DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Improving Public Health:

Promoting Safe and Effective Drug Use

The FDA’s Center for Drug

Evaluation and Research

(CDER) promotes and protects

the health of Americans by

assuring that all prescription and

over-the-counter drugs are safe

and effective. CDER evaluates

all new drugs before they are

sold, and serves as a consumer

watchdog for the more than

10,000 drugs on the market to be

sure they continue to meet the

highest standards. The center

routinely monitors TV, radio,

and print drug ads to ensure

they are truthful and balanced.

CDER also plays a critical role

in providing health professionals

and consumers information to

use drugs appropriately and

safely.

In 2002, the center focused on

five strategic areas:

• Strong FDA

Strong and sound science means

CDER scientists stay on the

cutting edge of new technologies. The center’s mission

depends more than ever on a

solid cadre of experienced

physicians, toxicologists, chemists, statisticians, mathematicians, project managers and

other highly qualified and

dedicated professionals.

• Efficient risk management

In 2002, CDER evaluated many

new drugs that offered important

treatment options for Americans.

However, it is of concern that the

approval of truly new drugs is at

the lowest level in a decade. The

center has launched two important initiatives to remove barriers

to innovation in drug development and to facilitate the modernization of American drug

manufacturing.

• Patient and consumer safety

CDER continued to enhance its

drug safety program to help

make sure that drugs are used

safely once they’re approved.

The center alerted the public to

the dangers of importing or

buying over the Internet 10

drugs that are marketed in this

country with special safety

restrictions.

• Better consumer information

CDER is collaborating with a

broad spectrum of groups to

improve information for prescribers and consumers. Industry

and consumers are increasingly

turning to the CDER Internet site

for important and up-to-date

information on the center’s

Publication No. FS 01-3

FDA Web site: www.fda.gov

Revised: August 2003

Year 2002 Drug Approvals

In 2002, CDER approved 78 new

drugs, 17 of which were never

before marketed in the United

States. Eleven of the new drugs

received priority status in recognition of their special importance for

the public health. Thirteen of the

newly approved drugs were

authorized for over-the-counter sale

without a prescription. The center

also approved 321 generic versions

of already-marketed drugs. More

details about CDER’s accomplishments in 2002 can be found in the

CDER Report to the Nation: 2002

at www.fda.gov/cder/reports/rtn/

2002/rtn2002.htm.

regulatory programs and on the

drugs they take to improve their

health.

• Counterterrorism

CDER continues to facilitate

development of new drugs and

new uses for already-approved

drugs that could be used as

medical countermeasures.

For more information, please

go to the CDER Web site at

www.fda.gov/cder, or call (888)

INFO-FDA (888-463-6332) and

follow the prompts for human

drugs.