Overview
Title
Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease; Draft Guidance for Industry; Availability
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ELI5 AI
The FDA is sharing a new idea about how they might not need to check every time scientists change the genes of farm animals like pigs and rabbits to study diseases, but only if they are sure it’s safe. People can tell the FDA what they think about this until March 2025.
Summary AI
The Food and Drug Administration (FDA) has announced the availability of a draft guidance titled "Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease." This guidance focuses on policy for genomic alterations in animals like swine and rabbits, which are used as models for human or animal diseases in biomedical research. The FDA may not require developers of these altered animals to submit an application for approval if the risk factors have been reviewed and are determined to be manageable. The public can submit comments about this draft guidance electronically or in writing until March 10, 2025.
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #251 entitled "Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease." This draft guidance, when finalized, will set forth FDA's policy regarding heritable intentional genomic alterations (IGAs) in animals of food- producing species, such as swine and rabbits, that are intended to be marketed for use as models of human or animal disease in biomedical research under contained and controlled conditions. The draft guidance describes the conditions under which we generally may not expect developers of IGAs in animal models of disease to submit an application to FDA's Center for Veterinary Medicine (CVM) or to get our approval before marketing their animals following CVM's prior review of risk factor data.
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AnalysisAI
The document discusses a draft guidance from the Food and Drug Administration (FDA) concerning heritable intentional genomic alterations (IGAs) in animals of food-producing species like swine and rabbits. These animals are intended to serve as models for biomedical research on human or animal diseases. This guidance, when finalized, will articulate the FDA's policy on how it regulates these animals with IGAs, specifically under the context that they will be used in controlled and contained environments. The idea is to possibly exempt developers from needing to submit formal approval applications if thorough reviews of risk factors show these risks are manageable.
Summary and Context
This draft guidance aims to streamline the process for using genetically altered animals in disease research by potentially waiving some regulatory requirements. With diseases in humans and animals often sharing similarities, these animal models can be crucial in understanding diseases better and testing new medical products before they're used on humans. The FDA is proposing that if it determines there is a clear understanding of the risks and these are mitigated well, formal application processes might be bypassed for developers, easing time and resource burdens.
Significant Issues and Concerns
One major concern is the lack of detailed criteria or a clear explanation for what exactly qualifies an IGA in an animal model to fit into Category 2, which is where developers might not need to seek approval. While examples and general guidance are discussed, clarity and specifics could help prevent misunderstandings.
Additionally, the brief mention of Category 1 and Category 2 IGAs, without detailed elaboration, may cause confusion. Stakeholders who are not intimately familiar with previous FDA guidelines, specifically GFI #187A, might struggle to navigate these regulatory waters without further clarification.
Public Impact
For the general public, this guidance represents a step towards potentially faster advancements in medical research that could translate into quicker development of treatments and medications. By potentially reducing the regulatory burden on researchers, it can expedite the process of understanding diseases and testing new treatments in more relevant animal models.
That said, the public may also have concerns regarding the use of genomic alterations, particularly in animals that may traditionally be part of the food supply. While the FDA mentions steps to ensure these animals do not enter the food supply or the natural environment, more explicit details would be reassuring.
Impact on Stakeholders
For researchers and developers, this draft guidance could signify a reduction in regulatory hurdles, saving both time and resources. It could encourage more innovative research and development by lowering the barrier to entry for using advanced genetic techniques in models of disease.
Conversely, those in the field who prefer clear regulatory frameworks might find the lack of specific criteria problematic, as it introduces uncertainty in how to align projects with regulatory expectations. For manufacturers and food safety entities, ensuring these animals remain out of the food chain is critical, and how well this is managed is of utmost importance.
Overall, while this draft guidance appears forward-thinking, it would benefit from additional specificity to ensure clarity and prevent misinterpretations among all stakeholders involved.
Issues
• The document does not specify the exact criteria for an IGA in animal models of disease to fit into Category 2, which may lead to ambiguous interpretation.
• The distinction between Category 1 and Category 2 IGAs and the resulting regulatory requirements are briefly mentioned but not elaborated on, which could lead to confusion for developers.
• The document potentially assumes a level of understanding regarding FDA's risk-based approach and GFI #187A, which may not be clear to all stakeholders without further context or explanation.
• The process for evaluating the appropriateness of IGAs in animal models for Category 2 designation and the criteria for evaluating risk factor data is not clearly articulated.
• There is a lack of detailed information on how FDA ensures that the IGAs do not enter the food supply or escape into the environment, apart from case-by-case evaluation.