FDA Goes Global: A New Approach to Food and Drug Import Safety

Last week, I participated in an event at the Center for Strategic and International Studies (CSIS) in which U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg announced a remarkable shift in the FDA’s thinking on food and drug import safety. If adequately supported by Congress and translated into concrete action, this change in strategy on food and drug safety could have significant benefits for U.S. and global health and development.

As I have discussed in depth elsewhere, food and drug safety are now global health programs. Unsafe food and drugs exact a staggering human and economic toll in developed and developing countries alike. Contaminated and adulterated food and drug products sicken and kill millions of consumers in the U.S. and elsewhere each year, fuel protectionism, raise business costs, and undermine development.In this context, the health of U.S. citizens is interdependent with the health of other states’ citizens. The unsafe products we consume domestically are often the same products we export to other nations; the same is true for our trading partners. Given the increasing complexity and volume of the global trade in these products, no one country or national regulator alone can ensure the safety of food and drugs used by its citizens.Ensuring the safety of foods and drugs requires strategies and tools similar to those used to successfully address other global health threats, like infectious diseases, that cross borders with trade and travel. Sustainable progress with those tools and strategies depends on the cooperation of trading partners, industry, and the multitude of entities involved in the international commerce and regulation of food and drugs.Commissioner Hamburg’s speech last week reflected a new, high-level recognition at the FDA of the global nature of the food and drug safety problem. In addition to announcing an important new risk-based assessment tool, the Commissioner argued that it is no longer appropriate to think of unsafe food and drugs as “international or domestic [issues], but as common problems in a dramatically fluid and interconnected world, and the same kinds of strategies that we need to apply internationally, we need to apply at home – the shift from a reactive mode to a preventive mode, the focus on really assuring the safety and security of the supply chain, the notion of working in critical partnership with both industry and, domestically, with state and local health authorities.” Maintaining that the FDA could no longer “inspect its way to safety” in an era of increasing global trade, complex products, and transnational food and drug supply chains, the Commissioner stated

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 – both for their own consumption and for export.

Achieving that vision will not be easy. To start, Congress must pass pending food and drug safety legislation and give FDA the tools and resources it needs to work with our trading partners, particularly developing countries, to improve inspection and quality control of food closer to its place of origin and coordinate food and drug safety efforts with trading partners and regional and multilateral health and economic institutions. More targeted, effective measures are needed to encourage U.S.-based retailers and manufacturers to adopt stronger prevention, surveillance, and control of their supply chains and supplier and producer partners. U.S. efforts on food and drug safety must leverage and support international and intergovernmental resources and tools, particularly on issues of regulator interoperability, information exchange, and cooperation.The potential implications of this new thinking for global health and development would be profound. The U.S. market has significant influence on food production and drug manufacturing practices globally. Today, 20 percent of all foods consumed in the United States originate outside our borders. As much as 40 percent of the medicines that Americans take and roughly 80 percent of the active pharmaceutical ingredients in all drugs sold in the U.S. originate from foreign sources. The FDA regulates all U.S. drugs and 80 percent of the U.S. food supply. In all, the FDA regulates nearly 20 million shipments of food, devices, drugs and cosmetics imports from more than more than 150 countries, 130,000 registered importers, and 300,000 foreign facilities. Even beyond its market influence, FDA is widely admired internationally and its practices emulated by regulators worldwide.One important caveat is that the U.S. must be careful to consider the legitimate expectations and needs of developing countries in formulating its approach. Agriculture is an important, and sometimes singular, area of comparative advantage for many developing countries. Congress and the FDA should consider funding appropriate mitigation strategies and initiatives to help reduce costs for small and medium-sized developing country producers to comply with stricter food standards.In the end, Commissioner Hamburg’s vision on food and drug safety is the right one. There is a pressing need for the U.S. and its trading partners to engage on global food and drug safety; the mandate for doing so has become nothing short of enlightened self-interest.