Will regulators be able to keep pace with biotechnology developments?

July 5, 2017

A new study predicts a potential disconnect between regulatory science and biotechnology product development, unless regulators scan the horizon for new developments and consider new potential risk pathways.

Several years ago, experts at the National Academy of Science Engineering and Medicine (NASEM) were asked to scope out future product development in biotech over the next five to ten years, to identify the tools that will be needed to develop them, as well as their impact. The views of expert committees studying these questions developed a comprehensive report, issued on June 30, 2017, that predicts strong growth and a movement from simpler to more complex products requiring greater levels of risk assessment.

The study recommends that regulatory systems provide a balanced approach for considering the many competing interests involved in biotech development, suggesting that the following be emphasized:

·      supporting innovation

·      protecting human health

·      preserving biodiversity

·      reducing negative environment effects

·      promoting public confidence in the regulatory process

·      increasing transparency and predictability in the regulatory process

·      reducing unnecessary costs and burdens

·      making use of new tools from a broad range of disciplines

·      interacting with the global economy.

NASEM experts expect the biotechnology pipeline to result in disruptive innovations and to have significant impacts on society.  In the report, however, they voice concern that the profusion of new products could overwhelm the US regulatory system. They believe that a disconnect between research in regulatory science and the expected uses of future biotech products could result in problems, such as new products being developed without enough attention paid to regulatory requirements, which would lead to delays late in the development cycle.

Among its recommendations, the committee suggests that EPA, FDA, USDA, and other agencies involved in regulating biotechnology products increase scientific capabilities, tools, expertise, and their ability to scan for new trends in critical areas where growth is expected, including:

·      comparators, off-target gene effects, and phenotypic characterization

·      genetic fitness, genetic stability, and horizontal gene transfer

·      impacts on nontarget organisms

·      control of organismal traits

·      modeling (including risk-analysis approaches under uncertainty) and life-cycle analyses monitoring and      surveillance

·      economic and social costs and benefits.

The report suggests that regulators build and maintain the ability to triage products rapidly when they resemble existing and well characterized products, once they enter the system, reducing the time and effort required for regulatory decision making.  In addition, the report says, they should be ready to focus questions on identifying new pathways to risk-assessment endpoints associated with products that are unfamiliar and that require more complex risk assessments.

They suggest that federal agencies build capacity to scan the horizon continuously for new products and processes that could present novel risk pathways, develop new approaches to assess and address more complex risk pathways, and implement mechanisms for keeping regulators aware of the emerging technologies they have to deal with.