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Continuing the "One U.S. Government" Approach to Import Safety

Remarks by Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy
Import Safety Conference
September 21, 2012

Thank you, Deputy Commissioner Aguilar.  FDA is honored to once again join you in co-hosting the second Import Safety Conference.  I also want to express my sincere appreciation to Administrator Shea for allowing us to use their facility and to all the individuals who worked so hard to organize and bring this conference to fruition. 

Spurred by the rising influence of globalization, we have reached a point where trade, economic development, and public health intersect as never before. And central to the goal of each is the safety, quality, and security of the products those of us in this room regulate.

I am delighted to be here today as we continue to collaborate on import safety improvements, and I want to emphasize the important role this meeting can play as we strive to successfully operate in a global environment.   

At the 2010 conference, Commissioner Hamburg announced that the FDA had engaged in key initiatives aimed at creating a modernized operational model for imports, as well as shifting our focus to one of prevention and one that encompasses a global supply chain.  She explained that the many challenges presented by the complex regulatory environment of today have far outstripped the nation’s resources, resulting in an increased risk to American consumers.

FDA-regulated products now account for approximately 10 percent of all U.S. imports.  For FDA to continue achieving its mission of protecting the public health, we must shift our current paradigm—of using the borders as the primary line of defense against unsafe imported products—to one that positions our borders as the final checkpoint on a long line of prevention controls throughout the supply chain.

We cannot deny that the world has changed, and that our historical, regulatory approaches and tools are insufficient to protect the public in this current global environment.  The numbers make it abundantly clear.  Today, FDA-regulated products originate from more than 150 countries, 130,000 importers, and hundreds of thousands of foreign facilities. 

Chances are very high that at least one thing you ate yesterday wasn’t produced or grown here in the United States.  Approximately 50 percent of fresh fruits and 20 percent of fresh vegetables, as well as 80 percent of seafood, come from outside our borders.  The same goes for the medication you take.  40 percent of finished drugs come from overseas. 

In the last ten years, the number of imported shipments of FDA-regulated products has quadrupled.  And since the Commissioner spoke in 2010, the number of FDA imports has increased from 21.1 to over 24 million!

Just as HIV/AIDS and pandemic flu have demonstrated the stark reality that disease knows no borders; public health crises, like the melamine and heparin contamination, have vividly demonstrated that the flow of goods, including the foods we eat and the medical products we use, also knows no borders. 

As Commissioner Hamburg has stated, "Today we recognize that to successfully protect U.S. public health, we must think, act, and engage globally.  Our interests must be broader than simply those within our own borders."

In short—to respond to this globalized environment, improve import safety, and adequately protect the public, we must work differently…and we must work together. 

This is true for all agencies that regulate imported products.  Regardless of our missions, it is imperative that we work together, today and in the future, to overcome the obstacles that have held us back and prevented us from collaborating and operating in a manner that reflects the realities of today’s world.

At the FDA, we fully realize we cannot do it alone.  In response, we’re transforming to an international operating model, outlined in our recent action plan, the "Pathway to Global Product Safety and Quality."  This model is built upon four pillars: global coalitions; global data systems; enhanced risk analytics; and leveraging the efforts of public and private third parties. 

Over the next decade, FDA will continue to transform from a predominantly domestically focused agency—operating in a globalized economy—to an agency fully prepared for a regulatory environment in which regulated products know no borders.  We will adopt a model of strategic and risk-based global industry oversight.  And the four pillars set forth in the Global Pathway Report will help us to get there. 

The first pillar involves the creation of global coalitions of regulators, focused on ensuring and improving global product and import safety. 

Today’s conference is an excellent example of this concept.  As a coalition of federal regulators, a key goal should be more comprehensive and systematic information sharing and deployment of resources.  As we move from a primarily domestic orientation to one that treats like risks in equivalent ways regardless of geographic origin, we must push towards mutual reliance—a point where we can rely on each other, on foreign regulators, as well as on private third parties, to protect and improve both product and import safety.  

FDA is starting, in some instances, to assess the compliance of foreign firms through a regulatory network…making decisions in some cases based solely on the work accomplished by our foreign partners.  We must do the same as federal partners.  As part of a "One U.S. Government Approach to Import Safety," we must rely on the expertise we all possess and harness it to make faster admissibility decisions and enhance import safety.

The second pillar of FDA’s Global Pathway strategy involves building global data systems and networks that allow for regular, systematic information exchange between our foreign and domestic regulatory partners.  To fully identify risks and emerging trends, and then strategically allocate limited resources, it is essential that both domestic and foreign regulators be able to aggregate multiple sources of information.  

It’s no different for us as federal regulators.  We should work together to focus our resources, share our data, and improve import safety.  While we may all regulate different products, if there’s an importer bringing in a variety of products using bad importer practices, it poses a risk to us all.  We need to share that information with each other in real time.

And that means we need to work together to identify critical data elements—such as unique facility identifiers—to better standardize reporting and create platforms for regular systematic information exchange. 

The third pillar of the Pathway Report involves an increased focus on risk analytics and thoroughly modernized IT capabilities.  Risk analytics can inform our strategies and our priorities in inspections, training, regulatory cooperation, and surveillance efforts.  It can help us to make timely, effective decisions. 

As we share information and analyze data about importers who consistently pose the greatest risks, we can all benefit by targeting our resources appropriately.  But we must take all of the information we each gather, combine it, and then actually apply it to inform our decisions and strategies. 

For example: Understanding the various partnership programs, the criteria used and the vetting process to be accepted into each program, and combining them into a "One U.S. Government" trusted trader program will reduce the overall risk of shipments, allowing the agencies to spend their resources on higher risk shipments.

The fourth and final pillar involves leveraging the efforts of public and private third parties.  One of the most fundamental changes any regulator can undertake is a more effective deployment of its own resources.  We can accomplish this through the strategic leveraging of third parties against risk-based priorities.  We need to ensure that our standards are well understood and fully applied, foster best practices in industry, and foster innovation to drive safety and quality.  Then we need to work with other stakeholders—public and private—to help to ensure compliance, and further best practices and innovation.

Over the past several years, we have made great strides in building relationships, and improving our collaboration.  But there is much work that still needs to be done to achieve our goal of building "One U.S. Government Approach to Import Safety" and maximize our effectiveness in protecting United States citizens from unsafe imported products. 

That’s why the discussions and exchanges we have over the next 3 ½ hours regarding the sharing of information, partnerships, and trade modernization are so vital.

We must work together to change the status quo by evaluating and updating our Memoranda of Understanding. 

We must work together to adopt new policies and procedures that will foster the real-time sharing of information, enhance collaboration through our organizations, and enhance uniformity, efficiency and effectiveness while maximizing governmental resources.  

We must work together to consider how trade agreements can facilitate trade in safe and high quality goods.

Globalization represents opportunities and challenges for all of us.  Building a robust, collaborative approach won’t be easy.  It will require tremendous effort, creativity, flexibility, and vision.  It will require us to come together in new and unprecedented ways…redefining and restructuring the ways we exchange information, the ways we rely on each other, and the ways we utilize private and third parties. 

Through the framework of the four pillars and working together towards "One U.S. Government Approach to Import Safety," we will help assure that the products imported into the United States provide the safety, effectiveness, and security that the American public has come to expect—and deserves.

Thank you.