Work Place Stress

In 1962 the Food and Drug Administration (FDA) was
formed by law to oversee drugs and foods placed on
the market for public consumption. The purpose of the
FDA is to provide an unbiased review of the products
to insure the safety for public consumption.

Since the FDA is a part of the government, it has
been affected by budget cuts. These budget cuts
caused a backlog of drugs and foods waiting to be
approved or disapproved. Drug companies were able to
use this situation to their advantage by bringing
pressure on Congress which approved deadlines
on the FDA.

Congress passed the legislation in 1992 with an
agreement that made drug companies pay millions
of dollar in fees to the FDA to hire more reviewers to
assist in clearing out 90% of the backlog. For this
fee the drug company received a money back
guarantee to have “lifesaving” or “high priority“drugs
processed within six months after submission to the FDA.

Other drugs would be processed within one year. If the
drug companies are paying for a guarantee that a
process is to be completed, does this impose any bias
upon the reviewers?

If someone is paying the reviewers to review their products,
I believe those reviewers will be bias toward the product.

Research showed that products like “Vioxx”,”Bextra”,
Rezuillin”, and “Baycal”, were all approved within the
two months before their deadlines. The results were
ultimately all the named drugs were eventually
removed from the market place.

Another tactic the drugs companies use is to have
former company employees on the review broads. How
can these former employees prove unbiased reviews of
products that they may have help formulate or been
responsible for producing?

No matter what happens as long as drug companies
are able to influence by direct or indirect means the
reviewers of the FDA, there will not be an unbiased
process. The FDA is needed to review the safety of
drugs and foods for public consumption.
T
he problem is how do we remove the drug companies
influence over the FDA’s decisions? Is America’s health
and safety being bought by big
drug companies monies?

The Americanhealth and safety is now taking backseat
to the FDA’s bottom line.