NCPA - National Center for Policy Analysis

The Food And Drug Administration Needs Egging On

August 26, 2010

Last year, after more than 20 years of deliberation, the Food and Drug Administration's (FDA) Center for Veterinary Medicine chose to require that every genetically engineered (GE) animal be subject to the same pre-market approval procedures and regulations as drugs, such as pain relievers and anti-flea medicines, which are used to treat animal diseases.  The rationale is that a genetically engineered construct "that is in a GE animal and is intended to affect the animal's structure or function meets the definition of an animal drug."  But this explanation conveniently ignores the science, the FDA's own precedents and the availability of other, better regulatory options, says Henry Miller, a fellow at Stanford University's Hoover Institution. 

An example is the Atlantic salmon, which has been awaiting an FDA policy for a decade, says Miller: 

  • The Atlantic salmon contains a Chinook salmon growth hormone gene that remains turned on all year (instead of during only the warmer months, as in nature).
  • This cuts the salmon's time to reach a marketable adult weight from 30 months to 18.
  • The extra gene confers no detectable differences in the salmon's appearance, taste or nutritional value; it just grows faster -- a tremendous economic advantage to those farming the fish. 

There are numerous other applications in various stages of research and development, says Miller: 

  • This includes livestock with leaner muscle mass and improved use of dietary phosphorus to lessen the environmental impacts of animal manure.
  • The technology could also be used both to inhibit micro-organisms' ability to grow within chickens and their eggs, and to block the synthesis and action of the bacterial toxins.
  • This same technology can be employed to produce antibodies that can be administered to infected patients to neutralize the toxins. 

The lengthy, expensive pre-marketing approval requirement only applies if the animal is crafted with state-of-the-art recombinant DNA ("gene-splicing") techniques.   In other words, the FDA's regulatory trigger is not the risk-related traits of an animal, but the use of a certain technology -- and the most precise and predictable one, at that, says Miller.  

The result of the FDA's risk-averse approach to genetically engineered animals is that yet another entire innovative business sector is burdened with an excessively regulatory policy that inflates research and development costs and inhibits innovation, says Miller. 

Source: Henry Miller, "The FDA needs egging on," The Guardian (UK), August 24, 2010. 

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