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BIO: FDA Oversight of Animal Biotechnology Must Be Changed

August 19, 2020
Media Contact
Karen Batra

America’s position as an innovation leader is at stake 

Washington, D.C. (August 19, 2020)The U.S. government’s system for regulating animal biotechnology – currently under the U.S. Food and Drug Administration (FDA) – is broken and is driving beneficial innovations to other countries, according to discussions taking place this week as part of the Animal Health in the Heartland virtual symposium.

Dr. Clint Nesbitt, Senior Director of Science and Regulatory Affairs for Food & Agriculture at the Biotechnology Innovation Organization (BIO), addressed symposium participants this morning during the presentation, “U.S. Oversight of Animal Biotechnology and the Need for Change.”

“Animal biotechnology holds tremendous potential for improving animal health and well-being, transforming our farming and food systems, boosting our bioeconomy, and even helping to prevent and respond to zoonotic diseases such as COVID-19,” said Nesbitt. “But these breakthroughs are dependent on a clear, timely, and science-based approval process that includes a viable path to market.”

In more than two decades, only one food animal has been approved by the FDA’s biotechnology process. “This does not foster confidence in the U.S. system for investors and developers,” said Nesbitt.

Dr. Nesbitt, as well as other presenters on the symposium program, made a strong case for overhauling the current system via a joint agreement between the FDA and the U.S. Department of Agriculture (USDA), which recently updated and streamlined its review process for plant biotechnology.

“FDA’s approach to animal biotechnology is inconsistent with the Administration’s efforts to modernize regulations. As a result, investment, research, jobs, and animal biotech innovation has abandoned the United States for other countries such as China, Brazil, and Argentina, where developers have a clearer understanding of the approval process,” said Nesbitt.

A joint agreement between FDA and USDA will reassure developers that the United States wants to be an innovation leader and deliver new tools and technologies to our nation’s farmers and ranchers.”

BIO sent a letter earlier this year to President Trump urging for changes to animal biotechnology oversight in a way that more appropriately draws upon existing legal authorities to safeguard animal health, food safety, and the environment. In a similar letter sent to Congressional leaders, BIO joined with 27 members of the Council of State Bioscience Associations calling for legislative action.

BIO is part of a diverse coalition of producer groups, academics, developers, and ag commissioners supporting animal innovation and an improved process for getting beneficial products into the marketplace.

“There have been a number of proposals brought forward by the stakeholder community. We are hopeful that the Administration will settle on a solution that will enable the United States to meet its innovation goals and position animal biotechnology to help us solve big challenges,” said Nesbitt. “The status quo is unacceptable.”


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