President Joe Biden has issued an Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy (EO) that will likely have impacts on the pharmaceutical, energy, agriculture, and engineering industries.

The Executive Order, issued on September 12, implements programs authorized by the CHIPS and Science Act of 2022, enlisting a whole-of-government effort to bolster R&D in biotechnology, improve biomanufacturing production capacity, streamline regulations, and promote biotechnology standards.  These will be accomplished through initiatives in data and information gathering, the promulgation of new policies and rules, as well as the encouragement of innovative education and safety in the bioeconomy.

This EO, together with the reignition of the Cancer Moonshot Initiative that aims to cure cancer “once and for all,” signals the Biden Administration’s commitment to ensure that the US leads the world in biotechnology and biomanufacturing.

Data and information gathering

In order to implement new initiatives in the biotechnology and biomanufacturing space, the Executive Order instructs certain federal agencies to gather data and information regarding US government involvement in the bioeconomy.

First, the Department of Commerce shall, in consultation with other agencies and private stakeholders, create and make publicly available a lexicon for the bioeconomy, with the goal of assisting in the development of measurements and measurement methods for the bioeconomy. This lexicon should be finalized by December 2022.

Then the Office of Management and Budget (OMB) and the White House Office of Science and Technology Policy (OSTP) will identify data types and sources, including genomic and multiomic information, that are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing. OSTP and OMB will also set forth a plan to fill any data gaps and make new and existing public data findable and accessible.

In concert with Commerce, OSTP and OMB, a team led by the Assistant to the President for National Security Affairs (APNSA), Assistant to the President for Economic Policy (APEP), and Assistant to the President for Domestic Policy (APDP) will work with major US agencies to produce reports on their current biotechnology and biomanufacturing processes and involvement. The Secretary of Health and Human Services (HHS) is expected to submit a report assessing how to use biotechnology and biomanufacturing to achieve medical breakthroughs, reduce the overall burden of disease, and improve health outcomes.

In the coming months, agencies will inventory current efforts and seek out new ideas to recommend for additional investment. Preliminary reports should be completed by March 2023.

New policies and rules

After gathering sufficient data and information, the Executive Order instructs federal agencies to refine their current regulations and implement new policies relating to the bioeconomy. By March 2023, agencies such as Defense (DoD), Agriculture, Commerce, HHS, Energy (DoE), NSF, and NASA have been asked to make recommendations to expand domestic biomanufacturing capacity for products in the health, energy, agriculture, and industrial sectors and mitigate risks posed by ‘foreign adversaries.’ Agencies have also been instructed to begin to create or expand programs supporting domestic biomanufacturing, especially in regard to securing supply chains.

Biotechnology and biomanufacturing are both heavily regulated areas in which technological advances often outpace the current regulatory framework. The Executive Order specifically asks the FDA Commissioner, the Secretary of Agriculture, and the Administrator of the EPA to identify areas of regulatory ambiguity, gaps, or uncertainties regarding biotechnology, and by June 2023, produce a plan to implement regulatory reform. It is likely that agencies will ask for public participation during any rulemaking process.

Education and safety

Additionally, the Executive Order implements new programs to expand the workforce in the bioeconomy while encouraging safety in new and existing investment. The Executive Order creates the Biosafety and Biosecurity Innovation Initiative, which will oversee the use of federal investments in applied biosafety research and innovations in biosecurity to reduce biological risk throughout the biotechnology R&D and biomanufacturing lifecycles.

Further, federal agencies and employees such as Commerce, Labor, Education, APDP, OSTP, and NSF will produce and make publicly available a plan to use relevant federal education and training programs to promote the implementation of formal and informal education and training for biotechnology and biomanufacturing.

Current biotechnology and biomanufacturing programs

Companies should note that while the Executive Order will result in more federal activity in the biomanufacturing and biotechnology spaces, there already exist multiple fully funded programs that may see expansion as a result of the EO.

For example, the Department of Health and Human Services will invest $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients, antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics. DoD is launching the Tri-Service Biotechnology for a Resilient Supply Chain program with more than $270 million investment over five years to turn research into products more quickly and to support the advanced development of bio-based materials for defense supply chains. Further, DoE’s National Nuclear Security Administration will initiate a new $20 million bioassurance program that will advance US capabilities to anticipate, assess, detect, and mitigate biotechnology and biomanufacturing risks.

Looking ahead

With the issuance of the Executive Order, the Administration has demonstrated significant interest in the bioeconomy. We can expect an agency-by-agency inventory of the current biotechnology landscape followed by proposed new actions to include increased federal funding and policy changes in the coming months. Interested clients should prepare to reach out and engage with agencies on each subject matter of interest. Further, there are more programs relating to biotechnology in the CHIPS and Science Act of 2022 that may be implemented in the coming months. For example, the CHIPS Act authorizes an advisory committee on bioengineering research and development composed of representatives from the private sector and academic institutions that has yet to be formally created by President Biden.

Our global team continues to monitor developments as they arise. If you have any questions regarding these programs and their implications, please contact any of the authors or your DLA Piper relationship attorney.