FDA maps out global strategy

Abstract

The US Food and Drug Administration is calling for greater reliance on global partners to improve the safety of America's foreign imports. Susan Jaffe reports from Washington, DC. In its latest effort to promote a global strategy for protecting Americans against unsafe imported pharmaceutical, food, and medical products, the US Food and Drug Administration (FDA) has called for unprecedented international cooperation to cope with seemingly overwhelming challenges. “In the past 10 years, the global production of FDA-regulated goods and materials has exploded”, said Jennifer Devine, deputy director of FDA's Office of Global Regulatory Operations and Policy. Some 24 million shipments enter the USA from over 300 000 foreign facilities, she added. FDA inspectors can visit only a fraction of those facilities. “The numbers are so daunting, we can't do this alone”, she said. In addition to approving the sale and effectiveness of US drugs, the FDA is required to certify the safety of imported medical products, pharmaceuticals, and food. Nearly 40% of the drugs Americans use are imported and, as the FDA notes, 80% of the active ingredients in US-consumed drugs are sourced from abroad. Roughly half of fresh fruit and about 20% of fresh vegetables consumed in the USA are also imported. Outlining their strategy in a recent report—Global Engagement—the FDA concludes that the agency cannot rely exclusively on common practices to meet these responsibilities: “In the face of these realities, inspection at the US borders or ports-of-entry is no longer sufficient to ensure the safety of the ever-increasing tide of imports to the United States.” The report proposes a global response that includes improving local regulatory oversight in foreign countries to prevent the export of contaminated products, aligning or harmonising disparate safety standards, sharing resources and information, using advanced technology to target high-risk imports, and relying on the latest scientific methods to detect contaminated products. “This is a great leap forward for the FDA”, said Laurie Garrett, Senior Fellow for Global Health at the Council for Foreign Relations, a New York-based non-partisan research organisation and publisher of the journal Foreign Affairs. “Very few pharmaceutical products or medical devices are 100% US-made anymore, and the pace of globalisation is breathtaking.” The report also describes what steps the USA is taking to achieve these goals, for example: working with regulators from more than 180 countries to conform food safety standards; studying how regulations and inspections in other countries differ from FDA procedures to determine whether foreign oversight could substitute for FDA inspections; and close cooperation with European regulators, including the European Medicines Agency and the European Food Safety Agency. By citing these and other activities, the agency also hopes to recast how it is viewed around the world. “Historically, FDA is not the first agency that comes to mind within a globalised context”, said Mary Lou Valdez, FDA Associate Commissioner for International Programs. The report can help “increase knowledge and appreciation about the challenges in the work we must do abroad”, she said. The report complements an FDA-commissioned study issued in early April by a committee of experts convened by the Institute of Medicine (IOM), which revealed vulnerabilities in the regulatory systems in developing countries. IOM's study—Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems—provided greater emphasis on risk management, said Prashant Yadav, an IOM committee member and director of Healthcare Research, at the University of Michigan's William Davidson Institute, MI, USA. Limited resources should be spent on the “biggest risks”, said Yadav, “instead of treating every importer, every exporter, every country, and every product the same”. Improving standards for inspections, information gathering and sharing, training in risk assessment and other steps will take time, but Yadav, Garrett, and other US observers agree that the FDA's focus on a global strategy is gaining in foreign capitals as well. “The issue of poor quality food and medicines and substandard and counterfeit products is coming up at the World Health Assembly and other high level forums”, Yadav said. Leaders in both developed and developing countries “are starting to realise this is a global problem much more than they have in the past”. Garrett believes a global response is imperative. “Any regulatory agency, in any country, that continues to pretend it can protect its population from fraudulent, substandard, or frankly toxic medicines by continuing business as usual is delusional”, she said.