Developing a Global Curriculum for Regulators

Abstract

Globalization has resulted in countries importing foreign products in numbers never before seen. For example, the U.S. Food and Drug Administration (FDA) estimates that the products it regulates now originate in more than 150 countries and 300,000 foreign facilities (FDA, 2011). Eighty percent of seafood consumed in the United States comes from abroad and 40 percent of finished drugs originate from overseas (FDA, 2013). The globalization of commerce brings both benefits and risks to consumers-the promise that goods are available at any time of the year, such as mangos in the winter, and the risk that when something comes from another country, its safety and quality are more difficult to ensure. At every step in the path to market, from raw materials to manufacture, storage, and distribution, a product can be contaminated, diverted, counterfeited, or adulterated. Language barriers, time differences, and distances multiply these risks, and the internet can exacerbate the problem by providing a veil of anonymity to dishonest sellers. Regulators are mobilizing to address the risks that come with globalization, and a recent FDA-commissioned Institute of Medicine (IOM) study titled Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad examines the challenges that many lowand middle-income countries (LMIC) face in doing this (IOM, 2012). It discusses the major gaps in these systems and offers remedies in the form of recommendations. The IOM study also identifies the core elements that all regulatory systems should have in order to protect the public's health (see Figure 1 in the Annex). One of these elements is a strong regulatory workforce, yet the IOM study identified a number of gaps in this area. To address these, it made a major recommendation-a call for the development of a standing global curriculum of fundamental regulator competencies. IOM Recommendation 6-3: The FDA should facilitate training for regulators in developing countries. The purpose is workforce training and professional development through an ongoing, standing regulatory science and policy curriculum…. (IOM, 2012, p. 204).