Docket Management
Docket: 02D-0324 - Draft Guid.: Drugs, Biologics & Medical Devices Derived from Bioengineered Plants
Comment Number: EC -91

Accepted - Volume 9

Comment Record
Commentor Dr. Susan Harlander Date/Time 2003-02-07 17:33:01
Organization BIOrational Consultants, Inc.
Category Individual

Comments for FDA General
1. General Comments I am submitting the following comments in response to the draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals announced in the Federal Register on September 12, 2002. The use of plants for the production of human pharmaceuticals has the potential to increase the availability and affordability of beneficial human drugs. At the same time, it is critically important these these plants, especially if they are food crops, are grown under strict confinement procedures to prevent contamination of the food supply. Since these products will not be approved for food and feed use, it is imperative that regulatory agencies develop an oversight system that will prevent their inadvertent introduction into the food supply chain. I support the efforts of FDA and USDA to develop draft guidance as I believe strong regulatory oversight is critically important to facilitate the development of plant made pharmaceuticals and at the same time ensure that these products do not become part of the commodity food supply chain. This guidance must continue to be science-based. Although the guidance is intended for industry, it must be recognized that research and development in this area also accurs at universities and private institutions. Therefore, I would encourage you to consider a more encompassing title for the guidance document so that these institutions are also included. For example, Guidance for the Production of .... As written the draft guidance applies only to plant made drugs, biologics and medical devices. I would strongly encourage you to either include plant made industrials within the scope of this document, or to draft new and similarly stringent guidance for this category of products. I believe it is imperativbe that FDA, in cooperation with USDA, develops a stringent and mandatory regulatory system to ensure that when food crops are used, the U.S. food supply is protected from inadvertent contamination with plant made pharmaceuticals and industrials. This regulatory system should include mandatory controls for the confinement and segregation of the entire processing system from seed production, through planting, harvesting, processing, distribution and disposal of plants. Strict standard operating procedures consistent with a HACCP approach need to be developed and these should be subject to audit and inspection. Dedicated land and equipment should be used for these products. Physical and biological barriers to cross-pollination must be encouraged, and if necessary, mandated. For example, FDA could require that plant made pharmaceuticals only be grown in regions of the country where little or none of the crop's food or feed counterparts are grown. How the land is used following production of plant made pharmaceuticals and industrials should be specified and subject to audit and inspection. Additionally, regulatory agencies need to have sufficient personnel to conduct inspections and audits on a routine basis to ensure compliance with permit conditions. Applicants for plant made pharmaceuticals and industrials should be required to make available testing methods as a requirement for receiving a field release permit from USDA. Validated and standardized test methods and assay standards should be deposited with an independent third party such as GIPSA. Contingency plans for the confinement measures should be made a requirement for obtaining field release permits from USDA. These plans should address response and mitigation procedures in the event of an inadvertent contamination of the food supply. I appreciate the opportunity to comment on the Draft Guidance.

EC -91