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The Competitive Status of the U.S. Pharmaceutical Industry The Influences of Technology in Determining International Industrial Competitive Advantage (1983) / Chapter Skim
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Index
Pages 93-104

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From page 93...
... (Great Britain) , 3 1 Brazil, foreign-owned firms, 11 Britain: See United Kingdom British Public Health Ministry, 35 Bureau of Drugs, 64, 65, 85 C Canada, drug industry drug approval process, time lapse, 65 foreign-owned firms, 11 Chemical industry patents granted, 59 production levels, 57, 60 RED, 8, 57, 61 sales, 58 Ciba-Geigy Limited (Switzerland)
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From page 94...
... , 80 England: See United Kingdom Europe, Western: See Western Europe Expert advisers/committees, 63, 83, 84, 86 Exports, 9 by country, 49, 50 GNP comparison, 48-49 percentage of domestic production, 47-49 restrictions, 5, 69, 78 (J.S. share of world, 3, 22, 47, 50 F Farbenindustrie, I.G., 9 Federal Drug Approval Process, Commission on the, proposed FDA reforms, 6, 81-86 Federal Food, Drug, and Cosmetic Act (1938)
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From page 95...
... regulations 53, 57-67, 81-86 Congressional scrutiny, 62, 65 consumer scrutiny, 64-65 cost/risk/benefit analysis, 16-17, 62 dispute resolution, 85 expert advisers/ committees, 63, 83, 84, 86 export restrictions, 5, 69, 78 foreign data, acceptance of, 63-64, 84 industry/FOA relationship, 65, 85, 86 innovation deterrent, 4, 16, 66-67, 70-71 OTC drug review, 12 personnel resources, 85 political pressure, 62 post-patent review, 79 p reposed reforms, 6, 81 -86 review process, tracking, 85 time lapse in approval process, 24, 65-66, 79 See also Investigational New Drug (INN) exemptions; New Chemical Entities (NC:E)
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From page 96...
... , 21 Human testing: See Clinical testing Imports percentage of domestic consumption, 9, 50 restrictions, 68, 69 IND exemptions: See Investigational New Drug (IND) exemptions Industrial policy: See Antitrust policy; Patent protection; Pricing policy; Tax policy; Trade barriers Industrial research and development: See Research and development (RED)
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From page 97...
... firms, 76 labor costs, 53-54 multinational expansion, 10, 77 NCE introductions, 32, 76 patent protection, 75-76 pricing policy, 75-76 production levels, 32, 60 production, percentage of worldwide, 37 RED expenditures, 24, 25, 26, 68, 75 R&D, government support, 68 RED, tax policy, 67-68 sales, domestic, 55 U.S.-owned share, 35, 40 sales, worldwide, by firm, 43 trade balance, 49 U.S. patent filings, 34, 76 Japan, productivity growth, 56 Joint ventures, U.S./Japanese drug firms, 76 Journal articles, U.S.
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From page 98...
... Netherlands, drug industry drug approval process acceptance of foreign data, 64 expert committees, 63 exports, 50 foreign location of Dutch firms, 1 1 RED expenditures, 25 sales, worldwide, by firm, 43 New Chemical Entities (NCE) introductions, 27, 28, 51, 72 by country, 30, 31, 32, 66 by firm size, 45, 46 costs of development, 27, 28, 66 foreign-owned firms, 30, 31,32, 33,35, 66,76 i nnovation/NCE relationship, 27, 45 marketing of, 30, 31 patent life, 80 R6cD/NCE relationship, 28, 31, 73 sales/NCE relationship, 14, 34-35, 37 time lag till approval, 24, 66 U.S.-located firms, 28, 41 U.S.-owned firms, 30-35, 46 New Drug Applications (NDA)
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From page 99...
... exemptions o O ver -~e-counter drugs, 1 2 p Parke-Davis & Co., 79 Parliamentary involvement in drug regulation, 64-65 Patent filings, 29 by country, 34 by industry, 59 foreign-owned firms, 28, 34, 76 IND/patents granted ratio, 28, 29 innovation/patent filing relationship, 27-30 U.S.-owned firms, 28, 31, 34, 59 Patent protection, 4 length of patent life, 5, 79, 80 to recoup R& D costs, 9, 13, 75 Patented drugs, 13 Unless otherwise specified, all entries concerning drugs refer to patented drugs. Penicillin, 9, 15, 62, 67 Pneumonia, 15-16 Political pressure on FDA, 6 2 Prescription drugs, 13 Pricing policy, 69, 75, 81 Product liability, 5, 6, 74, 81 Product life cycle, 34 Production levels, 22, 54 by branches of chemical industry, 60 by country, 37, 60 exports as a percentage, 4 7-49 U.S.-located firms, 3, 4, 32, 70 U.S.-owned firms, 7, 32, 70 See also Sales Proprietary drugs, 12 R Regulations: See Food and Drug Administration (FDA)
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From page 100...
... , 80 Sarett, Dr. Lewis, 74 Schmidt, Alexander, FDA Commissioner, 62 Schriffin, Leonard, 66 Scientific capacity, 2, 55, 72-73 Size of drug firms: See Firm size, effects Small firms: See Firm size, effects Smith Kline Laboratories, 37, 72, 76 S octal benefits of drugs, 14-1 6 Spain, drug industry foreign-owned firms, 11 sales, domestic, 55 Streptomyicin, 9 Structure: See Firm size S ulfanilamide, 9, 15 Sweden, drug industry drug approval process, acceptance of foreign data, 64 expert committees, 6 3 time lapse, 65 firm size, 41 foreign location of Swedish firms, 11 ROD expenditures, 25 Switzerland, drug industry drug approval process, acceptance of foreign data, 64
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From page 101...
... (Japan) , 68 Thalidomide, 59 "Therapeutic revolution," 8-9 Time lag in drug approval, 24, 29, 65-66, 79 Toxicology testing: See Clinical testing Trade balance, drug products, 47-49 See also Exports; Imports Trade barriers, 4, 5, 53, 68-69, 78-79 Tuberculosis, 15-16 U U.S.-located firms, 13, 22, 71 IND filings, 31, 36 N CE introductions, 28, 4 1 production levels, 3, 4, 32, 70 R&D expenditures, 4, 8, 26-27, 70 sales, 12,13, 34, 38-39, 41, 44 U.S.-owned firms, 13, 22, 71 IND filings, 3, 31, 35, 36, 46 NCE introductions, 30-35, 46 NDA approvals, 33 patent filings, 28, 31, 34, 59 production levels, 7, 32, 70 Rat D expenditures, 26-27, 28, 61, 70 reliance on sales rather than exports, 48 sales, 3, 10, 34-35, 37, 40, 42-43, 48, 58 See also Multinational expansion United Kingdom, drug industry clinical testing, 24 drug approval process acceptance of foreign data, 64 expert committees, 63 time lapse, 65 exports, 48-49, 50 foreign location of U.K.
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From page 102...
... patent filings, 34 Western Europe drug industry drug approval process expert committees, 63 politicization, 64 government/industry cooperation, 65 labor costs, 53-54 multinational expansion, 3, 10 p reduction levels, 32, 60 RED expenditures, 24 chemical industry, production levels, 57, 60 See also specific countries . World Health Organization, 18
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Key Terms

  • drug industry
  • approval process
  • clinical testing
  • labor costs
  • firm size

  • foreign data
  • nce introductions
  • trade balance
  • foreign location
  • production levels

  • expert committees
  • multinational expansion
  • industry drug
  • time lapse
  • drug applications

  • patent filings
  • patent protection
  • pricing policy
  • chemical entities
  • red expenditures

  • drug products
  • time lag
  • tax policy
  • process acceptance
  • ind filings

  • industry exports
  • cosmetic act
  • federal food
  • innovation concentration
  • proposed reforms


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