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 The
Food and Drug Administration (FDA) has been under surveillance as
its credibility has fallen into question. Some critics have staked
claims against the agency stating:
- Its system of regulating drugs is broken
- It approves drugs without thoroughly testing them
- It fails to keep tabs on unexpected side effects of drugs already
on the market
- Due to the pressures of getting lifesaving drugs to consumers,
it rushes drugs to the market
One unforgivable mistake the FDA made was when it suppressed information
regarding risks associated with taking arthritis drug Vioxx. Since
then, the agency has been pinned under the microscope. In fact,
a poll was taken to determine how confident Americans are in the
FDA and its ability to protect them.
The data showed:
- 70 percent of Americans remain confident in the FDA's ability
to ensure the safety of prescription drugs
- Nearly 40 percent of Americans said their confidence in the
FDA has decreased
Solutions to improve the quality of the FDA range from devising
steps the president and Congress could take to improve drug safety,
to forming an agency "that looks out for the health of patients
and not just the health of the pharmaceutical industry."
In addition, some members of the Congress, leading scientists and
an FDA insider agree that there is a need for a drastic "renovation"
of how the agency monitors medications once they hit the market.
One suggested method of doing this is to develop an FDA Office of
Postmarket Surveillance to observe drugs, medical devices and biologics
(products such as vaccines). This office will be independent of
the FDA's Center for Drug Evaluation and Research, as well as the
FDA divisions that review new product applications.
USA
Today December 19, 2004
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