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December 19, 2002
Dockets Management Branch (HFA-305
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Dear Sir or Madam:
In response to the recent draft entitled, "A Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals," Docket No. 02D-0324, the American Autoimmune Related Diseases Association supports the FDA and USDA's guidelines to ensure the safe production of plant-made pharmaceutical crops from commodity grains intended for food and feed. We agree that any company wishing to participate in producing bioengineered plants must adhere to strict, self-imposed stewardship principles and procedures.
While plant-made pharmaceutical technology represents a great opportunity with tremendous potential, the American Autoimmune Related Diseases Association also recognizes the potential risks to agriculture and the food industry. The success of this technology is predicated upon strong, transparent regulations coupled with an industry-wide commitment to stewardship. Government, the scientific community, and industry must continue to cooperate to develop flexible, science-based , performance standards in order to protect U.S. agriculture, instill confidence across the food chain, and to ultimately realize the potential benefits of this innovative technology.
The primary benefit of plant-made pharmaceuticals for patients may be the opportunity plants afford to produce a greater variety of novel life-saving drugs at more affordable prices. The American Autoimmune Related Diseases Association believes that it is important to pursue all new reasonable opportunities for advancements in medicine, especially those with the potential to develop cost-effective treatments that can reach patients more quickly. Simply stated, we encourage innovative research that can improve autoimmune diseases such as multiple sclerosis and diabetes to name just a few - and plant-made pharmaceuticals are a promising source of innovation. From the standpoint of economics, efficiency, and safety, this new technology possesses significant potential.
Even if only a small portion of the biologics currently in development turns out to be effective, crop plants could provide a viable alternative to traditional protein production methods. And because of this, we cannot afford not to take advantage of this innovative technology. Crop plants that produce protein pharmaceuticals can provide drug manufacturers with an alternative source of proteins free of potential animal contaminants; they can boost manufacturing capacity while they lower capital investments; and they offer an environmentally sustainable and renewable resource for the production of drugs in large volume.
This innovative technology appears to offer great promise for the economical and efficient productions of novel proteins to diagnose, treat or prevent a wide variety of human diseases. From autoimmune diseases such as multiple sclerosis and diabetes, cancer, HIV, and heart disease to Alzheimer=s, cystic fibrosis, and hepatitis, medical science is developing new approaches to the treatment of human disease that potentially could save hundreds of thousands of lives.
We strongly support this technology, and we applaud FDA and USDA's efforts to regulate this industry in a way that both allows for its advancement and protects the food supply.
Sincerely,
Virginia T. Ladd
President and Executive Director
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