The Institute of Medicine (IOM) Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries recently issued a report entitled “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad.” This 300-page-long report begins by noting that most of the active ingredients in the medications we take—perhaps up to 80 percent—come from foreign sources, including  low- and middle-income countries with less stringent regulatory requirements than those in place in the United States. Similarly, much of the food we eat comes from other countries, and its safety is also affected by regulatory deficits.

Given the large proportion of foods and drugs that come from foreign sources, Congress has required the Food and Drug Administration (FDA) to conduct more inspections. Weak regulatory systems in developing countries make it difficult for the FDA to monitor product safety, however, since it is only able to inspect a small proportion of foreign manufacturers. The IOM was thus commissioned by the FDA to “identify the core elements of food, drug, medical product, and biologics regulatory systems in developing countries; to identify the main gaps in these systems; and to design a strategy the FDA and other stakeholders can use to strengthen food and medical products regulatory systems abroad.”

The daunting task of incentivizing and helping foreign countries bolster their regulatory systems is laid out over the course of 300-plus pages in the previously referenced IOM report, which outlines core elements of successful regulatory systems, critical issues in developing countries that affect food and medical product safety, and strategies for bridging gaps in food and medical product safety systems in developing countries.

Given our solid basic infrastructure and stringent regulation of food and drugs in the United States, we may fail to consider problems that commonly affect developing countries. However, the IOM report brings to light problems such as:  

  • Difficulty controlling supply chain due to lack of proper refrigeration, lack of pest control, and lack of basic sanitation
  • The absence of laws governing product safety, poor or inconsistently written laws, or no enforcement of laws
  • Virtually non-existent product liability laws
  • Corruption among government regulators
  • Poor or nonexistent product safety surveillance systems
  • Lack of information technology to facilitate communication among agencies

The IOM report suggests that gaps in foreign food and medical product safety systems can be bridged through emphasis on “public health, market incentives, risk-based investments, and international coordination,” including, for example:

  • The encouragement of international and intergovernmental organizations to invest in strengthening the capacity of regulatory systems in developing countries
  • Engaging in open and regular discussions to exchange expert scientific and technical information
  • Working with strongly regulated agencies abroad to share inspection reports
  • Training regulators in developing countries
  • Ensuring an adequate mix of incentives to importers of food and medical products that meet U.S. regulatory standards

The recommendations contained in the IOM report are intended to span the next 10 years. The IOM report concludes “it has become clear that the FDA needs to refocus resources and attention to modern threats to the food and medical product supply. This will probably require rebalancing programs to give more attention to foreign producers and suppliers.”

Practically speaking, although it is difficult to say how this will affect industry, some of IOM’s shorter-term goals, including the application of current food-tracing requirements to medicines, biologics, and even medical devices, and providing incentives to firms that thoroughly trace their products, suggests that supply chain tracing may be of increased importance over the next three to five years. We also anticipate that importers may face more inspections and possibly sampling and detentions based on the FDA’s establishment of risk.