DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Confronting Cancer:

FDA’s Long Fight Against America’s Bane

Few health hazards have blazed a

trail as tragic as cancer, the second

deadliest disease in the United

States. And there is no public health

hazard that the Food and Drug

Administration has fought longer,

more persistently, and on more fronts

than this scourge, which currently

affects 8 million Americans.

In the last nine decades, the agency

has battled cancer by such means as

exposing fraudulent panaceas,

setting standards for radiationemitting equipment, and proposing

to regulate the use of tobacco.

After Congress passed the Mammography Quality Standards Act of

1992, the FDA launched a major

program to facilitate the diagnosis of

breast cancer by unifying and

strengthening the standards for

mammography facilities, their

equipment and the qualifications of

their personnel. The program helps

ensure that every mammogram is of

the highest quality.

In addition, the FDA has made

great strides in making effective new

drugs speedily available to patients.

Here are two mechanisms developed

by the agency for that purpose:

•Accelerated approval:The FDA

has speeded up approval for major

drugs whose effects on so-called

• Priority drugs: Medications that

promise major advances in health

care receive priority treatment to

accelerate their testing and availability to patients. The FDA enhances

the development process of these

products by helping the sponsors

design efficient clinical trials, and it

speeds up the review of the resulting

evidence by using additional resources.

The FDA also sponsors two

programs that enable cancer patients

or their family members to participate in the review and approval of

cancer drugs. The Patient Representative program trains and supports

patients who serve on the FDA’s

advisory committees that consider

the safety and effectiveness of new

cancer drugs. The Patient Consultant

program enables cancer patients to

participate in FDA meetings with

sponsors of key clinical trials for

cancer drugs.

For more information, call the

FDA’s office of special health issues

at 301-827-4460 or visit

www.fda.gov/oashi/home.html.

The National Institutes of Health

lists studies that are testing new

cancer treatments at http://

cancerTrials.nci.nih.gov.

“surrogate endpoints”—such as the

size or number of cancer tumors—

indicate the likelihood of extended

survival or other long-term health

benefits. Products that receive

accelerated approval must subsequently undergo additional trials to

provide clinical proof of the benefits

suggested by the surrogate endpoints.

Publication No. FS 02-4

(FDA Web site: www.fda.gov)

February 2002

New Advances Against Cancer

Since 1996, the FDA has approved

approximately 80 new cancerrelated medications or new uses of

already-available drugs. Some of

these products treat the disease,

some alleviate its pain and other

symptoms, some help to diagnose

it, and one reduces the risk of

cancer in people who are considered at high risk.

Thirty-five of these products have

been reviewed and marketed within

six months of their submission to

the agency; one of them—Gleevec,

for the treatment of a rare chronic

leukemia—was approved by the

FDA in the all-time record time of

2.4 months.

According to a recent survey, the

rate of new cancer cases in the

United States declined an average

of 1.1 percent a year from 1992 to

1998.