By: Margaret A. Hamburg, M.D.
Ensuring that the millions of FDA-regulated products that flood into the U.S. from 150 foreign countries every year are safe and effective can be daunting task. That’s why it was heartening for me to sign two cooperative arrangements this week with some of our international partners that will make this task a little easier. The arrangements also represent encouraging developments in the quest for a global safety net created through international cooperation.
One arrangement, a “Statement of Cooperation” with FDA’s counterpart in Brazil, outlines procedures for enhanced collaboration between our nations on common regulatory issues. The arrangement is particularly critical at a time when Brazil is dramatically increasing its trade with the U.S. The U.S.imported $31.4 billion worth of products (both FDA-regulated and not regulated) from Brazil last year — an increase of 126% from 2000.
The second arrangement, a “Statement of Cooperation” is between the FDA and our regulatory counterparts in Australia, Brazil and Canada. The arrangement creates stronger regulatory oversight that is less burdensome for both industry and regulators as we pool resources to cover a larger global array of medical device manufacturers.
I signed both arrangements while in Manaus, Brazil, in the heart of the Amazon River basin. The heads of counterpart regulatory agencies from around the world had come together to collaborate on ways to help better ensure the safety of products in all countries—an approach we refer to as the global safety net. Thus, this summit was a particularly appropriate occasion for signing these two arrangements.
The already difficult job of ensuring the safety of FDA-regulated products has grown exponentially due to two megatrends: the expansion of global trade, and the need for ever-greater expertise from regulators as innovations bring increasingly sophisticated products to market.
Our strategy is to create coalitions of regulators that bring together the best minds from around the world to work on the common goal of improving product safety and quality. As I outlined in a keynote address I delivered at the conference, we need to develop a strategy that moves us towards routine regulatory coherence and mutual reliance with our regulatory counterparts. While maintaining national sovereignty and individual agency decision-making responsibility, we can do much more to share regulatory information, strategies and resources.
The arrangements I signed while in Brazil stood as concrete examples of the broader concepts discussed at the conference.
The arrangement between the FDA and regulatory agencies in Australia, Brazil and Canada provides for the creation of a single audit program for medical device quality management systems. The four countries, in accordance with their respective legal authorities, would develop a plan to audit, or inspect, a device facility and then the other countries would utilize the regulatory findings.
The four countries also pledged to promote greater global alignment of regulatory approaches and technical requirements.
Standardized oversight procedures will bring more consistency, predictability and transparency to the regulatory process.
The broad arrangement between Brazil and the U.S. includes a number of provisions. Both countries will consider exchanging information collected during investigations or facility inspections. They will also identify research that supports the scientific basis for regulations and actions.
What is expected is increased understanding of each other’s regulatory systems and an opportunity to explore how to leverage each country’s resources to expand the safety net for both countries.
The arrangements, and the conference, are steps towards a future with better outcomes through global cooperation. I was pleased to be a part of it.
Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration.