Published online 16 January 2009 | Nature | doi:10.1038/news.2009.36

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FDA ready to regulate transgenic animals

Agency unveils path to approval after decade-long delay.

GoatThe FDA has recently said ATryn, purified from the milk of engineered goats, is safe.Getty

The US Food and Drug Administration (FDA) has adopted a policy that will govern approval of the use of genetically engineered animals.

The guidelines, released on 15 January, have been more than a decade in the making. In the interim, researchers have pushed forward with plans to develop a wide range of transgenic animals, including salmon engineered to grow faster, and the Enviropig, engineered to produce waste that is less polluting than that of normal pigs.

Last week, an FDA advisory committee deemed an anti-clotting drug called ATryn, produced in the milk of genetically engineered goats, to be safe — an important step towards the eventual approval of the drug for sale in US markets.

But the lack of a clear path to government approval has been a significant barrier to companies wishing to develop genetically engineered animals, says Ronald Stotish, chief executive of Aqua Bounty Technologies, a company based in Waltham, Massachusetts, that is developing fast-growing salmon.

"You can't persuade shareholders that they should invest money indefinitely in the absence of any light at the end of the tunnel," he says.

Secrecy concerns

Last September, the FDA released draft guidelines proposing that the agency regulate genetically engineered animals just as it regulates drugs, under the Federal Food, Drug, and Cosmetic Act. The agency argued that the recombinant DNA used to engineer the animals was in effect an animal 'drug'.

As such, the agency will investigate the safety of the 'drug' as well as possible environmental impacts if, for example, the animal were to escape into the wild. Genetically engineered animals developed for research purposes and kept in well-contained labs would not be subject to approval, the agency said.

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To some, the process raised concerns about a possible lack of transparency, because the decision-making process to approve a new drug is largely carried out behind closed doors.

Critics also questioned whether the FDA has the necessary expertise to evaluate the environmental risks posed by transgenic animals, and some consumer groups decried the lack of requirements regarding the labelling of products from such animals.

In response to concerns about transparency, the new guidelines note that the agency intends to hold public advisory committee meetings before approving any genetically engineered animals. But that may not go far enough because the information released to the public will still be restricted, says Doug Gurian-Sherman, a senior scientist at the Union of Concerned Scientists in Washington DC. "There's the possibility that a lot of pertinent information will not be disclosed to the public," he says.

That approach could end up backfiring for the FDA and for companies developing transgenic animals, Gurian-Sherman argues, by sacrificing consumer confidence. "When you have a secret process like this, it's not going to do anything to improve public confidence in this technology," he says. "The agency is shooting itself in the foot." 

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