Zuhal Reed, Esq. | Risk Management Senior Staff Attorney | Medmarc
September 28, 2022
On Monday, September 12, 2022, President Joe Biden signed an Executive Order to launch a National Biotechnology and Biomanufacturing Initiative. The official White House correspondence emphasizes that “[t]his Initiative will create jobs at home, build stronger supply chains, and lower prices for American families." This Initiative is intended help the United States further expand its role in the global bioeconomy, and it is expected to bolster biotechnology innovation.
The primary aim of this Initiative is to make the United States less reliant on biomanufacturing products made outside the country and to become a key source of materials and bioproduction globally. With an increased awareness of the supply chain issues that have stalled and even threatened some segments of the health sector, this Initiative highlights the need for access to important chemicals and active pharmaceutical ingredients. The U.S. Department of Health and Human Services (HHS) will implement the Initiative by “Invest[ing] $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. ” These announcements indicate a renewed interest and efforts in fortifying the US biotechnology industry to foster medical breakthroughs.
The influx of investment into drug production infrastructure will likely decrease US reliance on foreign manufacturers of pharmaceutical and biotechnology products. For domestic producers, this will mean an increased focus by the FDA on better understanding the science of advanced manufacturing and more opportunities for pre-submission interactions for those involved in advanced manufacturing of pharmaceuticals and biologics. This can be inferred from HHS highlighting the FDA’s Platform Vector Gene Therapy (PaVe-GT) Pilot Project in their project plan. It will be interesting to see how the FDA carves out new pathways to approval and guidelines to help facilitate this Initiative.
Interested parties in the biotechnology industry may want to look into the Summit on the National Biotechnology and Biomanufacturing Initiative, which was held on September 14, 2022. Herein, the administration unveiled their biotechnology investment plans and resources.
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