New advances in gene editing, precision medicine and synthetic biology are all likely to have a major impact on how the US Food and Drug Administration (FDA) shapes its regulations in the near- and long-term.

Now, FDA is formally asking interested parties to offer some fresh perspectives on these and other emerging technologies and cross-cutting scientific advances that could be of importance to FDA, with a focus on areas that may impact FDA in five to 10 years.

“FDA's ability to achieve its mission relies on awareness of, and proactive preparedness for, emerging issues and scientific advances, which will impact the development of regulated products well in advance of formal FDA regulatory submissions (e.g., 5-10 years),” according to a request for comment in Tuesday's Federal Register.

The call for more comments comes from FDA’s Emerging Sciences Working Group in order to provide for a better science-based forum to identify and communicate scientific regulatory approaches and to prepare for emerging science and technology.

“To realize this goal requires long-range horizon scanning by a cadre of scientific leaders from FDA, other government Agencies, interested stakeholders, and the public. Emerging sciences, such as synthetic biology, are expected to impact FDA regulated products in the relatively near term. The goal of this initiative is to identify issues and advances that will impact the Agency in the longer term and thus may be in their infancy,” the agency says.

The call for comments comes as FDA’s Science Board found in a 2007 report that it was “highly doubtful” that the agency could ensure the rapid entry of new life-saving medical therapies. However, a report from late 2015, called “Mission Possible: How FDA Can Move at the Speed of Science,” found that FDA has made many substantive changes, including:

• the creation of the Office of the Chief Scientist and other offices to support regulatory science, health informatics, the professional development of scientists, scientific integrity, minority health and a group devoted specifically to countermeasures for acts of terrorism and emerging threats
• initiatives that deal with new and emerging technologies, including stem cells, 3D printing, predictive toxicology, genome sequencing and computer simulations
• advances in regulatory science that promote the lifecycle approach for the regulation of drugs, devices and biologics
• an increased focus on active post-market surveillance, primarily related to the new Sentinel surveillance system

Federal Register