1 Drug Industry Act of 1962: Hearing on H.R. 11581 and H.R. 11582 before the H. Comm. on Interstate and Foreign Commerce, 87th Cong. 505 (1962), at 505 (statement of Miles H. Robinson, M.D.).Google Scholar

2 Id.

3 Drug Amendments of 1962 (Kefauver-Harris Amendments), Pub. L. No. 87-781, 76 Stat. 780, 781 (codified as amended 21 U.S.C. § 505(b) (2008)).

4 Drug Amendments of 1962, § 102(c), 76 Stat. at 781 (2008).

5 Evans, Barbara J., Seven Pillars of the New Evidentiary Paradigm: The Food, Drug, and Cosmetic Act Enters the Genomic Era, 85 Notre Dame L. Rev. 419, 434 (2010)Google Scholar.

6 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 55-56 (D.D.C. 1998), order amended by 36 F. Supp. 2d 16 (D.D.C. 1999), vacated in part by Wash. Legal Found. v. Henney, 202 F.3d 331 (D.C. Cir. 2000).

7 See Greenwood, Kate, The Mysteries of Pregnancy: The Role of Law in Solving the Problem of Unknown but Knowable Maternal-Fetal Medication Risk, 79 U. Cin. L. Rev. 267, 291-94 (2010).Google Scholar

8 See Investigational New Drug Application, 21 C.F.R. § 312.7(a) (2010) (banning promotion of investigational new drugs with the caveat that this “is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media”).

9 See Citizen Petition Regarding the Food and Drug Administration’s Policy on Promotion of Unapproved Uses of Approved Drugs and Devices; Request for Comments, 59 Fed. Reg. 59,820, 59,823 (Nov. 18, 1994) (providing that “information on unapproved uses may be disseminated through the submission of original research to peer-reviewed publications”).

10 Id. (providing that “companies may . . . disseminate information on unapproved uses in response to unsolicited requests for scientific information from health care professionals”).

11 Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,074, 64,093-100 (Dec. 3, 1997).

12 See Office of Policy, Office of the Comm’r, Food and Drug Admin., Guidance for Industry – Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (2009), available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm.

13 See, e.g., Osborn, John. E., Can I Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information, 10 Yale J. Health Pol’y L. & Ethics 299, 318 (2010)Google ScholarPubMed (“However . . . no federal appellate court and very few other federal district courts have had the occasion to opine on the question of whether the FDA’s policy of prohibiting the dissemination of truthful, non-misleading off-label scientific and medical information is unconstitutional”); Hall, Ralph F. & Sobotka, Elizabeth S., Inconsistent Government Policies: Why FDA Off-Label Regulation Cannot Survive First Amendment Review Under Greater New Orleans, 62 Food & Drug L.J. 1, 8 (2007)Google ScholarPubMed (“The issue that concerns the authors is whether FDA can prohibit truthful, off-label speech”); Elizabeth Blackwell, A. & Beck, James M., Drug Manufacturers’ First Amendment Right to Advertise and Promote Their Products for Off-Label Use: Avoiding a Pyrrhic Victory, 58 Food & Drug L.J. 439, 451 (2003)Google Scholar (“Further, FDA cannot justify the prohibition on truthful promotion of off-label uses by asserting concern that physicians might misuse the information provided in making their prescription choices.”).

14 Memorandum of Law in Support of Motion for Preliminary Injunction at 3, Allergan v. United States, No. 1:09-cv-01879-JDB (D.D.C. Oct. 1, 2009).

15 44 Liquormart v. Rhode Island, 517 U.S. 484, 503 (1996) (Stevens, J., Kennedy & Ginsburg, JJ., joining).

16 Id.

17 Id. at 501 (citation omitted).

18 Waxman, Henry A., A History of Adverse Drug Experiences: Congress Had Ample Evidence to Support Restrictions on the Promotion of Prescription Drugs, 58 Food & Drug L.J. 299, 303 (2003).Google ScholarPubMed

19 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 74-75 (D.D.C. 1998); Thompson v. W. States Med. Ctr., 535 U.S. 357, 357 (2002).

20 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d at 87.

21 In re R.M.J., 455 U.S. 191, 203 (1982).

22 Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 566 (1980).

23 Id.

24 Ibanez v. Fla. Dep’t of Bus. & Prof’l Regulation, Bd. of Accountancy, 512 U.S. 136, 142 (1994) (“[O]nly false, deceptive, or misleading commercial speech may be banned.”).

25 Edenfield v. Fane, 507 U.S. 761, 768-69 (1993).

26 Int’l Dairy Foods Ass’n v. Boggs, 622 F.3d 628, 636 (6th Cir. 2010).

27 Thompson v. W. States Med. Ctr., 535 U.S. 357, 371 (2002).

28 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 67 (D.D.C. 1998).

29 Id.

30 Id. at 69-70.

31 Id. at 56, 69-71.

32 Id. at 71.

33 Id. at 66 (explaining that because “the drugs subject to off-label prescriptions are already in interstate commerce . . . the obvious restriction on conduct is unavailable. Therefore, one of the few mechanisms available to FDA to compel manufacturer behavior is to constrain their marketing options; i.e. control the labeling, advertising and marketing.”). Without the ban on off-label promotion, companies’ incentives would weigh heavily in favor of ignorance. See generally Greenwood, supra note 7, at 280-306 (explaining that neither the three additional years of data exclusivity awarded under the Drug Price Competition and Patent Term Restoration Act of 1984 nor products liability law provide adequate incentives for knowledge-development).

34 Defendants’ Reply in Support of Motion to Dismiss or for Summary Judgment and Response to Cross-Motion for Summary Judgment at 2, Allergan v. United States, No. 1:09-cv-01879-JDB (D.D.C. Mar. 29, 2010).

35 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d at 73.

36 Id.

37 Id. at 68.

38 Id.

39 Id. at 69.

40 In fact, in a later decision the WLF court opined that “restrict[ing] constitutionally protected speech as an incentive device” is “a kind of constitutional blackmail” that “cannot survive judicial scrutiny.” Wash. Legal Found. v. Henney, 56 F. Supp. 2d 81, 86 n.7, 87 (1999).

41 Id.

42 Thompson v. W. States Med. Ctr., 535 U.S. 357, 368 (2002).

43 Id. at 369 (“Preserving the effectiveness and integrity of the FDCA’s new drug approval process is clearly an important governmental interest, and the Government has every reason to want as many drugs as possible to be subject to that approval process.”).

44 Id. at 372.

45 Id. at 376.

46 Edenfield v. Fane, 507 U.S. 761, 769 (1993).

47 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 72-73 (D.D.C 1998).

48 Central Hudson, 447 U.S. at 566.

49 See 44 Liquormart v. Rhode Island, 517 U.S. 484, 529-30 (O’Connor, J., joined by Rehnquist, C.J., Souter & Breyer, JJ., concurring) (explaining that “[i]f alternative channels permit communication of the restricted speech, the regulation is more likely to be considered reasonable[]” and that “[t]he availability of less burdensome alternatives to reach the stated goal signals that the fit between the legislature’s ends and the means chosen to accomplish those ends may be too imprecise to withstand First Amendment scrutiny”).

50 Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 556 (2001) (“We have made it clear that ‘the least restrictive means’ is not the standard; instead, the case law requires a reasonable ‘fit between the legislature’s ends and the means chosen to accomplish those ends, . . . a means narrowly tailored to achieve the desired objective.’”).

51 See Pearson v. Shalala, 164 F.3d 650, 659 (D.C. Cir. 1999) (taking issue with four specific FDA decisions regarding health claims about dietary supplements and remanding to the FDA to “draft precise disclaimers for each of appellants’ four claims[,]” without “rul[ing] out the possibility that where evidence in support of a claim is outweighed by evidence against the claim, the FDA could deem it incurable by a disclaimer and ban it outright”). Notably, when passing the revisions to the FDCA at issue in Pearson, Congress found that “safety problems with supplements are relatively rare.” Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, § 2(14), 108 Stat. 4325, 4326 (finding that dietary supplements are “safe within a broad range of intake, and safety problems with the supplements are relatively rare”). Given the absence of a risk that consumers would be harmed, except by having their too-high expectations dashed, the court’s paternalism concerns were heightened. Pearson, 164 F.3d at 656. The Pearson court took care to distinguish dietary supplements from drugs, which “appear to be in an entirely different category—the potential harm presumably is much greater.” Id. at 656 n.6.

52 Evans, supra note 5, at 488 (“FDA’s traditional premarket study requirements continue in effect and will provide a certain ‘floor’ of risk-benefit information that will be available for all approved drugs (although, as has been the case before FDAAA, this floor will be somewhat moveable based on the choice of clinical trial endpoints).”).

53 Tushnet, Rebecca, It Depends on What the Meaning of “False” Is: Falsity and Misleadingness in Commercial Speech Doctrine, 41 Loy. L.A. L. Rev. 227, 227-28 (2007)Google Scholar (“A key issue in advertising law is whether regulation of deception can be wholesale or retail.”).

54 Benson v. Kwikset Corp., 152 Cal. App. 4th 1254, 1268 (Cal. 2007); see also, e.g., Joe Conte Toyota, Inc. v. La. Motor Vehicle Comm’n, 24 F.3d 754, 754 (5th Cir. 1994) (upholding ban on use of “invoice price”); Adams Ford Belton, Inc. v. Mo. Motor Vehicle Comm’n, 946 S.W.2d 199, 203-05 (Mo. 1997) (same); Barry v. Arrow Pontiac, Inc., 494 A.2d 804, 815 (N.J. 1985) (same).

55 Benson, 152 Cal. App. 4th at 1268.

56 Bronco Wine Co. v. Jolly, 129 Cal. App. 4th 988, 999 (2005).

57 Id. at 1011.

58 Piazza’s Seafood World, LLC v. Odom, 448 F.3d 744, 747 n.7 (5th Cir. 2006).

59 Id. at 747.

60 Id. at 753.

61 Id.

62 Piazza’s Seafood World, LLC v. Odom, No. 04-690, 2004 U.S. Dist. LEXIS 25991, at *23 (E.D. La. Dec. 22, 2004).

63 Id.

64 Walraven v. NC Bd. of Chiropractic Exam’rs, 273 F. App’x 220, 226 (4th Cir. 2008).

65 Id. at 224-25 (quoting Walraven v. Cooper, No. 3:04-cv-21-W, 2007 WL 656284, at *2 (W.D.N.C. Feb. 27, 2007)).

66 Id. at 225 (quoting Walraven v. Cooper, 2007 WL 656284, at *3).

67 Id. at 225-26.

68 Id. at 226.

69 Goodman v. Ill. Dep’t of Fin. & Prof’l Regulation, 430 F.3d 432, 435 (7th Cir. 2005); see also Capobianco v. Summers, 377 F.3d 559, 560 (6th Cir. 2004) (upholding thirty-day moratorium on solicitation of accident victims by chiropractors or their agents); cf. Fla. Bar v. Went for It, Inc., 515 U.S. 618, 620 (1995) (upholding thirty-day moratorium on direct-mail solicitation of accident victims or their families by personal injury lawyers); Alexander v. Cahill, 598 F.3d 79, 82 (2d Cir. 2010) (upholding similar rule in New York).

70 Goodman, 430 F.3d at 436.

71 Id.

72 Id.

73 Id.

74 Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, 425 U.S. 748, 773 n.25 (1976).

75 Shapero v. Ky. Bar Ass’n, 486 U.S. 466, 475 (1988) (quoting Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626, 641 (1985)).

76 Goodman, 430 F.3d at 438.

77 Ohralik v. Ohio State Bar Ass’n, 436 U.S. 447, 466-67 (1978).

78 Greenwood, supra note 7, at 295.

79 Id.; Grande, David & Volpp, Kevin, Research Letter, Cost and Quality of Industry-Sponsored Meals for Medical Residents, 290 JAMA 1150, 1150-51 (2003).Google ScholarPubMed

80 Aaron S. Kesselheim et al., Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints, PLoS Med., Apr. 2011, at 2, 6.

81 Id. at 6.

82 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 73 (1998); see also id. at 59 (holding that physicians are “certainly capable of critically evaluating journal articles or textbook reprints that are mailed to them, or the findings presented at CME seminars” (emphasis added)).

83 Fed. Election Comm’n v. Wis. Right to Life, 551 U.S. 449, 466-68 (2007) (Roberts, J., Alito, J., joining).

84 Id. at 467-69.

85 Id. at 469.

86 Id.

87 Id.

88 In re R.M.J., 455 U.S. 191, 202 (1982).

89 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d at 66-67 (citing Central Hudson for the proposition that speech is “inherently misleading” if it is “more likely to deceive the public than to inform it,” Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 563 (1980)).

90 Shapero v. Ky. Bar Ass’n, 486 U.S. 466, 474 (1988).

91 Tushnet, supra note 53, at 234.

92 See, e.g., Pearson v. Shalala, 164 F.3d 650, 656 n.6 (D.C. Cir. 1999)

93 Bates v. State Bar of Ariz., 433 U.S. 350, 379 (1977).

94 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d at 70.

95 Id.

96 Fla. Bar v. Went for It, 515 U.S. 618, 626-27 (1995).

97 Bronco Wine Co. v. Jolly, 129 Cal. App. 4th 988, 1007 (2005).

98 Edenfield, 507 U.S. at 771; see also Rubin v. Coors Brewing Co., 514 U.S. 476, 490 (1995) (noting the government supported its argument mainly with “anecdotal evidence and educated guesses,” that the legislative history was scant, and that the government failed to update it with empirical evidence of current market conditions).

99 Waxman, supra note 18, at 303.

100 Id. at 302.

101 False and Misleading Advertising (Prescription Tranquilizing Drugs), Hearings Before the Subcomm. of Legal and Monetary Affairs of the H. Comm. on Gov’t Operations, 85th Cong. 177 (1958) (statement of Dr. Ian Stevenson, Chairman, Dep’t of Neurology and Psychiatry, Univ. of Va.).

102 Supplemental Declaration of Robert Temple, M.D., at 3, Allergan v. United States, No. 1:09-cv-01879-JDB (D.D.C. Mar. 29, 2010).

103 Id.

104 Paul S. Appelbaum, Contact with Pharmaceutical Representatives: Where Does Prudence Lead?, Am. J. Bioethics, Jan. 2010, at 11.

105 Ziegler, Michael G. et al., The Accuracy of Drug Information from Pharmaceutical Sales Representatives, 273 JAMA 1296, 1296-97 (1995)CrossRefGoogle ScholarPubMed; see also Lexchin, Joel, What Information Do Physicians Receive from Pharmaceutical Representatives?, 43 Can. Fam. Physician 941, 944 (1997)Google ScholarPubMed (reviewing study by Dr. Ziegler and his colleagues along with three other studies and finding that they “consistently demonstrated that detailers selectively transmit only positive information about their companies’ products. Side effects and contraindications are rarely mentioned, and the information that detailers give to physicians is frequently inaccurate.”).

106 Ziegler et al., supra note 105, at 1298.

107 Id.

108 Kesselheim et al., supra note 80, at 5.

109 Id.

110 Noordin Othman et al., Quality of Pharmaceutical Advertisements in Medical Journals: A Systematic Review, PLoS ONE, July 2009, at 7-8.

111 Id. at 8.

112 Id. at 10.

113 Some doctors will be misled by any off-label promotion, true or false, because they will believe that the use for which the drug is promoted has the FDA’s seal of approval. This would be minimized if the rules limiting off-label promotion were liberalized, however. If it were no longer impermissible to promote drugs for unapproved uses, promotion of a given use would no longer be as strong an indicator that the use was approved. Moreover, concern that off-label promotion will mislead physicians into thinking that unapproved uses are approved may be founded on an overestimation of the degree to which physicians are attuned to the actions of the FDA. The authors of a recently published national survey of physicians concluded that while “[t]here was a strong association between physicians’ belief that an indication was FDA-approved and greater evidence supporting efficacy for that use . . . 41% of physicians believed at least one drug-indication pair with uncertain or no supporting evidence . . . was FDA approved.” Chen, Donna T. et al., U.S. Physician Knowledge of the FDA-Approved Indications and Evidence Base for Commonly Prescribed Drugs: Results of a National Survey, 18 Pharmacoepidemiology & Drug Safety 1094, 1099 (2009)CrossRefGoogle ScholarPubMed.

114 Radley, David C. et al., Off-Label Prescribing Among Office-Based Physicians, 166 Archives Internal Med. 1021, 1023 (2006).CrossRefGoogle ScholarPubMed

115 Tushnet, supra note 53, at 245 (“‘Not treated with [synthetic growth hormone].’ The dispute is over whether the implications of ‘not treated with [synthetic growth hormone]’ mislead consumers and distort their purchases.”).

116 21 U.S.C. § 321(n); see also 21 C.F.R. § 202.1(e)(6)-(7) (2008) (delineating ways in which an advertisement for a prescription drug is or can be “false, lacking in fair balance, or otherwise misleading”).

117 Brody, Howard, The Company We Keep: Why Physicians Should Refuse to See Pharmaceutical Representatives, 3 Annals Fam. Med. 82, 83 (2005)CrossRefGoogle ScholarPubMed (noting that “almost all [physicians] agree that we are extremely busy and work under tremendous time pressure”).

118 Michael A. Steinman & Dean Schillinger, Drug Detailing in Academic Medical Centers: Regulating for the Right Reasons, with the Right Evidence, at the Right Time, Am. J. Bioethics, Jan. 2010, at 22.

119 Stryer, Daniel & Bero, Lisa A., Characteristics of Materials Distributed by Drug Companies: An Evaluation of Appropriateness, 11 J. Gen. Internal Med. 575, 578 (1996)CrossRefGoogle ScholarPubMed; see also Othman et al., supra note 110, at 7-8 (surveying seven studies of journal advertisements which found that the references included in advertisements were typically of low methodological quality); Macarena Gonzalez Santiago et al., Accuracy of Drug Advertisements in Medical Journals Under New Law Regulating the Marketing of Pharmaceutical Products in Switzerland, 8 BioMed Cent. Informatics & Decision Making, Dec. 2008, at 4 (finding that twenty-one percent of the seventy-eight claims in twenty-nine advertisements studied were not supported by the cited studies); Roberto Cardarelli et al., A Cross-Sectional Evidence-Based Review of Pharmaceutical Promotional Marketing Brochures and Their Underlying Studies: Is What They Tell Us Important and True?, BioMed Cent. Fam. Practice, Mar. 2006, at 2-3 (finding that twenty-five percent of the twenty advertisements studied cited invalid studies), available at http://www.biomedcentral.com/content/pdf/1471-2296-7-13.pdf.

120 See Cain, Daylian M. & Detsky, Allan S., Everyone’s a Little Bit Biased (Even Physicians), 299 JAMA 2893, 2894-95 (2008).CrossRefGoogle Scholar

121 Waxman, supra note 18, at 303.

122 Id.

123 Susan Heavey & Lisa Richwine, Special Report: Outgunned FDA Tries to Get Tough with Drug Ads, Reuters, Sept. 3, 2010, available at http://www.reuters.com/article/idUSTRE6821PN20100903.

124 Ben Comer, DDMAC Regulatory Letters Could Double in 2010, Med. Marketing & Media (July 22, 2010), http://www.mmm-online.com/ddmac-regulatory-letters-could-double-in-2010/article/175154/#.

125 See, e.g., Warning Letter from Thomas W. Abrams, Dir., Div. of Drug Marketing, Advertising, and Commc’ns, Office of Med. Policy, Ctr. for Drug Evaluation and Research, Food & Drug Admin., to Robert S. Whitehead, Chief Exec. Officer, Slate Pharm. (Mar. 24, 2010) (describing a sales aid “for Testopel present[ing] the headline claim, “RECLAIM YOUR LIFE™,” in conjunction with three graphic images of a man jogging, a man playing with a child, and a man kissing a woman” and noting that “FDA is not aware of any studies that measured” “the ability for patients to resume their ‘normal’ activities and lifestyle (i.e., to reclaim their lives)” “or any other evidence to support such effects of Testopel treatment”).

126 See, e.g., Warning Letter from Thomas W. Abrams, Dir., Div. of Drug Marketing, Advertising, and Commc’ns, Office of Med. Policy, Ctr. for Drug Evaluation and Research, Food & Drug Admin., to Andrew Witty, Chief Exec. Officer, GlaxoSmithKline (Apr. 19, 2010) (describing a slim jim “contain[ing] multiple claims regarding the superior potency of Altabax over mupirocin” that were unsupported by “a head-to-head clinical comparison” of the two products).

127 See, e.g., Warning Letter from Thomas W. Abrams, Dir., Div. of Drug Marketing, Advertising, and Commc’ns, Office of Med. Policy, Ctr. for Drug Evaluation and Research, Food & Drug Admin., to Brian Dickson, Chief Med. Officer, Cornerstone Therapeutics, Inc. (June 22, 2010) (describing a visual aid that relegated important risk information to the back of the piece where it was “not visible or even accessible to the viewer since the back of the visual aid contains an adhesive strip at the top of the page designed to be adhered to a flat surface”).

128 Comer, supra note 124.

129 Id.

130 Id. (reporting that as of July 22, 2010 DDMAC had “sent out 40 enforcement letters . . . in 2010, compared with a total of 41 enforcement letters . . . in all of 2009”); Covington & Burling, Trends in DDMAC Enforcement Activity During the Bush Administration, Food & Drug E-Alert (Covington & Burling, D.C.), Mar. 30, 2009, at 2Google Scholar (noting that “[a]fter a sharp drop (greater than 50%) in the total number of DDMAC letters between the first and second years of the Bush administration, the total number of letters remained relatively constant for the duration, averaging approximately 24 letters per year”).

131 Heavey & Richwine, supra note 123.

132 Sernyak, Michael & Rosenheck, Robert, Experience of VA Psychiatrists with Pharmaceutical Detailing of Antipsychotic Medications, 58 Psychiatric Services 1292, 1294 (2007)CrossRefGoogle ScholarPubMed (reporting that the over five-hundred salaried Veterans Administration psychiatrists surveyed estimated that they met with “pharmaceutical representatives an average of 14±26 times (range of 1-300)” in the previous year); Wazana, Ashley, Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?, 283 JAMA 373, 373, 376 (2000)Google ScholarPubMed (summarizing twenty-nine studies and concluding that “[p]hysician interactions with pharmaceutical representatives were generally endorsed, began in medical school, and continued at a rate of about 4 times per month”); Brodkey, Amy C., The Role of the Pharmaceutical Industry in Teaching Psychopharmacology: A Growing Problem, 29 Acad. Psychiatry 222, 223 (2005)CrossRefGoogle ScholarPubMed (reporting that there were an estimated sixty million pharmaceutical representative-physician visits in the year 2000).

133 The challenges confronting corporate compliance officers are in part a function of resource and technology limits. For example, as more and more sales representatives are provided with tablet personal computers, the doctor’s office may become less and less of a black box, facilitating efforts of regulators and compliance professionals to ensure that marketing messages are accurate and consistent. See Pfizer Equips Sales Reps with Tablet PCs, iHealthBeat (Dec. 16, 2009), http://www.ihealthbeat.org/articles/2009/12/16/pfizer-equips-sales-reps-with-tablet-pcs-for-physician-visits.aspx. Moreover, problems with the quality of off-label promotion stem in part from the fact of prohibition. Under the current legal regime, off-label promotion frequently amounts to claims made by sales representatives in the field that are not vetted by companies’ compliance or legal departments or even by headquarters sales and marketing personnel.

134 Mello, Michelle M. et al., Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals, 360 New Eng. J. Med. 1557, 1561 (2009).CrossRefGoogle Scholar

135 Burroughs, Allison D. et al., Off-Label Promotion: Government Theories of Prosecution and Facts that Drive Them, 65 Food & Drug L.J. 555, 565-66 (2010).Google Scholar

136 Tushnet, supra note 53, at 227-28.

137 Id. at 228.

138 Note that this would not necessarily be a net positive for the pharmaceutical industry. See, e.g., Katz, Ariel, Pharmaceutical Lemons: Innovation and Regulation in the Drug Industry, 14 Mich. Telecomm. & Tech. L. Rev. 1, 7 (2007)Google Scholar (“[T]he regulatory framework is not solely a burden imposed on the industry, but also a valuable service of drug quality certification . . . . [T]his aspect of the regulation, which may not be easily substituted by private market-based mechanisms, contributes to the value of new drugs”); Loucks, Michael K., Pros and Cons of Off-Label Promotion Investigations and Prosecutions, 61 Food & Drug L.J. 577, 580 (2006)Google ScholarPubMed (“[T]he core victims of the crimes of off-label promotion include those companies that have invested time and money to gain the benefit of the regulatory barrier to entry to the marketplace.”).