Reputation and Power

The U. S. Food and Drug Administration (FDA) is the most powerful regulatory agency in the world. The FDA's regulatory power has evolved over the years—and so has its reputation. Daniel Carpenter traces the history of drug regulation by the FDA and describes how FDA regulations are developed, including how expert committees assess new drugs, why preliminary approval is granted, and how multiyear, international research trials of drugs are conducted. He also describes how the FDA has cultivated a reputation for competence and vigilance throughout the last century, even while resisting efforts to curb its own authority. Carpenter answers questions such as: How does a drug become available to consumers? Is all this regulation effective? Which drugs do doctors prescribe? What happens when there is misuse or abuse of prescription medications? And why did drug regulation become an issue during the administration of President George W. Bush? Carpenter explains how the FDA's reputation and power have played out in these various arenas.