Confusion: FDA to Treat Genetically Engineered Animals as Drugs

The FDA has decided to regulate genetic engineering of animals. And it looks to be confusing. From the story:

The agency has premised the rules on an unusual reading of the federal Food, Drug and Cosmetic Act, saying that the inserted DNA used to modify an animal can be regulated as a “new animal drug” under the 1938 law from which the agency draws much of its regulatory clout. Under this interpretation, the same gene inserted into two different animals of the same species on separate occasions creates two different entities to regulate, because DNA integrates itself into the genome pretty much at random. However, the offspring of genetically modified animals will be, in regulatory terms, the same thing as their parents…

The new regulations are unlikely to have an impact on most bench scientists. The agency says genetically engineered laboratory animals are a “principal” case where it would exercise its discretion not to regulate. “In general we are not interested in having an application from every postdoc and grad student making a knockout mouse for this that or the other thing,” said Rudenko. The agency says it will also take what some would see as a light touch in not requiring foods from genetically engineered animals to be labelled as such unless the engineering was specifically designed to change their nutritional values, or if it did so by chance.

Not surprisingly, the industry is cheering and consumer groups are not amused:

The biotechnology industry, which has long urged the agency to issue such rules, praised the draft. Barbara Glenn, the managing director for animal biotechnology at the Biotechnology Industry Organization in Washington DC, says that about a dozen of her group’s 1,200 member companies are currently developing genetically engineered animals. “The guidance is going to ensure that we can reach the very compelling benefits of genetic engineering of animals,” she says. “It simply allows industry to move forward.”

Consumer groups, by contrast, were highly critical. They said that the guidance was far too vague, leaving consumers to trust that FDA will conduct adequate assessments of animals’ environmental and safety impacts.

It sounds to me as if Congress should revisit the law and grant the FDA more specific authority based on current science. But considering the Congress we have, they might make it worse instead of better.

Of course animal rights activists would prefer we receive no benefit from these genetically modified animals. But then, they don’t want us to benefit from the use of animals at all.