Reputation and power: organizational image and pharmaceutical regulation at the FDA
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Princeton [u.a.]
Princeton Univ. Press
2010
|
| Schriftenreihe: | Princeton studies in American politics
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | XX, 802 S. Ill., graph. Darst. |
| ISBN: | 9780691141794 9780691141800 |
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Datensatz im Suchindex
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| adam_text |
Titel: Reputation and power
Autor: Carpenter, Daniel P.
Jahr: 2010
CONTENTS
LIST OF ILLUSTRATIONS ix
LIST OF TABLES xi
ACKNOWLEDGMENTS xiii
LIST OF ABBREVIATIONS AND ACRONYMS xvii
INTRODUCTION
The Gatekeeper 1
CHAPTER ONE
Reputation and Regulatory Power 33
PART ONE: ORGANIZATIONAL EMPOWERMENT
AND CHALLENGE
CHAPTER TWO
Reputation and Gatekeeping Authority: The Federal Food,
Drug and Cosmetic Act of 1938 and Its Aftermath 73
CHAPTER THREE
The Ambiguous Emergence of American Pharmaceutical
Regulation, 1944-1961 118
CHAPTER FOUR
Reputation and Power Crystallized: Thalidomide,
Frances Kelsey, and Phased Experiment, 1961-1966 228
CHAPTER FIVE
Reputation and Power Institutionalized: Scientific Networks,
Congressional Hearings, and Judicial Affirmation, 1963-1986 298
CHAPTER SIX
Reputation and Power Contested: Emboldened Audiences
in Cancer and AIDS, 1977-1992 393
PART TWO: PHARMACEUTICAL REGULATION
AND ITS AUDIENCES
CHAPTER SEVEN
Reputation and the Organizational Politics
of New Drug Review 465
Vlll CONTENTS
CHAPTER EIGHT
The Governance of Research and Development:
Gatekeeping Power, Conceptual Guidance,
and Regulation by Satellite 544
CHAPTER NINE
The Other Side of the Gate: Reputation, Power,
and Post-Market Regulation 585
CHAPTER TEN
The Detente of Firm and Regulator 635
CHAPTER ELEVEN
American Pharmaceutical Regulation in International
Context: Audiences, Comparisons, and Dependencies 686
CHAPTER TWELVE
Conclusion: A Reputation in Relief 727
PRIMARY SOURCES AND ARCHIVAL COLLECTIONS 753
INDEX 759
ILLUSTRATIONS
2.1. Change in Probability of Pro-Regulatory Vote for Every
Additional UMMA Firm Headquartered in Senator's State 85
2.2. An Elixir Sulfanilamide Label, 1937 86
2.3. Distribution of Massengill's Elixir Sulfanilamide
(USDA Report to Congress, 1937) 88
2.4. The Joan Nidiffer Photo, in Report of the Secretary
of Agriculture, 1937 99
3.1. Edwin Goldenthal's Hairing of the NDA for Trancopal,
April 1958 144
3.2. The Published New Drug Application Form of 1956 158
3.3. FDA Food versus Drug Enforcement, 1947-1954 170
3.4. Quantiles of the Approval Time Distribution for New
Molecular Entities, 1950-1964 (by year of submission) 179
3.5. FDA Approval Hazard Ratios for NMEs under Three
Successive Regimes, 1950-1968 181
4.1. Thalidomide Images from the National Enquirer 239
4.2. The Washington Post Thalidomide Story
of July 15, 1962 243
4.3. Major Newspaper Articles Mentioning "Thalidomide" 244
4.4. Kennedy Awards the Distinguished Civilian Service
Medal to Frances O. Kelsey, 1962 246
5.1. Number of Major Newspaper Articles Mentioning
"Thalidomide" and Number Mentioning FDA and
"Protect," 1960-1985 385
6.1. NCI-FDA Memorandum of Understanding
(January 1979) 409
7.1. Bureau of Drugs Organizational Chart 482
7.2. Percentage of NME Applications "Rejected" or
Withdrawn, 1976-1998 495
7.3. Relative Speed of Approval by Therapeutic Category,
Approved NMEs Submitted 1962-1985 496
7.4. Expected Duration of Approval by Therapeutic
Category, NMEs Submitted 1986-2004 497
7.5. Change in NME Review Time (months) for Every
Standardized Increase in Media Coverage of NME's
Primary Indication Disease, 1976-1998 499
7.6. Change in Probability of Pre-Market Advisory
Committee Consultation for Every Standardized
Increase in Media Coverage of NME's Primary
Indication Disease, 1992-2004 500
X ILLUSTRATIONS
7.7. Average Approval Times by Order of Entry,
1962-2000 501
7.8. Paragraphs from William Gyarfas' October 24, 1978
Recommendation for Approval of Cisplatin (Platinol)
for Testicular and Ovarian Cancer 525
7.9. Percentage of NME Approvals in December,
1970-2000 532
8.1. Additional Drug Projects Abandoned for Every
Standardized Shock in Sponsor Firms' Asset Price
Induced by FDA Rejection or Delay 583
9.1. Change in Probability of Black-Box Label Warning
when Average Tenure of Approving Division Moves
from Minimum to Mean 625
10.1. Change in Probability of Non-Approvable Letter
Associated with One-Standard-Deviation Increase
in Sponsor's Previous INDs 674
10.2. Average NMEs Approval Time by Sponsor's
Previous NMEs 679
TABLES
I.i. Features of U.S. Pharmaceutical Regulation Adopted
in Other Nations 23
2.1. Subject Headings in the USDA's Report on Elixir
Sulfanilamide (November 1937) 98
z.2. Comparison of S.5 before and after Sulfanilamide Tragedy
and Wallace Proposal 106
3.1. Selected Members of the Post-War Cohort at the U.S. Food
and Drug Administration, 1947-1963 127
3.2. Variants of Coal-Tar Dyes Permitted in Marketing,
by Country, 1954 139
4.1. Partial Summary of Changes Effected by Kefauver-Harris
Amendments of 1962 262
4.2. References to Phased Clinical Studies in Western Medical
Literature, 1950-1980 293
5.1. Membership of the HEW Advisory Committee on the FDA,
September 1960 304
5.2. Membership of the Advisory Committee on Investigational
Drugs, January 1965 305
5.3. Membership of the Medical Advisory Board (FDA Bureau
of Medicine), 1969 308
5.4. Committee Memberships Formally Managed by the
FDA, 1967 309
5.5. FDA Public Advisory Committees, 1967 314
5.6. List of Congressional Hearings on Pharmaceutical
Regulation at FDA, 1960-1980 338
5.7. Frequency of Agency Mentions in Major Newspaper
Articles, 1960-2007 386
7.1. Medical Officers in the Investigational Drug Branch, Bureau
of Medicine, U.S. Food and Drug Administration, 1964 471
7.2. Ten Possible Outcomes in Treatment 475
7.3. Disease-Specific Entry-Order Gradients, Expressed
as Elasticities 502
9.1. Searle's Experience with New Drug Approval before
and after the 1968 Report 605
9.2. Drug Changes Requiring a Supplemental NDA,
1970-2006 613
9.3. Required Label Sections from Uniform Labeling
Requirements from 1979 615
10.1. Smith Kline and French Corporate Leadership
after 1971 643
Xll TABLES
io.z. Approval Probabilities (Expressed in Percentages),
by Quantiles of Firm Sales Distribution NMEs
Reviewed, 1977-2000 677
10.3. Rank Ordering of Aggregate Advantage for Firms
Sponsoring More than 1 Percent of Approved NMEs,
1977-2000 680
10.4. Variables Associated with Probability of Receiving
a Priority Rating, NMEs Submitted 1977-2000 683
11.1. Cross-National Dependencies in Global Pharmaceutical
Regulation in the Twentieth Century 724
1 z.i. "Rating the FDA" 749 |
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| spelling | Carpenter, Daniel P. 1967- Verfasser (DE-588)141562234 aut Reputation and power organizational image and pharmaceutical regulation at the FDA Daniel Carpenter Princeton [u.a.] Princeton Univ. Press 2010 XX, 802 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Princeton studies in American politics Includes bibliographical references and index United States Food and Drug Administration USA Food and Drug Administration (DE-588)10985-X gnd rswk-swf Geschichte 1927-2010 gnd rswk-swf Pharmaceutical policy United States Drugs Research United States Machtzuwachs (DE-588)7545408-7 gnd rswk-swf Organisationsstruktur (DE-588)4115464-2 gnd rswk-swf USA USA Food and Drug Administration (DE-588)10985-X b Organisationsstruktur (DE-588)4115464-2 s Machtzuwachs (DE-588)7545408-7 s Geschichte 1927-2010 z DE-604 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=020334931&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Carpenter, Daniel P. 1967- Reputation and power organizational image and pharmaceutical regulation at the FDA United States Food and Drug Administration USA Food and Drug Administration (DE-588)10985-X gnd Pharmaceutical policy United States Drugs Research United States Machtzuwachs (DE-588)7545408-7 gnd Organisationsstruktur (DE-588)4115464-2 gnd |
| subject_GND | (DE-588)10985-X (DE-588)7545408-7 (DE-588)4115464-2 |
| title | Reputation and power organizational image and pharmaceutical regulation at the FDA |
| title_auth | Reputation and power organizational image and pharmaceutical regulation at the FDA |
| title_exact_search | Reputation and power organizational image and pharmaceutical regulation at the FDA |
| title_full | Reputation and power organizational image and pharmaceutical regulation at the FDA Daniel Carpenter |
| title_fullStr | Reputation and power organizational image and pharmaceutical regulation at the FDA Daniel Carpenter |
| title_full_unstemmed | Reputation and power organizational image and pharmaceutical regulation at the FDA Daniel Carpenter |
| title_short | Reputation and power |
| title_sort | reputation and power organizational image and pharmaceutical regulation at the fda |
| title_sub | organizational image and pharmaceutical regulation at the FDA |
| topic | United States Food and Drug Administration USA Food and Drug Administration (DE-588)10985-X gnd Pharmaceutical policy United States Drugs Research United States Machtzuwachs (DE-588)7545408-7 gnd Organisationsstruktur (DE-588)4115464-2 gnd |
| topic_facet | United States Food and Drug Administration USA Food and Drug Administration Pharmaceutical policy United States Drugs Research United States Machtzuwachs Organisationsstruktur USA |
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