Industry Looks to FDA to Provide Guidance on Regulatory Process
SAN DIEGO--(Business Wire)--
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:
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1. 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.
2. 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.
3. Mitigate environmental impact: GE animals will contribute to
improving the environment and human health by consuming fewer
resources and producing less waste.
4. Optimize animal welfare. Genetic engineering offers tremendous
benefits to the animals by enhancing the health, well-being and
welfare of the animal itself.
5. Improve industrial products: Genetic engineering can produce
high-value industrial products, such as spider silk, for both
medical and defense applications.
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"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 www.bio.org.
About BIO
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.
Upcoming BIO Events
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-- Pacific Rim Summit on Industrial Biotechnology and Bioenergy
Sept. 10-12, 2008
Vancouver, B.C., Canada
-- BIO Investor Forum 2008
October 29-31, 2008
San Francisco, CA
-- BIO-Europe 2008
November 17-19, 2008
Mannheim/Heidelberg, Germany
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The Biotechnology Industry Organization
Karen Batra, 202-449-6382
kbatra@bio.org
www.bio.org
Copyright Business Wire 2008
