September 29, 2003
Via FedEx Mail
Melanie J. Loots
Associate Vice Chancellor for Research
University of Illinois at Urbana-Champaign
601 East John Street,
Swanland MC-304
Champaign, Illinois 61820
Dear Ms. Loots:
We are writing to follow up on an investigation conducted by Mr. Mark G. Peterson from the Chicago District Office and Drs. Amey L. Adams and Michele C. McGuinness from the Center for Veterinary Medicine (CVM) representing the Food and Drug Administration (FDA, Agency) at your facility between January 29 and 31, 2003. This inspection was initiated in response to a letter dated October 28, 2002 and signed by investigators Dr. Mathew B. Wheeler and Dr. Sharon M. Donovan. That letter informed the Agency that they had rendered a pig from a study of double transgenic [ redacted ] crossbred pigs. You are the sponsor and monitor of this study.
This study is one of several you are sponsoring that involves transgenic pigs. Dr. Mathew Wheeler, as the Principal Investigator, requested investigative new animal drug exemptions (INADs) from FDA for the conduct of these studies. The studies are: 1) Transgenic pigs that contain [ redacted ] ; 2) Transgenic pigs that contain the [ redacted ] ; and 3) Double transgenic pigs that contain [ redacted ] . These double transgenic pigs were obtained by cross breeding of [ redacted ] transgenic pigs.
FDA regulations for the conduct of studies under INAD are set forth at 21 CFR § 511.1. This rule includes the requirement that study animals may not be used for food without prior FDA authorization. To date, FDA has not permitted genetically engineered animals to be placed into the human food supply. Nevertheless, you released at least 386 pigs from INADs [ redacted ] for sale for slaughter as human food. FDA has only allowed animals from genetic engineering investigations to be rendered for incorporation into animal feed in limited circumstances. These limited circumstances do not include permission to render animals from [ redacted ].
Another requirement of 21 CFR § 511.1 is that the sponsor provide current monitoring of studies. [21 CFR 511.1(b)(8)(ii)]. During the inspection, FDA found no evidence that you provided for monitoring of the investigation. You had no documentation that the University has a formal monitoring program or that the studies conducted by Drs. Matthew B. Wheeler and Sharon M. Donovan were monitored.
This letter serves to remind you that FDA expects documentation of plans regarding the disposition of all investigational animals and that any study that must be under INAD must meet requirements for current sponsor monitoring. It is imperative that all safety regulations be followed scrupulously to help assure the highest level of confidence possible in the conduct of this type of research.
Please direct any written response to:
Vernon D. Toelle, Ph.D., Team Leader BIMO and Administrative Actions Team (HFV-234) Division of Compliance Office of Surveillance and Compliance Center for Veterinary Medicine 7500 Standish Place, Suite E469 Rockville, MD 20855-2773
If you have any questions please feel free to contact either Dr. Vernon D. Toelle at 301-827-0312 or Mr. George A. Prager at 301-827-7791.
Sincerely yours,
Gloria J. Dunnavan Director Division of Compliance (HFV-230)
Office of Surveillance and Compliance
Center for Veterinary Medicine
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