standards, and advancing health diplomacy (HHS, 2011). The committee recognizes that there are times when the goals of commerce and health will conflict. Some of the gaps Chapter 3 describes, especially the deficits in communication and political will, are a function of this tension. Nevertheless, it would be a mistake to ignore the broad common ground where nations can work together on health programs, development, and trade. The committee believes that food and medical product safety are in this common ground. Investments in food and drug regulation are to the mutual benefit of the investor and the recipient.


Adequate regulation aims to assure food and drug safety. Regulatory authorities have a first responsibility to look after the health of their own countries’ citizens. But in a larger sense, food and medical product safety is a cornerstone for global health, trade, and economic development (Bollyky, 2009; Fidler, 2001; Unnevehr, 2007).

Food and Medical Product Safety and Global Health

Rich and poor countries alike feel the costs of unsafe food and medical products. Foodborne disease outbreaks have occurred on every continent over the last decade (WHO, 2002). The Centers for Disease Control and Prevention (CDC) estimates that, in the United States alone, every year roughly 1 out of 6 (48 million people) are sickened, 128,000 are hospitalized, and 3,000 die from foodborne diseases (CDC, 2011). In developing countries, the burden is even greater. More than 2 million people die each year from diarrhea, much of which is caused by foodborne contaminants (WHO, 2012). At worst, toxically adulterated drugs kill patients; at best they hold back recovery, confuse clinicians, and impede disease control. Though precise estimate are hard to come by, millions of counterfeit prescriptions are probably filled every year in the United States alone (Pew Health Group, 2011). The incidence of counterfeiting is greater when regulatory and enforcement systems are weak: in Africa, parts of Asia and Latin America, and the former Soviet Union (WHO, 2009).

No national regulatory authority, including the FDA, can totally ensure the safety of food and medical products in its markets. Unsafe foods and drugs cross national boundaries with trade and travel; technology makes international commerce easier. The volume of the global trade in food and drugs and the complexity of its supply chains overwhelm border control and inspection efforts. There are legal and practical limits on the ability

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