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Food and Drugs: Can Safety Be Ensured in a Time of Increased Globalization?

Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Council on Foreign Relations New York Symposium
"Food and Drugs: Can Safety Be Ensured in a Time of Increased Globalization?"
January 31, 2011

It’s a pleasure to be back in New York and at the Council on Foreign Relations. I am a great admirer of this organization and am proud to be a longstanding member.

Some here may have been surprised to see that the Council is focusing on issues of food and drug safety. But it is highly appropriate, much needed, and very timely. So I am delighted that we are all here today.

This event grew out of a series of conversations between me and Laurie Garrett here at the Council about the new realities of food and drug regulation brought about by globalization—realities that have redrawn the path that food and medical products navigate to reach our homes, realities that make each and every one of us increasingly vulnerable—and realities that challenge virtually all nations.

Today, we hope to start a conversation that will be continued in broader foreign policy circles, and by next year perhaps reaching the G20 level. We hope that, together, our speakers can communicate to each of you the scale of our challenge and the steps we must take to meet the unique public health demands of our globalized world and assure the health, safety, and security of people of nations all over the world.

We cannot afford to ignore these issues. These are issues that must concern us all. Certainly as FDA Commissioner, I spend a lot of time grappling with them. They have major implications for how we fulfill our mission to promote and protect the health of the American people.

In this context, let me tell you a little about the agency and why this all matters so much. The FDA is responsible for overseeing the safety and manufacturing quality of food, drugs, medical devices, vaccines and biologics, cosmetics, dietary supplements, animal drugs and food, radiation-emitting devices, and tobacco products, as well. These products account for between 20 and 25 percent of every consumer dollar spent in this country—and, with the exception of tobacco, they are products that people need and rely on in fundamental ways every day.

As you can see, our scope and responsibilities are enormous. But during the early decades of FDA history when, in fact, most of our authorities were put in place, the world was very different.

Back then, most products FDA regulated were domestically manufactured. And for years, when it came to importation of foreign products, our activities to ensure safety and quality and to protect public health focused on catching problems at the border and then limited overseas inspections. But times have changed.

The realities of global economic conditions, as well as innovations in refrigeration, transportation, and communication, have enabled and spurred consolidation and globalization. This has resulted in a striking rise in imports of foods, pharmaceuticals, medical devices, and even, to some extent, biologics.

Today the world in which FDA-regulated products are discovered, developed, processed, and distributed is much bigger. FDA’s traditional model of manufacturing site inspections and border examinations is simply not adequate in today’s transformed world.

In 2010 alone, FDA estimates that more than 20 million import lines of food, devices, drugs, cosmetics, and tobacco arrived at U.S. ports of entry—more than a three-fold increase in regulated imports from a decade ago. Regulated products come from 300,000-plus facilities in more than 150 different countries all over the world. And they come through over 300 ports of entry into the United States.

At the same time, the supply chain from manufacturer to consumer has become more and more complex…involving a web of re-packagers and redistributors… making oversight significantly more difficult.
 
The numbers are staggering. In the food realm, about 40 or 45 percent of fresh fruit and produce and over 75 percent of seafood we eat in the United States come from other countries. And for medical products, a stunning 80 percent of the active pharmaceutical ingredients in our drugs come from outside our borders and about 40 percent of the finished drugs themselves.

Of course, much about this is positive…we can, for example, have fresh mangos and strawberries any time of the year…and it may lower some drug and device costs. But there are also huge negative implications.

The global supply chain has led to the distribution of unsafe or ineffective products and harm caused by economic adulteration and intentional fraud. I know you will hear directly from others, for example, of the tragic toll that the counterfeit trade is taking in many parts of the world. And for all of us, the global supply chain presents many new national and international security threats.

In recent years in this country, we experienced events—some clearly deliberate and some unintended—which had serious consequences for life, health, and safety, as well as for trade, commerce, and the economy: ranging from contaminated heparin (a blood thinning drug), to counterfeit glucose monitor strips and surgical mesh, to melamine-tainted vegetable protein and dairy products, salmonella in peppers, and other foodborne outbreaks, to name just a few.

And, the world is poised for even further globalization. There are macro trends at work that are impacting global commerce and the cumulative effect of these trends will ensure that ten years in the future, the world will be a still very different place. Undoubtedly, the pressure to reduce costs and increase productivity will lead companies to continue to move manufacturing activities to new and different locations, looking for cheaper sites and global supply chains to reduce production costs.

And countries like China and India that already produce many of the foods and medical products that Americans use, will likely in the future not only produce these goods, but will also be important centers of innovation, inventing new, groundbreaking products that Americans will want to buy.

Which means that we will have to continue to evolve to meet these new demands—and we have already begun to do so.

In the U.S., the Food Safety Modernization Act, which was signed into law earlier this month calls on the FDA to put into place a significant new approach that, among other things, promotes a new level of accountability for all entities involved in the supply chain from the farm to the fork. And although it is not perfect—we do face challenges, certainly including resources—it is a truly significant step in the right direction. Congress has also introduced a similar bill for drugs that would bring sorely needed modernization to our authorities.

But, even with that progress, globalization presents huge and growing challenges. Regrettably, another public health crisis like heparin or melamine seems inevitable unless we are able to truly forge changes in how we ensure the safety and quality of food and medical products for our citizens.

At FDA, we have realized that, in order to protect American consumers we must work globally because the products our consumers use are no longer simply American products. They are global products. And we know that our counterparts in other nations face similar challenges for their citizens.

This is a moment for leaders around the world to create a new vision of how we regulate. We have a shared interest in ensuring the safety and quality of food and medical products and a shared responsibility for safety and quality. By working together to monitor and improve safety and quality globally, we will benefit all the citizens of the world.

What I envision for the future is a public health safety net for consumers around the world that is created, supported, and maintained by a global alliance of regulators working closely with all our initial stakeholders. Some of the work for this is already underway and has been for several years, as regulators from many nations have begun to collaborate. But these efforts need to be taken to the next level. We must ask ourselves how we can weave our various efforts into a coherent global system of oversight and safety.

This will mean working toward greater coordination and enforcement of regulatory standards across nations to ensure safety and quality regardless of where a product is produced. We need not always apply absolutely identical methodologies, but we all need to work together toward the common goals of product safety and quality and to harmonize approaches.

As part of these efforts, regulatory authorities, especially those with the greatest experience and resources, must work together to help build regulatory capacity in those countries that are more resource poor and with still developing systems so that they can produce food and commodities that are safe, wholesome and meet international safety standards. This is surely in our vested interest, but it will have broader benefits for public health and economic development within those countries, as well.

And in addition to creating a global coalition of regulators, we must create a modern means to share data globally. And, we must use those data and advanced analytics to proactively prevent and identify problems. Detecting and preventing global problems demands global intelligence-sharing and data-mining.

Also, as the new food safety law recognizes and requires, we must also enlist public and private third parties, as well as industry and other organizations, to increase the global safety net. We must do this for foods and medical products. This is essential. Regulators cannot—and should not—do it alone.

Finally, we must create the momentum in the U.S. and in the global community to make these changes real—and sustainable. These changes must begin now, but they will take time and the support of many people to fully implement. A strong global safety net will be challenging to weave. But, we can do it together.

So let us continue the conversation today and—as regulators, consumers, academics, industry leaders, and others with expertise—find new ways to ensure the safety and quality of food and medical products and promote the health and well being of the American people and our fellow citizens around the globe.

These issues affect us all and we all must contribute to solutions. Thank you.