Pathway to Global Product Safety and Quality

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EXECUTIVE SUMMARY

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.  Between 10% and 15% of all food consumed by United States (U.S.) households is imported from abroad.  Nearly two-thirds of the fruits and vegetables--and 80% of seafood--eaten domestically come from outside the U.S.  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.

In the decade ahead, the world economy will be shaped by several distinct forces: the rise of emerging markets, the scarcity of natural resources, and the increased flow of capital, information and goods across borders.  The cumulative effect of these trends means not only phenomenal growth in the import sector but increasing complexity for regulators, as the distinction between foreign and domestic products continues to blur.

The manufacturers and producers that FDA regulates face intense pressure to lower costs and improve productivity, fueling a cycle in which the quest for efficiency leads to increased production abroad and higher volumes of imported products to regulate.  Goods entering the U.S. will come from new and different markets, flowing through long, multi-step processes to convert globally-sourced materials into finished goods.  The shift in global product flows will make it difficult to identify the “source” of a product and to ensure that all players along the supply chain meet their safety and quality responsibilities.  And it is not just legal activity that poses challenges for the FDA. Increasingly, the agency must contend with ever more sophisticated threats of fraud, product adulteration, and even terrorism.

In short, globalization has fundamentally altered the economic and security landscape and demands a major change in the way FDA fulfills its mission to promote and protect the health of the American people.  Just as public health leaders have long recognized that disease knows no borders, FDA in crafting its vision for the next decade knows that product safety and quality no longer begin or end at the border.

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.  Peppers, eggs, peanut butter, pistachios, spinach, and cookie dough have all been associated with serious disease outbreaks in recent years.  Many of the crises were due to, or exacerbated by, the regulatory challenges of globalization.

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.

FDA has also collaborated with its counterparts in the U.S. and Australia on drug inspections, engaged in harmonization of drug regulation via the International Conference on Harmonization, and joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) which is an informal organization of the drug manufacturing inspectorates from 39 countries.  For devices, FDA and other global leaders are creating an expanded global regulators’ forum for medical devices under the auspices of the Global Harmonization Task Force (GHTF). 

In addition, under the FDA Food Safety Modernization Act (FSMA) enacted in 2011, FDA has been granted new authorities that allow the agency to better ensure the safety of food.  Under the law, FDA has a new legislative mandate to require comprehensive, prevention-based controls across the food supply and new tools to hold all players in the supply chain accountable.  The law represents a paradigm shift in the area of imports.  For the first time, importers will have explicit responsibility to verify that their foreign supplies have adequate preventive controls in place and that the food they ship to the U.S. is otherwise safe.  The agency also has the power to establish a third-party program for certifying that foreign food facilities comply with U.S. food safety standards, to require certification as a condition of entry for certain high risk foods, and to reject entry of food if the foreign facility or country refuses an inspection by FDA or its designee.  Significantly, FSMA also explicitly encourages arrangements with foreign governments to leverage resources, provide for mutual recognition and capacity building.

Despite such recent improvements, FDA does not—nor will it—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.

The same holds for food products.  FSMA directs the agency to inspect at least 600 foreign food facilities within the next year and double those inspections every year for the next five.  While the goal may be attainable in the first year, it would be impossible for FDA to complete 19,200 foreign food inspections in year six without a substantial increase in resources or a complete overhaul in the way it operates.

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.  The reality facing FDA is that its mission will become ever more difficult to fulfill given the breadth and complexity of industries that it regulates during a time of constrained federal resources.

In order to cope with the magnitude of the fundamental shifts on the horizon, the agency is committed to substantially and fundamentally revising its approach to global product safety and quality.  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.

To achieve this transformation, FDA is developing an international operating model that relies on enhanced intelligence, information sharing, data-driven risk analytics, and the smart allocation of resources through partnerships. 

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.

• I. Ten years from now, the world will be very different than it is today
• II. The coming changes will make the FDA's product safety and quality responsibilities formidable and more global in the years ahead
• III. FDA must substantially change its operating model to address the challenges of the future
• IV. FDA is pursuing a strategy with four primary componets to address the coming challenges
• V. Implementing the Pathway to Global Product Safety and Quality
• Conclusion