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FDA Memo Indicates Biopharm
Contamination Was Human Drug,
Not Pig Vaccine

Web Note: Despite misleading press reports that the Prodigene's Biopharm
contamination in Nebraska and Iowa involved a pig vaccine in both states,
this memo clearly shows that a human drug was being gene-spliced into corn
in the Nebraska incident. This drug was apparently an experimental, and
possibly dangerous AIDS drug called the HIV glycoprotein gp120, a
blood-clotting agent (aprotinin). For more information on this see
<www.organicconsumers.org/ ge/Pharmageddon120502.cfm It will be interesting
to see how long it takes for the mass media to get their facts straight on
this.

T02-46 Media Inquiries: 301-827-6250
November 19, 2002 Consumer Inquiries: 888-INFO-FDA

FDA ACTION ON CORN BIOENGINEERED TO PRODUCE
PHARMACEUTICAL MATERIAL

The Food and Drug Administration (FDA) today announced that the
biotechnology firm ProdiGene has agreed to strengthen the controls on any
bioengineered plant it grows that will be used in current and future
clinical studies.

FDA obtained this commitment after learning that a small amount of corn
ProdiGene engineered to produce pharmaceutical material for a clinical
study had been harvested in a field of soybeans.

In the middle of October, a small number of volunteer corn stalks were
harvested in a field of soybeans in Nebraska and subsequently commingled
with approximately 500,000 bushels of soybeans.

FDA, USDA, and the State of Nebraska have ensured that the entire lot of
soybeans has been secured in the warehouse since their arrival. ProdiGene
has agreed to buy back this lot of soybeans, and the Federal
government will oversee their disposal. These products will not enter the
human or animal food supply.

Because of the very small amount of genetically modified material
co-mingled with such a large amount of soybeans, FDA is confident that the
material from the corn would pose virtually no health risk, but even the
miniscule amount of material in question should not have been present in
the soybeans.

The pharmaceutical material being produced in the corn plants was being
studied under an Investigational New Drug (IND) application, and today's
action will help ensure the proper handling of bioengineered materials
being studied by ProdiGene for pharmaceutical uses, now and in the future.

Before any proposed human drug therapy may be studied in humans, its
sponsor must submit an IND for FDA review. The IND details how the trial
will be conducted so that FDA can judge whether the study will be properly
carried out, whether study participants will be adequately informed and
protected, and whether the study material will be produced in a safe,
quality manner.

FDA is responsible for the safety of all human and animal food produced by
bioengineering. FDA also oversees clinical trials of new pharmaceutical
products, including bioengineered materials being studied as human drugs.

The U.S. Department of Agriculture (USDA) is responsible for ensuring that
field growth of bioengineered crops is conducted properly.

FDA and USDA will continue to work closely together to enforce current
safeguards covering research in bioengineered foods, and the agencies will
take whatever action is necessary and appropriate to protect human,
animal and plant health.

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