. If the
factories do not
meet certain standards, the FDA won’t
allow them to make drugs.
FACT

IF BRAND-NAME DRUGS AND
GENERIC DRUGS HAVE THE SAME
ACTIVE INGREDIENTS, WHY DO
THEY LOOK DIFFERENT?
In the United States, trademark laws
do not allow generic drugs to look
exactly like the
brand-name drug.
However, the
generic drug must
have the same
active ingredients.
Colors, flavors, and certain other parts
may be different. But these things don’t
affect the way the drug works and they
are looked at by FDA.

Generic Drugs:
Safe. Effective. FDA Approved.

DOES EVERY
BRAND-NAME DRUG HAVE
A GENERIC DRUG?

FACT

WHAT IS THE BEST
SOURCE OF
INFORMATION
ABOUT GENERIC
DRUGS?
Contact your doctor, pharmacist
or other healthcare worker for
information on your generic drugs.
For more information, you can also
visit the FDA website at:
http://www.fda.gov/cder and
click on Consumer Education.