As a follow-up to my comments on combating counterfeits on a global level (“Peggy’s Regulatory Marshall Plan”), let me share some comments from the Commissioner’s speech Monday at Council on Foreign Relations.
(The speech – as delivered – will be available shortly on the FDA’s website.)
It’s a pleasure to be back in New York and at the Council on Foreign Relations. I have admired this organization for many years and am proud to be a longstanding member.
Some here may have been surprised to see that CFR is focusing on issues of food and drug regulation. But it is highly appropriate, much needed, and very timely.
Our scope and responsibilities are enormous. But it hasn’t always been that way. As you can imagine the world in which FDR created the modern FDA in 1938 was very different from ours.
Back then, most products FDA regulated were domestically manufactured and the data supporting them came from American investigators. And for years, when it came to importation of foreign products, our authority 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.
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.
The numbers are staggering. In the food realm, about 40 percent of fresh fruit and produce and over 70 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 drugs themselves.
The global supply chain has led to the distribution of unsafe or ineffective products and harm caused by economic adulteration and intentional fraud. You will hear directly from others 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 have experienced events—some clearly deliberate and some unintended—with serious implications for health and safety, as well as for trade, commerce, and the economy: ranging from contaminated heparin (a blood thinning drug), counterfeit glucose monitor strips and surgical mesh, to melamine-tainted vegetable protein and dairy products, salmonella in peppers, to name just a few.
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. Some of the work for this is already underway and has been for several years, as regulators around the world 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.
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 America’s vested interest, but it will have broader benefits for public health and economic development within those countries.
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. Regulators cannot 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.
