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Getting the Guidance We Need: FDA Finalizes Regulatory Guidance for GE Animals

January 15, 2009
Well, it’s finally happened. The FDA announced today that it will make the final guidance available for governing genetically engineered animals. And if I strain carefully, I can already hear them -- the naysayers.

For example, back in November, the Consumers Union, the nonprofit publisher of Consumer Reports, submitted comments to the FDA containing the following statement, “A major problem with this proposal is that it is simply Guidance for Industry and so is not legally binding: “This draft guidance . . . does not create or confer any rights for on any person and does not operate to bind FDA or the public.” We urge the FDA to publish a legally binding regulation for genetically engineered animals, and not just a non-binding “guidance.””

That’s right; it’s guidance for the industry, on how to deal with the stuff that is legally binding. Submitting a product for regulatory approval is very complicated, and if the FDA never provided any guidance as to how to do that, well, we’d never have any new products.

In any event this is very exciting since scientists have been working for years to develop new products using goats, pigs, sheep, chicken, fish and cattle that will advance human health. These animals can be engineered to produce pharmaceutical proteins and replacement tissues in their milk, eggs and blood, which can be used in the treatment of human disease, to develop life-saving therapies.

That the FDA has developed this framework which is based on the Food, Drug and Cosmetic Act’s New Animal Drug (NAD) framework, means that these patients will have a greater chance of seeing these life-saving therapies. My organization put out a statement today that mentions, among other things,

BIO and its members engaged in animal biotechnology support a strong federal regulatory system to oversee development and approval of all genetically engineered (GE) animals and the products derived from them. The industry’s goal is to ultimately provide to the marketplace products that have been approved as safe and beneficial for society.”

I have to say, as a scientist and a consumer, that statement makes me proud to be a part of this industry, as I know that this is the first, in a long line of many steps, to make a product, which will ultimately save lives.