FDA Outlines Rules on Genetically Engineered Animals - Pharmaceutical Technology

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FDA Outlines Rules on Genetically Engineered Animals


ePT--the Electronic Newsletter of Pharmaceutical Technology

Rockville, MD (Sept. 24)—In an effort to clarify its policy on the use and creation of genetically engineered (GE) animals, the US Food and Drug Administration released the draft guidance The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs on Sept. 18, 2008. The guidance also outlines requirements and recommendations already existing in regards to GE animals and products derived from GE animals.

GE animals are animals whose DNA has been manipulated with a recombinant DNA (rDNA) construct to bring about new or specific traits. These animals are used to create pharmaceuticals, serve as models for human diseases, and produce consumer products.  According to FDA, rDNA constructs meet the definition of a new animal drug under the Food, Drug, and Cosmetic Act (FD&C Act), which classifies “articles (other than food) intended to affect the structure or any function of the body of man or other animals” as drugs. 

“Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and FDA has long been involved in the scientific evaluation. Our guidance provides a framework for both GE animals and products made from them to reach the market,” stated deputy commission for policy Randall Lutter, PhD, in a press release.

The guidance indicates areas in which FDA will be coordinating with other federal agencies in the US Department of Agriculture and the Environment Protection Agency to develop policies in regard to GE animals. Specific questions addressed in the guidance include FDA’s enforcement entitlements, current regulations, and product development processes. The guidance also outlines the responsibilities for meeting environmental assessment under the National Environmental Policy Act for those applying for an animal drug application.  The draft guidance is limited to heritable rDNA constructs. Nonheritable constructs may be addressed in a future guidance.

Public comment on the draft guidance is open until November 18, 2008. A copy of the guidance can be downloaded here.

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