FOOD AND DRUG ADMINISTRATION This research pape

FDA emerged in the post-World War II period as an extremely powerful federal regulatory agency, whose expansion has been episodic --in response to public health scandals and emergencies -- but nonetheless steady largely as a result of technological advances. FDA regulation of drugs, medical devices and food has an enormous impact on research and development, manufacturing, marketing, consumption and general health standards in the American economy. Because of the breadth of its impact, many of FDA's activities have become highly politicized and the subject of continuing controversy. During different decades the pendulum has shifted from concern over FDA's regulatory overreach and inefficiency to the belief that it has failed to keep pace with developments or to serve adequately the public interest.

Today FDA from its Parklawn headquarters office in Rockville, Maryland, and hundreds of field offices in the United States and abroad, its approximately 90,000 employees and an annual budget of about one billion dollars regulates premarketing and postmarketing activities relating about a trillion dollars annually worth of products (Miller, 2000, p.

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t only to the limits imposed by the Constitution. Former Commissioner David Kessler (1990-1997) sought (and largely failed to obtain) from Congress broader enforcement powers, such as "greater access to manufacturing, ingredient, and quality control records, more extensive powers to recall a product and issue subpoenas and the ability to embargo suspect foods" (2001, p. 46). Kessler explained that FDA lacked some of the investigative tools and powers than many other federal agencies possessed because "the agency had been empowered when regulatory agencies were few and even in the flush of the reforming zeal of the New Deal, federal enforcement authority was less favored than action by the states" (p. 46). FDA's enforcement activities increased both in frequency and intensity during Kessler's tenure as Commissioner. According to Higgs (1995), FDA "within broad and often vague statutory limits, . . . makes the rules, monitors compliance without inconveniences such as search warrants, and, within wide discretion, punishes those it finds guilty" (FDA Regulation, p. 68). Higgs said within the FDA "the Constitution . . . is evidently viewed as a nuisance" (pp. 68-69). One of Kessler's innovations was to establish within FDA its own
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Approximate Word count = 3063
Approximate Pages = 12 (250 words per page)