As a former FDA Associate Commissioner who has spent the last two decades consulting foreign ministries of health and other high-level individuals and businesses on healthcare policy issues, I understand the complexities of biopharmaceutical regulatory standards and practices. I recognize the importance of establishing robust partnerships to help facilitate innovation in the medical field, regardless of geographic location. And nowhere is this more timely or important than when it comes to solving America’s drug shortage problems through supply chain diversification.
Congress is acting. Recently proposed bipartisan legislation to establish an FDA Bureau in the Abraham Accords region is a groundbreaking step to align the Middle East’s biotech corridor and represents a legitimate and collaborative extension of the historic Abraham Accords agreement. It’s good for advancing America’s public health and good for advancing peace in the Middle East.
The Abraham Accords nations (especially Israel and the U.A.E) have become synonymous with innovation, particularly in biotechnology and pharmaceuticals, attracting global investment and pushing the boundaries of medical science. An FDA Bureau won’t offer shortcuts but will provide guidance and opportunities for Abraham Accords drug manufacturers and developers to navigate the FDA’s rigorous review processes. Such advice will enable these companies to better prepare their submissions for the U.S. market, ensuring that their groundbreaking technologies and manufacturing prowess can be reviewed more efficiently -- accelerating the availability of potentially life-saving medical solutions to Americans.
Another layer of bureaucracy? Just the opposite. This initiative is not an alternative route but a supplementary service. Companies in the region can choose to utilize this resource to enhance their understanding and approach to the FDA process or proceed through the traditional development and submission pathways. Freedom of choice is important to preserving the integrity of the regulatory framework while offering additional support to our allies in the region.
Additionally, an FDA Abraham Accords Bureau supports an important American national security goal -- diversifying the U.S. pharmaceutical supply chain. In a time when supply chain vulnerabilities have been laid bare by global events such as the COVID-19 pandemic and ongoing life-threatening drug shortages, this is not just strategic, it’s imperative to prevent a national healthcare crisis.
The FDA, and particularly the FDA Commissioner, Dr. Robert Califf, recognize the value and urgency of an FDA Abraham Accords Bureau for all the reasons mentioned, but also because of lessons learned during the COVID-19 pandemic. For example, when Israel sought to reach out to the FDA for vaccine development advice, the absence of a direct and immediate channel of communication cost America, Israel, and the global healthcare ecosystem valuable, lifesaving time. A key goal for this Bureau will be to alleviate communication hurdles and foster a collaborative environment that can respond quickly to global health challenges.
Any proper risk-benefit analysis of this initiative shows a highly positive outcome for both the Abraham Accords region and the United States. For the region, it represents an opportunity to elevate its biopharmaceutical sector to new heights on the world stage. For the U.S., it means access to a wider array of medical innovations and a strengthened supply chain — all within a framework that prioritizes patient safety. And, it must be said, that more integrated business efforts between the nations of the Abraham Accords further strengthens the bonds of regional friendship and peace.
Congress must enact legislation that pushes our country forward, builds bridges where there are gaps, and leverages strategic advantages for the greater good. The FDA Abraham Accords Bureau is a shining example of such legislation. It reflects the strength of bilateral, regional, and global collaboration aimed at achieving health and prosperity, and symbolizes a dedication to innovation, safety, a relentless drive for excellence in healthcare, along with a shared vision for a healthier world.
Peter Pitts is a former FDA Associate Commissioner and currently serves as a Senior Research Fellow at the U.S. Israel Education Association.
