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January 10, 2003
Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Docket No. 02D-0324, "Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals"
Dear Sir or Madam:
On behalf of the Cystic Fibrosis Foundation, we are responding to the guidance document (Docket No. 02D-0324) regarding the development of pharmaceuticals from bioengineered plants. We support the use of this technology to create new medical products, provided that oversight mechanisms are sufficiently strong to protect the food supply as well as address the potential for environmental contamination.
Cystic fibrosis (CF) is a genetic disease that affects the digestive, respiratory and reproductive systems. With 30,000 people in the US who have CF, the development of new pharmaceuticals to treat and cure this disease is vital. The life expectancy of people with CF has improved dramatically in the last several decades from early childhood in the 1950s to the early thirties today. However, the length and quality of life are dependent on the quality of medicines that make living with CF possible.
More than 90 percent of people with CF must take pancreatic enzymes to digest food. Proper nutrition is an essential foundation to maintaining overall health, particularly the respiratory system where lung infections can become life-threatening.
We understand that some researchers are using bioengineered corn to manufacture some of the protein products for these pancreatic enzymes. We think this new technology has potential to result in beneficial products for our patients. New technologies that can facilitate the development of an alternative, and even improved, source of pancreatic enzymes should be pursued, with appropriate government oversight.
We believe that the proposed guidance document would allow research of great importance to people with CF to move forward, and we support the judgment of FDA on this matter. However, we believe this is an area of research that requires careful monitoring to ensure that the strongest possible oversight is in place to protect against contamination of the food supply or environment. Government, the scientific community, industry, and the public must continue to cooperate to develop flexible, science-based, performance standards in order to facilitate agricultural development, ensure confidence across the food chain, and to realize the potential benefits of this new technology.
Thank you for the opportunity to comment on the oversight of this promising new technology. Please do not hesitate to contact us if you have questions.
Sincerely yours,
Robert J. Beall, Ph.D.
President and CEO
Cystic Fibrosis Foundation
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