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Remarks to the American Association of Exporters and Importers Bi-Annual Education Meeting

Remarks of Deborah M. Autor, Esq.
Deputy Commissioner for Global Regulatory Operations and Policy
U.S. Food and Drug Administration

March 20, 2013


Thank you, Marianne [Marianne Rowden, President and CEO of AAEI] for your introduction.  It is a pleasure to speak to an association that is somewhat of a Washington institution – 92 years of advocacy and involvement in the major trade issues of the 20th Century – such as, Foreign Trade Zones, GATT, and NAFTA. I’m certain the 21st Century is already providing you with its own changes… and challenges.

Indeed today, I will talk about these vast transformations, both at the FDA and on the team that it is my privilege to lead.  It is called the Office of Global Regulatory Operations and Policy …appropriately known in this age of change...as GO. 

As exporters and importers, you have a unique window on the world.  Just consider -- about 25 years ago, the Internet was little more than an idea on a sheet of paper.  Today, every person in this room is carrying the tremendous power of the Internet in a handheld device.  We are instantly connected to people, places, and ideas around the world with the touch of a button.  [In fact, I see some of you are doing that now.]

Down from the ether net or “cloud” to the tangible world, look at it this way:  When salmon is caught in the United States, shipped to China for packaging and processing, and then shipped back to the U.S. for consumption by American citizens, it is undeniable that the world has changed in fundamental ways.

A Changing World:  New Legislative Authorities…

For FDA and the Directorate I lead, we are also undergoing fundamental change – with new laws and the continual churn of globalization.
During the past two years, Congress has provided FDA with significant new legislative authorities.  The Food Safety Modernization Act – also known as FSMA – is the most sweeping reform of our food safety laws in more than 70 years. It was signed into law by President Obama on January 4, 2011 and aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination…to preventing it. FDA is currently conducting public meetings and collecting comments on proposed rules on produce and preventive controls.
The Food and Drug Administration Safety and Innovation Act of 2012 – again known by a resonant acronym, FDASIA -- provides critical resources the agency needs to support regulatory science, improve patient access to new and better treatments, and alleviate drug shortages.  FDASIA also gives the FDA important new authorities to protect the integrity of the drug supply chain.

Then…there is the Generic Drug User Fee Act – known by the less resonant acronym: GDUFA.  This program helps advance timely access to generic drugs, increases the safety of generic drugs, and maintains affordability of generic drugs.  More than just review, the act provides inspectional resources and leverages regular surveillance inspection for use in the review of generic drug applications.

It is perhaps to the credit of FDA’s reputation for consistency and effectiveness, that Congress and the Administration put aside differences and collaborated in historic fashion to shape a new regulatory paradigm.

…And Globalization

The legislative swirl in Congress, just seventeen blocks from where we sit today, is spurred by a sweep of change worlds apart from this room.

With 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 that provide a livelihood for you -- AAEI members -- and enhance the quality of life for consumers worldwide. 

As a one-time trial lawyer and Director of the Office of Compliance in CDER, I like data and I like numbers.  Both give a hard, fast…and unassailable… measure of reality.  Hence, here are just a few data points that underscore the steady march of globalization.

Today, FDA-regulated products originate from more than 150 countries – from 130,000 importers…and more than 300,000 foreign facilities.  The number of FDA-regulated shipments at more than 300 U.S. ports has quadrupled over ten years.

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

Complexity of the Global Supply Chain

You and I know…and this cannot be taken for granted…the complex mechanics behind this sheer volume of moving product.

You and I know… that a complex global supply presents increased opportunities for both safety and security problems.

Globalization greatly increases the risks of the unknown:

  • Who has handled the product?
  • How was it manufactured, packed, distributed, and stored?
  • Who supplied the ingredients?

Moreover, factor in the complexities of languages, time differences and distance.  It can indeed be an almost overwhelming landscape.

In my Directorate, we are seeing increasing numbers of firms involved in the production of one product…ingredients/components from dispersed sources…and increased product mobility – again, all of which lead to challenges.

In addition, there is the Internet…yes, represented by all those devices pulsing in this room…which presents an additional layer of complexity by introducing more players into the system and more opportunities for criminals to reach consumers.

Increasingly, the Agency – as well as industry - must contend with ever-more sophisticated threats of fraud, product adulteration, and even terrorism.

And yes, you and I also know…the reality is that manufacturers and others in the supply chain around the world may place economic gain above safety and public health or have even more malevolent motivations.

Hence, for FDA to continue achieving its mission of protecting the public health, we must not use our borders as the primary line of defense against unsafe imported products, but ensure that position our borders as the final checkpoint on a long line of prevention controls throughout the supply chain.

Pathway to Global Product Safety and Quality

FDA Commissioner Hamburg states it straightforwardly:  “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."

Our response to this inexorable globalization…a project on which I and many other FDA officials worked…is the Pathway to Global Product Safety and Quality. 

The Pathway report describes how FDA is transforming itself from a domestically-focused agency to a public health regulatory agency…fully prepared for a complex, globalized regulatory environment…one that treats like risks in equivalent ways, regardless of geographic location.  The report addresses globalization challenges 10 years down the road, as well as those that we face today.

Our Pathway model is built upon four pillars: global coalitions…global data systems…enhanced risk analytics…and leveraging the efforts of public and private third parties.
The first pillar involves the creation of global coalitions of regulators…focused on ensuring and improving global product and import safety.  We know that our own government must effectively organize our myriad of regulators to achieve a “One U.S. Government Approach to Import Safety.”  The agencies responsible for import safety must rely on the expertise each agency possesses and harness it to make faster admissibility decisions and enhance safety.
In order to accomplish this goal, we have formed the Border Interagency Executive Council (BIEC).  This is comprised of executives from each of the agencies responsible for import safety, as well as members of the National Security Staff.  The BIEC is looking across the import process of all agencies and identifying opportunities to leverage resources and improve the import process.

On a larger scale, we must push towards mutual reliance…and get to a point where we can rely on each other, on foreign regulators, as well as on private third parties…to improve both product and 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.
Again, closer to home, our government must do the same.  FDA is working closely with U.S. Customs and Border Protection on the development of ACE, the Automated Commercial Environment, which creates a single window for all agencies.  FDA has embedded both technical and operational staff in the ACE working groups in support of their new Agile implementation concept.

Although federal agencies have different missions and regulate different products, we need to share data effectively to prevent duplicative work…and we need to know the compliance history of facilities, importers, and filers.  FDA is working to implement the use of a unique identifier, and we will work with the BIEC on how we can use this identifier across government agencies.

The third pillar of our Pathway Report involves 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, among others.  Foundationally…and this should be of interest to every AAEI member…risk analytics can help us to make more timely and effective decisions.

If federal agencies share information and analyze data quickly about importers who consistently pose the greatest risks, we all benefit.  This type of system will lead to a “One US Government Approach to Import Safety” trusted trader program. 

The fourth and final pillar involves leveraging the efforts of public and private third parties.  One of the most fundamental reforms any regulator can undertake is a more effective deployment of its own resources.  One way to accomplish this is through collaborating with third parties to identify risk-based priorities. 

Over the past several years, through initiatives like the BIEC…participation at the COAC meeting, and our work with the Industry Working Group, we have made great strides in improving our collaboration with other federal agencies and the industry.   FDA is committed to the goal of “One U.S. Government at the Border.”

The GO Directorate

Commissioner Hamburg created an organizational structure to facilitate implementation of the “Pathway Report.”  As part of this agency reorganization, she established my position, Deputy Commissioner for Global Regulatory Operations and Policy.  My Directorate, GO, is comprised of the Office of International Programs, which leads the agency’s global engagement work, and the Office of Regulatory Affairs, which is our field component and provides leadership on imports, inspections, and enforcement policies.

Commissioner Hamburg charged my directorate with a profound responsibility:   To respond in comprehensive fashion…to globalization and import safety challenges.  She directed us to implement the recommendations in the Pathway Report and to ensure that FDA fully integrates its domestic and international programs in effectively promoting and protecting public health.

GO has seized this charge and is embarking on this mission…we are laying the groundwork for FDA to implement a new strategy for global product safety and quality.

The Go Strategic Framework

Within GO, our vision is a global product safety net: where all food is safe…where all medical products are safe and effective…and where the public health is advanced and protected.  To that end, I’ve worked closely with my colleagues in developing a Strategic Framework underscoring our vision.
First, we are a public health regulatory agency. With that tremendous responsibility…it is imperative that we use innovative regulatory science to arrive at risk-based decisions.

Second, in a world of seemingly countless actors…think of the 300,000 foreign facilities with FDA-regulated products…we are committed to leveraging and collaborating with domestic and global partners.  Mutual reliance can’t be hoped for – it is essential.  Equally essential are convergent standards and practices, which provide transparency and efficiency.
Third…and yes, here is the trial lawyer again…data is critical. We need to analyze and utilize global data to manage risks. This means forming global data networks and analytics…and what we call STARGO – Strategic and Risk Based Global Industry Oversight and Enforcement.  Within this system, our goal is for FDA and our global regulatory partners to gather and share enhanced information, use analytics to identify risks, and then adopt tailored, flexible strategies to address these risks.

Last, we have to look inward and ensure that we are achieving the accountability and excellence we ask of our outside partners…such as those of you in this room. This includes the efficient management of resources, notably IT…development of our workforce…and maintaining a quality management system.  As the memorable phrase says, if we’re going to ask others to step up, we ourselves need to be able to walk the walk.


I’ve covered a lot of ground.

As someone who has been with FDA for more than a decade…viewing up close the export and import issues so vital to your association…I keenly understand that you are all on the front lines.  I appreciate that for you, the massive forces of globalization present every-day, tangible decisions and opportunities within the framework of our current regulatory system.  You know first-hand that product safety and quality no longer begin or end at the border.

Globalization represents opportunities and challenges for all of us – for AAEI and for my GO team of hard-working professionals.  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…restructuring the ways we exchange information…redefining the ways we rely on each other…and the ways we interact.  At stake is nothing less than the vibrancy of trade enhancing the daily lives…and the safety…of the American public.

Thank you.