The conquering bureaucracy: a new history of the FDA shows how regulators entrenched and extended their own power.

• Author: Whittington, Keith E.
• Position: Book review

Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, by Daniel Carpenter, Princeton University Press, 856 pages, $29.95

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AFTER SPENDING months in the Amazon sometime in the early 1960s, a young pharmaceutical salesman just wanted to cross an airstrip and board a plane to begin his long journey home. But a Brazilian soldier had a different idea: "You can't come in."

The salesman pleaded, "I gotta come in!" The soldier pointed his rifle at the young American, unlocked the safety, and repeated, "You can't come in." The drug rep relented: "Oh, now

I got it. I can't go in there." In 1985 that salesman, G. Kirk Raab, was named the president of Genentech, which has since become one of the leaders of the modern biotech industry. But early in Raab's tenure Genentech was dealt an almost crippling blow at a critical stage of its development by the formidable Food and Drug Administration (FDA). In the spring of 1987, a mere suggestion that an advisory panel to the FDA was entertaining doubts about approving Genentech's first blockbuster drug was enough to send the company's stock plummeting, wiping out a quarter of its value overnight. When talking about the incident and its implications, Raab liked to recall his jungle encounter with state power. "The FDA is standing there with a machine gun against the pharmaceutical industry, so you better be their friend rather than their enemy. They are the boss.... They own you body and soul."

The FDA is one of the oldest and most powerful regulatory agencies in the United States. In his massive, magisterial Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, the Harvard political scientist Daniel Carpenter provides both a history of the agency and an analysis of how it gained and flexed its most important regulatory power, the ability to keep new drugs off the market. Carpenter carefully documents the ways FDA bureaucrats have worked to exploit opportunities to expand their influence and reshape how the drug industry and the medical profession operate.

The precursor to the FDA was launched in 1906, when the Pure Food and Drugs Act bestowed limited regulatory powers on the Department of Agriculture's Bureau of Chemistry, mostly in the identification and removal of impure or misbranded food and drugs used in interstate commerce. Though pressure for the law had been triggered by muckraking accounts of the food industry, such as Upton Sinclair's bestselling novel The Jungle, the government's chemists were...