Margaret Hamburg, FDA Commissioner

	We live in a nation that increasingly relies on other countries to produce the food, drugs, cosmetics, and devices we use in our daily lives. … Half of all medical devices used in this country are imported, while 80 percent of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere.

At the center of this global bazaar is the FDA. Today, nearly 25 cents of every dollar spent by Americans are on products regulated by the agency. FDA-regulated products account for about 10% of all imports into the U.S., arriving from more than 300,000 facilities in 150 different countries. 

The growth in imports has been rapid—and promises to accelerate. Just a decade ago, 6 million shipments of FDA-regulated goods passed through the nation’s 300 ports of entry. This year the number will quadruple to 24 million shipments. Each year over the last seven years, food imports have grown by an average of 10%, while imports of pharmaceutical products have increased at nearly 13% and devices have grown at over 10%. Between 2007 and 2015, it is estimated that imports of FDA-regulated products will triple, corresponding to a 15% growth rate. . . . 

This rapidly changing environment, and a desire to move from a posture of intercepting harmful products to anticipating and preventing the arrival of such goods, has prompted FDA leadership to develop this “Pathway to Global Product Safety and Quality.” 

Throughout history, FDA’s primary tools for product safety and quality have been inspections at production facilities and ports of entry. Over time the agency has developed additional methods for protecting the public, including laboratory sample analyses for select product categories (e.g., foods) and product safety reporting systems. 

Yet the safety of America’s food and medical products remains under serious threat. Imported vegetable protein contaminated with melamine has sickened and killed American pets, and milk tainted with melamine killed and injured children in China. Contaminated heparin, diverted and counterfeit glucose monitor test strips, glycerin contaminated with diethylene glycol (DEG), and low quality titanium destined for medical implants have all raised public health concerns…. 

In response to increasing globalization, FDA has expanded its capabilities and regulatory authority. The PREDICT system, for instance, uses novel data analytics from the entire life cycle of a product to better identify and target high-risk products before they enter the country. Armed with better intelligence, FDA regulators can both speed admissibility of safe products and focus their investigative energies on the goods most likely to harm the public. 

The agency has opened additional offices in key international locations and materially increased the number of certain types of foreign inspections. Inspections of overseas drug manufacturing plants, for example, increased from 333 in 2007 to 424 in 2009. … 

Despite such recent improvements, FDA does not—nor will it&mdash;have the resources to adequately keep pace with the pressures of globalization. In 2008 the Government Accountability Office (GAO), recommended that FDA increase inspections of foreign drug establishments and improve information it receives to manage overseas inspections. But at current rates, it would take an estimated nine years for FDA to inspect every high-priority pharmaceutical facility just once. … 

For decades, FDA has been a recognized world leader in product safety standards. But as the agency looks to the future, it can no longer rely on the historical tools, activities and strategies to regulate products. … Over the next decade, FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders. … 

The new approach rests on four core building blocks:

	1. FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.

	2. With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.

	3. FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.

	4. FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties. 

The essence of this strategy marries creative international coalitions with cutting-edge investigative tools to continue to provide the consistently high level of safety and quality assurance the public expects—and deserves. FDA will continue to partner with other federal agencies, the states, and nations across the world. It will also look to Congress to modernize its antiquated authorities so that FDA’s legal tools keep pace with globalization. 

To meet these ambitious goals and achieve a true and lasting paradigm shift, FDA will engage all stakeholders in a process that will unfold over several years. Success will require boldness, creativity, and patience. It will not be easy, but it is imperative. Global supply chains, international trade, foreign sourcing, and terrorism remind us daily that the rest of the world will not stop and wait for regulators to catch up. 

It is incumbent upon FDA to engage its international counterparts, industry, and stakeholders worldwide to blaze the Pathway to Global Product Safety and Quality. PC 

Excerpted from “Pathway to Global Product Safety and Quality,” FDA, July 7, 2011, available at 

Margaret Hamburg, FDA Commissioner

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