The federal agencies that share responsibility for regulating many biotechnology products in the United States – the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) – have jointly issued a plan for regulatory reform under the Coordinated Framework for the Regulation of Biotechnology. The agencies have promised to “update, streamline, and clarify” the regulation of biotechnology products that fall under the Coordinated Framework. The resulting changes to the regulatory landscape have the potential to significantly impact various regulated entities, including developers interested in bringing new biotechnology products to market.
Background
The plan was issued on May 8, 2024 in response to a September 12, 2022 Executive Order from the Biden Administration for agencies to focus on the advancement of biotechnology (“technology that applies to or is enabled by life sciences innovation or product development”) and biomanufacturing (“use of biological systems to develop products, tools, and processes at commercial scale”) to achieve societal goals – developing innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security. The Executive Order directs the EPA, FDA, and USDA to undertake specified tasks aimed at “clarify[ing] and streamlin[ing] regulations in service of a science- and risk-based, predictable, efficient, and transparent system to support the safe use of products of biotechnology.” This includes identifying “areas of ambiguity, gaps, or uncertainties” in the existing regulatory framework and developing a plan for regulatory reform (which the agencies have now issued).
The plan is part of a long history of efforts to modernize the regulation of biotechnology products, which started with the 1986 issuance of the Coordinated Framework under President Ronald Regan. There have been significant scientific and technological advances since the Coordinated Framework was issued in 1986 and most recently updated in 2017. The plan identifies initiatives that the agencies will undertake to modernize the U.S. government’s approach to the regulation of biotechnology products.
Path Forward
The plan specifically identifies five areas in the regulation of biotechnology products to focus on: (1) modified plants; (2) modified animals; (3) modified microorganisms; (4) human drugs, biologics, and medical devices; and (5) cross-cutting issues. One major focus of the plan is “clarify[ing] and streamlin[ing] regulatory oversight for genetically engineered (GE) plants, animals and microorganisms.” Recent efforts by the FDA to clarify and streamline the regulatory oversight of heritable intentional genetic alterations (IGAs) in animals demonstrates that the agencies have already begun to execute the plan.
The plan indicates that the EPA, FDA, and USDA intend to work together to update the Coordinated Framework by December 2024. Thereafter, the agencies have indicated that they will “review the Coordinated Framework on a biannual basis to ensure it remains up to date as science and technology advance.”
Updates Related to Modified Animals
On May 1, 2024, the FDA and USDA issued a memorandum of understanding that clarifies the regulatory roles of each agency in the oversight of IGAs in animals subject to USDA jurisdiction, including the timeline for the FDA’s review of IGAs in animals.
The FDA has indicated that it intends to take a risk-based approach to regulating heritable IGAs in animals – exercising enforcement discretion for heritable IGAs in animals whose risks are well understood and adequately mitigated. Consistent with this stated intent, the FDA has recently taken the following actions related to its regulatory oversight of IGAs in animals:
- Issued a two-part guidance on heritable IGAs in animals. The first part of the guidance sets forth the FDA’s risk-based approach to oversight of heritable IGAs in animals, and the second part of the guidance (which was issued in draft form) is geared toward developers of heritable IGAs in animals that will require FDA approval before marketing.
- Launched the Veterinary Innovation Program, which helps “developers of IGAs in animals … that provide a benefit to human health, animal health, animal well-being …, or enhanced food production.” This program offers developers various benefits, including potentially shortening the path to market by not restarting the 180-day clock for developers using the program if a technical section in the application for an IGA is deemed incomplete.
- Committed to transparency in its review process of IGAs in animals, posting information online for stakeholders about its decision-making processes.
Conclusion
While the agencies have promised to “update, streamline, and clarify” the regulations and guidance on biotechnology products, this is a complex, nuanced, and rapidly evolving area of law. We are keeping track of developments in this space, and we are readily available to assist impacted segments of the biotechnology industry. Stakeholders may also want to submit comments on the approval process for IGAs in animals before the upcoming deadline of July 31, 2024.