DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

The nation’s more than $40 billion annual investment in biomolecular research is fueling a

deluge of promising new medications that will eventually land at the

FDA’s door, seeking approval to

enter the market. For many of the

most exotic treatments—from

cellular replacement therapies to

animal organ transplants—the gatekeeper is the Center for Biologics

Evaluation and Research (CBER).

CBER regulates biological products for disease prevention and

treatment that are inherently more

complex than chemically synthesized pharmaceuticals, including:

• Blood and blood products, such

as plasma, blood-derived proteins

including clotting factors for

hemophilia, tests used to screen

blood donors and devices used to

make blood products.

• Vaccines and allergenic

products.

• Protein-based drugs, such as

monoclonal antibodies and cytokines that stimulate the immune

system to fight cancer, and enzyme

therapies that stop heart attacks.

These and other biological products have the potential to provide

immense public health benefits, and

they are being developed at an annual rate that has increased from 350 in

1990 to more than 650 in 2000.

In addition, CBER’s scientists are

prepared to evaluate the safety and

effectiveness of products that will

result from the most complex and

exciting areas of biomedical

research, including:

• Human gene therapy designed to

alleviate human diseases by transferring normal versions of genes into

target cells.

• Xenotransplantation, the

technique in which organs, tissues or

cells from animals such as pigs are

transplanted into patients.

• Cellular and tissue transplants,

including stem cell therapy, which

offer the promise of new therapeutic

treatments, including restoring

damaged tissue.

• Transgenic plants and animals

whose products will result in new

biotech vaccines and therapeutics.

• Genomics, proteomics and

bioinformatics, techniques that will

lead the way for new biological

product discovery and patient

management.

• Variant CJD and BSE.

Evaluation of methods for testing

and removal from blood products of

infectious particles that cause the

human illness associated with BSE

or “mad cow disease.”

• Nucleic Acid Testing, methods to

detect known pathogens with ever

greater sensitivity and to identify

emerging variants of these agents.

• New vaccines and new vaccine

technologies.Vaccines against

diseases like AIDS, TB, malaria,

antibiotic resistant infections and

chronic illnesses are beginning to

show promise.

For more information, please call

CBER at 1-800-835-4709 or 301-

827-2000, or visit the FDA Web site

at www.fda.gov/cber.

FDA’s Center on the

Front Line of the

Biomedical Frontier

The rising number of investigational new

biotech drug and device applications indicates an increasing number of new products

to be reviewed by CBER in the coming years.

CBER Biotech INDs/IDEs

Received Fiscal Year 87-FY 00

0

100

200

300

400

500

600

700

Other INDs/IDEs Biotech INDs/IDEs

‘87 ‘88 ‘89 ‘90 ‘91 ‘92 ‘93 ‘94 ‘95 ‘96 ‘97 ‘98 ‘99 ‘00*

*FY00 data includes October 1, 1999—September 25, 2000

Publication No. FS 01-4

FDA Web site: www.fda.gov

Revised: February 2002

Countering Bioterrorism

CBER plays an integral role in

several initiatives to protect the

Nation against bioterrorism. The

Center is helping to advance the

development and licensing of

products to diagnose, treat, or

prevent outbreaks from exposure to

bioterrorist pathogens by entering

the process at an early stage and

helping the products to rapidly meet

the regulatory requirements. The

Center also is developing procedures

and protocols to make possible the

safe use of promising experimental

products when there is no approved

medication for the treatment of

victims of terrorism.