Off-label promotion: Is FDA's final guidance on industry-supported scientific and educational programs enforceable?

Food and Drug Law Journal

Volumn 53, Issue 2, 1998, Pages 193-212

  Bass, I Scott ^a   Kalb, Paul E ^a   Berenson, Bradford A ^a  

^a Sidley and Austin   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; EDUCATION PROGRAM; FOOD AND DRUG ADMINISTRATION; MEDICAL EDUCATION; MEDICAL PERSONNEL; PRACTICE GUIDELINE; REVIEW;

CONFLICT OF INTEREST; FINANCIAL SUPPORT; FRAUD; HUMANS; INDUSTRY; INFORMATION SERVICES; PRODUCT LABELING; RESEARCH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; UNIVERSITIES;

EID: 0031865808     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (131)

1. 62 Fed. Reg. 64,074 (Dec. 3, 1997).
2. Draft Policy Statement on Industry-Supported Scientific and Educational Activities, 57 Fed. Reg. 56,412 (Nov. 27, 1992).
3. Washington Legal Found. v. Kessler, Civ. Action No. 1:94CV01306 (D.D.C. 1994).
4. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)).
5. See 21 U.S.C. § 333(a) (FDCA § 303(a)).
6. Based on confidential information of the authors.
7. 21 U.S.C. § 352(f) (FDCA § 502(f)).
8. Pub. L. No. 105-115, 111 Stat. 2295 (1997).
9. 21 C.F.R. § 312.7(a) (1997).
10. See 57 Fed. Reg. at 56,412.
11. Id.
12. See id. at 56,413-14.
13. 62 Fed. Reg. at 64,074.
14. Id.
15. Id.
16. Id. at 64,097.
17. Id.
18. Id. at 64,098.
19. Id. at 64,099.
20. Id.
21. Id. at 64,098.
22. Id.
23. Id.
24. Id. at 64,097.
25. Id.
26. Id.
27. Id. at 64,098.
28. Id.
29. Id.
30. Id. at 64,099.
31. Id.
32. Id.
33. Id.
34. Id. at 64,099-64,100.
35. 57 Fed Reg. at 56,412 (emphasis added).
36. Id. (emphasis added).
37. 21 U.S.C. § 331(a) (FDCA § 301(a)).
38. Id. § 352(a) (FDCA § 502(a)).
39. Id. § 352(f) (FDCA § 502(f)).
40. Id. § 352(b) (FDCA § 502(b)).
41. Id. § 352(n) (FDCA § 502(n)).
42. Id. § 321 (k) (FDCA § 201(k)).
43. Id. § 321 (m) (FDCA § 201 (m)).
44. 21 C.F.R. § 202.1(1)(2).
45. 335 U.S. 345 (1948).
46. Id. at 350.
47. United States v. 24 Bottles "Sterling Vinegar & Honey, Etc.," 338 F.2d 157, 158-59 (2d Cir. 1964).
48. Id. at 159-60.
49. United States v. Guardian Chem. Corp., 410 F.2d 157, 161 (2d Cir. 1969).
50. 21 C.F.R. § 202.1(1)(1).
51. See, e.g., Virginia State Bd. of Pharmacy v. Virginia Citizens' Consumer Council, Inc., 425 U.S. 748, 757 (1976) ("If there is a right to advertise, there is a reciprocal right to receive the advertising.").
52. Michael R. Taylor, Drug Regulation, Off-Label Uses, and CME - Reconciling Competing Values, Remarks at FDLI seminar, "Drug Advertising and Promotion," Arlington, VA (Feb. 26, 1992).
53. 62 Fed. Reg. at 64,076-82.
54. See infra text accompanying notes 64-130.
55. 62 Fed. Reg. at 64,075.
56. Id.
57. Id.
58. Id. (citing 21 U.S.C. § 352(f)(1) (FDCA § 502(f)(1))).
59. Id.
60. Pub. L. No. 105-115, § 401, 111 Stat at 2359.
61. 21 C.F.R. § 312.7(a) (emphasis added).
62. Id. §§ 301(d), 505.
63. Id. § 301(d).
64. 62 Fed. Reg. at 64,076.
65. Id.
66. Id. at 64,078-82.
67. Id. at 64,076-77.
68. See supra text accompanying note 62-63.
69. See, e.g., Linmark Assoc., Inc. v. Town of Willingboro, 431 U.S. 85 (1977) (effort to stem "white flight," however legitimate, cannot justify ban on "FOR SALE" signs).
70. 62 Fed. Reg. at 64,074.
71. First Nat'l Bank v. Bellotti, 435 U.S. 765, 777 (1978).
72. See, e.g., Virginia State Bd. of Pharmacy, 425 U.S. at 748.
73. 62 Fed. Reg. at 64,077.
74. 447 U.S. 557, 564 (1980).
75. There appears to be a narrow exception to this rule when the underlying activities fall into the category of traditional vice. See Posadas de Puerto Rico Assocs. v. Tourism Co., 478 U.S. 328 (1986); United States v. Edge Broad, Co., 509 U.S. 418 (1993).
76. See Edenfield v. Fane, 507 U.S. 761, 767 (1993).
77. 447 U.S. at 587-88 (Rehnquist, J. dissenting).
78. 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 516 (1996).
79. Id. at 511 (Stevens, J. concurring).
80. See Edenfield, 507 U.S. at 768-69 (when "truthful and nonmisleading expression will be snared along with fraudulent or deceptive commercial speech, the State must satisfy . . . the Central Hudson test); First Nat'l Bank, 435 U.S. at 785 (the government may not "dictat[e] the subjects about which persons may speak and the speakers who may address a public issue").
81. 62 Fed. Reg. at 64,078. See generally Central Hudson, 447 U.S. at 557.
82. 62 Fed. Reg. at 64,078. See generally Central Hudson, 447 U.S. at 557.
83. 62 Fed. Reg. at 64,078.
84. Id. at 64,097.
85. Id. at 64,078.
86. 463 U.S. 60, 67-68 (1983) (mailed flyers advertising condoms and including discussion of dangers of venereal disease constitute commercial speech).
87. 447 U.S. at 564 (utility's leaflets promoting the use of electricity analyzed as commercial speech).
88. 492 U.S. 469 (1989).
89. 507 U.S. 410 (1993).
90. Board of Trustees, 492 U.S. at 473; City of Cincinnati, 507 U.S. at 422.
91. Board of Trustees, 492 U.S. at 473; City of Cincinnati, 507 U.S. at 422.
92. 62 Fed. Reg. at 64,078.
93. Cf. Central Hudson, 447 U.S. at 579 (Stevens, J. concurring) ("it is important that the commercial speech concept not be defined too broadly lest speech deserving of greater constitutional protection be inadvertently suppressed").
94. First Nat'l Bank, 435 U.S. at 765.
95. 447 U.S. 530, 544 (1980).
96. Id. at 535.
97. E.g., 21 U.S.C. § 360cc (PDCA § 527).
98. DIVISION OF DRUG MARKETING, ADVERTISING AND COMMUNICATIONS, OFF. OF DRUG EVALUATION, CDER, FDA, CURRENT ISSUES AND PROCEDURES (Apr. 1, 1994).
99. Consolidated Edison Co., 447 U.S. at 535.
100. See Central Hudson, 447 U.S. at 564; Board of Trustees, 492 U.S. at 480.
101. See Central Hudson, 447 U.S. at 564; Board of Trustees, 492 U.S. at 480.
102. 62 Fed. Reg. at 64,079.
103. Id.
104. Virginia State Bd. of Pharmacy, 425 U.S. at 771-72.
105. This would be consistent with Congress' enactment of section 5 of the Dietary Supplement Health and Education Act of 1994, which provides an explicit exemption from the FDCA's labeling provisions for truthful, nonmisleading, balanced literature that contains approved or unapproved drug claims. Pub. L. No. 103-417, § 5, 108 Stat. 4325, 4328 (1994) (codified at 21 U.S.C. § 343-2).
106. 62 Fed. Reg. at 64,079.
107. Id.
108. See Edenfield, 507 U.S. at 774-77.
109. Id. at 776 (quoting Ohralik v. Ohio State Bar Ass'n, 436 U.S. 447, 466 (1978)).
110. Id. at 768-69.
111. Id. at 777.
112. Id. at 767.
113. Id. at 768.
114. 62 Fed. Reg. at 64,079-80.
115. Id. at 64,080.
116. 507 U.S. at 767.
117. 62 Fed. Reg. at 64,081.
118. Pub. L. No. 105-115, § 401, 111 Stat. at 2359.
119. See 62 Fed. Reg. at 64,079 (claiming substantial interest in "protecting the health and safety of its citizens by helping to ensure the dissemination of truthful and nonmisleading information about drugs and medical devices").
120. See, e.g., Reyes v. Wyeth Lab., 498 F.2d 1264 (5th Cir. 1974); accord Schenebeck v. Sterling Drug, Inc., 423 F.2d 919 (8th Cir. 1970).
121. Reyes, 498 F.2d at 1276;accord Schenebeck, 423 F.2d at 922.
122. 62 Fed. Reg. at 64,080.
123. Edenfield, 507 U.S. at 767.
124. Rubin v. Coors Brewing Co., 514 U.S. 476, 482 (1995) (quoting Central Hudson, 447 U.S. at 566).
125. 62 Fed. Reg. at 64,081-82.
126. Id. at 64,082.
127. See, e.g., Virginia Bd. of Pharmacy, 425 U.S. at 772 n.24 (it is sometimes appropriate for government to require speech to "appear in such a form, or include such additional information, warnings, and disclaimers, as are necessary to prevent its being deceptive").
128. Whitney v. California, 274 U.S. 357, 377 (1927) (Brandeis, J. concurring).
129. 62 Fed. Reg. at 64,080.
130. 44 Liquormart, 517 U.S. at 503 (Stevens, J. concurring) (quoting Linmark Assocs., 431 U.S. at 96).
131. Id.