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The FDA's Role By Mira Lowe, Staff Writer
How many times have you sought a
prescription only to find it has not been FDA-approved
and isn’t covered by your insurance? Who are the FDA and
what do they do? A better understanding of the FDA will
remove the mystery of this government agency.
Although small in size, the mission of the FDA is to
protect all consumers in the United States with a broad
umbrella of safeguards that enables them to go about
their daily business without worries about the safety of
the myriad of products that the FDA regulates. FDA is
determined to keep these public health protections what
they have always been: an effective armor against public
health hazards.
The goods whose standards are set by FDA’s scientists
and enforced by the agency’s regulators include all food
except for meat and poultry, all prescription and
non-prescription drugs, all blood products, vaccines,
tissues for transplantation, all medical equipment and
all devices that emit radiation including microwave
ovens, all animal drugs and feed, and even all
cosmetics. New products that are designed to treat human
conditions or diseases are examined by FDA’s reviewers
for safety and effectiveness before they can be made
available to consumers.
Moreover, FDA inspectors and scientists ensure the
safety and wholesomeness of 75 percent of all foods
consumed in the United States, and the agency is
responsible for products’ labeling, which must be
truthful and not misleading. The FDA also protects women
by making sure that all mammograms performed in the
United States are of the highest quality. To protect
senior citizens, the agency finds and brings to court
those responsible for bogus medicines on the market.
How long does something take to be approved by the FDA?
Before Congress passed the Prescription Drug User Fee
Act of 1992, it took the agency an average of 30 months
to clear a medication for public consumption. But after
the act was implemented, the agency was able to hire
additional reviewers and support staff who have helped
reduce the median review time for drugs to 12 months;
and for priority applications for products offering a
significant therapeutic advance, the median time for
approval has been cut to six months.
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