Global Health Management - What's In The News - February 16, 2007

The Deadly Partnership

The Food and Drug Administration (FDA) is an agency of the United States
Department of Health and Human Services and is responsible for regulating
food (humans and animal), dietary supplements, drugs (human and animal),
cosmetics, medical devices (human and animal) and radiation emitting devices
(including non-medical devices), biologics, and blood products in the United States.

But how do these questionable drugs make it on the market in the first place?
In 1992, under pressure from the public and the pharmaceutical industry,
Congress passed the “drug user fee act” which required the pharmaceutical
companies to pay a fee to the FDA, which would be used to help the FDA
approve drugs much faster. A pharmaceutical company actually pays the
FDA a “user fee” of $250,000 each time they submit a New Drug Application
to the FDA. This fee was to be used strictly to move this approval process along.
Additional pressure in this legislation forces the FDA to cooperate with the
pharmaceutical industry to get their drugs approved much faster.

Regarding drug approval

One of the key issues of drug safety dealt with by the FDA, and responsible for
much recent controversy, is related to the concept of patents. When a patent is
awarded, the drug's creator is given exclusive manufacturing rights. If the drug is
extremely popular, this motivates other companies to invent their own (different)
drugs which accomplish the same effect. For example, Cialis was created because
of the popularity of Viagra. However, the question is, when new, competing substances
come out should they be approved, not because of their absolute safety, but because
of their relative safety compared to an approved drug. For example, say "drug b" was
created to compete with "drug a". Now if "drug b" was the first one out, and it had a
5 percent chance of heart attack, the FDA might find this acceptable. However, if "drug a"
was already out, and it had a 2.5 percent chance of heart attack, then the FDA would be
reluctant to approve "b". Only people who were ignorant of that higher risk would take
drug b — unless it were significantly cheaper, and the purchaser preferred the price savings
of "b" to the relative safety of "a".

This phenomenon is at the center of the controversy over the recall of Vioxx, which is
causing more attention to be brought to the FDA. David Graham, a scientist with the FDA,
says he was pressured by his supervisors not to warn the public about dangers of drugs
like Vioxx, and so recommended to congress that a separate agency be created which is
dedicated to continuously monitoring drug safety.

Under the Prescription Drug User Fees Act, the FDA charges fees to pharmaceutical
companies in order to shorten the average length of the drug approval process.
These fees are meant to offset FDA staff costs and related expenses. This can be
considered to be a conflict of interest, as the companies who are supposed to be
regulated by the FDA are those who are paying them to conduct the approval process.
Some critics further allege that this "pay-off" may sacrifice the quality of studies.
However, these concerns are often based on an inadequate understanding of the
process. These fees are charged to all companies (except for orphan drug submissions
and first-time small business applicants), regardless of the priority or expedited status of
the review. Several options do exist to speed the review of a proposed drug, but the
criteria for priority status are designed in the interest of public health and are not tied in
any way to monetary payments.

The legislation has been effective. The time to get a drug approved has dropped
from an average of 24 months down to 12 months. Fasttrack drug approvals have
dropped from 12 months down to 6 months. Drugs are now being approved at an
unprecedented rate, far more quickly than at any time in the history of the FDA.

What is even more concerning is the fact that today over 50% of the FDA’s
budget now comes from the pharmaceutical companies via these “user fees.”
The industry that the FDA is supposed to be governing is now its primary source
of funds. The FDA has had a definite change in attitude. Instead of determining if a
drug should be approved, the FDA is now concerned with how to get a drug approved
and quickly.

Furthermore, the “user fee” money can only be used for the approval process of
new drugs. This raises major concerns about the safety of these drugs because
the post-marketing surveillance division of the FDA (the department responsible
for evaluating the seriousness of the adverse drug reactions after a drug has been
released to the public) has not had any significant increase in funding. Therefore,
more and more drugs are being approved faster and faster, which is placing a
greater burden on an underfunded, under-staffed safety department.

Kevin McNabb
http://tinyurl.com/38eoo7

How to start taking responsibility for your own health. Find out what true optimal health really means. tinyurl.com/38eoo7

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