The U.S. Food and Drug Administration (FDA) is one of the world’s most powerful regulatory agencies. No new drug can be marketed legally in the United States unless the FDA declares it to be “safe and effective” for its intended uses. Having set the scientific standards and processes for drug approval, the FDA has played a key role in the industry’s evolution worldwide and shapes how pharmaceutical companies develop, market, and manufacture their products. More subtly, the FDA undergirds public confidence in pharmaceuticals.

According to Daniel Carpenter, the Allie S. Freed Professor of Government and Director of the Center of American Political Studies at Harvard University, the primary source of the agency’s power is its professional and scientific reputation, carefully cultivated over time and guarded by FDA career officials.

But how did the FDA’s reputation invest it with so much influence? And how exactly does the FDA wield its extraordinary power? Carpenter has probed these and other intriguing questions about the FDA’s history, evolution and behavior, more deeply perhaps than any other scholar ever.

Carpenter traces the roots of his interest in the curious and sometimes troubled intermingling of regulation, power, and politics to his grandfather, Edward Krumbiegel, who served for 33 years as health commissioner for the city of Milwaukee, Wisconsin. The stories he heard from his grandfather and from his mother, Kathleen, who worked as a radiologist, about battles over fluoridation, pest control, and other public health issues led him to understand early on that health policy does not emerge purely or even largely from the world of science. “I learned that public health was an endeavor not only of science, but of politics in its best and worst aspects,” Carpenter says.