FDA Warns Universities Over Studies Involving Transgenic Animals
By JEFFREY BRAINARD
(Washington) - The U.S. Food and Drug Administration has written to the leaders of 70 universities reminding them to comply with the agency's regulations on research to create transgenic animals with desired traits. The letter follows a February incident in which the agency accused the University of Illinois at Urbana-Champaign of failing to document whether hundreds of pigs connected to such a study had entered the human food supply (The Chronicle, February 7).
The university says that transgenic animals did not enter the food supply. Nevertheless, watchdog groups that follow biotechnology research have called for tighter government oversight of the studies, arguing that transgenic animals might cause human health problems if they wind up in the food supply or are made into food for other animals.
The FDA sent the letter last week to all of the nation's land-grant institutions and to other universities that conduct agricultural research. The letter says that university scientists may need to file an application with the agency before pursuing such studies. It notes that the agency has not allowed transgenic animals to be used for human consumption to date and only in limited cases has allowed such animals to be used to make animal feed.
University scientists have led the way in the young but growing field of transgenic animals. The work involves inserting genes into a variety of domesticated livestock and fish species in order to give them traits useful to people. These include faster growth, better nutritional composition, or the ability to produce chemicals that act as vaccines or hormones in humans. To date, such experiments have not led to these commercial products.
The FDA has given relatively little guidance to universities doing the studies, perhaps because the agency is more used to dealing with corporations and trade groups, said Gregory A. Jaffe, director of the biotechnology project at the Center for Science in the Public Interest, an advocacy group based here. "Industry is used to being regulated, whereas universities don't necessarily know that the [transgenic-animal] research they're doing requires regulation by the FDA," he said.
Mr. Jaffe said that the letter was helpful, but that the agency's policy remains unclear -- it does not say, for example, whether certain test-tube studies not involving live transgenic animals might be considered exempt from regulation. The letter stated generally that the FDA has jurisdiction over such animals because of its authority to regulate new drugs in animals, and the agency invited researchers to contact it for further guidance.
Meanwhile, the FDA has not yet issued a final decision in the Illinois case, which led to last week's letter. In that case, the university's researchers had inserted genes into pigs designed to make sows increase milk production and allow baby pigs to digest the milk better, which in turn would make the piglets healthier and make them grow faster without the use of drugs.
An FDA inspection in January faulted the university for selling 386 pigs connected with the experiment to a livestock dealer between 2001 and 2003. The university said that it sold only the offspring of pigs that had received the experimental genes and that none of the offspring had inherited those genes. The agency said in a statement in February that the university researchers had not conducted sufficient evaluations or kept sufficient records to assess whether that was true. The university has disputed that assertion.
The university had hoped that last week's letter from the FDA would clarify how the agency's regulations apply to the offspring of transgenic animals like those in the pig experiment, but the letter did not do so, said Bill Murphy, associate chancellor for public affairs at Illinois.
"This is a new area for the FDA and for the researchers, who aren't really used to dealing with the FDA, and I think it will take a little patience to work through" some of these issues, Mr. Murphy said. "As long as it's worked through in good faith, we don't have any problem" with the FDA's oversight, he said.