Industry Looks to FDA to Provide Guidance on Regulatory Process
San Diego, Cal. (June 18, 2008) – Genetically engineered (GE) animals provide innovative technologies that are transforming public health through biomedical, food and environmental applications, according to a scientific report released today at the BIO 2008 International Convention .
The report, Genetically Engineered Animals and Public Health – Compelling Benefits for Health Care, Nutrition, the Environment and Animal Welfare, details how GE animals are enhancing human health, food production, environmental protection, animal health and cutting-edge industrial applications. The report was authored by Scott Gottlieb, MD, of the American Enterprise Institute, and Matthew B. Wheeler, PhD, of the Institute for Genomic Biology, University of Illinois at Urbana-Champaign. Dr. Gottlieb and Dr. Wheeler are experts in the field of genetic engineering of animals.
Genetic engineering is the deliberate modification of the animal’s genome using techniques of modern biotechnology. By incorporating genes from other organisms in a process called transgenesis, GE animals are being developed to address five broad goals:
Advance human health: GE animals will improve human health by producing novel replacement proteins, drugs, vaccines and tissues for the treatment and prevention of human disease.
Enhance food production and quality: Animals that are genetically engineered will have improved food production capabilities, enabling them to help meet the global demand for more efficient, higher quality and lower-cost sources of food.
Mitigate environmental impact: GE animals will contribute to improving the environment and human health by consuming fewer resources and producing less waste.
Optimize animal welfare. Genetic engineering offers tremendous benefits to the animals by enhancing the health, well-being and welfare of the animal itself.
Improve industrial products: Genetic engineering can produce high-value industrial products, such as spider silk, for both medical and defense applications.
“There are now dozens of products under development derived from genetically engineered animals that hold promise of benefit to human health,” says Dr. Gottlieb. “But the practical benefits of this technology have not yet reached American patients and consumers primarily because of regulatory and political obstacles rather than the limits of science.”
The authors make a strong case for creating a regulatory pathway for commercialization of these beneficial technologies. The report illustrates how the production of GE animals promises benefits in both biomedicine and agriculture. But Gottlieb and Wheeler agree that the science requires regulations that bridge the divide between food and biomedical products.
“Until we resolve how we are going to deal with the food capabilities of this science, the medical applications will remain largely undeveloped and many opportunities for curing and treating disease will go unrealized,” said Dr. Wheeler. “These promising technologies are now dependent on science-based regulatory framework to govern how these animals can also provide food and agricultural benefits.”
The Biotechnology Industry Organization (BIO), which commissioned Gottlieb’s and Wheeler’s report, supports the application of a strong science-based regulatory process to the regulation of GE animals and their products, based on the Food Drug and Cosmetic Act’s New Animal Drug framework.
“The FDA has worked closely with the industry and academia on the diverse applications of the technology for over ten years, and it has mapped the road forward with a rigorous science-based framework,” says Dr. Barbara Glenn, BIO’s Managing Director for Animal Biotechnology. “Clearly the societal benefits of GE animals are fascinating. Decision makers in the federal government should advance the publication of the regulatory process for GE animals so we’re able to achieve the promises of the technology.”
A copy of the full report, Genetically Engineered Animals and Public Health – Compelling Benefits for Health Care, Nutrition, the Environment and Animal Welfare, is posted at :
Upcoming BIO Events
Pacific Rim Summit on Industrial Biotechnology and Bioenergy
Sept. 10-12, 2008
BIO Investor Forum 2008
October 29-31, 2008
San Francisco, CA
November 17-19, 2008
BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.