DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 01-13

FDA Web site: www.fda.gov

Revised: February 2002

Science at FDA:

The Mainstay of Public Health Protection

New Technology is FDA’s Greatest Challenge

Science is the solid bedrock of

all the FDA’s decisions, whether

they involve product review,

research, policy development, or

law enforcement. In recent years,

findings by the FDA’s scientists

have been critical to the agency’s

most significant public health

accomplishments, including its

ability to do the following:

• Determine the safety of

bioengineered foods and enhance

their acceptance by the public.

• Characterize and mitigate the

real public health threat of antimicrobial resistance.

• Understand the cause and

transmission of BSE, or bovine

spongiform encephalopathy

(“mad cow disease”), which has

enhanced the FDA’s ability to

keep this disease out of the United

States.

At present, the quickening pace

of scientific discoveries is propelling the development of a tidal

wave of novel, extremely complex

products and processes that will

soon put the FDA to a crucial test.

They include genomics- and

proteomics-assisted drug development and disease detection and

diagnosis; robotics; nanotechnology; minimally invasive

surgery and medical imaging;

xenotransplantation and organ

replacements; stem cell-derived

products and assisted reproduction; biosensors and new drug

delivery systems; individualized

drug therapy; and transgenics.

The FDA will have to acquire

expertise in new informatics,

artificial intelligence, and new

knowledge management; develop

better tools for quantitative risk

assessment, modeling, clinical trial

design and analysis; design better

predictive tests involving

transgenics, biomarkers, alternatives to test animals, and computational science; and find better

methods for rapid product testing,

and for easier identification of

foodborne, waterborne and other

natural toxins, allergens, and

transmissible spongiform encephalopathies.

And as if that were not sufficiently challenging, the FDA will

have to accomplish these tasks at a

time when our rapidly aging

population will increase the need

and expectations for the FDA’s

public health services. To meet

this historic test, and to expedite

the availability of new medical

marvels to the public, the FDA

cannot wait until the products

emerge from R&D pipelines. The

agency must achieve the critical

mass of scientific, medical and

financial resources—without

delay.

For more information, call the

FDA’s Office of Science Communication and Coordination at 301-

827-3340 and refer to the Science

@ FDA Web site, www.fda.gov/

oc/science.html.

The Human Genome Mapped—

New Horizons

Francis S. Collins, MD, PhD, the

director of the National Human

Genome Research Institute at the

National Institutes of Health, predicts

that within 10 years genome research

will lead to genetic testing for a

dozen medical conditions. In 20

years, there will be gene-based

designer drugs to treat diabetes,

hypertension, and cancer. In 30

years, comprehensive genomicsbased health care will be “the norm.”

As the gatekeeper for these products

and technologies, the FDA will have

a decisive impact on their safety,

effectiveness, and the speed of their

availability to the public.