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Feb 15, 2017

Will genetically engineered animals finally bring home the bacon?

It’s unusual for an obscure procedural federal law to attract much attention, especially if it’s 20 years old, but the Congressional Review Act is creating buzz.  A game-changer for regulatory reform, it could be a significant stimulus to job creation and economic growth. Excerpt - My own prime candidate is an Obama-era Food and Drug Administration policy that has decimated an entire once-promising biotechnology sector--the genetic engineering of animals with novel and valuable traits. After more than a decade of deliberation (read: dithering), the FDA’s Center for Veterinary Medicine finalized a policy that makes every animal crafted with the most precise genetic engineering techniques subject to the onerous procedures and regulations for new drugs used to treat animal diseases, such as pain relievers or flea medicines. What kinds of animals? One that endured a 22-year review is an Atlantic salmon that contains a newly introduced Chinook salmon growth hormone gene that remains turned on all year round (instead of during only the warmer months, as in nature) thanks to a new regulatory sequence from the ocean pout. This cuts the time to marketable adult weight from 30 months to 18. The extra gene confers no detectable differences in the salmon’s appearance, taste, nutritional value or ultimate size; it just grows faster. (As a former FDA medical reviewer of biopharmaceuticals, I believe that that review was grotesquely incompetent; it should have taken much closer to 22 weeks than 22 years.)  Read the article.

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