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Chapter Three. The Ambiguous Emergence of American Pharmaceutical Regulation, 1944–1961

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Reputation and Power
This chapter is in the book Reputation and Power
CHAPTER THREEThe Ambiguous Emergence of American Pharmaceutical Regulation, 1944–1961It has been my experience in the past that when such differences arose between ourselves and the New Drug Division, we were told to go get the needed data—and did, because we knew that if we didn’t we damn well wouldn’t get our NDA approved. I don’t see how you can get more power than that, and it’s being used now—and boy, are they asking for minutiae!—Searle medical director I. C. Winter, December 1960The bureaucratic regulation of pharmaceuticals arrived not starkly in new laws, nor in scientifi c and medical upheavals, but continuously, halt-ingly, and ambiguously in regulatory practice. It came in administrative con-fl ict and the symbolic lessons that citizens, journalists, scientists, company offi cials, and federal policymakers drew from those struggles. In tilts be-tween competing visions of scientifi c experiment, between alternative views of the relationship between medicine and business, between brash pharma-ceutical fi rms and newly cautious medical reviewers—in these battles the regulatory system of the past half-century was created. There was no de-signer, no founding moment. Instead, a slow, publicly imperceptible clash of administrative practices, scientifi c debates, business strategies, and individ-ual agendas issued in a set of alternative understandings of regulation, in-dustry, and science. These understandings were increasingly codifi ed on paper, refl ecting a broader impulse toward protocol. In these post-War developments was established the interlacing of reputa-tion and regulatory power in American pharmaceuticals. The Administra-tion’s identity was partially recast—less and less as a market cop or fi eld enforcer, more and more as a health protection agency whose fundamental capacity lay in the governance of new drugs. The fi rst face of regulatory power was sculpted in the 1938 Federal Food, Drug and Cosmetic Act, and it began to crystallize in federal rules and guidelines issued in the 1950s. Yet the intertwining of reputation and power came most forcefully in the second

CHAPTER THREEThe Ambiguous Emergence of American Pharmaceutical Regulation, 1944–1961It has been my experience in the past that when such differences arose between ourselves and the New Drug Division, we were told to go get the needed data—and did, because we knew that if we didn’t we damn well wouldn’t get our NDA approved. I don’t see how you can get more power than that, and it’s being used now—and boy, are they asking for minutiae!—Searle medical director I. C. Winter, December 1960The bureaucratic regulation of pharmaceuticals arrived not starkly in new laws, nor in scientifi c and medical upheavals, but continuously, halt-ingly, and ambiguously in regulatory practice. It came in administrative con-fl ict and the symbolic lessons that citizens, journalists, scientists, company offi cials, and federal policymakers drew from those struggles. In tilts be-tween competing visions of scientifi c experiment, between alternative views of the relationship between medicine and business, between brash pharma-ceutical fi rms and newly cautious medical reviewers—in these battles the regulatory system of the past half-century was created. There was no de-signer, no founding moment. Instead, a slow, publicly imperceptible clash of administrative practices, scientifi c debates, business strategies, and individ-ual agendas issued in a set of alternative understandings of regulation, in-dustry, and science. These understandings were increasingly codifi ed on paper, refl ecting a broader impulse toward protocol. In these post-War developments was established the interlacing of reputa-tion and regulatory power in American pharmaceuticals. The Administra-tion’s identity was partially recast—less and less as a market cop or fi eld enforcer, more and more as a health protection agency whose fundamental capacity lay in the governance of new drugs. The fi rst face of regulatory power was sculpted in the 1938 Federal Food, Drug and Cosmetic Act, and it began to crystallize in federal rules and guidelines issued in the 1950s. Yet the intertwining of reputation and power came most forcefully in the second

Chapters in this book

  1. Frontmatter i
  2. Contents vii
  3. List of Illustrations ix
  4. List of Tables xi
  5. Acknowledgments xiii
  6. List of Abbreviations and Acronyms xvii
  7. Introduction. The Gatekeeper 1
  8. Chapter One. Reputation and Regulatory Power 33
  9. Part One: Organizational Empowerment and Challenge
  10. Chapter Two. Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath 73
  11. Chapter Three. The Ambiguous Emergence of American Pharmaceutical Regulation, 1944–1961 118
  12. Chapter Four. Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961–1966 228
  13. Chapter Five. Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963–1986 298
  14. Chapter Six. Reputation and Power Contested: Emboldened Audiences in Cancer and Aids, 1977–1992 393
  15. Part Two: Pharmaceutical Regulation and Its Audiences
  16. Chapter Seven. Reputation and the Organizational Politics of New Drug Review 465
  17. Chapter Eight. The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite 544
  18. Chapter Nine. The Other Side of the Gate: Reputation, Power, and Post-Market Regulation 585
  19. Chapter Ten. The Détente of Firm and Regulator 635
  20. Chapter Eleven. American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies 686
  21. Chapter Twelve. Conclusion: A Reputation in Relief 727
  22. Primary Sources and Archival Collections 753
  23. Index 759
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https://doi.org/10.1515/9781400835119.118

Chapters in this book

  1. Frontmatter i
  2. Contents vii
  3. List of Illustrations ix
  4. List of Tables xi
  5. Acknowledgments xiii
  6. List of Abbreviations and Acronyms xvii
  7. Introduction. The Gatekeeper 1
  8. Chapter One. Reputation and Regulatory Power 33
  9. Part One: Organizational Empowerment and Challenge
  10. Chapter Two. Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath 73
  11. Chapter Three. The Ambiguous Emergence of American Pharmaceutical Regulation, 1944–1961 118
  12. Chapter Four. Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961–1966 228
  13. Chapter Five. Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963–1986 298
  14. Chapter Six. Reputation and Power Contested: Emboldened Audiences in Cancer and Aids, 1977–1992 393
  15. Part Two: Pharmaceutical Regulation and Its Audiences
  16. Chapter Seven. Reputation and the Organizational Politics of New Drug Review 465
  17. Chapter Eight. The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite 544
  18. Chapter Nine. The Other Side of the Gate: Reputation, Power, and Post-Market Regulation 585
  19. Chapter Ten. The Détente of Firm and Regulator 635
  20. Chapter Eleven. American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies 686
  21. Chapter Twelve. Conclusion: A Reputation in Relief 727
  22. Primary Sources and Archival Collections 753
  23. Index 759
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