President Biden Issues Executive Order to Boost Federal Investment in Domestic Biotechnology and Biomanufacturing

September 16, 2022By Holly N. Brevig, Senior Regulatory Device and Biologics Expert

Earlier this week, President Biden signed Executive Order 14081, titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”  The Executive Order was spurred in part by the COVID-19 pandemic, but it points out that biotechnology and biomanufacturing—defined as use of biological systems to develop products, tools, and processes at commercial scale—has other uses outside of human health, including securing supply chains and growing the American economy.   Efforts to further policies outlined in the order are referred to as the National Biotechnology and Biomanufacturing Initiative (NBBI).

The Executive Order includes objectives to bolster and coordinate Federal investment in biotechnology and biomanufacturing, and to improve and expand on domestic biomanufacturing production capacity and processes while also accelerating the translation of basic research results into practice (section 1).  It also includes a Section on improving the clarity and efficiency of the regulatory process for agricultural biotechnology products (section 8).   The Executive Order also mentions the need to develop genetic engineering technologies and techniques and advance the science of scale-up production so that innovative technologies and products can reach markets faster.  We’ve only touched on a few of the objectives identified in this ambitious and all-encompassing order.

To achieve the objectives outlined in section 1, several heads of agencies, including the Health and Human Services (HHS) are to submit reports to the President through the Assistant to the President for National Security Affairs (APNSA), in consultation with the Assistant to the President for Economic Policy (APEP) and the Director of the Office of Science and Technology Policy (OSTP) within 180 days of the order.  Each report is to identify high-priority basic research and technology development, opportunities for public-private collaboration, and actions to enhance biosafety and biosecurity.  These reports will be used to develop an implementation plan and by September 2024, HHS and other heads of agencies will report on measures taken and resources allocated to enhance biotechnology and biomanufacturing per the plan.

HHS published a press-release in response to the Executive Order, stating that it will support development of 1) FDA research programs for advanced manufacturing technologies, 2) Advanced Manufacturing Innovation Hub in the FDA’s Office of Counterterrorism and Emerging Threats, 3) FDA Center for Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals, etc.  While it is not clear what HHS will discuss in its report, the FDA/CDER Emerging Technology Program and FDA/CBER Advanced Technologies Program are collaborative programs where industry, innovators/developers, and the FDA can discuss advanced technologies, including advanced manufacturing.  However, the Committee on Identify Innovative Technologies to Advance Pharmaceutical Manufacturing, indicated industry is still hesitate to implement innovative technologies due to inconsistent feedback from the FDA during these meetings.  In addition to holding meetings, FDA also solicits applications for extramural funding to support advanced manufacturing and other innovative technologies through the FDA Broad Agency Announcement and the NIH Grants and Funding portal.  While HHS mentions the FDA’s Center for Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals, there is little information on this center aside what the FDA stated in October 2021 and January 2021.  The HHS’s report may consider incorporating some of the FDA’s efforts (Framework for Regulatory Advanced Manufacturing Evaluation) to identify and implement changes in the regulatory structure to enable new technologies, including advanced manufacturing mentioned very, briefly, here.