Key Takeaways
- The FDA will lead the regulation of genetically altered animals, aided by the USDA as outlined in a recent memorandum of understanding.
- New guidance clarifies a risk-based approach for approvals, facilitating a smoother process for developers of intentional genomic alterations (IGAs) in animals.
- Concerns remain about potential barriers for academic researchers and the overall approval process’s complexity, which could hinder innovation.
New Regulatory Framework for Genetically Altered Animals
The Food and Drug Administration (FDA) announced its continued leadership in regulating intentional genomic alterations (IGAs) in animals, following a memorandum of understanding (MOU) with the U.S. Department of Agriculture (USDA). This MOU, signed last month, delineates communication and collaboration protocols between the agencies, aiming to streamline oversight of genetically modified animals while not altering developers’ existing regulatory requirements.
Tracey Forfa, director of the FDA’s Center for Veterinary Medicine, emphasized the need for the agency’s regulatory approach to adapt alongside advancements in animal biotechnology, which promise benefits for both human and animal health. A significant change is that the FDA can now share information with the USDA during the review process, a move welcomed by many but viewed by some as insufficient in scope.
Jon Oatley, an associate dean at Washington State University, expressed cautious optimism about the MOU but believes greater USDA involvement could further enhance regulatory efficacy. The FDA has faced criticism from the livestock industry for what many consider a slow and cumbersome approval process, exacerbated during the Trump administration when efforts were made to transfer some regulatory authority to the USDA.
Consumer advocates, like Peter Lurie, president of the Center for Science in the Public Interest, found merit in the current FDA guidance. They argue that the USDA, lacking adequate scientific expertise initially, would not handle the regulatory framework effectively. Lurie warned that shifting oversight to USDA could create a disjointed regulatory environment.
In conjunction with the MOU, the FDA has released updated guidance on heritable IGAs, clarifying how developers can navigate existing statutory and regulatory frameworks. This guidance introduces a risk-based evaluation system, attaching greater scrutiny to higher-risk alterations while allowing more lenient requirements for those deemed lower risk.
The updated guidelines aim to ease the developer’s path toward obtaining enforcement discretion for certain IGAs, particularly those analogous to existing animal traits with established safety records. Laura Epstein, associate director at the FDA, noted that this approach marks a positive change in recognizing modifications that could benefit animals, such as those with a shortened coat.
Despite this, the updated guidance raises concerns among academic researchers. Alison Van Eenennaam, a professor at the University of California-Davis, criticized the classification of IGAs as animal drugs, suggesting that it continues to create barriers and increases the costs associated with research. Researchers are now faced with the expense of navigating regulatory processes that could compel them to dispose of genetically altered animals rather than conduct valuable studies.
Oatley highlighted the impractical nature of numerous requirements, such as assessing how IGAs may alter an animal’s product composition. He raised concerns that these challenges could hinder the transition from research innovations to commercially viable solutions.
In response, the FDA’s Forfa affirmed the agency’s commitment to support innovation while prioritizing public safety. She noted that flexibility exists in the regulatory process and reiterated that the FDA engages closely with developers on an individual basis to facilitate progress.
As the landscape of genomic alterations in animals evolves, the new FDA-USDA collaboration and updated guidance signal a pivotal shift in regulatory oversight, yet challenges in the approval process and implications for research remain significant points of contention.
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