President Biden's Biotechnology and Biomanufacturing Executive Order: Funding

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President Biden announced his signing of an Executive Order launching a major effort to enhance U.S. capabilities in biotechnology and biomanufacturing last week (see "President Biden Signs Executive Order on Biotechnology and Biomanufacturing Innovation").  The White House also held a Summit on Biotechnology and Biomanufacturing last week to discuss how these efforts will be funded (accompanied by a Fact Sheet).

The summit, led by National Security Advisor Jake Sullivan, Director of the National Economic Council Brian Deese, and Director of the Office of Science and Technology Alondra Nelson, Ph.D., was attended by various biotechnology and biomanufacturing stakeholders who spoke to the importance of the initiative and the funding it will provide for its stated goals.  Also participating were Secretary of Health and Human Services Xavier Becerra, Secretary of Energy Jennifer Granholm, Deputy Secretary of Defense Kathleen Hicks, Deputy Secretary of Agriculture Jewel Bronaugh, Under Secretary of Commerce for Standards and Technology and Director of the National Institute for Standards and Technology Laurie Locascio, and Director of the National Science Foundation Sethuraman Panchanathan, as well as Senator Mark Warner (D-VA) and Representative Deborah Ross (D-NC, 2nd).

This funding, amounting to a $2 billion commitment of Federal money, included:

• $40 million from the Department of Health and Human Services to expand the role of biomanufacturing for active pharmaceutical ingredients (APIs), antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics.

• $1 billion from the Department of Defense over five years to improve the bioindustrial domestic manufacturing infrastructure over five years to catalyze the establishment of the domestic bioindustrial manufacturing base that is accessible to U.S. innovators.

• Also from the Department of Defense is $270 million over five years to commercialize research and "support the advanced development of bio-based materials for defense supply chains, such as fuels, fire-resistant composites, polymers and resins, and protective materials."

• And also from the Department of Defense is $200 million to "support enhancements to biosecurity and cybersecurity posture" for biomanufacturing facilities and defense supply chains.

• $500 million from the Department of Agriculture to support "independent, innovative, and sustainable American fertilizer production to supply American farmers" using biotechnology and biomanufacturing advances.

• $100 million from the Department of Energy for R&D for conversion of biomass to fuels and chemicals, including R&D for improved production and recycling of biobased plastics.

• Another $60 million from the Department of Energy to "de-risk" scale-up of biotechnology and biomanufacturing to increase commercialization of biorefineries that produce renewable chemicals and fuels that significantly reduce greenhouse gas emissions from transportation, industry, and agriculture.

• $20 million from the National Nuclear Security Administration in the Department of Energy to "advance U.S. capabilities to anticipate, assess, detect, and mitigate biotechnology and biomanufacturing risks, and . . . integrate biosecurity into biotechnology development."

• $14 million from the Department of Commerce for the National Institute of Standards and Technology (NIST) for biotechnology research programs to develop measurement technologies, standards, and data for the U.S. bioeconomy.

In addition to these specific funding announcements, the National Institutes of Health is expanding its biotechnology entrepreneurship bootcamp (the I-Corps program); the National Science Foundation will implement its previously announced competition for funding of regional Innovation Engines; and the FDA will attempt to use regulatory science, technical guidance, and increased engagement with industry to support advanced manufacturing.

Of course, these commitments reflect current budgets and (to some extent) discretionary spending for these agencies and Executive branch Departments.  Whether and the extent to which President Biden's vision encompassed by the Executive Order will come to fruition will depend on further funding from Congress in the regular budgetary process, and those decisions cannot be other than politically motivated.  In view of the propensity for support or opposition to government policies such as this one to depend on whether the administration is on the "right" side of the aisle illustrates the truth in the adage that elections have consequences, even for programs aiming to enhance and improve the country's competitiveness in important areas like biotechnology and biomanufacturing.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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