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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Protecting Health: FDA’s Global Challenge

Remarks of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Protecting Health: FDA’s Global Challenge
Commonwealth Club, San Francisco
January 28, 2010


Thank you for inviting me today.  I am very pleased to be here, and delighted that some of our FDA leadership from the Regional Office are able to join us here as well. As I was preparing for my visit here, I was impressed to learn that the Commonwealth Club is the oldest public affairs society in America—and that it also shares a certain connection to the Food and Drug Administration.

If you go back to our roots, you’ll see that both of our institutions are children of the Progressive Era. .. 1906, the year of the great San Francisco Quake, was also the year the first federal food and drug agency was created—and it was three years after the creation of the Commonwealth Club.

San Francisco was the leading West Coast port in those days—an entry way for new people, foods – and germs. And Teddy Roosevelt – who signed the Pure Food and Drug Act, which established the agency that would in time become the FDA--was also the first in a virtually unbroken chain of US presidents to address the Commonwealth Club.

We’ve come an awfully long way since Teddy Roosevelt’s day with respect to our ability to safeguard our nation’s supply of food and medical products.  But when it comes to a few issues, such as import safety -- the subject of my talk today -- our approach is only starting to keep up with the changes that have swept the world since then.

So as we enter the 21st century, and more and more need to look at the world through a Pacific lens, I am delighted to be here in San Francisco and honored to have this chance to address this special institution on a very important topic. 

The scope of FDA’s mission is tremendous.  The products we oversee account for more than 20 cents of every dollar spent by American consumers.  They include many of the foods we eat; the medications, vaccines, and devices upon which we rely; and numerous other products that are an integral part of our everyday lives.

It is already a daunting task, but globalization has multiplied the scale of our responsibility… and the challenges we face. 

FDA-regulated products are currently imported from more than 150 countries, with more than 130,000 importers of record, and more than 300,000 foreign facilities.

This year, nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry.  Just a decade ago, that number was closer to 6 million, and a decade before, only a fraction of that.

It is estimated that up to 20% of all foods now consumed in the U.S. originate outside our borders. In fact, some 75% of seafood eaten in this country comes from foreign waters and about 35% of fresh fruit and vegetables consumed in the U.S. come from outside the United States. Strikingly, these are some of the most vulnerable foodstuffs in terms of potential for contamination.

Up to 40% of the drugs Americans take are imported, and about 80% of the active pharmaceutical ingredients in those drugs come from foreign sources.  I understand that 75% of our aspirin comes from China.

The rise of imports has brought clear benefits to the American people.  For example, we can eat a huge variety of delicious products from around the world and we can enjoy all kinds of fruits and vegetables way out of season.  We can benefit from medical innovation across the globe and we can get certain products more cheaply than might have otherwise been possible. 

Yet this tremendous shift in the global market for food and medical products also has brought important new challenges.

 In addition to the sheer volume of imports and foreign facilities, there has been an increase in the variety and complexity of imported products …. and  a large expansion in the number of countries involved in producing these products … including many with less sophisticated regulatory systems than our own.

Simultaneously, the supply chain from manufacturer to consumer has become more and more complex … involving a web of re-packagers and redistributors… and making oversight significantly more difficult.

This all adds up to an enormous task for the FDA. 

We know that there are very real concerns here.  For example, in early 2007, melamine-contaminated protein ingredients manufactured in China made their way into U.S. pet foods and animal feed, causing illness and death among household pets across the country. 

This incident also had major economic consequences, including the recall of hundreds of brands of pet food, and State quarantine or voluntary holds on livestock that had consumed suspect feed.

Soon after the melamine incident, the highly poisonous industrial chemical diethylene glycol, or DEG, was found in toothpastes imported from China.  Thankfully, FDA was able to issue import alerts and support the voluntary recall of the contaminated products before they brought harm to U.S. consumers. 

However, other countries have not been so lucky: DEG-contaminated products have led to scores of deaths elsewhere in the last several years. 

And the year before last, you may recall the tragedy that occurred when contaminated heparin (a blood thinning drug) from China caused deaths and hundreds of allergic reactions here at home.

These episodes were particularly disturbing because they represented economically motivated adulteration: truly despicable acts of seeking profit by putting lives at risk. We see this also in the worldwide marketing of counterfeit drugs. And in our modern world, profit is not the only dark motive we must grapple with. Sadly, we know that we are also vulnerable to potential attacks involving our food and drug supply by terrorists determined to do harm.

While these may be the most dramatic real and potential cases, there have been many other significant, but perhaps less intentional, episodes associated with contaminated and adulterated products, both food and medical goods. In addition, every day, FDA rejects imports at the border for a range of problems including illegal drug residues, bacterial contamination, unapproved food additives, pesticides, heavy metals, and filth.

Every problem with an imported food or medical product is serious in its own way. There are human costs, economic costs, and often an undermining of confidence in government agencies, other critical institutions, and in the products themselves

Together, these incidents reflect a new reality: globalization has fundamentally altered the markets for food and medical products.  And FDA needs to change in order to keep up.

When Teddy Roosevelt created the agency that would become the FDA more than a century ago, imports were not particularly significant. Americans grew most of their food themselves or purchased it from nearby sources. The pharmaceutical and medical device industries were in their infancy.

Import safety was hardly a front burner issue, but Congress did authorize FDA to examine an imported food or drug when it arrived at a port. That likely meant cracking open a barrel of molasses to look for mold or some other visible sign of contamination.

In the late 1930s, another Roosevelt Administration and Congress reworked our nation’s food and drug laws to create the modern FDA.  In this process, the only provision from the 1906 act that was carried over with the least change was the one covering imports.   Because there had been little change in the volume and nature of what was being imported into the United States, it was felt that this authority remained adequate to protect consumers. 

Today, however, the world has changed dramatically and this approach is no longer adequate to meet our needs.

It is easy to see that in today’s world FDA faces a Sisyphean task if inspections at ports of entry remains our main strategy for identifying and stopping harmful products. In FY2009, approximately 18 million shipments of FDA-regulated product came to our borders … but we had fewer than 500 inspectors to ensure their safety.  No matter how hard these employees may work, they will examine less than one percent of these products before entry into the U.S. 

It is simply not possible to count on interdicting everything harmful at our borders. 

Similarly, FDA cannot alone conduct a sufficient number of inspections at foreign manufacturing facilities to help ensure product safety.  The Government Accountability Office estimates that FDA inspects only about 8% of foreign drug manufacturing establishments each year.  At this rate, it would take us more than 13 years to inspect all registered foreign drug facilities. 

It is simply not possible for FDA to inspect our way to safety.

Clearly our nations’s traditional approach – relying on FDA inspections to catch problems at the border or in foreign facilities – needs a significant makeover.

To assure the safety of imported products and fulfill our public health mission in a global age, the FDA must adopt a modern approach ….  an approach that will address product safety by preventing problems at every point along the global supply chain… from the raw ingredients… through production… and distribution… all the way to U.S. consumers. 

We must move from an approach based on reacting to problems… to one that proactively prevents such problems from ever occurring. 

This idea is embodied in the food safety legislation now moving through Congress, which would for the first time allow FDA to establish basic preventive controls over food production. 

This modernizing of our basic authorities is critical to our success as a public health agency in the 21st century. And we must apply this basic principle of prevention to imports. 

FDA is starting to make this shift.

I would like to share three key elements of our strategy.

First, we are seeking better controls at the point of production.

This is a shared responsibility among manufacturers, who have the primary responsibility for the quality and safety of their products … national regulatory agencies, which we are supporting through collaboration and with technical assistance … and the global regulatory community, which must come together as never before.

We’re moving into a phase where FDA works with regulators, manufacturers and suppliers in places as far afield as Bangladesh and Tunisia. We now have permanent overseas offices in Beijing, Shanghai, and Guangzhou, China, in New Delhi and Mumbai, India, in San Jose, Costa Rica, Mexico City and Santiago, Chile. We’ll soon have an office in Amman, Jordan. These offices enable us to have a regional presence around the world; a home base from which to undertake a range of important activities.

We are working with these countries and others to help assure oversight and regulatory capacity. By helping more countries build their regulatory capacity, we not only build confidence in the imports they send us. We’re also helping them build regulatory powers that will improve the safety and value of goods their own people consume.

There is also much work to be done with our allies who already have well developed regulatory systems. For example, FDA and our partners in the European Union and Australia are jointly planning and conducting inspections of facilities in countries that manufacture the starting materials for many of our drugs.

FDA has more than 30 additional agreements with foreign counterpart agencies to share inspection reports and other non-public information that can help us make better decisions about the safety of foreign products.

This means that if a shipment of fish contaminated with banned fungicides shows up in, say, Ancona, Italy, we’ll hear about it immediately and be on the lookout for products from the same shipper. We’ve set up offices in London, Belgium and in Parma—the center of the Italian food processing industry—to build on these relationships.

We are also piloting the concept of third-party inspection, which can stretch our resources and provide new assurances of safety. And we continue to engage in bilateral and multilateral international standards-development and harmonization efforts. 

These programs are promising, and all of them make one thing clear: to address import safety, we will not be able to go it alone. 

A second key element of our strategy is to hold importing companies responsible for their supply chain.

Some companies already do a terrific job keeping tabs on where and how their products are made and the path taken to reach our shores. These best practices need to spread around the industry.  And FDA will work with the industry to set standards for technologies and other approaches that can help them strengthen their supply chains.

On the other hand, companies that sell contaminated products because of loose supply chain oversight need to face serious penalties … and cannot excuse themselves by blaming their suppliers, blaming the FDA, or blaming anyone else.  

Only when everyone involved shares responsibility for safety will we succeed in our mission.

Third, we are going to deploy our agency’s resources strategically. This is essential as our mandate keeps expanding, even in these economically challenging times.

Early next month I expect to formally announce a new FDA program—an information technology system developed for use by our border inspection operations that will allow us to monitor products at the port of entry more reliably and to prioritize shipments that potentially pose the greatest risk to public health. But this is just one step.

More broadly, we are moving from a system that places most of the regulatory burden on the FDA’s modest inspection force, to one that creates greater oversight at points further back along the production chain.

To succeed, we will both need more resources, such as those provided by the food safety bill.  And we will need to be very smart about what we do with them.

We need to know who is making our foods and drugs, where they are located, and we need to be sure that these facilities are being inspected and are accountable for what goes into their products as well as the products they produce. We need to create a global safety net.

I can assure you that addressing the problem of global supply chain safety, and shifting the existing paradigm from reaction to prevention, is one of my highest priorities for FDA. Refining our understanding of the problem and exploring and assessing possible solutions will be a major focus of our work over this next year and well beyond.

Ironically, seventy years ago, DEG – the same poisonous chemical found just a few years ago in tainted Chinese toothpaste – precipitated another similarly significant shift in the FDA’s approach to product safety. 

In 1937, 105 people in the U.S. died after ingesting Elixir Sulfanilamide, an antimicrobial medication that included DEG as an ingredient.  In response to this tragedy, Congress passed the 1938 Federal Food, Drug, and Cosmetic Act.  As a result, FDA moved beyond simply responding to problems and intercepting adulterated drugs on the market: we began to conduct premarket evaluations to prevent unsafe drugs from entering the market in the first place.

The most recent DEG episodes show that we need another fundamental change in the way we do business… this time on a global scale. 

This will require new ways of thinking and new partnerships, in addition to new resources.  Now is the time for FDA to fully engage –bilaterally, multilaterally and through international and regional organizations—to work with countries throughout the world to share scientific and technical expertise; to harmonize international standards for safe food, drugs and medical products; and, very importantly, to help countries with less mature economies and regulatory systems build capacity so that they can produce food and commodities that are safe, wholesome and meet international safety standards for both their own consumption and for export. 

The benefits of this new paradigm for global product safety go well beyond our borders, and in fact, they go beyond health.  When governments collaborate to invest in the capacity of countries to produce food, drugs, medical devices, and cosmetics for export in accordance with strong safety standards, there are multiple and mutual benefits.  The developing countries can have both a domestic source of safe products and a strong, reliable export market.  Strengthening their regulatory capacity will help them to extend their own health protection activities, as well as their own economic and development in very fundamental, long-lasting ways.  Moreover, it will keep us all safer

Although my duty as FDA commissioner is to protect the health of the American people-- and importantly the safety of our nation’s supply of food and medical products--my experience throughout my career has shown me, time and again, that public health protection is a global endeavor.

All people in the world deserve safe food and access to quality medical care.  All nations deserve the opportunity to participate and prosper in the global economy.

We as an agency have difficult work ahead of us … but this is a challenge that we are eager to meet. And going forward, I firmly believe that we need to marshal the talents and engage the creative thinking of determined citizens, scientists, government officials, business and political leaders, thought leaders….in short, all of you…because this is a universal vulnerability and a universal responsibility

Thank you, and I welcome your questions.