FDA Boosted by President Biden’s Executive Order on Biotechnology and Biomanufacturing
On September 12, 2022, President Biden signed an executive order entitled: “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” This is a whole-government effort with specific focus on projects at the Department of Defense and the Department of Health and Human Services.
Two days later, DHHS released a fact sheet describing the initiatives on which the department will focus. It is good news for FDA (additional resources for some hotspot areas that need more resources). Here are some of the projects that will boost FDA:
Support development of FDA research programs for advanced manufacturing technologies, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Support development of the Advanced Manufacturing Innovation Hub in the FDA’s Office of Counterterrorism and Emerging Threats.
Support development of the FDA Center for Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals to enhance coordination and collaboration of science, regulatory, and policy activities between CDER and CBER.
Offer additional pre-submission support for applicants looking to adopt advanced manufacturing technologies: operating and enhancing CDER’s Emerging Technology Program (ETP), CBER’s Advanced Technologies Team, and the FDA Center for Devices and Radiological Health’s Advanced Manufacturing Clearinghouse, to provide more opportunities for drug, biologics, and device manufacturers to engage with FDA.
Lead international regulators in harmonizing requirements to promote innovation, including spearheading the development of the ICH Q13 guideline on continuous manufacturing of drug substances and drug products, the ICH Q5A guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, and the ICH Q14 guideline on analytical procedure development.
Continue to facilitate advancements in development of innovative animal products produced with biotechnology, whether intended for agricultural or biopharmaceutical use, through the Veterinary Innovation Program (VIP) at the FDA’s Center for Veterinary Medicine (CVM).
Invest $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients, antibiotics, and industrially relevant key starting materials needed to produce essential medications and respond to the current or a future pandemic.
Continue to innovate treatments using pilots such as the National Centers for Advancing Translational Sciences Platform Vector Gene Therapy (PaVe-GT) pilot program which is testing whether it is practical to use the same gene delivery system and manufacturing methods for multiple rare diseases in gene therapy clinical trials.
Expand cell engineering capabilities and platforms and establish synthetic biology approaches through programs such as the Biopharmaceutical Development Program at the Frederick National Lab which is developing a new cell line to treat acute myeloid leukemia, a particularly aggressive form of pediatric blood cancer.
Launch a Biosafety and Biosecurity Innovation Initiative, in collaboration with the National Institutes of Health, to reduce risk associated with advances in biotechnology, biomanufacturing, and the bioeconomy.