FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

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 commingled 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 minuscule 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.

####

Media Contacts   |   FDA News Page   |   FDA Home Page

Office of Public Affairs
Web page created by clb 2002-NOV-19.