Reputation and Power

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

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    Reputation and Power
    Book Description:

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

    eISBN: 978-1-4008-3511-9
    Subjects: Political Science, Health Sciences, History

Table of Contents

  1. Front Matter
    (pp. i-vi)
  2. Table of Contents
    (pp. vii-viii)
    (pp. ix-x)
    (pp. xi-xii)
    (pp. xiii-xvi)
    (pp. xvii-xx)
  7. INTRODUCTION The Gatekeeper
    (pp. 1-32)

    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...

  8. CHAPTER ONE Reputation and Regulatory Power
    (pp. 33-70)

    In ways that are stark and in ways not easily seen, organizational reputations animate, empower, and constrain the manifold agencies of government. Reputations are composed of symbolic beliefs about an organization—its capacities, intentions, history, mission—and these images are embedded in a network of multiple audiences. From military bodies and diplomatic establishments to disaster relief outfits and regulatory commissions, government agencies are buffeted and suffused by a multidimensional politics of legitimacy. Reputations can expand or deflate the legal authority that agencies exercise by virtue of law and delegation. Reputations can intimidate or embolden the subjects of government and, in...

    • CHAPTER TWO Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath
      (pp. 73-117)

      Reputation and power in American pharmaceutical regulation evolved jointly in an extended moment of image making and lawmaking. These crucial steps toward the interlacing of reputation and power came in the middle of the New Deal, with the Federal Food, Drug and Cosmetic Act of 1938, its subsequent enforcement by the FDA, and the Supreme Court’s decision inUnited States v. Dotterweich(1943).

      From the vantage of the early twenty-first century, the Act of 1938 stands as one of the most important regulatory statutes in American and perhaps global history. The Act created an original legal category—the “new drug”...

    • CHAPTER THREE The Ambiguous Emergence of American Pharmaceutical Regulation, 1944–1961
      (pp. 118-227)

      The bureaucratic regulation of pharmaceuticals arrived not starkly in new laws, nor in scientific and medical upheavals, but continuously, haltingly, and ambiguously in regulatory practice. It came in administrative conflict and the symbolic lessons that citizens, journalists, scientists, company officials, and federal policymakers drew from those struggles. In tilts between competing visions of scientific experiment, between alternative views of the relationship between medicine and business, between brash pharmaceutical firms and newly cautious medical reviewers—in these battles the regulatory system of the past half-century was created. There was no designer, no founding moment. Instead, a slow, publicly imperceptible clash of...

    • CHAPTER FOUR Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961–1966
      (pp. 228-297)

      Image and power in American pharmaceutical regulation took new shape in the early 1960s. In a series of events at the crossroads of legislative politics, national media attention, scattered personal tragedies and triumphs, scientific debate, and administrative interpretation and rulemaking, a new combination of reputation and power came into being. These changes were vast. In the policy tragedy of thalidomide, a new image of the Administration crystallized in the public and legislative imagination. Frances Kelsey came to national limelight and public commemoration as a new icon for the government physician and regulatory reviewer. A new statute—the Drug Amendments of...

    • CHAPTER FIVE Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963–1986
      (pp. 298-392)

      In the quarter-century following the thalidomide crisis, reputation and power in American pharmaceutical regulation slowly became institutionalized. By the 1980s, the politics of reputation and the patterns of government power had become somewhat predictable, though not entirely so. For nearly every debate about drug regulation, a set of audiences arose and aligned upon the theme of safety and consumer protection, while another set of audiences emerged on the theme of research, innovation, and the “drug lag.” The politics of reputation became predictable in the minimal sense that voices surfaced that would stably characterize and inform much of the debate. These...

    • CHAPTER SIX Reputation and Power Contested: Emboldened Audiences in Cancer and AIDS, 1977–1992
      (pp. 393-462)

      Observers in journalism and academics have often claimed that American pharmaceutical regulation was irrevocably altered by the AIDS crisis. The clash of dying protesters and white-coated bureaucrats, and the resulting tale of institutional change, have been woven into something of a common parable. In this narrative, a new social movement representing people with nothing to lose aggressively confronted a tradition- and procedure-bound bureaucracy and compelled institutional change. As this telling goes, when the Administration was confronted with tangible sufferers of an illness that promised certain death for them, sufferers who organized into new forms of activism, who made effective moral...

    • CHAPTER SEVEN Reputation and the Organizational Politics of New Drug Review
      (pp. 465-543)

      The review of a new drug application marks the pivotal moment in the transformation of a scientific concept into a therapeutic commodity. The process seems at first glance to compose a simple, even predictable task. New drug review denotes the organizational process of deciding whether a sponsor’s New Drug Application shall be deemed “effective” in regulation and at law. In the United States, a sponsor with an effective NDA can legally market a molecule in conjunction with a specific claim of healing. If and when these rights have been conferred upon a sponsor, the Administration’s power—over those sponsors and...

    • CHAPTER EIGHT The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite
      (pp. 544-584)

      A regulator’s authority over admittance to the pharmaceutical marketplace has become—contingently, gradually, and forcefully—a set of powers over the research and development that precedes market entry: its conduct, its practitioners, its essential concepts and ruling structures. The Administration now governs the qualification of clinical investigators and can essentially debar researchers from the practice of drug research. It has cleaved the process of drug experimentation into four “phases” and has all but defined the notions of “effectiveness,” “safety,” “efficacy,” “adequate,” “bioequivalence,” and “bioavailability” by which drugs are compared and judged. In a series of rules elaborated over one half-century,...

    • CHAPTER NINE The Other Side of the Gate: Reputation, Power, and Post-Market Regulation
      (pp. 585-634)

      Once the Administration declares a New Drug Application “effective,” a drug legally enters the U.S. market. At this point, the agency’s statutory and public responsibilities continue. An effective NDA is still the object of regulation. Federal law, Congress, and the public still hold the agency responsible for ensuring drug safety, and the agency’s work is now called “post-market regulation.” But the powers of the Administration have changed. And its incentives have changed. And hence the ballgame has changed. What was once caution about the drug itself is now aversion to bad news about a product that has the imprimatur of...

    • CHAPTER TEN The Détente of Firm and Regulator
      (pp. 635-685)

      Astride the Administration itself, there is no more central or powerful agent in the development, evaluation, production, and marketing of medicines than the organization commonly known as a “drug company.” Most of the sponsors of investigational drugs and new drug applications are for-profit entities. Among these are both privately held companies and publicly owned (stock) corporations. There are, to be sure, important roles played by nonprofit, academic, and government organizations in drug development and distribution. There are telling cases of national and academic sponsorship—numerous antibiotics of the middle twentieth century serve as examples, and many of the drugs in...

    • CHAPTER ELEVEN American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies
      (pp. 686-726)

      Government regulation of the development and market entry of therapeutic medicines is a global phenomenon. Many countries—including most member states of the European Union today—possess their own regulatory agencies dedicated to pre-market review and post-market surveillance of medicines. Over the course of the late twentieth century, these agencies spread persistently across continents, economies, and contexts. Many of the world’s pharmaceutical regulatory agencies—in Australia, Taiwan, South Korea, Brazil, China, and other countries—have been created or fundamentally transformed since 1989. At present, dozens of nations (comprising at least three-quarters of the world’s population) have their own legislation governing...

    • CHAPTER TWELVE Conclusion: A Reputation in Relief
      (pp. 727-752)

      Whether or not their members find comfort in the fact, regulatory organizations are carriers of reputations. The organizations and the individuals attached to them are known alternatively for bumbling or for dramatic success, for gentility and laxity or for vigor and fierceness, for risk-aversion and methodical scrutiny or for sleeping at the wheel. Those reputations reflect, encode, and simplify complicated histories. And ultimately, those reputations feed back to shape the organizations they represent. A reputation becomes a tool of regulation, a tool with which federal officials herd citizens, firms, and medical researchers into more appropriate, legal behavior. Reputations become organizational...

    (pp. 753-758)
  12. INDEX
    (pp. 759-802)
  13. Back Matter
    (pp. 803-804)