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FIGURE 1-1
Imports of regulated products increased nearly three-fold between 2002 and 2010.

SOURCE: Gill, 2011.

Quality pointed out, the distinction between foreign and domestic producers is no longer clear (FDA, 2011b).

For the same reasons, through international travel and trade, the health and safety of the American public is now intricately linked to the health and safety of people around the world. Recognition of this reality is the cornerstone of the Department of Health and Human Services’ (HHS’s) 2011 Global Health Strategy. Secretary of Health Kathleen Sebelius called for the new strategy to guide the Department in realizing its own goals and those of other countries, explaining that “only through … multiple and collaborative efforts will [HHS] truly make a mark by improving global health” (HHS, 2011, p. 3). The strategy lays out three interconnected goals for HHS, the parent agency of the FDA. They are protecting and promoting the health of Americans through global health action; providing leadership and technical expertise to improve global health; and advancing U.S. interests through global health action (HHS, 2011). (See Figure 1-5.)

The Global Health Strategy marks a departure from the traditional conception of HHS and its agencies, including the FDA, as purely domestic organizations with an almost exclusively domestic focus. For the FDA in particular, the new HHS strategy aims to “strengthen regulatory capacity on a global basis. Extending … surveillance, regulatory, and program activities beyond the U.S. borders enables more effective protection of Americans’ health through improving the health of the world’s population” (HHS, 2011, p. 19). This is consistent with the evolving scope of the FDA’s work presented in the Pathway to Global Product Safety and Quality. This report explains the changes the FDA sees as necessary to “transform itself from a domestic agency operating in a globalized world to a truly global



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