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Margaret A. Hamburg, M.D., Commissioner of Food And Drugs - FDA and the American Public: The Safety of Foods and Medical Products in the Global Age

Remarks of Margaret A. Hamburg, M.D.
Commissioner of Food And Drugs
Center for Strategic and International Studies
February 4, 2010


Good morning. I’d like to thank CSIS for giving me the opportunity to speak about a topic that is some timely and of such critical concern to the FDA and the American public: the safety of foods and medical products in the global age. I’m delighted to be here, and I am certain that we will have an opportunity for rich discussion this morning, between the expert members of the panel that will follow my talk, and those of you in this distinguished audience.

I want to compliment Tom Bollyky for his truly excellent background paper, which I think has been made available to all of you.

I’m also delighted to take this occasion to be able to announce a new FDA program that should bring us a step closer to assuring the safety and quality of imported goods.

Since I assumed leadership of the FDA a little over eight months ago, each day has been an opportunity to delve more deeply into another aspect of the vast and complex mission of the agency… an agency that touches the lives of all Americans in the most fundamental ways.

One of our nation’s greatest champions of public health, the late Senator Kennedy, once said that FDA is the most important health agency in America. Some people raised eyebrows at that thought, but every day I spend on the job, I gain a deeper understanding of what Senator Kennedy meant… and a fuller appreciation of just how right he was.

For one thing, I really did not truly appreciate how crucial and unique the FDA is... As a science based agency with mission to protect and promote the public it does have a very special role in addressing threats to health, and as the gateway for products that people need.

Our responsibility and reach is enormous. The products we oversee account for about 20 cents of every dollar of consumer spending in this country—food, drugs, medical devices, vaccines and biologics, cosmetics, dietary supplements, animal drugs and food, tobacco products, and certain products that emit radiation.

Today the FDA faces a daunting set of tasks. Globalization has multiplied the scale of our responsibility, and the challenges we face.

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

This year, we expect that 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 somewhere around 15 to 20% of all food now consumed in the U.S. originates outside our borders. In fact, some 70 percent of seafood and about 35 percent of fresh produce consumed in the U.S., come from outside our borders. Strikingly those are some of the most vulnerable foodstuffs in terms of potential for contamination.

Up to 40% of the drugs Americans take are imported, and up to 80% of the active pharmaceutical ingredients in those drugs come from foreign sources. So we are definitely talking about real numbers.

Imported medical devices are another rapidly growing area.

The rise of imports has brought clear benefits to the American people. We can eat a huge variety of delicious products from around the world and 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 otherwise might otherwise have been possible.

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

In addition to this growth in 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 repackagers and redistributors, and making oversight significantly more difficult.

This all adds up to an enormous task for the FDA, and we know that there are very real concerns.

A few examples.

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.

Although these melamine-tainted ingredients were only found in animal products in the U.S., it is not difficult to imagine that they might just as easily have been used in the U.S. production of human food products.

In fact, melamine did appear in Chinese infant formula, causing an estimated 300,000 illnesses and at least six deaths in China, and prompting worldwide recalls of milk-containing products. Unfortunately, melamine contamination appears to be a persistent problem, as only last week, Chinese authorities announced that they were pulling more milk products contaminated with the chemical from store shelves.

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, which led to 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, many of you may recall the tragedy that occurred when contaminated heparin (a blood thinning drug) came from China and 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 medical products.

Here in the U.S., federal and state authorities have done a lot to keep counterfeiting of drugs to a minimum because of our extensive system of laws, regulations and enforcement. But it requires constant vigilance, and the problem is growing.

Counterfeit drugs represent a much greater threat in the developing world, where the system of laws and regulatory oversight do not afford so much protection. Numbers are hard to substantiate and estimates vary, but studies in some countries suggest that between 30 and 50 percent of certain available drugs are actually counterfeit.
Needless to say, this is devastating to health and safety.

And in our modern world, profit isn’t the only dark motive we must face. Sadly, we know that we are also vulnerable to potential attacks involving our food or drug supply by terrorists determined to do harm.

While it is easy to focus on the most dramatic scenarios, there have also been many other significant, but less intentional, episodes associated with contaminated and adulterated products, both food and medical goods.

Outbreaks associated with melons, peppers, raspberries, and seafood have all been in the headlines in recent years to name a few.

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 just plain filth.

Each of these crises and near-misses is deeply troubling in and of itself. There are human costs, economic costs, and sometimes an undermining of confidence in government agencies, other critical institutions, and in the products themselves

Even more troubling is the fact that these events are more than isolated incidents.They are symptoms of a significant underlying problem: globalization has fundamentally altered our market landscape.

When the modern FDA was created in 1938, imports were a tiny part of the products used in our country. FDA’s import inspection system reflected that fact -- and unfortunately it still does. Massive change will be required for FDA to be able to keep up with a globalized economy.

It is easy to see that FDA faces a Sisyphean task if its employees are asked to inspect everything that enters our ports. The estimated 20 million shipments of FDA-regulated imports that will come into the country this year will be handled by fewer than 500 inspectors.Though these employees work tirelessly, they typically are able to examine less than one percent of these products before entry into the U.S. I’m going to talk briefly later about some improvements in this area.

But 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. Current estimates are 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. We are taking important steps to increase the number of inspections, as well as follow up inspections of establishments that previously had violations or deficiencies.

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

Clearly our nations’ traditional approach – relying on FDA inspections to catch problems at the border or in foreign facilities – needs significant overhaul. We need to recognize that addressing the challenge must be a collective and collaborative effort on an international scale…and it will require fundamental and systemic change in the way we, and all of our trading partners, think about import safety.

To assure the safety of imported products and fulfill our public health mission in a global age, the FDA must adopt a new approach …. an approach that takes into account the entire supply chain and its complexity; and 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 is a simple, yet profound paradigm shift.

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 throughout the food production process.

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 all imports. We are starting now to make this shift.

So let me now share a few elements of our overall 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 wherever they are. We now have permanent FDA offices in Beijing, Shanghai and Guangzhou, China, in New Delhi and Mumbai, India, in San Jose, Costa Rica, Mexico City, Santiago, Chile, and—soon—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 build confidence in the safety and quality of the goods they send us. But we are doing much more….we’re helping them establish the regulatory powers necessary to support safe products for their own domestic use and a strong, reliable export market. It will benefit their health and development in very fundamental, long-lasting ways.

In addition, there is also much important collaborative work to be done with allies who already have well-developed regulatory systems.

In fact, we now have more than 30 agreements with foreign counterparts to share inspection reports and other non-public information that can help us make better decisions about the safety of foreign products.

So if a shipment of fish contaminated with a banned fungicide shows up in a port in Italy, we’ll hear about it swiftly and be on the lookout for products from the same shipper.

Or if our British counterparts share with us critical information about their inspections of certain factories in China, or Egypt or Thailand, we can use that information and not re-inspect those same facilities behind them, but rather use our resources to inspect elsewhere .. places that otherwise none of us would have seen.

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.

And we also now have FDA staff working in the offices of key regulatory agencies overseas to build on these relationships, and we have EU representatives working with us.

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. In this day and age, companies must be able to effectively demonstrate that safety, quality and compliance with international and U.S. standards are built into every component of every product and every step of the production process.

Some companies already do a terrific job at this, tracking where and how their products are made and the path taken to reach our shores. Obviously they have a vital interest in assuring confidence in the safety and quality of their products and their brand. These best practices need to become standard practice throughout industry. And FDA will work with industry to set standards for technologies and other approaches that can help them strengthen the safety of 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 FDA or blaming anyone else. Only when we have a sense of shared responsibility – and accountability – will we have a truly safe global supply chain.

Third, we at FDA have a responsibility to deploy our agency’s resources as strategically as possible. This is more critical than ever, as our mandate keeps expanding, despite these economically challenging times.

In this regard, I want to take this opportunity today to formally announce a new FDA program that will enable us to more effectively and efficiently do import inspections.

I have already discussed how in today’s world, we can’t simply be “guardians at the gate” attempting to detect and weed out dangerous and contaminated products at our ports and borders. But as part of a comprehensive program we still need to screen at the borders….and we can and must do it in a much more meaningful way.

The system we are now deploying is called PREDICT--the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting. It is a sophisticated 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 target shipments for inspection that pose the greatest risk.

The system was piloted in Los Angeles and we are currently bringing it on line in New York. Hopefully we will have it up and running around the country by the end of the Spring.
With PREDICT, investigators will still be checking only a small percentage of all import shipments. But they’ll be using better intelligence to decide which shipments to check. PREDICT uses a variety of assessments to rank import shipments according to risk.

It considers everything from whether a product is intrinsically risky--raw seafood falls into this category– to information we’ve acquired from previous examinations of shippers or producers. We can even add information on things like floods, hot weather or market conditions that suggest whether a particular shipment is at risk of being spoiled or shoddy. These and other factors are added up to give a risk score—and the riskiest items are the ones that our investigators will check first.

We expect PREDICT to offer two major benefits to FDA import inspectors, to importers, and to the public. First, the system will automatically flag potentially risky shipments.

Second, the system will give lower risk scores to more innocuous materials, which can then be cleared through FDA inspection rapidly. This allows FDA inspectors to spend their time looking at the highest-risk items. It also means that carefully labeled products with good histories will be held up for shorter periods, which is better for everyone.

I brought a short video demonstrating the PREDICT system in action which I think we may show when I am done speaking. It’s only about four minutes I’m told .. PREDICT is an exciting innovation, that harnesses advances in information science to enable us to do our job better and to improve our service to the nation. But it 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.

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 and new authorities.

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; to work with industry to enhance compliance with standards; 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.

Such an approach represents a shift to a new paradigm for the safety of U.S. food and drug imports, and it will not be easy to accomplish. We will need to marshal the support of our stakeholders, our international partners, and the Congress.

However, 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.

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. I look forward to hearing your ideas about how we can move toward a global vision for import safety …and how we can do it together.

Thank you.