The White House, through the Office of Science and Technology Policy (OSTP), announced a major initiative to overhaul the regulation of biotechnology products (OSTP Memo), which are products developed through genetic engineering (excluding human drugs and medical devices). This initiative, detailed in a memorandum to the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Department of Agriculture (USDA), aims to improve biotechnology regulation by reducing regulatory burdens and improving transparency, predictability, and coordination among regulatory agencies. The new regulatory approach will significantly impact the manner in which biotechnology products are approved, making this initiative an important one to follow.
The FDA, EPA, and USDA currently regulate biotechnology products in accordance with the Coordinated Framework for the Regulation of Biotechnology promulgated in 1986. Generally, FDA regulates the use of biotechnology products as food or food additives; EPA regulates the use of bioengineered products as pesticides or plant incorporated protectants; and USDA regulates (through the Animal and Plant Health Inspection Service) the release into the environment of genetically engineered plants, seeds, and other regulated articles. The OSTP updated the Coordinated Framework in 1992, setting forth a risk-based approach for the oversight of activities that introduce biotechnology products into the environment. This update affirmed that federal oversight should focus on the characteristics of the biotechnology product and the environment into which it is being introduced, rather than the process by which the product is created.
The recently announced initiative is the first major revision in over 20 years. The OSTP acknowledged that a revision is needed because the current system can cause biotechnology product developers to encounter “unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other [issues].” OSTP Memo at 2. These burdens have “limited the ability of small and mid-sized companies to navigate the regulatory process and of the public to understand easily how the safety of these products is assured,” resulting in reduced economic growth, innovation, and competitiveness.
To address these problems, the OSTP details five main developments that will take place over the next year. The first step in the process involves the creation of a new working group consisting of representatives from the Executive Office of the President, EPA, FDA, and USDA. Then, the working group will have one year to clarify the current roles and responsibilities of the regulatory agencies and develop a long-term strategy designed to efficiently assess risks of future biotechnology products while supporting innovation. In designing a regulatory program, the OSTP stresses that the working group must focus on “protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens.” OSTP Memo at 4. In addition to the working group’s own study, the EPA, FDA, and USDA also will commission an external, independent analysis of the future landscape of biotechnology products to identify potential new risks and determine how to assess those risks and ascertain areas in which the risks (or lack thereof) relating to the products are well understood.
The remaining two developments are ministerial in nature, requiring the working group to come up with a budget to implement the provisions of the OSTP Memo and to produce an annual progress report detailing the actions taken to improve the regulatory framework. The progress report will be sent to the Executive Office of the President and made available to the public.
Given the breadth of this initiative, it will be important for biotechnology companies to review proposed regulatory revisions and provide the working group with comments. The OSTP Memo directs the working group to involve the public in the review process by seeking “input from the public” before updating the Coordinated Framework. OSTP Memo at 3. Public comments will likely help identify “the best available science” to be used in product evaluations, the “impediments to innovation,” ways to streamline the review and approval process, and which products are or are not regulated. OSTP Memo at 3-4. While there are no current opportunities for public participation, such opportunities will likely arise shortly given the working group’s one-year deadline.