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Kathy's response to Frontline on behalf of Guai-Support
For previous history on this
issue please click here
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November 14, 2003
Frontline is asking some very good
questions about FDA rules. There is another side to this story that no one is
questioning..in public that is. Thousands of citizens are questioning it at
every level of government. Industry is doing likewise. FDA's policy of forcing
all old, safe drugs, that existed previous to the development of FDA as a
goverment run agency, to apply for New Drug Application is going to remove
THOUSANDS of those drugs from the market. Guaifenesin, the active
ingredient in Robitussin cough syrup, is just the first attack.
Last year, FDA approved a drug that has been in use for hundreds of years in one
form or another. That drug is guaifenesin based Mucinex. The media reported this
story as FDA TAKES COUGH MEDICINE OFF THE MARKET. What they did is something
more sinister as it pertains to public health and safety.
Adams Laboratories, original owner of the patent on Humibid, an extended release
form of guaifenesin, can not get another patent extension. The Hatch-Waxman Act
stopped that. So they did the next best thing. They "invented" a unique way of
manufacturing a "sustained release" guaifenesin tablet and filed a NEW patent on
it. The unique tablet is not unique. The patent is not valid. The FDA accepted
every word they said without checking out any of their data. Industy is checking
their data and finding it to be invalid.
On October 25, of this year, FDA released a statement to the public that states
all old non FDA approved drugs must submit to time consuming, very expensive,
NDA approval. This will bankrupt many small manufacturing companies. The end
result is that many old, safe drugs we all take for granted, like
DEXTROMETHORPHAN, the only non-narcotic cough supressant we have, will disappear
from the market.
THIS information needs to receive MAJOR media attention but no one will touch
it. After all, these medicines have no safety problems. This is a political
action that has nothing to do with the promotion of public health. It is about
FDA action to justify their existance and their
jobs. FDA is now headed by political appointees who make decisions based on
outside influence that goes all the way to the Oval OFFICE. Check out who runs
the FDA and who is the new PR man for President Bush. They are BROTHERS! BOTH
are Bush appointees.
An online petition to Congress to overturn the FDA attack on the drugs most poor
people rely on for survival, will soon be available for signature.I will return
here to post that URL. This FDA action affects young, old and everyone
in-between. It affects YOU! Wake up before it is
too late. While the FDA is pushing big industry's new and expensive drugs, they
are quietly removing the old affordable standby drugs. You have until December
25 to stop it.
Click here
to go to FDA site and input Docket number 2003D-0478. Read it and weep.
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