ABSTRACT

The Department of Health and Human Services (DHHS) is the U.S. government’s principal agency charged with protecting the health of all Americans and providing essential human services to U.S. citizens. To perform its functions, the DHHS budget for FY2002 was $460 billion, and it currently has 65,110 employees.1 Its programs are administered by 11 operating divisions, including eight agencies in the U.S. Public Health Service and three human services agencies. The agency is organized as shown in Figure 1.1.2 Before turning our attention to the U.S. Food and Drug Administration (FDA), we will first focus on the three healthcare DHHS divisions shown in Table 1.1, which details the functions, number of employees, and fiscal budgets of these divisions. As can be seen in the table, the National Institutes of Health (NIH), the oldest of these three operating divisions, has been around since 1887. The FDA was created in 1906, followed 40 years later by the Centers for Disease Control (CDC). Each of these healthcare-related agencies was established in response to specific events that prompted passage of new government regulations to ensure the public’s safety. The FDA’s delegated statutory authority is discussed in this book, but further research into the events leading to the development of the NIH and CDC and their authority is well worth the reader’s time.