Public policy issues in direct-to-consumer advertising of prescription drugs

Journal of Public Policy and Marketing

Volumn 21, Issue 2, 2002, Pages 174-193

  Calfee, John E ^a  

^a AMERICAN ENTERPRISE INSTITUTE   (United States)

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[No Author keywords available]

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EID: 0036027204     PISSN: 07439156     EISSN: 15477207     Source Type: Journal    
DOI: 10.1509/jppm.21.2.174.17580     Document Type: Article

References (162)

1. (2000), "Are Consumers Well Informed About Prescription Drugs? The Impact of Printed Direct-to-Consumer Advertising," (accessed September 28), [available at http://research.aarp. org/health/2000_04_advertising.html].
2. Adams, Chris (2002), "FDA Is Inundated Trying to Assess Drug Ad Pitches," The Wall Street Journal, (March 14).
3. Aikin, Kathryn J. (2002), "DTC Advertising," presentation at a conference convened by Prevention Magazine (April 10).
4. Allen, Jane E. (1999), "A Feeling Deep in Your Bones," Los Angeles Times, (February 22).
5. Allison-Ottey, Sharon D., Karen Ruffin, and Kimberly B. Allison (2002), "'To Do No Harm' Survey of the Physicians of the National Medical Association Regarding Perceptions on DTC Advertisements," Journal of the National Medical Association, 94 (4), 194-202.
6. Altman, Stuart H. and Cindy Parks-Thomas (2002), "Controlling Spending for Prescription Drugs," New England Journal of Medicine, 346 (11), 855-56.
7. American Medical Association (2000), Council on Ethical and Judicial Affairs of the American Medical Association, "Direct-to-Consumer Advertisements of Prescription Drugs," Food and Drug Law Journal, 55 (1), 119-24.
8. Anand, Geeta (2002), "Schering to Pay $500 Million In Consent Decree With FDA," The Wall Street Journal, (May 20).
9. Aoki, Naomi (2002), "FDA Walks Fine Line on Drug Approvals: Battle over Irritable-Bowel Medication's Risks, Benefits Illustrates Pressures Facing Regulators," Boston Globe, (June 26).
10. Ayanian, John Z., Paul J. Hauptman, Edward Guadagnoli, Elliott M. Antman, Chris Pashos, and Barbara J. McNeil (1994), "Knowledge and Practices of Generalist and Specialist Physicians Regarding Drug Therapy for Acute Myocardial Infarction," New England Journal of Medicine, 331 (17), 1136-42.
11. Bell, Robert A., Richard Kravitz, and Michael S. Wilkes (1999), "Direct-to-Consumer Prescription Drug Advertising and the Public," Journal of General Internal Medicine, 14 (11), 651-57.
12. _, _, and _ (2000a), "The Educational Value of Consumer-Targeted Prescription Drug Print Advertising," Journal of Family Practice 49 (12), 1092-98.
13. _, _, and _ (2000b), "Direct-to-Consumer Prescription Drug Advertising, 1989-1998: A Content Analysis of Conditions, Targets, Inducements, and Appeals," Journal of Family Practice, 49 (4), 329-35.
14. Bennett, Kathryn J., George W. Torrance, Michael H. Boyle, and Richard Guscott (2000), "Cost-Utility Analysis in Depression: The McSad Utility Measure for Depression Health States," Psychiatric Services, 51 (9), 1171-76.
15. Berger, Mitchell S. (2000), "A Tale of Six Implants: The Perez v. Wyeth Laboratories Norplant Case and the Applicability of the Learned Intermediary Doctrine to Direct-to-Consumer Drug Promotion," Food and Drug Law Journal, 55 (4), 525-74.
16. Berndt, Ernest (2001), "The U.S. Pharmaceutical Industry: Why Significant Growth in Times of Cost Containment?" Health Affairs, 20 (2), 100-14.
17. Bero, Lisa A. and Shira Lipton (2001), "Methods for Studying the Effects of Direct-to-Consumer Pharmaceutical Advertising on Health and Health Services Utilization," a background report prepared for the U.S. Department of Health and Human Services Conference on Assessing the Impact of Direct to Consumer Advertising on Health Care Use, Costs, and Outcomes (May 30).
18. Blue Cross Blue Shield Association (2002), "Business Leaders Identify Healthcare Cost Drivers BCBSA Research Highlights Perception of Key Cost Drivers," press release, Chicago, IL (March 7).
19. Bonaccorso, Silvia N. and Jeffrey L. Sturchio (2002), "Education and Debate-Against: Direct to Consumer Advertising Is Medicalising Normal Human Experience," British Medical Journal, 324 (April 13), 908-11.
20. Burton, Thomas M. (2002), "Backlash Rises Against Flashy Ads for Prescription Pharmaceuticals," The Wall Street Journal, (March 13).
21. Calfee, John E. (1996), "The Leverage Principle in FDA Regulation of Information," in Competitive Strategies in the Pharmaceutical Industry, Robert Helms, ed. Washington, DC: American Enterprise Institute, 306-21.
22. _ (1997), Fear of Persuasion: A New Perspective on Advertising and Regulation. London: Agora; North American Distribution by the American Enterprise Institute.
23. _ (2000a), Prices, Markets, and the Pharmaceutical Revolution. Washington, DC: American Enterprise Institute [available at http://www.aei.org/shop1/shops/1/7147-3.pdf].
24. _ (2000b), "The Increasing Necessity for Market-Based Pharmaceutical Prices," Pharmacoeconomics, 18 (1), 47-57.
25. _ (2000c), "The Historical Significance of 'Joe Camel,'" Journal of Public Policy & Marketing, 19 (2), 168-82.
26. (2001a), "It Is Time for Canada to Rethink its Ban on Direct-to-Consumer Advertising of Prescription Drugs," Fraser Forum, (February), 4-5.
27. _ (2001b), "Testimony before the Senate Commerce Committee Subcommittee an Consumer Affairs," hearing on Direct-to-Consumer Advertising, Washington, DC (July 24).
28. _ (2001c), "Pharmaceutical Price Controls and Patient Welfare," Annals of Internal Medicine, 134 (1), 1060-64.
29. _ (2002), "The Role of Marketing in Pharmaceutical Research and Development," Pharmacoeconomics, 18 (Supplement 3).
30. _ and Lamar McGinniss (1997), A Representative National Survey of Oncologists on Off-Label Prescribing and FDA Policies Toward Information Dissemination, (September 12). Washington, DC: American Enterprise Institute.
31. _ and Janis K. Pappalardo (1989), How Should Health Claims for Foods Be Regulated? An Economic Perspective. Washington, DC: Federal Trade Commission, Bureau of Economics.
32. _ and _ (1991), "Public Policy Issues in Health Claims for Foods," Journal of Public Policy & Marketing, 10 (1), 33-54.
33. _ and Debra Jones Ringold (1994), "The Seventy Percent Majority: Enduring Consumer Beliefs About Advertising," Journal of Public Policy & Marketing, 13 (2), 228-38.
34. _, Clifford Winston, and Randolph Stempski (2002), "The Effects of Direct-to-Consumer Advertising for Cholesterol-reducing Drugs," Journal of Law and Economics, forthcoming.
35. Chau, lan and David Cunningham (2001), "Cyctooxygenase Inhibition in Cancer: A Blind Alley or a New Therapeutic Reality?" New England Journal of Medicine, 346 (14), 1085-87.
36. Cleeman, James I. and Claude Lenfant (1998), "The National Cholesterol Education Program: Progress and Prospects," Journal of the American Medical Association, 280 (December 23/30), 2099-2104.
37. Craswell, Richard (1991), "Regulating Deceptive Advertising: The Role of Cost-Benefit Analysis," Southern Caifornia Law Review, 64, 549-604.
38. DiMasi, Joseph A. (1996), "A New Look at United States Drug Development and Approval Times," American Journal of Therapeutics, 3 (9), 1-11.
39. Dubois, Robert W., Charles M. Alexander, Sally Wade, Andrew Mosso, Leona Markson, J.D. Lu, Soma Nag, and Marc L. Berger (2001), "Growth in Use of Lipid Lowering Therapies: Bad News? Good News? Or the Wrong Question?" American Journal of Managed Care, forthcoming.
40. _, Anita J. Chawla, Cheryl A. Neslusan, Mark W. Smith, and Sally Wade (2000), "Explaining Drug Spending Trends: Does Perception Match Reality?" Health Affairs, 19 (2), 231-39.
41. Ellickson, Paul, Scott Stern, and Manuel Trajtenberg (1999), "Patient Welfare and Patient Compliance: An Empirical Framework for Measuring the Benefits from Pharmaceutical Innovation," NBER Working Paper No. 6890, Cambridge, MA.
42. Elliott, Victoria Stagg (2000), "FDA Advisory Committee Vetoes OTC Status for Low-dose Anti-cholesterol Drugs," American Medical News, (August 7).
43. _ (2002), "New Osteoporosis Treatments Offer Diagnosis Incentives: More Options to Prevent Brittle Bones and Multiple Fractures Add Imperative for Treatment," American Medical News, (April 1).
44. European Commission (2001), "Commission Proposes Comprehensive Reform of EU Pharmaceutical Legislation," press release, IP/01/1027, Brussels (July 18).
45. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (2001), "Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)," Journal of the American Medical Association, 285 (May 16), 2486-97.
46. Families USA (2002), "Bitter Pill: The Rising Prices of Proscription Drugs for Older Americans," Publication No. 02-104, Washington, DC (June).
47. Federal Trade Commission (1983), "Policy Statement on Deception," (accessed September 25, 2002), [available at http://www.ftc.gov/bcp/policystmt/ad-decept.htm].
48. _ (1984), "Advertising Substantiation Policy Statement," (accessed September 25, 2002), [available at http//www.ftc.gov/bcp/guides/ad3subst.htm].
49. _, Bureau of Consumer Protection, and Bureau of Economics (1996), "Comments to the Food and Drug Administration on Direct-to-Consumer Promotion of Proscription Drags," (January 11), (accessed September 22, 2002), [available at http://www.ftc.gov/be/v96001.htm].
50. _, _, _, and Office of Policy Planning (2001), "Comments to the Office of Management and Budget on the Assessment of Physician and Patient Attitudes Toward Direct-to-Consumer (DTC) Promotion Drugs," Docket No. 01N-0078, (September 24), (accessed September 22, 2002), [available at http://www.ftc.goo/be/v010008.htm].
51. Felch, W.C. and D.M. Scanlon (1997), "Bridging the Gap Between Research and Practice: The Role of Continuing Medical Education," Journal of the American Medical Association, 277 (2), 155-56.
52. Findlay, Steven (2002), "Do Ads Really Drive Pharmaceutical Sales?" Marketing Health Services, 22 (Spring), 21-25.
53. Fisherow, Benjamin (1987), "The Shape of Prescription Drug Advertising: A Survey of Promotional Techniques and Regulatory Trends," Food Drug Cosmetic Law Journal, 42, 213-236.
54. Fleming, Patricia, Robert Byers, Patricia Sweeney, Danni Daniels, John Karon, and Robert Janssen (2002), "HIV Prevalence in the United States, 2000," presentation at the 9th Conference on Retroviruses and Opportunistic Infections, Seattle (February 25).
55. Food and Drug Administration (1997), Center for Drug Evaluation and Research, "Draft Guidance for Industry on Consumer-directed Broadcast Advertisements," (July 1997), Federal Register, 62 (155), 43171-73 (August 12, Docket 97D-0302).
56. _ (1999a), Center for Drug Evaluation and Research, "Guidance for Industry: Consumer-directed Broadcast Advertisements," (August 1999), Federal Register, 64 (152), 43197-98 (August 9, Docket 97D-0302).
57. _ (1999b), Center for Drug Evaluation and Research, "Questions and Answers on Guidance for Industry: Consumer-directed Broadcast Advertisements," (August 1999), Federal Register, 64 (152), 43197-98 (August 9, Docket 97D-0302).
58. _ (1999c), Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, "Attitudes and Behaviors Associated with Direct-to-Consumer (DTC) Promotion of Prescription Drugs: Main Survey Results," (accessed April 10, 2002), [available at http://www.fda.gov/cder/ddmac/dtcindex.htm].
59. _ (1999d), Center for Drug Evaluation and Research, From Test Tube to Patient: New Drug Development in the United States. Washington, DC: FDA.
60. _ (2001a), "Agency Information Collection Activities; Proposed Collections; Comment Request; Assessment of Physician and Patient Attitudes Toward Direct-to-Consumer Promotion of Prescription Drugs," (March 2001), Federal Register, 66 (53), 15494-495 (March 19, Docket No. 01 N-0078).
61. _ (2001b), Center for Drug Evaluation and Research, "Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001," final report, by Bonnie L. Svarstad and Jeanine K. Mount, (accessed December 21, 2001), [available at www.fda.gov/cder/reports/prescriptionInfo/].
62. _ (2002a), "Request for Comment on First Amendment Issues," Federal Register, 67 (95), 34942-44.
63. _ (2002b), Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, "Assessment of Physician and Patient Attitudes Toward Direct-to-Consumer Promotion of Prescription Drugs," survey instrument (consumer portion only).
64. _ (2002c), Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, "DTC Advertising," presentation of results from the 2002 consumer survey on attitudes toward direct-to-consumer promotion of prescription drugs, (April 10).
65. Food, Drug, and Cosmetic Act (1962), Pub. L. No. 87-781,76 Stat. 780.
66. Ford, Gary T. and John E. Calfee (1986), "Recent Developments in FTC Policy on Deception" Journal of Marketing, 50 (July), 82-103.
67. Frank, Richard G., Ernst R. Berndt, Julie M. Donohue, and Meredith B. Rosenthal (2001), "Determinants and Effects of Direct to Consumer Advertising of Prescription Drugs: A Research Agenda," a background report prepared for the U.S. Department of Health and Human Services Conference on Assessing the Impact of Direct to Consumer Advertising on Health Care Use, Costs, and Outcomes (May 30).
68. Friedman, Michael A., Janet Woodcock, Murray M. Lumpkin, Jeffrey E. Shuren, Arthur E. Hass, and Larry J. Thompson (1999), "The Safety of Newly Approved Medicines: Do Recent Market Removals Mean There Is a Problem?" Journal of the American Medical Association, 281 (May 12), 1728-34.
69. Galambos, Louis (2001), "The Critical and Widely Misunderstood Role of Marketing in Pharmaceutical Innovation," address delivered at Rutgers University, New Jersey (April 6).
70. Gemperli, Marcel P. (2000), "Rethinking the Role of the Learned Intermediary: The Effect of Direct-to-Consumer Advertising on Litigation," Journal of the American Medical Association, 284 (November 1), 2241.
71. Glick, Ira D., Trisha Suppes, Charles DeBattista, Rona J. Hu, and Stephen Marder (2001), "Psychopharmacologic Treatment Strategies for Depression, Bipolar Disorder, and Schizophrenia," Annals of Internal Medicine, 134, 47-60.
72. Goetzl, David (2001), "Advertising Age Marketer of the Year: Pfizer," Advertising Age, (December 10).
73. Greene, Kelly (2002), "AARP Takes On Big Drug Firms, Urging People to Seek Generics," The Wall Street Journal, (April 17).
74. Harris, Gardiner (2001), "When Its Patents Expired, Merck Didn't Merge-It Found New Drugs," The Wall Street Journal, (January 10).
75. Hoek, Janet and Philip Gendall (2002a), "To Have or Not to Have? Ethics and Regulation of Direct to Consumer Advertising of Prescription Medicines," Journal of Marketing Communications, 8, 1-15.
76. _ and _ (2002b), "Direct-to-Consumer Advertising Down Under: An Alternative Perspective and Regulatory Framework," Journal of Public Policy & Marketing, 21 (2), 202-12.
77. Hollon, Matthew F. (1999), "Direct-to-Consumer Marketing of Prescription Drugs: Creating Consumer Demand," Journal of the American Medical Association, 281 (4), 382-84.
78. Hutt, Peter (1993), "The Regulation of Pharmaceutical Products in the USA," in Pharmaceutical Medichie, 2d ed. Denis Burley, Joan M. Clarke, and Louis Lasagna, eds. London: Edward Arnold Publications, 211-44.
79. IMS Health (1997), "Majority of Physicians Want 'Direct-to-Consumer' Prescription Ads to Decrease or Disappear," Plymouth Meeting, PA, (December 2).
80. _ (2002), "Total U.S. Promotional Spending by Type, 2001," (accessed June 23, 2002), [available at http://www.imshealth.com/public/structure/dispcontent/1,2779,1203-1203-144077,00 .html].
81. Kaiser Family Foundation (2001), "Understanding the Effects of Direct-to-Consumer Prescription Drug Advertising," (November).
82. _ (2002), National Survey of Physicians, Part II: Doctors and Prescription Drugs. Menlo Park, CA: Kaiser Family Foundation.
83. Kane, Robert L. and Judith Garrard (1994), "Changing Physician Prescribing Practices: Regulation Versus Education," Journal of the American Medical Association, 271 (5), 393-94.
84. Kessler, David A. and Wayne L. Pines (1990), "The Federal Regulation of Prescription Drug Advertising and Promotion," Journal of the American Medical Association, 264 (18), 2409-15.
85. Kleinke, J.D. (2001), "The Price Of Progress: Prescription Drugs in the Health Care Market," Health Affairs, 25 (5), 43-60.
86. Knopp, Robert H. (1999), "Drug Treatment of Lipid Disorders," New England Journal of Medicine, 341 (7), 498-511.
87. Kohlmeier, Lynn (1999), "Osteoporosis Update: Prevention and Treatment," Drug Benefit Trends, 11 (7), 43-44, 47-50, 53-54.
88. Kranhold, Kathryn (1999), "Lowe Group Sets Deal To Aid Drug Marketing," The Wall Street Journal, (November 9).
89. Lancet (1988) Editorial, "Pushing Ethical Pharmaceuticals Direct to the Public," 351 (March 28).
90. Landers, Susan J. (2001), "Beyond Cholesterol: New Uses for Statins," American Medical News, (June 18).
91. Langreth, Robert (1998), "Drug Marketing Drives Many Clinical Trials," The Wall Street Journal, (November 16).
92. Lasser, Karen E., Paul D. Allen, Steffie J. Woolhandler, David U. Himmelstein, Sidney M. Wolfe, and David H. Bor (2002), "Timing of New Black Box Warnings and Withdrawals for Prescription Medications," Journal of the American Medical Association, 287 (17), 2215-20.
93. Leape, Lucian L. (1995), "Translating Medical Science into Medical Practice: Do We Need a National Standards Board?" Journal of the American Medical Association, 273 (19), 1535-37.
94. Lexchin, Joel and Barbara Mintzes (2002), "Direct-to-Consumer Advertising of Prescription Drugs: The Evidence Says No," Journal of Public Policy & Marketing, 21 (2), 194-201.
95. Lichtenberg, Frank R. (2001), "Are The Benefits of Newer Drugs Worth Their Cost? Evidence From The 1996 MEPS," Health Affairs, 25 (5), 43-60.
96. Lueck, Sarah (2000), "FDA Examines More Switches of Drugs to Be Nonprescription," The Wall Street Journal, (June 29).
97. Lyles, Alan (2002), "Direct Marketing of Pharmaceuticals to Consumers," Annual Review of Public Health, 23, 73-91.
98. Manning, Richard L. and Alison Keith (2001), "The Economics of Direct-to-Consumer Advertising of Prescription Drugs," Economic Realities in Health Care, 2 (1), 3-9.
99. Mantz, Beth (2001), "Cause of Lilly's Warning Not a Surprise, Just the Size," The Wall Street Journal, (October 3).
100. Marks, Harry M. (1995), "Revisiting the Origins of the Compulsory Drug Prescriptions," American Journal of Public Health, 85 (1), 109-15.
101. McGinley, Laurie (1999), "Heavy Advertising Is Cited in Rapid Rise of Drug Costs," The Wall Street Journal, (July 7).
102. Meek, Colin (2001), "Direct-to-Consumer Advertising of Prescription Medicines: A Review of International Policy and Evidence Review of International Policy and Evidence," prepared for the Royal Pharmaceutical Society of Great Britain, (November), (accessed September 30, 2002) [available at http://www.rpsgb.org.uk/pdfs/dtcarep.pdf].
103. Mintzes, Barbara (2002), "Education and Debate-For: Direct to Consumer Advertising is Medicalising Normal Human Experience," British Medical Journal, 324 (April 13), 908-11.
104. Mishra, Raja (2002), "Ex-FDA Chief Recants on Drug Advertising: Kessler Tells Industry He Was Wrong to Resist," Boston Globe, (April 17), 11.
105. Morris, Louis, David Brinberg, Ronald Klimberg, Carole Rivera, and Lloyd Millstein (1986), "The Attitudes of Consumers Toward Direct Advertising of Prescription Drugs," Public Health Reports, 101 (1), 82-89.
106. _ and Lloyd Miltstein (1984), "Drug Advertising to Consumers: Effects of Formats for Magazine and Television Advertisements," Food Drug Cosmetic Law Journal, 39 (4), 497-503.
107. _, Michael Ruffner, and Ronald Klimberg (1985), "Warning Disclosures for Prescription Drugs," Journal of Advertising Research, 25 (5), 25-35.
108. Morrison, Steven A. and Clifford Winston (1995), The Evolution of the Airline Industry. Washington, DC: Brookings Institution.
109. Musto, David (1991), "Opium, Cocaine and Marijuana in American History," Scientific American, (July), 40-47.
110. National Consumers League (1998), Health Care Information and the Consumer: A Public Opinion Survey. Washington, DC: National Consumers League.
111. National Health Council (2002a), "Statement: Direct-To-Consumer Prescription Drug Advertising," (January), (accessed September 29, 2002) [available at www.nationalhealthcouncil. org/advocacy/dtc.htm].
112. _ (2002b), "Direct-to-Consumer Prescription Drug Advertising: Overview and Recommendations," (January), (accessed June 30, 2002), [available at http://www.nationalhealthcouncil.org/advocacy/DTC_paper.pdf].
113. National Institute for Health Care Management (2001), Prescription Drugs and Mass Media Advertising. Washington, DC: NIHCM.
114. _ (2002), Prescription Drug Expenditures in 2001: Another Year of Escalating Costs. Washington DC: NIHCM.
115. National Medical Association (2002), "Position Statement of the National Medical Association on Direct to Consumer Advertising," Journal of the National Medical Association, 94 (4), 302.
116. Nelson, Karin, Keith Norris, and Carol M. Mangione (2002), "Disparities in the Diagnosis and Pharmacologic Treatment of High Serum Cholesterol by Race and Ethnicity: Data from the Third National Health and Nutrition Examination Survey," Archives of Internal Medicine, 162 (8), 929-35.
117. Neumann, Peter J., Eileen A. Sandberg, Chaim M. Bell, Patricia W. Stone, and Richard H. Chapman (2000), "Are Pharmaceuticals Cost-Effective? A Review Of The Evidence," Health Affairs, 19 (2), 92-109.
118. NewsHour with Jim Lehrer, Kaiser Family Foundation, and Harvard School of Public Health (2000a), National Survey on Prescription Drugs: Toplines. Menlo Park, CA: Kaiser Family Foundation.
119. _, _, and _ (2000b), National Survey on Prescription Drugs: Highlights and Chartpaek. Menlo Park, CA: Kaiser Family Foundation.
120. O'Connell, Vanessa (2002), "Ad Agencies Begin to Participate In Development of New Drugs," The Wall Street Journal, (March 13).
121. Oliphant, Jim (2000), "FDA's New Drug War: industry Fights for Alternative Uses of Approved Products," Legal Times, (January 10).
122. Ostrove, Nancy (2001), "Testimony before the Senate Commerce Committee Subcommittee on Consumer Affairs," hearing on Direct-to-Consumer Advertising (July 24).
123. Pallarito, Karn (2001), "States Target Direct-to-Consumer Drug Ads," Reuters Health, (June 28), (accessed September 22, 2002), [available at http://www.health4us.org/news/2001_06_28_01.htm].
124. Pear, Robert (2002) "U.S., in Court Filing, Backs Maine's Drug Discount Plan," New York Times, (June 1).
125. Pearson v. Shalala (1999), 164 F.3d 650 (D.C. Cir. 1999); reh'g denied 172 F.3d 72 (D.C. Cir. 1999).
126. Peltzman, Sam (1973), "An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments," Journal of Political Economy, 81 (5), 1049-91.
127. Petersen, Melody (2002), "TV Ads Spur a Rise in Prescription Drug Sales," New York Times, (March 8).
128. _ and Reed Abelson (2002), "Drug Makers and F.D.A. Fighting Hard Over Quality," New York Times, (May 17).
129. Pines, Wayne L. (1999), "A History and Perspective on Direct-to-Consumer Promotion," Food and Drug Law Journal, 54, 489-518.
130. Pitofsky, R. (1996), "The FTC's Advertising Program for the 1990s," remarks at the American Advertising Federation Government Affairs Conference, Washington, DC (March 14).
131. Reissman, Debi (1998), "Issues in Drug Benefit Management: Back to Compliance," Drug Benefit Trends, 10 (10), 18.
132. Researched Medicines Industry Association of New Zealand (n.d.), "Marketing and Direct-to-Consumer (DTC) Advertising of Prescription Medicines," position paper, (accessed April 23, 2002), [available at: http://www.rmianz.co.nz/Briefing%20Papers/marketing.htm].
133. Rodale Publications (1999), Prevention Magazine: A National Survey of Consumer Reactions to Direct-to-Consumer Advertising. Emmaus, PA: Rodale Publications.
134. _ (2000), Prevention Magazine: International Survey on Wellness and Consumer Reactions to DTC Advertising of Rx Drugs. Emmaus, PA: Rodale Publications.
135. Rosenthal, Meredith B., Ernst R. Berndt, Julie M. Donohue, Richard G. Frank, and Arnold M. Epstein (2002), "Promotion of Prescription Drugs to Consumers," New England Journal of Medicine, 346 (February 14), 498-505.
136. Sandercock, Pater (2001), "Commentary: Statins for Stroke Prevention?" Lancet, 357 (May 19), 1548.
137. Schommer, Jon C. and Richard A. Hansen (2001), "A Problem Well Defined is Half Solved: Methodological Issues Related to the Study of Direct-to-Consumer Advertising (DTCA) for Prescription Drugs," a background report prepared for the U.S. Department of Health and Human Services Conference on Assessing the Impact of Direct to Consumer Advertising on Health Care Use, Costs, and Outcomes (May 30).
138. Senate Commerce Committee Subcommittee (2001), Consumer Affairs Hearing on Direct-to-Consumer Advertising, (July 24).
139. Simon, Gregory (2001), "Choosing a First-line Antidepressant: Equal on Average Does Not Mean Equal for Everyone," Journal of the American Medical Association, 286 (23), 3003-3004.
140. Stolberg, Sheryl Gay (2000), "Ads that Circumvent Doctors: Want a New Drug? Plenty to Choose From on TV," New York Times, (January 23).
141. Tabarrock, Alexander T. (2000), "Assessing the FDA via the Anomaly of Off-Label Drug Prescribing," The Independent Review, 5 (1), 25-53.
142. Temin, Peter (1979), "The Origins of Compulsory Drug Prescriptions," Journal of Law and Economics, 22 (April), 91-105.
143. Temple, Robert and Martin H. Himmel (2002), "Safety of Newly Approved Drugs: Implications for Prescribing," Journal of the American Medical Association, 287 (17), 2273-75.
144. Thakkar, S. (1997), "Oncologists Judge Themselves the Best Judges of Cancer Treatments," Journal of the National Cancer Institute, 16 (August 20), 1188-89.
145. Triplett, Jack, ed. (1999), Measuring the Prices of Medical Treatments. Washington, DC: Brookings Institution.
146. U.S. Department of Health & Human Services (2001), Conference on Assessing the Impact of Direct to Consumer Advertising on Health Care Use, Costs, and Outcomes, (May 30).
147. _ (2002a), Health Care Financing Administration, National Health Care Expenditures Projections: 2001-2011. Washington, DC: USDHHS.
148. _ (2002b), "HHS, ABC Radio Networks Launch Campaign to Encourage Doctor Visits; 'Take A Loved One To The Doctor Day' Aims At Improving Health of African-Americans," press release, (April 18).
149. U.S. General Accounting Office (1991), Off-Label Drugs: Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies, GAO/PEMD-91-14. Washington, DC: USGAO.
150. _ (2002), "Financial Outlook Poses Challenges for Sustaining [Medicare] Program and Adding Drug Coverage," statement of David M. Walker Before the Committee on Ways and Means, House of Representatives, (April 17).
151. U.S. Public Health Service (1999), Mental Health: A Report of the Surgeon General. Washington, DC: Government Printing Office.
152. Wardell, William M. and Louis Lasagna (1975), Regulation and Drug Development. Washington, DC: American Enterprise Institute.
153. Washington Legal Foundation (1995), "Citizen Petition" to the Food and Drug Administration on direct-to-consumer advertising, (July 20).
154. Washington Legal Foundation v. Kessler (1994), No. 94 CV 01306 (D.D.C., filed June 13, 1994).
155. Wazana, A. (2000), "Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?" Journal of the American Medical Association, 283 (3), 373-80.
156. Wertheimer, Albert, Thomas W. O'Connor Jr., and Richard Levy (2001), "The Value of Incremental Pharmaceutical Innovation for Older Americans," Temple University Center for Pharmaceutical Health Services Research, Philadelphia [available at www.temple.edu/tuhs].
157. Wilkes, Michael S., Robert A. Bell, and Richard L. Kravitz (2000), "Direct-To-Consumer Prescription Drug Advertising; Trends, Impact, and Implications," Health Affairs, (March/April).
158. Willman, David (2001), "FDA Moving to Revive Deadly Drug: Agency Director Works with Manufacturer to Bring Back Lotronex Despite Fatalities," Los Angeles Times, (May 30).
159. Wolfe, Sidney M. (2002), "Direct-to-Consumer Advertising: Education or Motion Promotion?" New England Journal of Medicine, 346 (7), 524-626.
160. Woloshin, Steven et al. (2001), "Direct-to-Consumer Advertising for Prescription Drugs: What Are Americans Being Sold?" Lancet, 358 (October 6), 1141-46.
161. Wosinska, Marta (2001), "Effects of Direct-to-Consumer Drug Advertising on Prescription Choice," working paper, Department of Economics, University of California, Berkeley.
162. Yanovski, Susan Z. and Jack A. Yanovski (2002), "Drug Therapy: Obesity," New England Journal of Medicine, 346 (8), 591-602.