Direct-to-Consumer broadcast advertising: Empowering the consumer or manipulating a vulnerable population?

Food and Drug Law Journal

Volumn 53, Issue 4, 1998, Pages 661-679

  Reeves, Kelly N ^a  

^a NONE

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LORATADINE;

ADVERTIZING; CONFERENCE PAPER; CONSUMER; DRUG INDUSTRY; DRUG LABELING; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; PRACTICE GUIDELINE; UNITED STATES;

ADVERTISING; CONSUMER PARTICIPATION; HISTORY, 20TH CENTURY; HUMANS; INFORMATION SERVICES; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0032431098     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (252)

1. See All Things Considered: Concern Over Drug Ads (Nat'l Pub. Radio broadcast, Mar. 18, 1998) (audio clip Claritin® television commercial) [hereinafter Concern Over Drug Ads].
2. See id.
3. See id.
4. See Announcing Availability of Draft Guidance for Industry: Consumer-Directed Broadcast Advertisements, 62 Fed. Reg. 43,171, 43,172 (Aug. 12, 1997).
5. See Concern Over Drug Ads, supra note 1.
6. 21 C.F.R. § 202.1(e)(2)(i) (1997). See infra notes 31-34, 59-64 and accompanying text.
7. See All Things Considered: FDA Media Rules Change (Nat'l Pub. Radio broadcast, Aug. 9, 1997) [hereinafter Media Rules Change]; Tamara Nordenberg, Direct to You: TV Ads That Make Sense, FDA CONSUMER, Jan.-Feb. 1998, at 7.
8. See All Things Considered: FDA Media Rules Change (Nat'l Pub. Radio broadcast, Aug. 9, 1997) [hereinafter Media Rules Change]; Tamara Nordenberg, Direct to You: TV Ads That Make Sense, FDA CONSUMER, Jan.-Feb. 1998, at 7.
9. See 62 Fed. Reg. at 43,172. It took more than a decade of considerable consumer group and industry pressure for the agency to begin-shaping a policy on direct-to-consumer (DTC) prescription drug advertising. See infra notes 67-121 and accompanying text. The draft guidelines clarifying the "adequate provision" requirement are anticipated to begin this policy formation. See Direct-to-Consumer Promotion Public Hearing Announced, 60 Fed. Reg. 42,581 (Aug. 15, 1995).
10. See 62 Fed. Reg. at 43,172. It took more than a decade of considerable consumer group and industry pressure for the agency to begin-shaping a policy on direct-to-consumer (DTC) prescription drug advertising. See infra notes 67-121 and accompanying text. The draft guidelines clarifying the "adequate provision" requirement are anticipated to begin this policy formation. See Direct-to-Consumer Promotion Public Hearing Announced, 60 Fed. Reg. 42,581 (Aug. 15, 1995).
11. See Concern Over Drug Ads, supra note 1.
12. See 62 Fed. Reg. at 43,171; Guidance for Industry: Consumer-Directed Broadcast Advertisements (Draft Guidance), Division of Drug Marketing, Advertising, and Communications (DDMAC), FDA (July 1997) [hereinafter Draft Guidance]; Michael Wilke, Pharmaceutical Companies and the Food & Drug Administration Face Great Challenges as They Work on Designing a Marketing Map for the Flourishing Prescription Drug Universe: Prescription for Profit, ADVER. AGE, Mar. 16, 1998, at 1, available in 1998 WL 6629326.
13. See 62 Fed. Reg. at 43,171; Guidance for Industry: Consumer-Directed Broadcast Advertisements (Draft Guidance), Division of Drug Marketing, Advertising, and Communications (DDMAC), FDA (July 1997) [hereinafter Draft Guidance]; Michael Wilke, Pharmaceutical Companies and the Food & Drug Administration Face Great Challenges as They Work on Designing a Marketing Map for the Flourishing Prescription Drug Universe: Prescription for Profit, ADVER. AGE, Mar. 16, 1998, at 1, available in 1998 WL 6629326.
14. See 62 Fed. Reg. at 43,171; Guidance for Industry: Consumer-Directed Broadcast Advertisements (Draft Guidance), Division of Drug Marketing, Advertising, and Communications (DDMAC), FDA (July 1997) [hereinafter Draft Guidance]; Michael Wilke, Pharmaceutical Companies and the Food & Drug Administration Face Great Challenges as They Work on Designing a Marketing Map for the Flourishing Prescription Drug Universe: Prescription for Profit, ADVER. AGE, Mar. 16, 1998, at 1, available in 1998 WL 6629326.
15. See Carl T. Hall, Drug Ads Boost Profits, But Consumers May Feel Pinch, S.F. CHRON., Mar. 12, 1998, at E1 (citing estimates by The Plymouth Group). The majority of spending results from the surge of advertisements after the Draft Guidance was issued. See also Wilke, supra note 10, at 1 (quoting similar estimates of DTC broadcast advertising spending); Greg Borzo, New FDA Rules for Advertising Drugs on TV Raise Questions, AM. MED. NEWS, Sept. 8, 1997, at 5-6, available in 1997 WL 9149598. DTC advertising appears to be working; more than three-quarters of physicians surveyed in 1996 said that their patients ask for drugs they see advertised. See Nordenberg, supra note 7, at 8 (citing 1996 study by Scott-Levin Associates, named Direct-to-Consumer Advertising).
16. See Carl T. Hall, Drug Ads Boost Profits, But Consumers May Feel Pinch, S.F. CHRON., Mar. 12, 1998, at E1 (citing estimates by The Plymouth Group). The majority of spending results from the surge of advertisements after the Draft Guidance was issued. See also Wilke, supra note 10, at 1 (quoting similar estimates of DTC broadcast advertising spending); Greg Borzo, New FDA Rules for Advertising Drugs on TV Raise Questions, AM. MED. NEWS, Sept. 8, 1997, at 5-6, available in 1997 WL 9149598. DTC advertising appears to be working; more than three-quarters of physicians surveyed in 1996 said that their patients ask for drugs they see advertised. See Nordenberg, supra note 7, at 8 (citing 1996 study by Scott-Levin Associates, named Direct-to-Consumer Advertising).
17. See Steals & Deals: Few Pharmaceutical Companies Take Advantage of New FDA Rule Allowing for Changes in Prescription Drug Advertisements (CNBC radio broadcast, Sept. 4, 1997) (quoting Kal Leibowitz, President, KSL Media); see also Borzo, supra note 11, at 3 ("DTC broadcast spending is expected to be 15% to 20% over what was already projected for the coming year.") (quoting Daniel L. Jaffe, Executive Vice President, Ass'n of Nat'l Advertisers).
18. See Borzo, supra note 11, at 3.
19. See Walt Sandulli et al., Winning Strategies in DTC, 32 MED. MKTG. & MEDIA 41, 42 (1997). But see Ivy Kazenhoff, Prescription for Profit: Balance Unsteady Between Creative Strict Compliance: Relationships, Ethnic Diversity Still Common Ad Themes, ADVER. AGE, Mar. 16, 1998, at 28, available in 1998 WL 6629316 (describing restrictions that regulations place on advertisement creativity).
20. See Walt Sandulli et al., Winning Strategies in DTC, 32 MED. MKTG. & MEDIA 41, 42 (1997). But see Ivy Kazenhoff, Prescription for Profit: Balance Unsteady Between Creative Strict Compliance: Relationships, Ethnic Diversity Still Common Ad Themes, ADVER. AGE, Mar. 16, 1998, at 28, available in 1998 WL 6629316 (describing restrictions that regulations place on advertisement creativity).
21. See infra notes 99-105 and accompanying text.
22. Id.
23. Id.
24. See 62 Fed. Reg. at 43,172. See also infra notes 138-44 and accompanying text.
25. See Draft Guidance, supra note 10, at 43,171.
26. See Jack Volpi, Prescription for Profit: Research Is Still at a Premium for All Groups Seeking Answers, ADVER. AGE, Mar. 16, 1998, at 20, available in 1998 WL 6629324. In the interim. FDA is accepting information from external studies on the effectiveness of the proposed policy. See 62 Fed. Reg. at 43,171, 43,172. The final guidance is not legally binding on the agency and is subject to change as the agency's "current thinking" on the topic changes. See id. See also infra notes 129-34 and accompanying text.
27. See Jack Volpi, Prescription for Profit: Research Is Still at a Premium for All Groups Seeking Answers, ADVER. AGE, Mar. 16, 1998, at 20, available in 1998 WL 6629324. In the interim. FDA is accepting information from external studies on the effectiveness of the proposed policy. See 62 Fed. Reg. at 43,171, 43,172. The final guidance is not legally binding on the agency and is subject to change as the agency's "current thinking" on the topic changes. See id. See also infra notes 129-34 and accompanying text.
28. 62 Fed. Reg. at 43,172.
29. Id.
30. Federal Food, Drug, and Cosmetic Act (FDCA), Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)).
31. 21 U.S.C. § 352(n) (FDCA § 502(n)).
32. Id. § 352(n)(1)-(3). The typesize of the established drug name must be at least half as large as the typesize of the brand name and display the formula showing quantitatively each drug ingredient. Id. An advertisement not meeting the requirements set out in the FDCA or FDA regulations will be deemed misbranded and subject to FDA enforcement proceedings. Id. § 352(a) (FDCA § 502(a)).
33. Id. § 352(n)(3) (FDCA § 502(n)(3)). FDA promulgated regulations immediately after the amendments passed in 1963 and 1964, and later revised them in 1967, 1968, and 1969. See 28 Fed. Reg. 1448 (Feb. 14, 1963); 28 Fed. Reg. 6375 (June 20, 1963); 28 Fed Reg. 9837 (Sept. 10, 1963); 28 Fed. Reg. 10,993 (Oct. 15, 1963); 29 Fed. Reg. 257 (Jan. 10, 1964); 32 Fed. Reg. 7533 (May 23, 1967); 33 Fed. Reg. 9393 (June 27, 1968); 34 Fed. Reg. 7802 (May 16, 1969) (codified in 21 C.F.R. § 202.1).
34. Id. § 352(n)(3) (FDCA § 502(n)(3)). FDA promulgated regulations immediately after the amendments passed in 1963 and 1964, and later revised them in 1967, 1968, and 1969. See 28 Fed. Reg. 1448 (Feb. 14, 1963); 28 Fed. Reg. 6375 (June 20, 1963); 28 Fed Reg. 9837 (Sept. 10, 1963); 28 Fed. Reg. 10,993 (Oct. 15, 1963); 29 Fed. Reg. 257 (Jan. 10, 1964); 32 Fed. Reg. 7533 (May 23, 1967); 33 Fed. Reg. 9393 (June 27, 1968); 34 Fed. Reg. 7802 (May 16, 1969) (codified in 21 C.F.R. § 202.1).
35. Id. § 352(n)(3) (FDCA § 502(n)(3)). FDA promulgated regulations immediately after the amendments passed in 1963 and 1964, and later revised them in 1967, 1968, and 1969. See 28 Fed. Reg. 1448 (Feb. 14, 1963); 28 Fed. Reg. 6375 (June 20, 1963); 28 Fed Reg. 9837 (Sept. 10, 1963); 28 Fed. Reg. 10,993 (Oct. 15, 1963); 29 Fed. Reg. 257 (Jan. 10, 1964); 32 Fed. Reg. 7533 (May 23, 1967); 33 Fed. Reg. 9393 (June 27, 1968); 34 Fed. Reg. 7802 (May 16, 1969) (codified in 21 C.F.R. § 202.1).
36. Id. § 352(n)(3) (FDCA § 502(n)(3)). FDA promulgated regulations immediately after the amendments passed in 1963 and 1964, and later revised them in 1967, 1968, and 1969. See 28 Fed. Reg. 1448 (Feb. 14, 1963); 28 Fed. Reg. 6375 (June 20, 1963); 28 Fed Reg. 9837 (Sept. 10, 1963); 28 Fed. Reg. 10,993 (Oct. 15, 1963); 29 Fed. Reg. 257 (Jan. 10, 1964); 32 Fed. Reg. 7533 (May 23, 1967); 33 Fed. Reg. 9393 (June 27, 1968); 34 Fed. Reg. 7802 (May 16, 1969) (codified in 21 C.F.R. § 202.1).
37. Id. § 352(n)(3) (FDCA § 502(n)(3)). FDA promulgated regulations immediately after the amendments passed in 1963 and 1964, and later revised them in 1967, 1968, and 1969. See 28 Fed. Reg. 1448 (Feb. 14, 1963); 28 Fed. Reg. 6375 (June 20, 1963); 28 Fed Reg. 9837 (Sept. 10, 1963); 28 Fed. Reg. 10,993 (Oct. 15, 1963); 29 Fed. Reg. 257 (Jan. 10, 1964); 32 Fed. Reg. 7533 (May 23, 1967); 33 Fed. Reg. 9393 (June 27, 1968); 34 Fed. Reg. 7802 (May 16, 1969) (codified in 21 C.F.R. § 202.1).
38. Id. § 352(n)(3) (FDCA § 502(n)(3)). FDA promulgated regulations immediately after the amendments passed in 1963 and 1964, and later revised them in 1967, 1968, and 1969. See 28 Fed. Reg. 1448 (Feb. 14, 1963); 28 Fed. Reg. 6375 (June 20, 1963); 28 Fed Reg. 9837 (Sept. 10, 1963); 28 Fed. Reg. 10,993 (Oct. 15, 1963); 29 Fed. Reg. 257 (Jan. 10, 1964); 32 Fed. Reg. 7533 (May 23, 1967); 33 Fed. Reg. 9393 (June 27, 1968); 34 Fed. Reg. 7802 (May 16, 1969) (codified in 21 C.F.R. § 202.1).
39. Id. § 352(n)(3) (FDCA § 502(n)(3)). FDA promulgated regulations immediately after the amendments passed in 1963 and 1964, and later revised them in 1967, 1968, and 1969. See 28 Fed. Reg. 1448 (Feb. 14, 1963); 28 Fed. Reg. 6375 (June 20, 1963); 28 Fed Reg. 9837 (Sept. 10, 1963); 28 Fed. Reg. 10,993 (Oct. 15, 1963); 29 Fed. Reg. 257 (Jan. 10, 1964); 32 Fed. Reg. 7533 (May 23, 1967); 33 Fed. Reg. 9393 (June 27, 1968); 34 Fed. Reg. 7802 (May 16, 1969) (codified in 21 C.F.R. § 202.1).
40. Id. § 352(n)(3) (FDCA § 502(n)(3)). FDA promulgated regulations immediately after the amendments passed in 1963 and 1964, and later revised them in 1967, 1968, and 1969. See 28 Fed. Reg. 1448 (Feb. 14, 1963); 28 Fed. Reg. 6375 (June 20, 1963); 28 Fed Reg. 9837 (Sept. 10, 1963); 28 Fed. Reg. 10,993 (Oct. 15, 1963); 29 Fed. Reg. 257 (Jan. 10, 1964); 32 Fed. Reg. 7533 (May 23, 1967); 33 Fed. Reg. 9393 (June 27, 1968); 34 Fed. Reg. 7802 (May 16, 1969) (codified in 21 C.F.R. § 202.1).
41. 21 U.S.C. § 352(n) (FDCA § 502(n)). See generally 21 C.F.R. § 202.1 (regulations on prescription drug advertising); Withdrawal of Moratorium on Direct-to-Consumer Prescription Drug Advertising, 50 Fed. Reg. 36,677, 36,678 (1985) ("FDA will continue to regulate prescription drug advertising, regardless of its intended audience, in accordance with section 502(n) . . . and the implementing regulations (21 C.F.R. pt. 202)"). Ironically, the legislative history of the Kefauver-Harris Amendments reveals that Senator Kefauver was primarily concerned with prescription drug advertisements directed at physicians, not consumers, 108 CONG. REC. 17,369 (1962). We found cases concerning drugs that were addictive and in which nothing at all was said about side effects . . . that has been misleading to the physician. This proposal [advertisements must be accurate with respect to what it is said a drug will do and state the side effects and effectiveness] is a very important part of the bill. It will provide the physician with honest and useful information. Id. (statement of Sen. Estes Kefauver, cosponsor of the 1962 Amendments) (alteration in original; emphasis added).
42. 21 C.F.R. § 202.1. This distinction between physician and consumer-targeted advertising is significant and has been the subject of FDA discussions because the information needs and sophistication level of patients and physicians are recognizably different. Information targeted to both populations, however, is governed by the same regulations, which do not recognize the different needs. See infra notes 88-95 and accompanying text.
43. 21 C.F.R. § 202,1(1)(1). Advertisements in journals, brochures, and direct mail are regulated as print advertisements, and advertisements broadcast via television, radio, and telephone communication systems are regulated as broadcast advertisements. Id. See infra notes 31-42 and accompanying text.
44. 21 C.F.R. § 202,1(e).
45. Id. § 202.1(e)(1). The brief summary must be a "true statement" of information; it can not be false or misleading; fail to present a fair balance of information relating to drug effectiveness and side effects; or fail to reveal material facts about the consequences of using the drug as recommended. Id. § 202.1(e)(5)(i)-(iii). See infra notes 47-51 for discussion of the "fair balance" requirement. Labeling is defined as "all other written, printed, or graphic matter upon any article or on of its containers, or wrappers, or accompanying such article." 21 U.S.C. § 321(m) (FDCA § 201(m)).
46. 21 C.F.R. § 202.1(e)(1).
47. Id. Reminder, help-seeking, bulk-sale, and prescription-compounding drug advertisements are exempt from the brief summary requirements because they do not advertise the drug indication. Id. § 202.1(e)(2)(i)-(iii). See also infra notes 59-62 and accompanying text.
48. 21 C.F.R. § 202.1(e)(1).
49. Id.
50. Id.
51. Id. § 202.1(e)(3)(iii)(a). An advertiser also may use a single term for a group of side effects and contraindications, but only if the use of that single term is permitted or approved in the drug labeling. Id. § 202.1(e)(3)(iii)(b). The major statement regulation has been criticized as being ill-defined and misguiding to consumers because it only requires the most common side effects to be revealed, omitting uncommon side effects, which are often the most disturbing. See Wilke, supra note 10, at 2; Borzo, supra note 11, at 4.
52. See 62 Fed. Reg. at 43,171; see infra notes 67-121 and accompanying text for the history of DTC regulatory policy prior to the Draft Guidance publication.
53. See Nordenberg, supra note 7, at 7; see infra notes 59-62 for discussion of reminder and help-seeking advertisements.
54. See Nordenberg, supra note 7, at 7.
55. See supra notes 1-3 and accompanying text.
56. See 21 C.F.R. § 202.1(e)(5)-(7).
57. Id. § 202.1(e)(6)(i). See, e.g., Letter from Minnie Baylor-Henry, Director, DDMAC, FDA, to Patrick J. Zenner, President & CEO, Hoffman-La Roche, Inc. (Roche) (Mar. 5, 1998) (warning letter to Roche for promotion of Accutane® for an unapproved use) (on file with FDA). Roche . . . has not systematically studied the ability of Accutane® to modify or prevent such illness as depression and has presented no basis for asserting Accutane® is effective in improving the psychosocial and emotional well-being of such patients . . .[the] claim is particularly troublesome in light of information presented recently in a Dear Doctor letter, that Accutane® may cause depression, psychosis, and rarely . . . suicide. Id. See also infra notes 80-87 (discussing FDA's regulation of unapproved uses). Unapproved, or "off-label," uses have not been approved by FDA; information about the safety and effectiveness of the off-label use has not been submitted to, reviewed by, and approved by FDA, and, therefore, is prohibited from appearing on approved product labeling. See 21 C.F.R. § 202.1(e)(6)(i).
58. Id. § 202.1(e)(6)(ii).
59. Id. § 202.1(e)(6)(vii).
60. Id. § 202.1(e)(5)(ii). The fair balance provision is somewhat subjective, but the agency has given some guidance as to acceptable fair balance. See DDMAC, FDA, Current Issues and Procedures 1-2 (Apr. 1994) [hereinafter Current Issues].
61. See Current Issues, supra note 46, at 3.
62. See Letter from Mark W. Askine, Regulatory Review Officer, DDMAC, FDA, to Carol D. Karp, Vice President Regulatory Affairs, Vivus, Inc. (Feb. 19, 1998) (notice-of-violation letter regarding broadcast advertisement for MUSE® that side effects insufficiently communicated to consumer and advertisement was not in fair balance because information about effectiveness was not presented in a manner comparable to presentation of effectiveness) (on file with FDA). Specifically, the voice-over that conveys risk information . . . is read at a pace that is too rapid to effectively communicate this important information, especially given the complexity of information containing ratios, percentages . . . [T]he statement "three percent of patients reported symptoms from lowering of blood pressure" does not adequately communicate . . . the potential severity of possible hypotensive related treatment emergent events associated with the drug . . . risk disclosure should indicate actual symptoms . . . observed in clinical trials for MUSE, including fainting, dizziness, and lightheadedness. Id.
63. See Letter from Joan Hankin, Regulatory Review Officer, DDMAC, FDA, to Barbara A. Thompson, Regulatory Affairs, Glaxo-Wellcome (Oct. 30, 1997) (notice-of-violation letter for Flovent® DTC advertisement suggesting unapproved use on examination of "totality of elements") (on file with FDA).
64. See id. The television medium, which allows for competing visual and audio messages, adds another twist to the totality of the elements test. If an audio message of the major statement contradicts the concurrent visual image, then the advertisement is not in fair balance. See Current Issues, supra note 46, at 3. To avoid conflicting messages, the agency advises advertisers to use consistent audio and visual messages. Id.
65. See id. The television medium, which allows for competing visual and audio messages, adds another twist to the totality of the elements test. If an audio message of the major statement contradicts the concurrent visual image, then the advertisement is not in fair balance. See Current Issues, supra note 46, at 3. To avoid conflicting messages, the agency advises advertisers to use consistent audio and visual messages. Id.
66. 21 U.S.C. § 352(n)(3)(A) (FDCA § 502(n)(3)(A)).
67. Id. Section 502(n) explicitly prohibits FDA from promulgating regulations requiring prior approval of advertisement content, except in extraordinary circumstances. "Extraordinary circumstances" would exist when, for example, FDA receives information that a drug causes fatalities or serious injuries, and despite FDA notification, the sponsor fails to adequately publicize the information. 21 C.F.R. § 202.1(j)(1)(i)-(iii). See also id. §§ 314.550, 601.45 (requiring advertisement review in accelerated approval cases); id. §§ 807.87(e), 814.20(b)(1 O) (requiring advertisement review in premarket notifications and premarket approval applications). Preclearance of advertisements not only violates the congressional intent of FDCA, but may violate the First Amendment right to commercial free speech. U.S. CONST. amend, 1; 21 U.S.C. § 352(n) (FDCA § 502(n)). Responding to the DTC advertising flood in the early 1990s, FDA informally requested manufacturers to voluntarily submit DTC advertisements for prepublication review. Letter from the FDA to the Pharmaceutical Industry (July 1993) (on file with FDA). See 21 C.F.R. § 202.1(j)(4) (stating "any advertisement may be submitted to the Food and Drug Administration prior to publication for comment") (emphasis added); Announcement of Public Hearing on DTC Promotion, 60 Fed. Reg. 42,582, 42,582 (Aug. 16, 1995); Direct-to-Consumer Promotion, 61 Fed. Reg. 24,314 (May 14, 1996). The request led to industry confusion and criticism, prompting FDA to clarify its policy not to require preclearance of prescription drug advertising, but merely offering advertisement review to help resolve noncompliance issues in advance of publication. 61 Fed. Reg. at 24,314.
68. Id. Section 502(n) explicitly prohibits FDA from promulgating regulations requiring prior approval of advertisement content, except in extraordinary circumstances. "Extraordinary circumstances" would exist when, for example, FDA receives information that a drug causes fatalities or serious injuries, and despite FDA notification, the sponsor fails to adequately publicize the information. 21 C.F.R. § 202.1(j)(1)(i)-(iii). See also id. §§ 314.550, 601.45 (requiring advertisement review in accelerated approval cases); id. §§ 807.87(e), 814.20(b)(1 O) (requiring advertisement review in premarket notifications and premarket approval applications). Preclearance of advertisements not only violates the congressional intent of FDCA, but may violate the First Amendment right to commercial free speech. U.S. CONST. amend, 1; 21 U.S.C. § 352(n) (FDCA § 502(n)). Responding to the DTC advertising flood in the early 1990s, FDA informally requested manufacturers to voluntarily submit DTC advertisements for prepublication review. Letter from the FDA to the Pharmaceutical Industry (July 1993) (on file with FDA). See 21 C.F.R. § 202.1(j)(4) (stating "any advertisement may be submitted to the Food and Drug Administration prior to publication for comment") (emphasis added); Announcement of Public Hearing on DTC Promotion, 60 Fed. Reg. 42,582, 42,582 (Aug. 16, 1995); Direct-to-Consumer Promotion, 61 Fed. Reg. 24,314 (May 14, 1996). The request led to industry confusion and criticism, prompting FDA to clarify its policy not to require preclearance of prescription drug advertising, but merely offering advertisement review to help resolve noncompliance issues in advance of publication. 61 Fed. Reg. at 24,314.
69. Id. Section 502(n) explicitly prohibits FDA from promulgating regulations requiring prior approval of advertisement content, except in extraordinary circumstances. "Extraordinary circumstances" would exist when, for example, FDA receives information that a drug causes fatalities or serious injuries, and despite FDA notification, the sponsor fails to adequately publicize the information. 21 C.F.R. § 202.1(j)(1)(i)-(iii). See also id. §§ 314.550, 601.45 (requiring advertisement review in accelerated approval cases); id. §§ 807.87(e), 814.20(b)(1 O) (requiring advertisement review in premarket notifications and premarket approval applications). Preclearance of advertisements not only violates the congressional intent of FDCA, but may violate the First Amendment right to commercial free speech. U.S. CONST. amend, 1; 21 U.S.C. § 352(n) (FDCA § 502(n)). Responding to the DTC advertising flood in the early 1990s, FDA informally requested manufacturers to voluntarily submit DTC advertisements for prepublication review. Letter from the FDA to the Pharmaceutical Industry (July 1993) (on file with FDA). See 21 C.F.R. § 202.1(j)(4) (stating "any advertisement may be submitted to the Food and Drug Administration prior to publication for comment") (emphasis added); Announcement of Public Hearing on DTC Promotion, 60 Fed. Reg. 42,582, 42,582 (Aug. 16, 1995); Direct-to-Consumer Promotion, 61 Fed. Reg. 24,314 (May 14, 1996). The request led to industry confusion and criticism, prompting FDA to clarify its policy not to require preclearance of prescription drug advertising, but merely offering advertisement review to help resolve noncompliance issues in advance of publication. 61 Fed. Reg. at 24,314.
70. 21 C.F.R. § 314.81(3)(i). FDA often requires the submission of advertisement content in cases of corrective advertising following sanctions for false or misleading claims. See, e.g., Letter from Minnie Baylor-Henry, Director, DDMAC, FDA, to Richard J. Kogan, CEO, Schering Corp. (July 31, 1997) (warning letter requiring FDA's approval of corrective materials prior to dissemination) (on file with FDA); Letter from Lisa L. Stockbridge, Regulatory Review Officer, DDMAC, FDA, to Michael M. Rosen, Director, Regulatory Affairs, Forest Laboratories (Mar. 27, 1997) (notice-of-violation letter requiring FDA's approval of corrective campaign materials prior to dissemination) (on file with FDA). Because FDA cannot review prescription drug advertisements prior to publication, it can prohibit an advertiser only from continuing a false or misleading advertisement after it has been published. 21 U.S.C. § 352(n) (FDCA § 502(n)).
71. See FOOD AND DRUG ADMIN., WARNING LETTER REFERENCE GUIDE, at 12 (Oct. 1994). A notice of violation or untitled letter is issued in response to illegal promotional activities when the relevant center is not prepared to support further agency action if the illegal activities are continued. Id.
72. See FOOD AND DRUG ADMIN., WARNING LETTER REFERENCE GUIDE, at 12 (Oct. 1994). A notice of violation or untitled letter is issued in response to illegal promotional activities when the relevant center is not prepared to support further agency action if the illegal activities are continued. Id.
73. See id. at 12. Warning letters are issued when the relevant center is prepared to support further agency action if the practice does not cease. Id. Notice-of-violation and warning letters provide the recipient an opportunity to take self-corrective measures and are informal and advisory. Id. The letters communicate the agency's position on a matter, but do not commit FDA to enforcement action. Therefore, the agency does not consider a warning letter a final agency action for which it can be sued. Id.
74. See id. at 12. Warning letters are issued when the relevant center is prepared to support further agency action if the practice does not cease. Id. Notice-of-violation and warning letters provide the recipient an opportunity to take self-corrective measures and are informal and advisory. Id. The letters communicate the agency's position on a matter, but do not commit FDA to enforcement action. Therefore, the agency does not consider a warning letter a final agency action for which it can be sued. Id.
75. See id. at 12. Warning letters are issued when the relevant center is prepared to support further agency action if the practice does not cease. Id. Notice-of-violation and warning letters provide the recipient an opportunity to take self-corrective measures and are informal and advisory. Id. The letters communicate the agency's position on a matter, but do not commit FDA to enforcement action. Therefore, the agency does not consider a warning letter a final agency action for which it can be sued. Id.
76. See id. at 12. Warning letters are issued when the relevant center is prepared to support further agency action if the practice does not cease. Id. Notice-of-violation and warning letters provide the recipient an opportunity to take self-corrective measures and are informal and advisory. Id. The letters communicate the agency's position on a matter, but do not commit FDA to enforcement action. Therefore, the agency does not consider a warning letter a final agency action for which it can be sued. Id.
77. For example, a company may be asked to send a "Dear Doctor" letter or to run corrective advertisements. See supra note 53 and accompanying text.
78. 21 U.S.C. § 334 (FDCA § 304). FDA can pursue criminal prosecutions of the company or individuals involved with false or misleading promotional claims that seriously threaten public health and welfare. 21 U.S.C. § 333 (FDCA § 303).
79. See 60 Fed. Reg. at 42,581, 42,582-83.
80. 21 C.F.R. § 202.1(e)(2)(i).
81. Id.
82. See 60 Fed. Reg. at 42,582 (defining help-seeking advertisements).
83. See id. (defining product claim advertisements); 21 C.F.R. § 202.1(1).
84. See Nordenberg, supra note 7, at 7.
85. See Draft Guidance, supra note 10, at 1.
86. See Wayne L. Pines, New Challenges for Medical Product Promotion and Its Regulation, 52 FOOD & DRUG L.J. 61, 62 (1997). In 1981, Merck & Co. launched advertisements in Reader's Digest and newspapers announcing its new pneumonia vaccine, Pneumovax®. See Prescription for Profit, ADVER. AGE, Mar. 16, 1998, at 4, available in 1998 WL 6629328. Until that time, drug manufacturers generally limited prescription drug promotion to healthcare professionals. See 60 Fed. Reg. at 42,581.
87. See Wayne L. Pines, New Challenges for Medical Product Promotion and Its Regulation, 52 FOOD & DRUG L.J. 61, 62 (1997). In 1981, Merck & Co. launched advertisements in Reader's Digest and newspapers announcing its new pneumonia vaccine, Pneumovax®. See Prescription for Profit, ADVER. AGE, Mar. 16, 1998, at 4, available in 1998 WL 6629328. Until that time, drug manufacturers generally limited prescription drug promotion to healthcare professionals. See 60 Fed. Reg. at 42,581.
88. See Wayne L. Pines, New Challenges for Medical Product Promotion and Its Regulation, 52 FOOD & DRUG L.J. 61, 62 (1997). In 1981, Merck & Co. launched advertisements in Reader's Digest and newspapers announcing its new pneumonia vaccine, Pneumovax®. See Prescription for Profit, ADVER. AGE, Mar. 16, 1998, at 4, available in 1998 WL 6629328. Until that time, drug manufacturers generally limited prescription drug promotion to healthcare professionals. See 60 Fed. Reg. at 42,581.
89. See Wayne L. Pines, New Challenges for Medical Product Promotion and Its Regulation, 52 FOOD & DRUG L.J. 61, 62 (1997). In 1981, Merck & Co. launched advertisements in Reader's Digest and newspapers announcing its new pneumonia vaccine, Pneumovax®. See Prescription for Profit, ADVER. AGE, Mar. 16, 1998, at 4, available in 1998 WL 6629328. Until that time, drug manufacturers generally limited prescription drug promotion to healthcare professionals. See 60 Fed. Reg. at 42,581.
90. See Arthur Hull Hayes, Jr., Comm'r of Food and Drugs, Direct-to-Consumer Advertising of Prescription Drugs: Moratorium, Address Before Pharmaceutical Advertising Council (Feb. 17, 1983). In 1984, a symposium sponsored by the University of Illinois and the Stanford Research Institute was held to discuss consumer-directed prescription drug advertising. See 60 Fed. Reg. at 42,581.
91. See Arthur Hull Hayes, Jr., Comm'r of Food and Drugs, Direct-to-Consumer Advertising of Prescription Drugs: Moratorium, Address Before Pharmaceutical Advertising Council (Feb. 17, 1983). In 1984, a symposium sponsored by the University of Illinois and the Stanford Research Institute was held to discuss consumer-directed prescription drug advertising. See 60 Fed. Reg. at 42,581.
92. Withdrawal of Moratorium on Direct-to-Consumer Advertising of Prescription Drugs, 50 Fed. Reg. 36,677 (Sept. 9, 1985) (Frank E. Young, Comm'r of Food and Drugs).
93. Id.
94. See Pines, supra note 65, at 62.
95. Id.
96. Id. at 61, 62. See David A. Kessler & Wayne L. Pines, The Federal Regulation of Prescription Drug Advertising and Promotion, 264 JAMA 2409 (1990); FDA Talk Paper (July 18, 1991) (noting increased emphasis on compliance of prescription drug promotion with ethical and legal standards); David A. Kessler et al., Therapeutic Class Wars, Drug Promotion in a Competitive Marketplace, 331 NEW ENG. J. MED. 1350 (1994) [hereinafter Kessler, Therapeutic Class Wars]. See also Thomas M. Hayes, Drug Labeling and Promotion: Evolution and Application of Regulatory Policy, 51 FOOD & DRUG L.J. 64 (1996) [hereinafter Hayes] (discussing FDA's enforcement response to pharmaceutical manufacturers' marketing initiatives in the early 1990s). Dr. Kessler had personal and professional interest in marketing issues. See Pines, supra note 65, at 62.
97. Id. at 61, 62. See David A. Kessler & Wayne L. Pines, The Federal Regulation of Prescription Drug Advertising and Promotion, 264 JAMA 2409 (1990); FDA Talk Paper (July 18, 1991) (noting increased emphasis on compliance of prescription drug promotion with ethical and legal standards); David A. Kessler et al., Therapeutic Class Wars, Drug Promotion in a Competitive Marketplace, 331 NEW ENG. J. MED. 1350 (1994) [hereinafter Kessler, Therapeutic Class Wars]. See also Thomas M. Hayes, Drug Labeling and Promotion: Evolution and Application of Regulatory Policy, 51 FOOD & DRUG L.J. 64 (1996) [hereinafter Hayes] (discussing FDA's enforcement response to pharmaceutical manufacturers' marketing initiatives in the early 1990s). Dr. Kessler had personal and professional interest in marketing issues. See Pines, supra note 65, at 62.
98. Id. at 61, 62. See David A. Kessler & Wayne L. Pines, The Federal Regulation of Prescription Drug Advertising and Promotion, 264 JAMA 2409 (1990); FDA Talk Paper (July 18, 1991) (noting increased emphasis on compliance of prescription drug promotion with ethical and legal standards); David A. Kessler et al., Therapeutic Class Wars, Drug Promotion in a Competitive Marketplace, 331 NEW ENG. J. MED. 1350 (1994) [hereinafter Kessler, Therapeutic Class Wars]. See also Thomas M. Hayes, Drug Labeling and Promotion: Evolution and Application of Regulatory Policy, 51 FOOD & DRUG L.J. 64 (1996) [hereinafter Hayes] (discussing FDA's enforcement response to pharmaceutical manufacturers' marketing initiatives in the early 1990s). Dr. Kessler had personal and professional interest in marketing issues. See Pines, supra note 65, at 62.
99. See Pines, supra note 65, at 62.
100. Martin S. Wilkes et al., Pharmaceutical Advertisements in Leading Medical Journals: Expert's Assessments, 116 ANNALS OF INTERNAL MED., 912-19 (1992) (reporting survey of physicians and pharmacists' comparisons of 109 full-page advertisements with FDA guidelines and assessments of their educational value).
101. See Paul H. Rubin, Are Pharmaceutical Ads Deceptive?, 49 FOOD & DRUG L.J. 7, n.3 (1994).
102. See Kessler, Therapeutic Class Wars, supra note 71, at 1350. Unauthorized therapeutic substitutions or "switch campaigns" are industry efforts to switch patients from their originally prescribed medications to "me-too" drugs marketed by the companies. Id. at 1352.
103. See Kessler, Therapeutic Class Wars, supra note 71, at 1350. Unauthorized therapeutic substitutions or "switch campaigns" are industry efforts to switch patients from their originally prescribed medications to "me-too" drugs marketed by the companies. Id. at 1352.
104. Id. at 1350. Kessler attributed switch campaigns and unsubstantiated superiority claims to competition within therapeutic drug classes, stating: "The preponderance of me-too drugs has created a highly competitive marketplace for prescription drugs. Pharmaceutical companies are waging aggressive campaigns to change prescribers' habits and to distinguish their products from competing ones, even when the products are virtually indistinguishable." Id. Between 1989 and 1993, FDA's Center for Drug Evaluation and Research (CDER) approved 127 new molecular entities, but only a minority offered a clear clinical advantage over existing therapies. Id. at 1350 n.1.
105. Id. at 1350. Kessler attributed switch campaigns and unsubstantiated superiority claims to competition within therapeutic drug classes, stating: "The preponderance of me-too drugs has created a highly competitive marketplace for prescription drugs. Pharmaceutical companies are waging aggressive campaigns to change prescribers' habits and to distinguish their products from competing ones, even when the products are virtually indistinguishable." Id. Between 1989 and 1993, FDA's Center for Drug Evaluation and Research (CDER) approved 127 new molecular entities, but only a minority offered a clear clinical advantage over existing therapies. Id. at 1350 n.1.
106. Id. at 1350. Kessler attributed switch campaigns and unsubstantiated superiority claims to competition within therapeutic drug classes, stating: "The preponderance of me-too drugs has created a highly competitive marketplace for prescription drugs. Pharmaceutical companies are waging aggressive campaigns to change prescribers' habits and to distinguish their products from competing ones, even when the products are virtually indistinguishable." Id. Between 1989 and 1993, FDA's Center for Drug Evaluation and Research (CDER) approved 127 new molecular entities, but only a minority offered a clear clinical advantage over existing therapies. Id. at 1350 n.1.
107. Claims made as to product safety and effectiveness in comparison with competing products are subject to the same standards of review as safety and efficacy claims in product labeling, that is, claims must be supported by substantial evidence or substantial clinical trial experience. See Current Issues, supra note 46, at 3.
108. See Kessler, Therapeutic Class Wars, supra note 71, all 351; Hayes, supra note 71, at 62.
109. See infra notes 80-86 and accompanying text.
110. See 21 U.S.C. §§ 355(a), 352(a), 352(f), 331(a), and 331(d); 21 C.F.R. § 202.1(e)(6)(i). FDA permits information about unapproved uses of approved drugs to be disseminated to physicians through peer-reviewed reprints. FDA Modernization Act of 1997 (FDAMA), Pub. L. No. 105-115, § 401, 111 Stat. 2356 (1997) (codified at 21 U.S.C. § 360aaa).
111. See infra notes 83-87 and accompanying text. See also Request for Comments on Citizen Petition Regarding the FDA's Policy on Promotion of Unapproved Uses of Approved Drugs and Devices, 59 Fed. Reg. 59,820 (Nov. 18, 1994); Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg, 64,074 (Dec. 3, 1997).
112. See infra notes 83-87 and accompanying text. See also Request for Comments on Citizen Petition Regarding the FDA's Policy on Promotion of Unapproved Uses of Approved Drugs and Devices, 59 Fed. Reg. 59,820 (Nov. 18, 1994); Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg, 64,074 (Dec. 3, 1997).
113. See 59 Fed. Reg. at 59,820; 62 Fed. Reg. at 64,074. But see Paul H. Rubin, FDA Advertising Restrictions: Ignorance is Death, in HAZARDOUS TO OUR HEALTH? FDA REGULATION OF HEALTH CARE PRODUCTS (Robert Higgs ed. 1995) (advocating promotion of off-label uses to consumers, as well as to physicians).
114. See 59 Fed. Reg. at 59,820; 62 Fed. Reg. at 64,074. But see Paul H. Rubin, FDA Advertising Restrictions: Ignorance is Death, in HAZARDOUS TO OUR HEALTH? FDA REGULATION OF HEALTH CARE PRODUCTS (Robert Higgs ed. 1995) (advocating promotion of off-label uses to consumers, as well as to physicians).
115. See 59 Fed. Reg. at 59,820; 62 Fed. Reg. at 64,074. But see Paul H. Rubin, FDA Advertising Restrictions: Ignorance is Death, in HAZARDOUS TO OUR HEALTH? FDA REGULATION OF HEALTH CARE PRODUCTS (Robert Higgs ed. 1995) (advocating promotion of off-label uses to consumers, as well as to physicians).
116. Washington Legal Found. v. Kessler, 880 F. Supp. 26, 27-28 (D.D.C. 1995). In 1994, the Washington Legal Foundation filed a citizen petition in response to an FDA policy proposal limiting manufacturers' dissemination of information about off-label uses of approved drugs to physicians. See 59 Fed. Reg. at 59,820.
117. See 62 Fed. Reg. at 64,079.
118. See Hayes, supra note 71, at 62.
119. Id. Furthermore, false or misleading advertising is not a valid use of commercial speech, so restrictions on advertising of unapproved uses are not invalid. See 62 Fed. Reg. at 64,079 (analyzing ban on promotion of unapproved uses favorably using four-prong test articulated by Supreme Court in Central Hudson Gas & Electric Corp. v. Public Serv. Comm'n of New York, 447 U.S. 557 (1980)). See also Rhode Island v. Rhode Island Liquor Stores Assoc., 317 U.S. 484, 487 (1996) (declaring state ban on nonmisleading commercial speech unconstitutional); Virginia State Bd. of Pharm. v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976) (declaring state ban on advertising of drug prices unconstitutional); Coyne Beahm, Inc. v. Kessler, 966 F. Supp. 1374, 1398-99 (M.D.N.C. 1997) (holding Congress did not intend to grant FDA authority to regulate advertising or promotion under section 360j(e), which permits FDA to restrict "sale, distribution, or use" of restricted devices); Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44,396 (Aug. 28, 1996).
120. Id. Furthermore, false or misleading advertising is not a valid use of commercial speech, so restrictions on advertising of unapproved uses are not invalid. See 62 Fed. Reg. at 64,079 (analyzing ban on promotion of unapproved uses favorably using four-prong test articulated by Supreme Court in Central Hudson Gas & Electric Corp. v. Public Serv. Comm'n of New York, 447 U.S. 557 (1980)). See also Rhode Island v. Rhode Island Liquor Stores Assoc., 317 U.S. 484, 487 (1996) (declaring state ban on nonmisleading commercial speech unconstitutional); Virginia State Bd. of Pharm. v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976) (declaring state ban on advertising of drug prices unconstitutional); Coyne Beahm, Inc. v. Kessler, 966 F. Supp. 1374, 1398-99 (M.D.N.C. 1997) (holding Congress did not intend to grant FDA authority to regulate advertising or promotion under section 360j(e), which permits FDA to restrict "sale, distribution, or use" of restricted devices); Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44,396 (Aug. 28, 1996).
121. See Letter from Joan Hankin, Regulatory Review Officer, DDMAC, FDA, to Barbara A. Thompson, Regulatory Affairs, Glaxo Wellcome (Oct. 30, 1997) (notice-of-violation letter that Flovent® DTC advertisement depicting Jackie Joyner Kersee engaged in strenuous physical activity suggested product was approved for use in exercise-induced bronchospasm); Letter from Lisa L. Stockbridge, Regulatory Review Officer, DDMAC, FDA, to Eloise R. Scott, Associate Director, Regulatory Affairs, SmithKline Beecham Pharmaceuticals (Mar. 9, 1998) (notice-of-violation letter that Paxil® T-shirts distributed at children's health fair suggested product was approved for use in children).
122. In January 1996, the Secretary of the Department of Health and Human Services (DHHS) accepted a Keystone Center report containing guidelines for improving patient access to prescription drug information. See DEP'T OF HEALTH & HUMAN SERVS., HHS NEWS, No. P97-02 (Jan. 14, 1997) (announcing Secretary's plan to adopt "Action Plan for the Provision of Useful Prescription Medicine Information," a voluntary plan in which manufacturers distribute patient labeling, termed "Medical Guides" to patients receiving prescription drug products). See also 62 Fed. Reg. at 43,172.
123. In January 1996, the Secretary of the Department of Health and Human Services (DHHS) accepted a Keystone Center report containing guidelines for improving patient access to prescription drug information. See DEP'T OF HEALTH & HUMAN SERVS., HHS NEWS, No. P97-02 (Jan. 14, 1997) (announcing Secretary's plan to adopt "Action Plan for the Provision of Useful Prescription Medicine Information," a voluntary plan in which manufacturers distribute patient labeling, termed "Medical Guides" to patients receiving prescription drug products). See also 62 Fed. Reg. at 43,172.
124. FDA Proposal, 60 Fed. Reg. 44,182 (Aug. 24, 1995).
125. See FDA Order, 45 Fed. Reg. 60,754 (Sept. 12, 1980); Howard M. Rowe, Patient Package Inserts: The Proper Prescription?, 50 FOOD & DRUG L.J. 95, 95 (1995). PPIs were product information written for a nontechnical audience and required to accompany the dispensed prescription drug product. See 45 Fed. Reg. at 60,754. The Pharmaceutical Manufacturers' Association challenged FDA's authority to mandate PPIs, but the court ultimately held FDA had the authority, extending to PPIs, to promulgate regulations to ensure labeling is not false or misleading. Pharmaceutical Mfrs. Assn. v. FDA, 484 F. Supp. 1179, 1186 (D. Del.), aff'd, 634 F.2d 106 (3d Cir. 1980) (per curiam).
126. See FDA Order, 45 Fed. Reg. 60,754 (Sept. 12, 1980); Howard M. Rowe, Patient Package Inserts: The Proper Prescription?, 50 FOOD & DRUG L.J. 95, 95 (1995). PPIs were product information written for a nontechnical audience and required to accompany the dispensed prescription drug product. See 45 Fed. Reg. at 60,754. The Pharmaceutical Manufacturers' Association challenged FDA's authority to mandate PPIs, but the court ultimately held FDA had the authority, extending to PPIs, to promulgate regulations to ensure labeling is not false or misleading. Pharmaceutical Mfrs. Assn. v. FDA, 484 F. Supp. 1179, 1186 (D. Del.), aff'd, 634 F.2d 106 (3d Cir. 1980) (per curiam).
127. See FDA Order, 45 Fed. Reg. 60,754 (Sept. 12, 1980); Howard M. Rowe, Patient Package Inserts: The Proper Prescription?, 50 FOOD & DRUG L.J. 95, 95 (1995). PPIs were product information written for a nontechnical audience and required to accompany the dispensed prescription drug product. See 45 Fed. Reg. at 60,754. The Pharmaceutical Manufacturers' Association challenged FDA's authority to mandate PPIs, but the court ultimately held FDA had the authority, extending to PPIs, to promulgate regulations to ensure labeling is not false or misleading. Pharmaceutical Mfrs. Assn. v. FDA, 484 F. Supp. 1179, 1186 (D. Del.), aff'd, 634 F.2d 106 (3d Cir. 1980) (per curiam).
128. See FDA Order, 47 Fed. Reg. 39,147 (Sept. 7, 1982). Some drug classes, such as estrogenic products and oral contraceptives, are still required to include PPIs. See 42 Fed. Reg. 37,636 (Sept. 20, 1977) (codified at 21 C.F.R. § 310.515). Several private sector organizations voluntarily distribute patient information leaflets, including the American Medical Association, American Society of Hospital Pharmacists, U.S. Pharmacopoeia, and the American Association of Retired Persons. 47 Fed. Reg. at 39,147, pmbl.
129. See FDA Order, 47 Fed. Reg. 39,147 (Sept. 7, 1982). Some drug classes, such as estrogenic products and oral contraceptives, are still required to include PPIs. See 42 Fed. Reg. 37,636 (Sept. 20, 1977) (codified at 21 C.F.R. § 310.515). Several private sector organizations voluntarily distribute patient information leaflets, including the American Medical Association, American Society of Hospital Pharmacists, U.S. Pharmacopoeia, and the American Association of Retired Persons. 47 Fed. Reg. at 39,147, pmbl.
130. See FDA Order, 47 Fed. Reg. 39,147 (Sept. 7, 1982). Some drug classes, such as estrogenic products and oral contraceptives, are still required to include PPIs. See 42 Fed. Reg. 37,636 (Sept. 20, 1977) (codified at 21 C.F.R. § 310.515). Several private sector organizations voluntarily distribute patient information leaflets, including the American Medical Association, American Society of Hospital Pharmacists, U.S. Pharmacopoeia, and the American Association of Retired Persons. 47 Fed. Reg. at 39,147, pmbl.
131. See DHHS, supra note 88. See also Proposed Prescription Drug Labeling Requirements: Medical Guides, 60 Fed. Reg. 44,182 (Aug. 24, 1995); Public Meeting Announcement for Issue of Professional Product Labeling, 60 Fed. Reg. 52,196 (Oct. 5, 1995) (announcing public meeting to discuss product labeling for healthcare professionals).
132. See DHHS, supra note 88. See also Proposed Prescription Drug Labeling Requirements: Medical Guides, 60 Fed. Reg. 44,182 (Aug. 24, 1995); Public Meeting Announcement for Issue of Professional Product Labeling, 60 Fed. Reg. 52,196 (Oct. 5, 1995) (announcing public meeting to discuss product labeling for healthcare professionals).
133. Congress threatened to table the policy permanently if FDA did not first accept and respond to public comments on the proposal. See Pub. L. No. 104-180, 110 Stat. 1569 (1996) (codified at 21 U.S.C. § 353). See, e.g., FDA Reform Legislation: Hearing on FDA Proposed MedGuide Regulation Before the Subcomm. on Health of the House Commerce Comm., 104th Cong., 2d Sess. (1996), available in WESTLAW, 1996 WL 270840 at *3 (statement of John M. Scheels, Director of Regulatory Affairs, Eckerd Corp.) (opposing proposed "MedGuide" regulations as unnecessary burdens on pharmacy providers).
134. See DHHS, supra note 88.
135. See 60 Fed. Reg. 59,570, 59,571 (Nov. 28, 1995).
136. See No, 95P-0224/CP2 (Nov. 1995) Food Drug Cosm. L. Rep. (CCH) ¶ 41,466; No. 95P-0224 (July 1995) Food Drug Cosm. L. Rep. (CCH); No. 95P-0104 (Apr. 1995) Food Drug Cosm. L. Rep. (CCH) ¶ 41,146. FDA regulation of Internet advertising also has been the subject of citizen petitions, and FDA has undertaken the development of an policy addressing Internet promotion. See No. 96P-0501/CPI (Dec. 1996) Food Drug Cosm. L. Rep. (CCH) ¶ 41,755; Notice of Public Meeting on Promotion of FDA-Regulated Products on the Internet, 61 Fed. Reg. 48,707 (Sept. 16, 1996); Milton Liebman, FDA Hearings on What the Internet Can Show, 31 MED. MKTG. & MEDIA 62 (1996). See also Peter Reichertz, Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 355, 356-61 (1996).
137. See No, 95P-0224/CP2 (Nov. 1995) Food Drug Cosm. L. Rep. (CCH) ¶ 41,466; No. 95P-0224 (July 1995) Food Drug Cosm. L. Rep. (CCH); No. 95P-0104 (Apr. 1995) Food Drug Cosm. L. Rep. (CCH) ¶ 41,146. FDA regulation of Internet advertising also has been the subject of citizen petitions, and FDA has undertaken the development of an policy addressing Internet promotion. See No. 96P-0501/CPI (Dec. 1996) Food Drug Cosm. L. Rep. (CCH) ¶ 41,755; Notice of Public Meeting on Promotion of FDA-Regulated Products on the Internet, 61 Fed. Reg. 48,707 (Sept. 16, 1996); Milton Liebman, FDA Hearings on What the Internet Can Show, 31 MED. MKTG. & MEDIA 62 (1996). See also Peter Reichertz, Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 355, 356-61 (1996).
138. See No, 95P-0224/CP2 (Nov. 1995) Food Drug Cosm. L. Rep. (CCH) ¶ 41,466; No. 95P-0224 (July 1995) Food Drug Cosm. L. Rep. (CCH); No. 95P-0104 (Apr. 1995) Food Drug Cosm. L. Rep. (CCH) ¶ 41,146. FDA regulation of Internet advertising also has been the subject of citizen petitions, and FDA has undertaken the development of an policy addressing Internet promotion. See No. 96P-0501/CPI (Dec. 1996) Food Drug Cosm. L. Rep. (CCH) ¶ 41,755; Notice of Public Meeting on Promotion of FDA-Regulated Products on the Internet, 61 Fed. Reg. 48,707 (Sept. 16, 1996); Milton Liebman, FDA Hearings on What the Internet Can Show, 31 MED. MKTG. & MEDIA 62 (1996). See also Peter Reichertz, Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 355, 356-61 (1996).
139. See 60 Fed. Reg. at 42,582 (listing citizen petition requests for the agency to ban DTC advertising, issue a moratorium on new DTC restrictions, promulgate new regulations on prescription drug advertising, and refrain from any DTC restriction in the interim).
140. Id. See also Borzo, supra note 11, at 4, 5 (noting assertions of public interest groups, e.g., Public Citizen, that consumers cannot counter effects of sophisticated advertising and that DTC will lead to overprescribing); Letter from Larry D. Sasich & Sidney M. Wolfe, Public Citizen's Health Research Group to FDA (Aug. 12, 1996) (enumerating DTC advertising concerns), available at Public Citizen's website 〈www.citizen.org/ hrg/PUBLICATIONS/1400.htm〉; Lynnette R. Bradley & Julie Magno Zito, Direct-to-Consumer Prescription Drug Advertising, 35 MED. CARE 86, 88 (1997) (noting that consumers lack "necessary clinical and pharmacologic expertise to accurately evaluate and comprehend prescription drug advertising" and that DTC may encourage unnecessary drug consumption). But see Media Rules Change, supra note 7, at *2 (disputing physician capitulation to patient demands).
141. Id. See also Borzo, supra note 11, at 4, 5 (noting assertions of public interest groups, e.g., Public Citizen, that consumers cannot counter effects of sophisticated advertising and that DTC will lead to overprescribing); Letter from Larry D. Sasich & Sidney M. Wolfe, Public Citizen's Health Research Group to FDA (Aug. 12, 1996) (enumerating DTC advertising concerns), available at Public Citizen's website 〈www.citizen.org/ hrg/PUBLICATIONS/1400.htm〉; Lynnette R. Bradley & Julie Magno Zito, Direct-to-Consumer Prescription Drug Advertising, 35 MED. CARE 86, 88 (1997) (noting that consumers lack "necessary clinical and pharmacologic expertise to accurately evaluate and comprehend prescription drug advertising" and that DTC may encourage unnecessary drug consumption). But see Media Rules Change, supra note 7, at *2 (disputing physician capitulation to patient demands).
142. Id. See also Borzo, supra note 11, at 4, 5 (noting assertions of public interest groups, e.g., Public Citizen, that consumers cannot counter effects of sophisticated advertising and that DTC will lead to overprescribing); Letter from Larry D. Sasich & Sidney M. Wolfe, Public Citizen's Health Research Group to FDA (Aug. 12, 1996) (enumerating DTC advertising concerns), available at Public Citizen's website 〈www.citizen.org/ hrg/PUBLICATIONS/1400.htm〉; Lynnette R. Bradley & Julie Magno Zito, Direct-to-Consumer Prescription Drug Advertising, 35 MED. CARE 86, 88 (1997) (noting that consumers lack "necessary clinical and pharmacologic expertise to accurately evaluate and comprehend prescription drug advertising" and that DTC may encourage unnecessary drug consumption). But see Media Rules Change, supra note 7, at *2 (disputing physician capitulation to patient demands).
143. See 60 Fed. Reg. at 42,582.
144. See E. Havvi Morreim, Diverse and Perverse Incentives of Managed Care: Bringing Patients Into Alignment, 1 WIDENER L. SYMP. J. 89 (1996).
145. See id at 97-98..
146. See id.
147. See id. at 101.
148. See Ernestine McCarren, Is DTC Advertising a Palatable Medium for Managed Care Organizations?, 31 MED. MKTG. & MEDIA 57, 58 (1996)
149. See id. at 58; Borzo, supra note 11, at 3 (quoting Paul Rubin, Emory University economics professor, on consumers' increased leverage in dealing with managed care companies because of increased information).
150. See McCarren, supra note 104, at 58.
151. See id.
152. See Sandulli, supra note 14, at 42. Building consumer brand name loyalty also is a strategy used in anticipation of a prescription to over-the-counter switch. Id. at 44.
153. See Kessler, Therapeutic Class Wars, supra note 71, at 1350. For example, in the nasal allergy pharmaceutical market, Schering-Plough markets Claritin® and Claritin-D®, Merrell Pharmaceuticals markets Allegra®, Glaxo Wellcome markets Flonase® and Vacenase®, Rhone-Poulenc Rohr markets Nasalcort®, and Boehringer Ingelheim markets Atrovent®. See also Schering-Plough, Claritin®, Allergy Relief Zone (visited Mar. 30, 1998) 〈http://www.claritin.com〉.
154. See Kessler, Therapeutic Class Wars, supra note 71, at 1350. For example, in the nasal allergy pharmaceutical market, Schering-Plough markets Claritin® and Claritin-D®, Merrell Pharmaceuticals markets Allegra®, Glaxo Wellcome markets Flonase® and Vacenase®, Rhone-Poulenc Rohr markets Nasalcort®, and Boehringer Ingelheim markets Atrovent®. See also Schering-Plough, Claritin®, Allergy Relief Zone (visited Mar. 30, 1998) 〈http://www.claritin.com〉.
155. See Kessler, Therapeutic Class Wars, supra note 71, at 1350. Sales in the top eighteen therapeutic categories each exceeded $1 billion in 1993. Id. Drug companies selectively advertise drugs, reserving big DTC campaigns for drugs with large populations needing chronic treatment, such as for asthma and diabetes; acute therapy drugs with maintenance follow-up; long treatment cycles; and seasonal treatment. See Sandulli, supra note 14, at 42; Jan Hodnett, Targeting Consumers, 30 MED. MKTG. & MEDIA 91, 92-93 (1995).
156. See Kessler, Therapeutic Class Wars, supra note 71, at 1350. Sales in the top eighteen therapeutic categories each exceeded $1 billion in 1993. Id. Drug companies selectively advertise drugs, reserving big DTC campaigns for drugs with large populations needing chronic treatment, such as for asthma and diabetes; acute therapy drugs with maintenance follow-up; long treatment cycles; and seasonal treatment. See Sandulli, supra note 14, at 42; Jan Hodnett, Targeting Consumers, 30 MED. MKTG. & MEDIA 91, 92-93 (1995).
157. See Direct-to-Consumer Promotion Public Hearing, 60 Fed. Reg. 42,581 (Aug. 16, 1995); Direct-to-Consumer Promotion, 61 Fed. Reg. 24,314 (May 14, 1996); Kessler, Therapeutic Class Wars, supra note 71, at 1350.
158. See Direct-to-Consumer Promotion Public Hearing, 60 Fed. Reg. 42,581 (Aug. 16, 1995); Direct-to-Consumer Promotion, 61 Fed. Reg. 24,314 (May 14, 1996); Kessler, Therapeutic Class Wars, supra note 71, at 1350.
159. See Direct-to-Consumer Promotion Public Hearing, 60 Fed. Reg. 42,581 (Aug. 16, 1995); Direct-to-Consumer Promotion, 61 Fed. Reg. 24,314 (May 14, 1996); Kessler, Therapeutic Class Wars, supra note 71, at 1350.
160. See supra notes 93-109 and accompanying text. Congress also has been influenced FDA's advertising policy. For example, FDA has been the subject of several bills and legislative proposals seeking to limit the agency's authority over prescription drug promotion. See FDAMA, H.R. 1742, 104th Cong., 1st Sess. (1995). See also H.R. 2932, 104th Cong., 2d Sess. (1996); S. 1744, 104th Cong., 2d Sess. (1996); S. 1197, 104th Cong., 1st Sess. (1995).
161. See supra notes 93-109 and accompanying text. Congress also has been influenced FDA's advertising policy. For example, FDA has been the subject of several bills and legislative proposals seeking to limit the agency's authority over prescription drug promotion. See FDAMA, H.R. 1742, 104th Cong., 1st Sess. (1995). See also H.R. 2932, 104th Cong., 2d Sess. (1996); S. 1744, 104th Cong., 2d Sess. (1996); S. 1197, 104th Cong., 1st Sess. (1995).
162. See supra notes 93-109 and accompanying text. Congress also has been influenced FDA's advertising policy. For example, FDA has been the subject of several bills and legislative proposals seeking to limit the agency's authority over prescription drug promotion. See FDAMA, H.R. 1742, 104th Cong., 1st Sess. (1995). See also H.R. 2932, 104th Cong., 2d Sess. (1996); S. 1744, 104th Cong., 2d Sess. (1996); S. 1197, 104th Cong., 1st Sess. (1995).
163. See supra notes 93-109 and accompanying text. Congress also has been influenced FDA's advertising policy. For example, FDA has been the subject of several bills and legislative proposals seeking to limit the agency's authority over prescription drug promotion. See FDAMA, H.R. 1742, 104th Cong., 1st Sess. (1995). See also H.R. 2932, 104th Cong., 2d Sess. (1996); S. 1744, 104th Cong., 2d Sess. (1996); S. 1197, 104th Cong., 1st Sess. (1995).
164. See supra notes 1-4 and accompanying text.
165. Nordenberg, supra note 7, at 7 (quoting Alex Giaquinto, Senior Vice President, Worldwide Regulatory Affairs, Schering-Plough Corp. (manufacturer of Claritin®)).
166. See supra notes 99-105 and accompanying text.
167. See supra notes 32-34 and accompanying text.
168. See supra notes 39-42 and accompanying text.
169. See Letter from Russell Fleischer, Regulatory Review Officer, DDMAC, FDA, to Michelle N. Hardy, Regulatory Affairs, Glaxo-Wellcome (Jan. 28, 1997) (notice-of-violation letter for Valtrex® broadcast advertisement making indication claims without a brief summary); Letter from Joan Hankin, Regulatory Review Officer, DDMAC, FDA, to Ronald J. Garutti, Director, Marketed Products Support, Schering Corp. (Mar. 3, 1997) (notice-of-violation letter for Claritin® broadcast advertisement making indication claims without brief summary).
170. Letter from Joan Hankin, Regulatory Review Officer, DDMAC, FDA, to Ronald J. Garutti, Director, Marketed Products Support, Schering Corp. (Mar, 26, 1997); Letter from Minnie Baylor-Henry, Director, DDMAC, FDA, to Richard U. De Schutter, Chairman, President & CEO, G.D. Scarle & Co. (Nov. 21, 1997).
171. See supra note 118-19.
172. See supra notes 67-121 and accompanying text.
173. See supra notes 93-123 and accompanying text.
174. See Pines, supra note 65, at 62.
175. Direct-to-Consumer Promotion Public Hearing Announced, 60 Fed. Reg. 42,581 (Aug. 16, 1995).
176. See id.
177. Direct to Consumer Promotion, 61 Fed. Reg. 24,314, 24,315 (May 14, 1996).
178. 62 Fed. Reg. at 43,171. The Draft Guidance did not announce a dramatic change or stray from the original prescription drug advertising regulations; rather it merely clarified FDA's interpretation of the all-important phrase "adequate provision" in prescription drug broadcast advertising. Id.
179. 62 Fed. Reg. at 43,171. The Draft Guidance did not announce a dramatic change or stray from the original prescription drug advertising regulations; rather it merely clarified FDA's interpretation of the all-important phrase "adequate provision" in prescription drug broadcast advertising. Id.
180. See Notice of the FDA's Development, Issuance, and Use of Guidance Documents, 62 Fed. Reg. 8961, 8963 (Feb. 27, 1997); Community Nutrition Inst. v. Young, 818 F.2d 943 (D.C. Cir. 1987) (holding guidance documents not binding on FDA). Guidance documents include "documents prepared by FDA, applicants/sponsors, and the public" that "describe the Agency's policy and regulatory approach to an issue." 62 Fed. Reg. at 8961.
181. See Notice of the FDA's Development, Issuance, and Use of Guidance Documents, 62 Fed. Reg. 8961, 8963 (Feb. 27, 1997); Community Nutrition Inst. v. Young, 818 F.2d 943 (D.C. Cir. 1987) (holding guidance documents not binding on FDA). Guidance documents include "documents prepared by FDA, applicants/sponsors, and the public" that "describe the Agency's policy and regulatory approach to an issue." 62 Fed. Reg. at 8961.
182. Id. at 8962, 8964.
183. See 62 Fed. Reg. at 43,171. In issuing the Draft Guidance, FDA requested comments and other information pertaining to the Draft Guidance policy's effectiveness. Id.
184. See 62 Fed. Reg. at 43,171. In issuing the Draft Guidance, FDA requested comments and other information pertaining to the Draft Guidance policy's effectiveness. Id.
185. See 62 Fed. Reg. at 8962 (discussing Administrative Procedure Act requirements for rulemaking).
186. Id.
187. See supra notes 55-60 and accompanying text for FDA enforcement authority. Guidance documents will not use mandatory language. 62 Fed. Reg. at 8963. Establishing policy via guidance documents gives the public less input and FDA more flexibility. While the lack of public involvement in the development of guidance documents is a valid concern, it is preferable for the agency to announce its policy in the form of guidance documents, rather than establishing policy piecemeal in regulatory warning letters to individual drug manufacturers. Id; Community Nutrition Inst., 818 F.2d at 943. The pharmaceutical industry, however, should note that the agency can change its policy with no public input or formal administrative procedure.
188. See supra notes 55-60 and accompanying text for FDA enforcement authority. Guidance documents will not use mandatory language. 62 Fed. Reg. at 8963. Establishing policy via guidance documents gives the public less input and FDA more flexibility. While the lack of public involvement in the development of guidance documents is a valid concern, it is preferable for the agency to announce its policy in the form of guidance documents, rather than establishing policy piecemeal in regulatory warning letters to individual drug manufacturers. Id; Community Nutrition Inst., 818 F.2d at 943. The pharmaceutical industry, however, should note that the agency can change its policy with no public input or formal administrative procedure.
189. 21 C.F.R. § 202.1(e)(1). The Draft Guidance does not change the major statement provision. Draft Guidance, supra note 10, at 1.
190. 21 C.F.R. § 202.1(e)(1). See also supra notes 32-34 and accompanying text.
191. Draft Guidance, supra note 10, at 1.
192. Id.
193. Id. at 2. See, e.g., Astra Merck: Prilosec® advertisement (CBS television broadcast, Mar. 11, 1998); Glaxo Wellcome: Flonase® advertisement (CBS television broadcast, Mar. 11, 1998); Merck: Zocor® advertisement (CBS television broadcast, Mar. 27, 1998); Bristol-Myers Squibb: Pravachol® advertisement (CBS television broadcast, Mar, 27, 1998).
194. See Borzo, supra, note 11, at 3. "There seems to be some miscommunication . . . so let me clarify it here: To comply with this approach, an advertiser would have to include all four of these components." Id. (quoting Nancy Ostrove, FDA public health analyst) (emphasis added); Letter from Stephen W. Sherman, Regulatory Review Officer, DDMAC, FDA, to Vivian Chester, Vice President, Regulatory Affairs, McNeil Consumer Products Co. (Mar. 19, 1998) (notice-of-violation letter regarding broadcast ad for Nicotrol Inhaler® charging adequate provision requirement was not met because advertisement recommended viewer to "ask your doctor," rather than "ask your doctor for additional product information."); Letter from Jean B. Raymond, Regulatory Review Officer, DDMAC, FDA, to Brenda Horn, Regulatory Affairs, Gualderma Laboratories, Inc. (Mar. 20, 1998) (notice-of-violation letter regarding Metrogel® broadcast advertisement, stating that the advertisement must include reference to product information in "magazines, newspapers, or brochures" to satisfy adequate provision requirement).
195. Draft Guidance, supra note 10, at 2.
196. See Letter from Warren F. Rumble, Regulatory Review Officer, DDMAC, FDA, to Richard Gural, Vice President Regulatory Affairs, Alcon Laboratories, Inc. (Mar. 20, 1998) (notice-of-violation letter regarding Patanol® broadcast advertisement that stated "a few people may experience side effects, like a headache," which FDA considered inadequate presentation of risk information).
197. See, e.g.,. Zocor®, supra note 138Flonase®, supra note 138. See also Elizabeth A. Rothermich et al., Health-Related Quality of Life Claims in Prescription Drug Advertisements, 53 AM. J. HEALTH-SYST. PHARM. 1565, 1567 (1996).
198. See, e.g., Stephen W. Sherman, supra note 139, at 1 (notice-of-violation letter regarding broadcast advertisement for Nicotrol Inhaler® that failed to present risk information prominently "during the audio presentation of the risk information, six different visual presentations distract attention from" and "interfere with" risk presentation).
199. See supra notes 44-51 and accompanying text.
200. See Media Rules Change, supra note 7 (quoting Robert Temple, Associate Director of Medical Policy, FDA).
201. See id. See, e.g., Letter from Lesley R. Frank, Regulatory Counsel, DDMAC, FDA, to Joseph S. Sonk, Senior Director, Women's Healthcare Products, Wyeth-Ayerst Research (Oct. 30, 1997) (expressing thanks for notification of misleading promotional claims made by competitor Parke-Davis). Drug companies also must maintain credibility with consumers; this requirement serves as an incentive to follow FDA guidelines, thereby avoiding a corrective campaign. See Media Rules Change, supra note 7.
202. See id. See, e.g., Letter from Lesley R. Frank, Regulatory Counsel, DDMAC, FDA, to Joseph S. Sonk, Senior Director, Women's Healthcare Products, Wyeth-Ayerst Research (Oct. 30, 1997) (expressing thanks for notification of misleading promotional claims made by competitor Parke-Davis). Drug companies also must maintain credibility with consumers; this requirement serves as an incentive to follow FDA guidelines, thereby avoiding a corrective campaign. See Media Rules Change, supra note 7.
203. Draft Guidance, supra note 10, at 1.
204. Id.
205. Id. at 2. "Timely manner" means labeling must be mailed within two days of the request for receipt by the requester within four to six days and must be faxed on completion or within a few hours of the call. Id. at 2. See also Letter from Joan Hankin, Regulatory Review Officer, DDMAC, FDA, to Ronald J. Garutti, Director, Schering Corp. (Mar. 10, 1997) (notice-of-violation letter stating "DDMAC does not consider a two-three week actual response time for receipt of the Claritin® approved product labeling to meet the 'adequate provision' requirements.").
206. Id. at 2. "Timely manner" means labeling must be mailed within two days of the request for receipt by the requester within four to six days and must be faxed on completion or within a few hours of the call. Id. at 2. See also Letter from Joan Hankin, Regulatory Review Officer, DDMAC, FDA, to Ronald J. Garutti, Director, Schering Corp. (Mar. 10, 1997) (notice-of-violation letter stating "DDMAC does not consider a two-three week actual response time for receipt of the Claritin® approved product labeling to meet the 'adequate provision' requirements.").
207. Draft Guidance, supra note 10, at 2. The Draft Guidance suggests this requirement can be fulfilled by offering the consumer a selection of prerecorded labeling topics. Id.
208. Draft Guidance, supra note 10, at 2. The Draft Guidance suggests this requirement can be fulfilled by offering the consumer a selection of prerecorded labeling topics. Id.
209. Id.
210. Prescription drug commercials have referred to print advertisements in People, Newsweek, and Cooking Light. For example, see Prilosec®, supra note 138; Flonase®, supra note 138; Pravachol®, supra note 138; Zocor®, supra note 138.
211. Draft Guidance, supra note 10, at 2. See 21 C.F.R. § 202.1 (e)(1); supra notes 32-34 and accompanying text.
212. Draft Guidance, supra note 10, at 2.
213. Id.
214. Id.
215. Id.
216. Id.
217. Id. See supra notes 88-121 and accompanying text for issues surrounding FDA regulation of prescription drug promotion. See infra notes 168 for drug manufacturers' use of Internet websites to fulfill the adequate provision requirement.
218. Draft Guidance, supra note 10, at 2.
219. Id.
220. Id. (emphasis added). The Draft Guidance gives FDA-approved patient labeling as an example of nonpromotional, consumer-friendly product information, such as PPIs for estrogenic drugs. Id.
221. Id. (emphasis added). The Draft Guidance gives FDA-approved patient labeling as an example of nonpromotional, consumer-friendly product information, such as PPIs for estrogenic drugs. Id.
222. See infra notes 164-69 and accompanying text.
223. The call is used to solicit consumer information from the targeted patient population, which could be used in subsequent marketing campaigns. See infra note 166 and accompanying text.
224. Telephone interview with Renova® information specialist, Ortho Pharmaceuticals Corp. (Mar. 2, 1998) (requesting basic demographic information from caller); telephone interview with Valtrex® information specialist, Glaxo Wellcome (Feb. 20, 1998) (requesting personal health information from caller in a survey, including such questions as "How long have you had Herpes?" and "What other treatments have you sought?").
225. See telephone interview with Renova® information specialist, supra note 165; telephone interview with Valtrex® information specialist, supra note 165. Notably, medical records and information shared by a patient with his or her physician generally are protected. See, e.g., Drug Abuse and Treatment Acts and Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act, 42 U.S.C. §§ 290dd-3, 390ee-3 (West 1994 & Supp. 1996) (imposing rigorous requirements on disclosure of information from alcohol and drug abuse treatment programs); Berry v. Moench, 331 P.2d 814 (Utah 1958) (imposing liability on doctors for violating duty of confidentiality expressed or implied in state licensure or privilege statute); Felis v. Greenberg, 273 N.Y.S. 2d 288 (1966); Humphers v. First Interstate Bank of Or., 696 P.2d 527 (Or. 1985) (holding physician had duty under state statute to keep patient's medical information confidential).
226. See, e.g., HEADWAY: THE MIGRAINE NEWSLETTER, Vol. 3, No. 3 (published by Glaxo Wellcome, Shawnee Mission, KS) (received following earlier request and receipt of approved Imitrex® labeling). Accompanying the product labeling, a consumer may receive any of the following: • a list of doctors in the area that prescribe the product (see Letter from Sherrin E. Johnson, Senior Product Director for Renova®, Ortho Pharmaceuticals Corp., to author (Mar. 28, 1998) (on file with author) [hereinafter Renova® packet]); • a diary in which to record symptoms and bring to a doctor appointment (see Letter from Astra Merck, to author (Mar. 22, 1998) (diary accompanying Prilosec® product information packet to help doctor "evaluate your symptoms") (on file with author)); • a questionnaire to help the consumer determine if he or she is suffering from a certain health problem or disease (see Letter from Migraine Resource Center, Glaxo Wellcome, to author (Mar. 15, 1998) (accompanying Imitrex® product information packet) (on file with author)); • a survey accompanied by prepaid postage envelopes (see Letter from Miles Jones, Senior Product Manager for Valtrex®, to author (Mar. 4, 1998) (accompanying Valtrex® product information packet) (on file with author) [hereinafter Valtrex® packet]); or • product discount coupons (see Valtrex® packet; Renova® packet; Letter from Mark Salyer, Director, Respiratory Products, Glaxo Wellcome, to author (Mar. 15, 1998) (accompanying Flonase® product information packet) (on file with author) [hereinafter Flonase® packet]). Product coupons may offer a $5.00 discount, for example, or a "free trial" of the drug. See Flonase®, packet supra.
227. The confidentiality of consumer information also is an issue for Internet websites. See Janet Carlson, Online Turn On: Reaching the Health-service Consumer, 32 MED. MKTG. & MEDIA 61,61 (1997). Similarly, the required Internet websites also give manufacturers a promotional opportunity. A website visitor in search of product labeling information may be: • invited to enter a weekly give-away (see Schering Co., Allergy Relief Zone: Claritin®(visited Mar. 30, 1998) 〈http://www.claritin.com〉); • offered product news letter subscriptions (see Glaxo Wellcome, Migraine Resource Center: Imitrex® (visited Apr. 26, 1998) 〈http://www.imitrex.com〉 (offering free subscription to Headway, a newsletter for migraine sufferers)); or • product coupons (see Glaxo Wellcome, Welcome to Flonase.com: Flonase® (visited Mar. 30, 1998) 〈http:/ /www.flonase.com〉 (offering free nasal allergy kit, including $5 savings certificate, subscription to On the Nose newsletter, and information on products that treat nasal allergies)). Conversely, product websites may be useful as they may feature product labeling, disease information, and links to other health related websites. See infra note 183. See also Carlson, supra note 168, at 61 (describing consumer service health information websites).
228. The confidentiality of consumer information also is an issue for Internet websites. See Janet Carlson, Online Turn On: Reaching the Health-service Consumer, 32 MED. MKTG. & MEDIA 61,61 (1997). Similarly, the required Internet websites also give manufacturers a promotional opportunity. A website visitor in search of product labeling information may be: • invited to enter a weekly give-away (see Schering Co., Allergy Relief Zone: Claritin®(visited Mar. 30, 1998) 〈http://www.claritin.com〉); • offered product news letter subscriptions (see Glaxo Wellcome, Migraine Resource Center: Imitrex® (visited Apr. 26, 1998) 〈http://www.imitrex.com〉 (offering free subscription to Headway, a newsletter for migraine sufferers)); or • product coupons (see Glaxo Wellcome, Welcome to Flonase.com: Flonase® (visited Mar. 30, 1998) 〈http:/ /www.flonase.com〉 (offering free nasal allergy kit, including $5 savings certificate, subscription to On the Nose newsletter, and information on products that treat nasal allergies)). Conversely, product websites may be useful as they may feature product labeling, disease information, and links to other health related websites. See infra note 183. See also Carlson, supra note 168, at 61 (describing consumer service health information websites).
229. The confidentiality of consumer information also is an issue for Internet websites. See Janet Carlson, Online Turn On: Reaching the Health-service Consumer, 32 MED. MKTG. & MEDIA 61,61 (1997). Similarly, the required Internet websites also give manufacturers a promotional opportunity. A website visitor in search of product labeling information may be: • invited to enter a weekly give-away (see Schering Co., Allergy Relief Zone: Claritin®(visited Mar. 30, 1998) 〈http://www.claritin.com〉); • offered product news letter subscriptions (see Glaxo Wellcome, Migraine Resource Center: Imitrex® (visited Apr. 26, 1998) 〈http://www.imitrex.com〉 (offering free subscription to Headway, a newsletter for migraine sufferers)); or • product coupons (see Glaxo Wellcome, Welcome to Flonase.com: Flonase® (visited Mar. 30, 1998) 〈http:/ /www.flonase.com〉 (offering free nasal allergy kit, including $5 savings certificate, subscription to On the Nose newsletter, and information on products that treat nasal allergies)). Conversely, product websites may be useful as they may feature product labeling, disease information, and links to other health related websites. See infra note 183. See also Carlson, supra note 168, at 61 (describing consumer service health information websites).
230. The confidentiality of consumer information also is an issue for Internet websites. See Janet Carlson, Online Turn On: Reaching the Health-service Consumer, 32 MED. MKTG. & MEDIA 61,61 (1997). Similarly, the required Internet websites also give manufacturers a promotional opportunity. A website visitor in search of product labeling information may be: • invited to enter a weekly give-away (see Schering Co., Allergy Relief Zone: Claritin®(visited Mar. 30, 1998) 〈http://www.claritin.com〉); • offered product news letter subscriptions (see Glaxo Wellcome, Migraine Resource Center: Imitrex® (visited Apr. 26, 1998) 〈http://www.imitrex.com〉 (offering free subscription to Headway, a newsletter for migraine sufferers)); or • product coupons (see Glaxo Wellcome, Welcome to Flonase.com: Flonase® (visited Mar. 30, 1998) 〈http:/ /www.flonase.com〉 (offering free nasal allergy kit, including $5 savings certificate, subscription to On the Nose newsletter, and information on products that treat nasal allergies)). Conversely, product websites may be useful as they may feature product labeling, disease information, and links to other health related websites. See infra note 183. See also Carlson, supra note 168, at 61 (describing consumer service health information websites).
231. Such claims, however, could not be related to the safety and effectiveness of the drug. See supra note 77 and accompanying text. For example, based on response to a consumer survey, a drug company may claim, "100,000 people have tried Nasalcort® and switched to Flonase®."
232. See supra note 167.
233. See Sandulli, supra note 14, at 48 ("[e]ffecrive messages to consumers need to be simple and easily understood").
234. For example, the product information packets for Imitrex® and Prilosec® contained disease-oriented informational brochures that educate the consumer about the disease or symptoms for which the product is prescribed. See supra note 167.
235. See supra notes 32-34 and accompanying text.
236. As noted, incentives include diaries, coupons, and questionnaires to help identity candidates for a drug. See supra note 167 and accompanying text.
237. See supra notes 88-92 and accompanying text.
238. Id.
239. Id.
240. See Draft Guidance, supra note 10, at 3; see supra notes 88-92 and accompanying text (regarding FDA MedGuide initiative to improve product labeling for consumers).
241. Draft Guidance, supra note 10, at 3.
242. See supra notes 88-92 and accompanying text. The need for nonpromotional information written for patients could provide additional support for expediting compliance or making mandatory the agency's MedGuide initiative. See id
243. See Availability of Draft Guidance for Industry, 62 Fed. Reg. at 43, 171.
244. See id; Draft Guidance, supra note 10, at 3 (suggesting that FDA recognizes the limits of promoting only the approved product labeling in response to requests for product information).
245. See id; Draft Guidance, supra note 10, at 3 (suggesting that FDA recognizes the limits of promoting only the approved product labeling in response to requests for product information).
246. Industry's attempt to meet consumer information needs has spawned the new trend of direct-to-patient (DTP) advertising, a kind of continuing medical education for consumers. See Jan Hodnett, supra note 110, at 95. DTP advertising is patient-oriented, although drug companies sponsor DTP materials and may refer to specific drug products. DTP advertisements tend to be more informational than promotional, dealing with general health and quality of life improvement topics. Publications like Headway (see HEADWAY, supra note 167 (Glaxo Wellcome, maker of Imitrex®) (containing information on headache triggers and testimonials); infomercials like Women Only: What To Do When Hair Gets Thinner (see Hodnett, supra note 110, at 94 (Roche, maker of Rogaine®)); and Internet websites educate consumers about specific diseases and symptoms, as well as treatments. See Allergy Relief Zone, supra note 109 (Schering Plough, maker of Claritin®) (featuring a monthly information newsletter, and offered to create a customized area for the web visitor to give customized information such as daily pollen counts in the area where the web visitor lives). See also Welcome to Flonase.com: Flonase®, supra note 168 (visited Mar. 30, 1998) 〈http://www.flonase.com〉 ( featuring a hypertext link to frequently asked questions about nasal allergies, answered by a prominent physician, as well as an offer to receive the company-sponsored allergy information newsletter On the Nose); The Cholesterol Medicine That Helps Save Lives: Zocor®, (visited Mar. 30, 1998) 〈http://www.zocor.com〉 (featuring a "risk factor" quiz designed to give a personalized heart disease risk assessment as well as commonly asked questions about heart attack prevention); What You Should Know About First Heart Attack Prevention and Pravachol®, (visited Mar. 30, 1998) 〈http://www.pravachol.com〉 (featuring a "risk factor" quiz designed to give a personalized heart disease risk assessment as well as commonly asked questions about heart attack prevention).
247. Industry's attempt to meet consumer information needs has spawned the new trend of direct-to-patient (DTP) advertising, a kind of continuing medical education for consumers. See Jan Hodnett, supra note 110, at 95. DTP advertising is patient-oriented, although drug companies sponsor DTP materials and may refer to specific drug products. DTP advertisements tend to be more informational than promotional, dealing with general health and quality of life improvement topics. Publications like Headway (see HEADWAY, supra note 167 (Glaxo Wellcome, maker of Imitrex®) (containing information on headache triggers and testimonials); infomercials like Women Only: What To Do When Hair Gets Thinner (see Hodnett, supra note 110, at 94 (Roche, maker of Rogaine®)); and Internet websites educate consumers about specific diseases and symptoms, as well as treatments. See Allergy Relief Zone, supra note 109 (Schering Plough, maker of Claritin®) (featuring a monthly information newsletter, and offered to create a customized area for the web visitor to give customized information such as daily pollen counts in the area where the web visitor lives). See also Welcome to Flonase.com: Flonase®, supra note 168 (visited Mar. 30, 1998) 〈http://www.flonase.com〉 ( featuring a hypertext link to frequently asked questions about nasal allergies, answered by a prominent physician, as well as an offer to receive the company-sponsored allergy information newsletter On the Nose); The Cholesterol Medicine That Helps Save Lives: Zocor®, (visited Mar. 30, 1998) 〈http://www.zocor.com〉 (featuring a "risk factor" quiz designed to give a personalized heart disease risk assessment as well as commonly asked questions about heart attack prevention); What You Should Know About First Heart Attack Prevention and Pravachol®, (visited Mar. 30, 1998) 〈http://www.pravachol.com〉 (featuring a "risk factor" quiz designed to give a personalized heart disease risk assessment as well as commonly asked questions about heart attack prevention).
248. Industry's attempt to meet consumer information needs has spawned the new trend of direct-to-patient (DTP) advertising, a kind of continuing medical education for consumers. See Jan Hodnett, supra note 110, at 95. DTP advertising is patient-oriented, although drug companies sponsor DTP materials and may refer to specific drug products. DTP advertisements tend to be more informational than promotional, dealing with general health and quality of life improvement topics. Publications like Headway (see HEADWAY, supra note 167 (Glaxo Wellcome, maker of Imitrex®) (containing information on headache triggers and testimonials); infomercials like Women Only: What To Do When Hair Gets Thinner (see Hodnett, supra note 110, at 94 (Roche, maker of Rogaine®)); and Internet websites educate consumers about specific diseases and symptoms, as well as treatments. See Allergy Relief Zone, supra note 109 (Schering Plough, maker of Claritin®) (featuring a monthly information newsletter, and offered to create a customized area for the web visitor to give customized information such as daily pollen counts in the area where the web visitor lives). See also Welcome to Flonase.com: Flonase®, supra note 168 (visited Mar. 30, 1998) 〈http://www.flonase.com〉 ( featuring a hypertext link to frequently asked questions about nasal allergies, answered by a prominent physician, as well as an offer to receive the company-sponsored allergy information newsletter On the Nose); The Cholesterol Medicine That Helps Save Lives: Zocor®, (visited Mar. 30, 1998) 〈http://www.zocor.com〉 (featuring a "risk factor" quiz designed to give a personalized heart disease risk assessment as well as commonly asked questions about heart attack prevention); What You Should Know About First Heart Attack Prevention and Pravachol®, (visited Mar. 30, 1998) 〈http://www.pravachol.com〉 (featuring a "risk factor" quiz designed to give a personalized heart disease risk assessment as well as commonly asked questions about heart attack prevention).
249. Industry's attempt to meet consumer information needs has spawned the new trend of direct-to-patient (DTP) advertising, a kind of continuing medical education for consumers. See Jan Hodnett, supra note 110, at 95. DTP advertising is patient-oriented, although drug companies sponsor DTP materials and may refer to specific drug products. DTP advertisements tend to be more informational than promotional, dealing with general health and quality of life improvement topics. Publications like Headway (see HEADWAY, supra note 167 (Glaxo Wellcome, maker of Imitrex®) (containing information on headache triggers and testimonials); infomercials like Women Only: What To Do When Hair Gets Thinner (see Hodnett, supra note 110, at 94 (Roche, maker of Rogaine®)); and Internet websites educate consumers about specific diseases and symptoms, as well as treatments. See Allergy Relief Zone, supra note 109 (Schering Plough, maker of Claritin®) (featuring a monthly information newsletter, and offered to create a customized area for the web visitor to give customized information such as daily pollen counts in the area where the web visitor lives). See also Welcome to Flonase.com: Flonase®, supra note 168 (visited Mar. 30, 1998) 〈http://www.flonase.com〉 ( featuring a hypertext link to frequently asked questions about nasal allergies, answered by a prominent physician, as well as an offer to receive the company-sponsored allergy information newsletter On the Nose); The Cholesterol Medicine That Helps Save Lives: Zocor®, (visited Mar. 30, 1998) 〈http://www.zocor.com〉 (featuring a "risk factor" quiz designed to give a personalized heart disease risk assessment as well as commonly asked questions about heart attack prevention); What You Should Know About First Heart Attack Prevention and Pravachol®, (visited Mar. 30, 1998) 〈http://www.pravachol.com〉 (featuring a "risk factor" quiz designed to give a personalized heart disease risk assessment as well as commonly asked questions about heart attack prevention).
250. See supra notes 88-95 for FDA'S concern about meeting consumer information needs.
251. This monitoring particularly should occur to ensure drug companies do not invent health problems and then provide a solution with their advertised prescription product. See e.g., Wilke, supra note 10, at 1 (reporting on recent toenail fungus advertising campaign by Jannsen Pharmaceuticals).
252. As discussed, consumers need information on prescription drug therapy in light of managed care and restrictive drug formularies in order to ensure that they receive adequate healthcare services. Consumers' prescription drug information needs currently are not met under the present framework. The new DTC broadcast advertising Draft Guidance for Industry will aid in improving consumer access to information. See supra notes 138-40, 147-55 and accompanying text. Though the product information delivered by drug manufacturers is promotional in nature, it can help fill the public health and drug information void. The product materials are consumer-oriented, so consumers are more likely to actually read and understand it.