Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA

Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA

Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA

Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA

Synopsis

The U. S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.


Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today.



Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.

Excerpt

Regulation and law currently put American citizens at second remove from therapeutic medicines. In order to use most drugs, citizens must obtain a prescription from a licensed and qualified medical authority, usually a physician. Yet before anyone can prescribe, the U.S. Food and Drug Administration must approve. No new drug can be legally marketed in the United States unless the Administration has explicitly declared it “safe and effective” for its intended uses. This authority renders the FDA the gatekeeper of the American pharmaceutical marketplace, and it sustains a battery of vast powers. Among these are the power to define medical success and shape scientific careers, the power to limit advertising and product claims, the power to govern drug manufacturing, the power to enable drug firms to generate vast riches and the power to chase those same firms from the marketplace, the power to sculpt medical and scientific concepts, and ultimately the power to influence the lives and deaths of citizens. Some of those citizens may be harmed from hazardous or ineffective therapies that the FDA has approved. Other citizens may suffer or die waiting for the agency to approve a potentially effective cure. Still others, perhaps most, may easily use a drug whose dosage, label, and chemical form have been carefully honed through the scrutiny that regulation brings. Whatever the outcome, the FDA has shaped the lives of one and all. Among the thousands of people who daily give painstaking attention to the agency's every utterance and movement, there is considerable disagreement about the Food and Drug Administration—it is venerated in one corner and bemoaned in another; it is targeted for expansion by one voice, for evisceration by a second—but there is no serious doubt about its reach or significance.

The Administration's formal powers engender a broader and more opaque set of informal forces. From one vantage, the agency's formal authority is limited to the jurisdictions and territories of the United States. It legally tends the boundaries of only one nation. From another vantage, however, the FDA rules the entire global pharmaceutical market. The United States is among the world's wealthiest nations and its pharmaceutical market is, at this time, by far the world's largest. And it has exploded in recent decades; the American market accounted for $216 billion in spending on prescription drugs in 2006, more than five times the $40.3 billion spent in 1990. At this writing, furthermore, the United States is the only major world economy without explicit pharmaceutical price controls through national health insurance. Because admission to the U.S. market is the preeminent site of profit for the world's drug companies, the FDA's veto power over entry into the American health-care system translates into global economic and scientific reach. Be-

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