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.
The FDA has plans for the future
to ensure the safety of the population. These plans include
improvement of the diagnostic tests for the nation’s blood supply,
enhancement of the quality and accuracy of clinical trial designs so
that firms can bring new drugs to patients faster and more
cost-effectively, and new methods to detect food contaminants to
counter the emergence of previously unknown foodborne pathogens like
mad cow disease.
So now, when you as caregiver or
senior citizen read about or hear about a new drug that has not yet
been approved by the FDA, you know that this means that the time it
takes to hit the market, if approved, can be anytime from six months
to a year; perhaps not as long as you expected.
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