Drug labeling and promotion: Evolution and application of regulatory policy

Food and Drug Law Journal

Volumn 51, Issue 1, 1996, Pages 57-73

  Hayes, Thomas A ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVERTIZING; DRUG LABELING; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; LAW; REVIEW;

ADVERTISING; COST-BENEFIT ANALYSIS; DRUG LABELING; GUIDELINES; HUMANS; PATIENT EDUCATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0029987734     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (121)

1. While Congress Remains Silent, Health Care Transforms Itself, N.Y. TIMES, Dec. 18, 1994, at 34.
2. Advertising - Prescription Drug Campaigns Aimed Directly at Consumers Expanded Rapidly During the Last Year, N.Y. TIMES, Jan. 9, 1995, at D7.
3. N.Y. TIMES, supra note 1, at 1.
4. N.Y. TIMES, 1. Id.
5. In the Matter of the Upjohn Company, No. C7-94-7856 (Minn. Ramsey Co. Dist. Ct. Aug. 1, 1994) (order approving assurance of discontinuance and assurance of discontinuance/assurance of voluntary compliance).
6. 54 F-D-C REP., ("The Pink Sheet"), July 13, 1992, at 8.
7. 55 F-D-C REP., ("The Pink Sheet"), Nov. 1, 1993, at 10.
8. 56 F-D-C REP., ("The Pink Sheet"), July 25, 1994, at 3.
9. Id.
10. July 1992 F-D-C REP., supra note 6.
11. HHS NEWS No. P91-27 (Oct. 10, 1991).
12. 54 F-D-C REP. ("The Pink Sheet"), Mar. 23, 1992, at 12.
13. HHS NEWS No. P93-32 (Aug. 2, 1993).
14. See 56 F-D-C REP. ("The Pink Sheet"), Dec. 12, 1994, at 8.
15. Stephen Paul Mahinka & Kathleen M. Sanzo, Pharmaceutical Industry Restructuring and New Market Approaches: Enforcement Responses, 50 FOOD & DRUG L.J. 313 (1995).
16. 42 C.F.R. pt. 1001 (1995); 56 Fed. Reg. 35,952 (July 29, 1991). The Medicare Anti-Kickback Act, established penalties for offering or paying any remuneration to induce the referral of a patient or the purchase of any item or service for which costs may be payable under Medicare or a federally-funded state health care program. 42 U.S.C. § 13209(a)-7b(b) (1988).
17. See 56 F-D-C REP., ("The Pink Sheet"), Aug. 8, 1994, at 3.
18. See 57 F-D-C REP., ("The Pink Sheet"), Jan. 16, 1995, at 8.
19. Id.
20. David G. Adams, FDA Regulation of Communications on Pharmaceutical Products, 24 SETON HALL L. REV. 1399 (1994).
21. David G. Adams, FDA Regulation of Communications on Pharmaceutical Products, SETON HALL L. REV. 24 1399 (1994). Id.
22. FDA's Advertising Organization: Who Does What, in FDA ADVERTISING AND PROMOTION MANUAL 21 (W. Pines ed. 1995).
23. See 56 F-D-C REP., ("The Pink Sheet"), Oct. 17, 1994, at 6; MEDICAL MKTG. & MEDIA, Dec. 1994, at 18.
24. Id.
25. Pub. L. No. 101-629, 104 Stat 4511.
26. Adams, supra note 20, at 1401.
27. Pub. L. No. 57-244, 32 Stat. 728 (1902).
28. E.g., E.R. Squibb, Proposed Legislation on the Adulteration of Food and Medicine (1879) in PETER BARTON HUTT, INVESTIGATIONS AND REPORTS ON THE FOOD AND DRUG ADMINISTRATION 44 (1991).
29. Pub. L. No. 59-384, 34 Stat. 768 (1906).
30. Pub. L. No. 75-717, 52 Stat. 1040 (1938), as amended 21 U.S.C. §§ 301 et seq. (1988).
31. Pub. L. No. 87-781, 76 Stat. 780.
32. Peter Barton Hutt & Peter Barton Hutt II, A History of Government Regulation of Adulteration and Misbranding of Food, 39 FOOD DRUG COSM. L.J. 2 (1984);
33. Peter Barton Hutt, Criminal Prosecution for Adulteration and Misbranding of Food at Common Law, 15 FOOD DRUG COSM. L.J. 382 (1960).
34. United States v. Johnson, 221 U.S. 488 (1911).
35. Peter Barton Hutt, Investigations and Reports on the Food and Drug Administration, in FOOD AND DRUG LAW 41 (The Food and Drug Law Inst. 1991).
36. Enforcement actions in the 1994 fiscal year included eight prosecutions, 16 injunctions, 98 seizures, and 1626 warning letters. FDA ALMANAC FY 95, at 72-74 (1996).
37. 185 F.2d 321 (9th Cir. 1950).
38. 21 C.F.R. § 200.128.
39. Id. See also Adams, supra note 20, at 1403.
40. Id.
41. Pub. L. No. 82-215, 65 Stat. 648 (1951) (codified at 21 U.S.C. § 353(b)).
42. Kleinfeld, Kaplan & Becker, Human Drug Regulation: Comprehensiveness Breeds Complexity, in FOOD AND DRUG LAW, supra note 34, at 243.
43. Harry W. Chadduck, In Brief Summary: Prescription Drug Advertising, 1962-71, in FDA PAPERS (Feb. 1972).
44. 21 U.S.C. § 352.
45. Kleinfeld, Kaplan & Becker, supra note 40, at 288.
46. Id.
47. 21 C.F.R. § 202.1(e)(4)(b)(1), (2), (3).
48. Id. § 201.56(c).
49. Pub. L. No. 87-781, 76 Stat. 780.
50. Adams, supra note 20, at 1405.
51. 44 Fed. Reg. 74,817 (1979).
52. Kleinfeld, Kaplan & Becker, supra note 40, at 290-92.
53. Regulating Cost-Effectiveness Claims, Remarks by Janet L. Rose, Dir., Div. of Drug Marketing, Advertising & Communication (DDMAC), CDER, FDA (Mar. 24, 1995).
54. SCRIP, Sept. 27, 1994, at 10 (remarks by Janet L. Rose, Dir., DDMAC, CDER, FDA).
55. 56 F-D-C REP. ("The Pink Sheet"), Nov. 28, 1994, at 9.
56. FOOD AND DRUG ADMIN., DRAFT PRINDPLES FOR THE REVIEW OF PHARMACOECONOMIC PROMOTION (Mar. 20, 1995).
57. 21 C.F.R. § 202.1(e)(5).
58. David A. Kessler & Wayne L. Pines, The Federal Regulation of Prescription Drug Advertising and Promotion, 264 NEW ENG. J. MED. 2409 (1990).
59. FDA TALK PAPER (July 18, 1991)
60. Letter from Lillian Gavrilovich & Janet L. Rose, FDA, on Anti-Infective Promotion (Sept. 1994).
61. Id.
62. Id.
63. J.P. Kassirer & M. Angell, The Journal's Policy on Cost Effectiveness Analyses, 331 NEW ENG. J. MED. 669 (1994).
64. J.P. Kassirer & M. Angell, The Journal's Policy on Cost Effectiveness Analyses, 331 NEW ENG. J. MED. 669 (1994). Id.
65. Correspondence, 332 NEW ENG. J. MED. 123 (1995)
66. 332 NEW ENG. J. MED. 123 (1995) Id.
67. T.A. Brennan, Buying Editorials, 331 NEW ENG. J. MED. 675 (1994).
68. T.A. Brennan, Buying Editorials, 331 NEW ENG. J. MED. 675 (1994). Id.
69. Remarks by Janet L. Rose, supra note 52.
70. Ch. 37, 12th Cong., 2d Sess. (Feb. 27, 1813).
71. William R. Pendergast, Biologic Drugs, in FOOD AND DRUG LAW, supra note 34, at 303.
72. Pub. L. No. 57-244, 32 Stat. 328.
73. S. REP. No. 1980, 57th Cong., 1st Sess. 2 (1902).
74. Pub. L. No. 75-717, § 902(c), 52 Stat. at 1059.
75. Pendergast notes that the U.S. Attorney General had issued an opinion stating that the Biologics (or "Virus") Act governed only the "sale" of products. In 1938, six patients died from tetanus after receiving injections of a serum "given free" by physicians, but the product was regarded as being outside the jurisdiction of the Virus Act because the serum was not being sold. Following this experience, Congress wanted to ensure that biologies would be covered by the proposed new drug law. Pendergast, supra note 69, at 309.
76. Pub. L. No. 85-410, 58 Stat. 702 (1944).
77. Pub. L. No. 97-414, 96 Stat. 2049.
78. Pub. L. No. 99-660, 100 Stat. 3743.
79. Michael Brannon, Organizing and Reorganizing FDA, in FOOD AND DRUG LAW, supra note 34, at 113.
80. Id. at 130-132.
81. 59 Fed. Reg. 54,034 (Oct. 27, 1994); 59 Fed. Reg. 54,046 (Oct. 27, 1994).
82. 58 Fed. Reg. 42,340 (Aug. 9, 1993).
83. Letter from Janet L. Rose, Dir., DDMAC, CDER, FDA, on Pre-Approval Promotion Guidance (Mar. 1994)
84. Id.
85. Nancy M. Ostrove, DDMAC, FDA, Regulatory Aspects of Directly Communicating to Consumers, presentation at the Regulatory Affairs Professional Society meeting "Advertising, Labeling, and Consumer Education," Chicago, Ill. (Mar. 1-2, 1994).
86. David A. Kessler, Janet L. Rose, Robert J. Temple, Robert Shapiro & J.P. Griffin, Therapeutic Class Wars - Drug Promotion in a Competitive Marketplace, 331 NEW ENG. J. MED. 1350 (1994).
87. Id. at 1351.
88. Id.
89. N.Y. TIMES, Feb. 1, 1995, at D3.
90. N.Y. TIMES, 1995, D3. Id.
91. N.Y. TIMES, 1995, D3. Id.
92. 56 F-D-C REP., ("The Pink Sheet"), Sept. 26, 1994, at 3.
93. 56 F-D-C REP., ("The Pink Sheet"), Aug. 29, 1994, at 3.
94. 60 Fed. Reg. 41,891 (Aug. 14, 1995). See, for example, Bruce N. Kuhlik, The PDA's Regulation of Pharmaceutical Communications in the Context of Managed Care: A Suggested Approach, 50 FOOD & DRUG L.J. 23 (1995), for a comprehensive discussion of possible approaches to the regulation of pharmaceutical communications in the context of managed care.
95. Letter from A. Adler, Pres., Excerpta Medica, to L. Millstein, Dir., Division of Drug Advertising, FDA (May 27, 1983).
96. Letter from L. Millstein, Dir., Div. of Drug Advertising, FDA, to A. Adler, Pres., Excerpta Medica (June 6, 1983).
97. Letter from Kenneth Feather, Act. Dir., Div. of Drug Advertising and Labeling, CDER, FDA, to R. Gelb, Chairman of the Bd., Bristol-Myers Squibb (Jan. 25, 1991).
98. Id.
99. Id. See also 53 F-D-C REP., ("The Pink Sheet"), Feb. 11, 1991, at 12.
100. Kessler & Pines, supra note 56.
101. FDA TALK PAPER (July 18, 1991).
102. 53 F-D-C REP., ("The Pink Sheet"), Feb. 18, 1991, at 6.
103. 57 Fed. Reg. 56,412 (Nov. 27, 1992) (Dkt. No. 92N-0434).
104. Id.
105. Id.
106. Citizen's Petition by Washington Legal Found, to FDA, 57 F-D-C REP., ("The Pink Sheet"), Feb. 20, 1995, at 8.
107. Washington Legal Found. v. David A. Kessler & Donna Shalala, Civ. No. 94-1306, mem. op. (D.D.C. Mar. 9, 1995).
108. 59 Fed. Reg. 59,820 (Nov. 18, 1994).
109. Id. at 59,821.
110. Id.
111. Mark E. Boulding, The Statutory Basis for FDA Regulation of Scientific and Educational Information, 4 J. OF PHARMACY AND L. 131 (1995).
112. Mark E. Boulding, The Statutory Basis for FDA Regulation of Scientific and Educational Information, 4 J. OF PHARMACY AND L. 131 (1995) Id.
113. Mark E. Boulding, The Statutory Basis for FDA Regulation of Scientific and Educational Information, 4 J. OF PHARMACY AND L. 131 (1995) Id.
114. 59 Fed. Reg. at 59,821.
115. 59 Fed. Reg. at 59,821 Id.
116. Id. at 59,822.
117. FDA Dkt. No. 92N-0434, comment nos. 99 (Jan. 28, 1993), 187 (Feb. 16, 1995).
118. Id. See also 57 F-D-C REP., ("The Pink Sheet"), Feb. 27, 1995, at T&G7.
119. FDA Dkt. No. 92N-0434, comment nos. 25 (Jan. 19, 1993), 105 (Feb. 1, 1993), 196 (Feb. 16, 1995). See also F-D-C REP., supra note 116.
120. Washington Legal Found., Civ. No. 94-1306.
121. Id.