1 Frank Vinluan, Pharma Spending on R&D Nosedived in 2009, Study Finds, Triangle Bus. J. (May 31, 2010), http://www.bizjournals.com/triangle/stories/2010/05/31/story12.html (“R&D spending among U.S. pharma companies last year declined by thirteen percent, to $17.2 billion from $19.8 billion in 2008.”).

2 Hopkins v. Dow Corning Corp., 33 F.3d 1116, 1119 (9th Cir. 1994).

3 Id.

4 See, e.g., Friedberg, Mark et al., Evaluation of Conflict of Interest in Economic Analyses of New Drugs Used in Oncology, 282 JAMA 1453, 1453 (1999)CrossRefGoogle Scholar (“Similarly, a study of clinical trial publications determined that there was a significant association between positive results in general internal medicine clinical trials and funding from a pharmaceutical manufacturer.”) Of note, the Friedberg study was funded by an unrestricted grant from Amgen, Inc., which had a contractual right to review and comment on the manuscript and abstract prior to publication. See also Chopra, Sameer S., Industry Funding of Clinical Trials: Benefit or Bias?, 290 JAMA 113, 113 (2003)CrossRefGoogle ScholarPubMed (“Research supported by pharmaceutical companies may also be subject to methodological bias. Industry funded clinical trials and cost-effectiveness analyses, for instance, yield positive results far more often than studies that are funded or conducted by other entities.”).

5 See Chopra, supra note 4, at 113 (“Numerous industry-sponsored trials, for example, are prematurely terminated for financial rather than for scientific or ethical reasons.”).

6 In 2007, Congress expanded the use of a trial registry data bank that requires the registration of clinical trials for life-threatening conditions. Food and Drug Administration Amendments Act, Pub. L. No. 110-85, § 801, 121 Stat. 823, 904-22 (2007) [hereinafter FDAAA] (amending 42 U.S.C. § 282). This is a limited regulation that does not encompass all the past and ongoing studies conducted by the pharmaceutical companies. See also Clinicaltrails.gov Fact Sheet, Nat’l Insts. of Health, http://www.nlm.nih.gov/pubs/factsheets/clintrial.html (last updated Sept. 15, 2009) (The legislation requires the Department of Health and Human Services, through the NIH, to establish a registry of clinical trials for both federally and privately funded trials “of experimental treatments for serious or life-threatening diseases or conditions.”).

7 Friedberg et al., supra note 4, at 1455 (“Studies funded by pharmaceutical companies were nearly 8 times less likely to reach unfavorable qualitative conclusions than nonprofit-funded studies and 1.4 times more likely to reach favorable qualitative conclusions.”).

8 Wagner, Wendy & Michaels, David, Equal Treatment for Regulatory Science: Extending the Controls Governing the Quality of Public Research to Private Research, 30 Am. J.L. & Med. 119, 120 (2004).Google ScholarPubMed

9 Id. at 125 (“Some sponsors, for example, have been caught publishing the same study in different journals under different author names with no cross-references, making it appear that the research support in favor of their product or activity is based on several independent studies, rather than simply a re-reporting of the same findings”); see Sismondo, Sergio, Ghost Management: How Much of the Medical Literature is Shaped Behind the Scenes by the Pharmaceutical Industry?, 4 PLoS Med. 1429, 1429 (2007)CrossRefGoogle ScholarPubMed (“In extreme cases, drug companies pay for trials by contract research organizations (CROs), analyze the data in-house, have professionals write manuscripts, ask academics to serve as authors of those manuscripts, and pay communication companies to shepherd them through publication in the best journals. The resulting articles affect conclusions found in the medical literature, and are used in promoting drugs to doctors”); see also Smith, Richard, Conflicts of Interest: How Money Clouds Objectivity, 99 J. Royal Soc’y Med. 292, 293 (2006)Google ScholarPubMed (“In fact, the only factor associated with the review’s conclusion was whether the author was affiliated with the tobacco industry. Three-quarters of the articles concluding that passive smoking was not harmful were written by tobacco industry affiliates” (citation omitted)).

10 See Friedberg et al., supra note 4, at 1453; Smith, supra note 9, at 293 (“The JAMA review found 11 studies that compared the outcome of studies sponsored by industry and those not so sponsored. In every study those that were sponsored were more likely to have a finding favourable to industry” (internal citation omitted)); see also Sismondo, supra note 9, at 1429.

11 See Friedberg et al., supra note 4, at 1453.

12 See id. at 1455. A number of reasons may account for this. For example, the pharmaceutical company may be more likely to conduct clinical trials based on highly positive initial studies. Another reason, however, could be that pharmaceutical companies may want to control what is published and simply decide not to publish negative results. These, and other reasons, are suggested in the study conducted by Friedberg and colleagues.

13 See id.

14 Sismondo, supra note 9, at 1429; see also Foote, MaryAnn & Noguchi, David, Posting of Clinical Trials and Clinical Trial Results: Information for Medical Writers, 20 Am. Med. Writers Ass’n 47, 47 (2005)Google Scholar (informing medical writers who work for drug sponsors of the new rules regarding the reporting of clinical trials).

15 Sismondo, supra note 9, at 1430; see also Our Work, Current Medical Directions, http://www.cmdny.com/work.html (last visited Apr. 10, 2011).

16 Sismondo, supra note 9, at 1430 (“[T]he CMD articles were published in more prominent journals, had nearly twice as many authors per article, and garnered nearly three times as many citations.”).

17 Cf. Wagner & Michaels, supra note 8, at 122 (“At the same time that privately sponsored research provides a critical input to regulation, there is growing evidence that it can be compromised in ways that might underreport or even suppress evidence of harm. Sponsors face strong incentives to design and report research in ways most favorable to their interests and to suppress adverse results provided they can do so without detection.”).

18 The FDA may approve this drug to treat high cholesterol if the results demonstrate that the new drug is safe and effective. This is so, even if, for example, the new drug does not offer benefits beyond the standard treatment.

19 Cf. Wagner & Michaels, supra note 8, at 126 (“Finally and perhaps most serious is the ability of sponsors to suppress research when the results are adverse to their interests. Unlike fraud, suppressing adverse results can sometimes be done with discretionary judgments that are not illegal. For example, sponsors can abort research before it is completed, and base this decision on limited resources or some purported design flaw in the study. For research that is completed, sponsors can still justify withholding the results based on discretionary judgments that the research design or reporting was incomplete or flawed in some way or that follow-up research is needed to confirm or validate the findings.” (citations omitted)).

20 See DeAngelis, Catherine, The Influence of Money on Medical Science, 296 JAMA 996, 996 (2006)CrossRefGoogle ScholarPubMed (“There have been a number of high-profile examples of such research irregularities involving for-profit companies, such as . . . reporting only 6 months of data in a trial designed to have 12 months of data as the primary outcome . . . .”); Chopra, supra note 4, at 114 (“Bias may also occur in the reporting of industry-funded clinical trials. Withholding the publication of unfavorable results, for example, is not uncommon although the practice is considered scientific misconduct.”).

21 Hopkins v. Dow Corning Corp., 33 F.3d 1116, 1118 (9th Cir. 1994).

22 Id. at 1119.

23 Id.

24 Id.

25 Id. at 1127.

26 Sax, Joanna K., Reforming FDA Policy for Pediatric Testing: Challenges and Changes in the Wake of Studies Using Antidepressant Drugs, 4 Ind. Health L. Rev. 61, 71-75 (2007)Google Scholar.

27 Id. at 75.

28 Id. at 75.

29 Cf. DeAngelis, supra note 20, at 996 (“In some instances, the marketing goal of a company dominates the scientific aspect of the company-funded research.”).

30 Cf. Ledford, Heidi, Diabetes Drugs Offered Fresh Start, 466 Nature 420, 420 (2010)CrossRefGoogle ScholarPubMed (“Since Avandia (rosiglitazone) hit the market, he [Steven Nissen] said, developers have wasted their time on at least 50 other drugs that act by a similar mechanism. All of them failed, Nissen said, some because they posed similar risks to the heart.”).

31 Wagner & Michaels, supra note 8, at 121.

32 See also DeAngelis, Catherine D., Phil Fontanarosa, B., & Flanagin, Annette, Reporting Financial Conflicts of Interest and Relationships Between Investigators and Research Sponsors, 286 JAMA 89, 90 (2001)CrossRefGoogle ScholarPubMed (“Moreover, this level of involvement and control of the research could be viewed as the sponsor having the potential to influence the study results and might create doubts about the validity of the research. These concerns are not without foundation; previous reports have documented several major problems in some industry-sponsored studies, including issues related to trial design, data availability, and control over publication.” (internal citations omitted)).

33 See Lisa A. Bero, Tobacco Industry Manipulation of Research, 120 Pub. Health Rep. 200, 200-01 (describing strategies utilized by the tobacco industry to manipulate the research on the harmful effects of smoking).

34 See id. at 202-03 (“The tobacco industry uses several vehicles to publish the findings of its sponsored research, including symposium proceedings, books, journal articles, and letters to the editor in medical journals”); Smith, supra note 9, at 293.

35 Bero, supra note 33, at 202-03.

36 Smith, supra note 9, at 293 (“Three-quarters of the articles concluding that passive smoking was not harmful were written by tobacco industry affiliates.”).

37 Bero, supra note 33, at 202.

38 Id. at 203.

39 Id.

40 Id. at 204.

41 The reason that the industry publications may not be subject to the Lanham Act is if the publications in journals are not considered “commercial advertising or promotion.” Lanham Act, 15 U.S.C. § 1125(a)(1)(B) (2006).

42 15 U.S.C. § 1125(a).

43 15 U.S.C. § 1125(a)(1)(B).

44 United Indus. Corp. v. Clorox Co., 140 F.3d 1175, 1180 (8th Cir. 1998).

45 This is a simplified explanation of establishing a claim. These types of claims are broken down further into commercial claims that are literally false and claims that may be literally true, but convey a false impression. Id. Depending on the type of misleading industry publication, claims may fall under one category or the other. See William H. Manning & Jennifer L. McKenna, Lanham Act Also Applies to False Advertising Claims, Nat’l L.J., May 13, 2002, at C23, available at http://www.rkmc.com/Lanham_Act_Also_Applies_to_False_Advertising_Claims.htm. Implicitly misleading claims are probably harder to prove.

46 15 U.S.C. § 1125(a)(1)(B).

47 Advertisement Definition, Merriam-Webster (italics omitted), http://www.merriam-webster.com/dictionary/advertisement (last visited Apr. 10, 2011); see also Global Telesystems, Inc. v. KPNQwest, N.V., 151 F. Supp. 2d 478, 483 (S.D.N.Y 2001) (citing a dictionary definition to define advertisement).

48 FDAAA §§ 401-02, 501-02, 121 Stat. 823, 866, 876 (reauthorization of the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act).

49 Sax, supra note 26, at 71-75.

50 Expanded Clinical Trial Registry Data Bank, Pub. L. No. 110-85, § 801(a)(2)(C), 121 Stat. 907 (2007).

51 See, e.g., United States v. Caronia, 576 F. Supp. 2d 385, 395 (E.D.N.Y. 2008) (Scientific and academic speech are “at the core of the First Amendment and, therefore, should receive the highest constitutional protection as pure speech.”).

52 See, e.g., Hopkins v. Dow Corning Corp., 33 F.3d 1116 (9th Cir. 1994).

53 See, e.g., Dickerson, Kay & Rennie, Drummond, Registering Clinical Trials, 290 JAMA 516, 518 (2003)Google Scholar; Sim, Ida & Detmer, Don E., Beyond Trial Registration: A Global Trial Bank for Clinical Trial Reporting, 2 PLoS Med. 1090, 1090-92 (2005)CrossRefGoogle ScholarPubMed. Of note, required trial registry is not mandated for non-serious or non-life-threatening diseases. See Food and Drug Administration Modernization Act of 1997 § 113, 42 U.S.C. 282(i) (2006).

54 Select peer reviewed medical journals require that a clinical trial be registered in order to publish in that journal. See Erin D. Williams, Cong. Research Serv., RL 32832, Clinical Trials Reporting and Publication 4 (2005). This does not, however, address the problem of industry publications in non-peer-reviewed publications.

55 Id. at 5 (discussing S. 470, the Fair Access to Clinic Trials Act of 2005). The 2007 version was called the Fair Access to Clinical Trials Act of 2007, S. 467, 110th Cong. (2007) [hereinafter FACT Act 2007].

56 Williams, supra note 54, at 5; FACT Act 2007, §§ 2(1)-(4).

57 Williams, supra note 54, at 5; FACT Act 2007, § 3(a)(4) (“The registry shall include information for all clinical trials conducted to test the safety or effectiveness (including comparative effectiveness) of any drug, biological product, or device (including those drugs, biological products or devices approved or cleared by the Secretary) intended to treat serious or life-threatening diseases and conditions . . . .”) (emphasis added). But see FACT Act 2007 § 3(a)(4) (“The database shall include information for all clinical trials conducted to test the safety or effectiveness (including comparative effectiveness) of any drug, biologic product, or device . . . .”)

58 See S. 467: FACT Act, Govtrack.us, http://www.govtrack.us/congress/bill.xpd?bill=s110-467 (last visited Apr. 14, 2011).

59 See Sax, supra note 26, at 76-78.

60 Id. at 74-75 (citing and discussing the hearings on antidepressant pediatric trials).

61 FDAAA §§ 901-03, 121 Stat. 823, 939-43.

62 Id. § 902(a), 121 Stat. 939 (“The secretary may require the submission of any television advertisement for a drug (including any script, story board, rough, or a completed video production of the television advertisement) to the Secretary for review under this section not later than 45 days before dissemination of the television advertisement.”)

63 Id. § 902(g), 121 Stat. 940.

64 As described in Part III below, the FDA should be able to regulate the content of the industry publications so long as the publications are deemed commercial speech and any regulation does not violate the test articulated in Central Hudson. See Cent. Hudson Gas & Electric Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980).

65 FDA, Truthful Prescription Drug Advertising and Promotion (Bad Ad Program), http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm (last updated Mar. 31, 2011).

66 Id.

67 Id.

68 Cf. Spence, David, The Shadow of the Rational Polluter: Rethinking the Role of the Rational Actor Model in Environmental Law, 89 Cal. L. Rev. 917, 940 (2001)CrossRefGoogle Scholar (“Most environmental statutes bar citizens from proceeding if the government is diligently prosecuting the violations in question.”).

69 Id. at 920 (demonstrating this formula for prospective violators of environmental laws). The underlying rationale of environmental law can be applied to the FDA because the Environmental Protection Agency and FDA are both large regulatory regimes.

70 Id. at 921.

71 Id. at 931.

72 See, e.g., C. Edwin Baker, Paternalism, Politics, and Citizen Freedom: The Commercial Speech Quandary in Nike, 54 Case W. Res. L. Rev. 1161 (2003-04)Google Scholar; Smith, Glenn C., Avoiding Awkward Alchemy–In the Off-Label Drug Context and Beyond: Fully Protected Independent Research Should Not Transmogrify into Mere Commercial Speech Just Because Product Manufacturers Distribute It, 34 Wake Forest L. Rev. 963, 988-1016 (1999).Google Scholar

73 Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 770 (1976).

74 Id. at 771.

75 See id.

76 Cent. Hudson Gas & Electric Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 563 (1980).

77 Id.

78 Id. at 567.

79 See, e.g., United States v. Caronia, 576 F. Supp. 2d 385, 395 (E.D.N.Y. 2008) (describing that speech protected by the First Amendment receives the highest constitutional protection).

80 Id. at 396; see also Bolger v. Youngs Drug Prod. Corp., 463 U.S. 60, 67 & n.14 (1983) (describing that the “combination of all these characteristics” provides strong support to characterize speech as commercial, but that the characteristics of all three do not have to be present in order for the speech to be commercial).

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

82 Id.

83 Id.

84 Id.

85 Id.

86 United States v. Caronia, 576 F. Supp. 2d 385, 396-97 (E.D.N.Y. 2008).

87 Id. at 397 (quoting Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 74-75 (D.D.C. 1998)).

88 Id. This summary of the commercial speech doctrine is cursory. Legal scholarship in this area analyzes the clarity or lack thereof in utilizing the commercial speech doctrine. Indeed, even decisions in lower courts demonstrate uncertainty when applying the commercial speech doctrine. See generally Smith, supra note 72, at 988-1016.

89 Advertisement, supra note 47; see also Global Telesystems, Inc. v. KPNQwest, N.V., 151 F. Supp. 2d 478, 483 (S.D.N.Y. 2001) (citing a dictionary definition to define advertisement).

90 See IMS Health Inc. v. Ayotte, 550 F.3d 42, 45, 54 (2008) (finding valid a restriction of the ability of pharmaceutical representatives to utilize physicians’ prescribing history for use in detailing).

91 See Cent. Hudson Gas & Electric Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 561-63 (1980).

92 See, e.g., Caronia, 576 F. Supp. 2d at 395 (addressing arguments as to whether “promotional activities amounted to scientific and academic speech, which resides at the core of the First Amendment”).

93 See id. (“[A]lthough the prescription drug industry presented a different context than traditional forms of consumer advertising, it was clear that the speech to doctors was intended to drive sales of products because ‘to the extent that physicians are the gatekeepers to sales, the marketing efforts must be directed at them.’” (citation omitted)).

94 If the speech was not deemed commercial, the question then arises as to whether the TIM Act regulates protected speech and could survive strict scrutiny. I thank my colleague, Larry Benner, for raising this important issue. An argument can be made that the government has a compelling interest to regulate the conduct of the speech at issue in this article and that the TIM Act is narrowly tailored to this interest.

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

96 Id.

97 Cohen v. JP Morgan Chase & Co., 498 F.3d 111, 126 (2d Cir. 2007) (citing Oswego Laborers’ Local 214 Pension Fund v. Marine Midland Bank, 647 N.E.2d 741, 745 (N.Y. 1995)).

98 See Central Hudson, 447 U.S. at 566.

99 Ass’n of Am. Med. Colls., Industry Funding of Medical Education: Report of an AAMC Task Force 4 (2008), www.aamc.org/publications (search publications: Industry Funding) (“Supplementing the robust psychosocial evidence regarding the effect of gifts on physician decision making, recent neurobiological studies document that inherent biological processes can cause individuals to respond reciprocally—and typically unconsciously—to relationships involving even simple gifts, sponsorships, or the development of personal relationships.”)

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

101 Centers & Offices, FDA (last updated Feb. 15, 2011), http://www.fda.gov/AboutFDA/CentersOffices/default.htm (“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products”); see also Thompson v. W. States Med. Ctr., 535 U.S. 357, 368-69 (2002)Google Scholar (describing the Government’s interest under the Food and Drug Administration Modernization Act (FDAMA) and Food, Drug, and Cosmetic Act (FDCA)).

102 Investigational New Drug Application, FDA (last updated Nov. 5, 2010), http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm (“Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks.”).

103 New Drug Application, Introduction, FDA (last updated Aug. 20, 2010) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm (“The documentation required in an NDA is supposed to tell the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.”).

104 NIH & Clinical Research: About Us, Nat’l Insts. of Health, http://clinicalresearch.nih.gov/about.html (last visited Apr. 14, 2011) (“The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research.”).

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

106 Food and Drug Administration Modernization Act of 1997 § 113, 42 U.S.C. 282(i) (2006); see Guidance for Industry, Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Condition (Mar. 2002), http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126838.pdf (“Section 113 of the Modernization Act creates a public resource for information on studies of drugs, including biological drug products, to treat serious or life-threatening diseases and conditions conducted under FDA’s investigational new drug (IND) regulations (21 CFR part 312).”).

107 See Turner, Erick H., A Taxpayer-Funded Clinical Trials Registry and Results Database, 1 PLoS Med. 180, 180-81 (2004)CrossRefGoogle ScholarPubMed (describing the NDA process); New Drug Application, Introduction, supra note 103.

108 Central Hudson, 447 U.S. at 566. Another issue that may need to be addressed is whether there are means by which the government can regulate the dissemination of results in a way that does not affect speech. I thank my colleague, Larry Benner, for raising this important point. See, e.g., Thompson v. W. States Med. Ctr., 535 U.S. 357, 371-73 (2002)Google Scholar (addressing the issue of ways the “Government could achieve its interests in a manner that does not restrict speech, or that restricts less speech”). For example, a different approach would be to have the government independently run all the clinical trials for any new drug and then report the results. In this way, the process of reporting clinical trial information would be controlled in all respects by the government. The problem with this type of solution is that it is probably economically and logistically impossible. Since there is a private market for clinical trials, it might be considered economic waste to have the government commandeer all parts of all clinical trials. While this would avoid the First Amendment problem, it seems, for practical purposes, impossible.