In the last quarter of the 20th century, politicians in Washington, as well as interest groups, regulatory policy makers, and drug industry leaders were forced to confront the hot-button issue of pharmaceutical regulation. The struggle always centered on product innovation, consumer protection, and choice in the free market. As the American economy stuttered in the late 1970s, the stakes were extremely high for the powerful drug industry and the American public. At the center of this drama was the Food and Drug Administration, which was censured from both the left and right of the political spectrum for being too strict and too lenient in the application of its regulatory powers. Lucas Richert explores the FDA, drugs, and politics in the context of the watershed Reagan era, a period when the rhetoric of limited government, reduced regulation, and enhanced cooperation between businesses and U.S. regulatory agencies was on the ascent. As he investigates the controversies surrounding Laetrile, Reye’s Syndrome, Oraflex, patient package inserts, diet pills, and HIV/AIDS drugs, Richert argues that the practical application of conservative economic principles to the American drug industry was A Prescription for Scandal.

How the FDA became the world's most powerful regulatory agency 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. Some images inside the book are unavailable due to digital copyright restrictions.

How do drugs get to the market? What controls are there and what procedures for monitoring their effects? And how adequate are the regulators in protecting public health when new drugs have serious side effects? The Therapeutic Nightmare tells the story of the sleeping pill Halcion - a story which is far from over. First marketed in the 1970s, Halcion has been taken by millions of patients around the world. For many years it has been associated with serious adverse effects such as amnesia, hallucinations, aggression and, in extreme cases, homicide. Thirteen years after its first release, it was banned by the British government. It remains on sale in the United States and many other countries. This book explains why patients have come to be exposed to Halcion's risks and examines the corporate interests of the manufacturers, the professional interests of the scientists and medical researchers and the interests of patients in safe and effective medication. It reveals how these contending forces shape the regulatory decision-making process about drug safety. As the number of new drugs and health products grows, a major challenge facing regulators and the medical profession is how to put the interests of public health decisively and consistently above the commercial interests of the drugs industry, while becoming more accountable to patient and consumer organizations.