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Can Speech by FDA-Regulated Firms Ever Be Noncommercial?
Published online by Cambridge University Press: 06 January 2021
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For over a century, the Food and Drug Administration (FDA or the Agency) and its precursors have regulated what companies say about their products. The FDA itself notes that the regulatory scheme imposed by the Federal Food, Drug, and Cosmetic Act “depends on the use of words” and that its requirements can “explicitly limit speech.” For seventy years, the FDA had little reason to worry about First Amendment constraints. But since 1976, when the Supreme Court reversed its longstanding position that the First Amendment does not protect commercial speech, the Agency has had to confront–perhaps more than any other federal agency–the free speech rights of regulated firms.
But how far do those rights extend, and what room do they leave for regulators like the FDA? The answer largely depends on another question: Is the speech commercial or noncommercial? The distinction is paramount. If speech by a regulated firm is commercial, then the FDA can ensure that it is not false or misleading; the Agency can require or compel certain speech; it can impose prior restraints; and it can even limit truthful speech, all within certain parameters.
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References
1 Pure Food and Drug Act of 1906, Pub. L. No. 59-384, 34 Stat. 768 (prohibiting “misbranding”).
2 Request for Comment on First Amendment Issues, 67 Fed. Reg. 34,942, 34,943 (May 13, 2002).
3 Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 762 (1976).
4 Bennigson, Tom, Nike Revisited: Can Commercial Corporations Engage in Non-Commercial Speech?, 39 Conn. L. Rev. 379, 386-87 (2006)Google Scholar (contrasting cases of commercial and noncommercial speech).
5 Bolger v. Youngs Drug Prods., 463 U.S. 60, 66-67 (1983).
6 See Nike v. Kasky, 539 U.S. 654 (2003).
7 See, e.g., Consol. Edison Co. of N.Y. v. Pub. Serv. Comm’n, 447 U.S. 530 (1980); First Nat’l Bank of Boston v. Bellotti, 435 U.S. 765 (1978). As Justice Kennedy recently emphasized in his majority opinion in Citizens United v. Federal Election Commission, the First Amendment generally prohibits “restrictions distinguishing among different speakers.” Citizens United v. Fed. Election Comm’n, 130 S. Ct. 876, 898 (2010).Google Scholar But, cf. 130 S. Ct. at 949 (Stevens, J., dissenting) (noting that the majority “dramatically overstates its critique of identity-based distinctions”).
8 Indeed, Bill Vodra, a longtime food and drug lawyer and former attorney in FDA’s Office of Chief Counsel, made a similar observation over twenty years ago. Vodra, William W., How the FDA Regulates Drug Promotion and Medical Education Before Drug Approval, 23 Drug Info. J. 585, 586 (1989)CrossRefGoogle Scholar (noting that “promotional technologies and strategies for marketing drugs have expanded and evolved with unpredicted speed and diversity over the last 10 years”).
9 Kozinski, Alex & Banner, Stuart, Who’s Afraid of Commercial Speech?, 76 Va. L. Rev. 627, 640 (1990).CrossRefGoogle Scholar
10 See infra Tbl. 1: Cases in Which FDA-Regulated Firms Claimed First Amendment Protection.
11 And for good reason. Bill Vodra notes that “[t]he FDA would probably agree that the pharmaceutical industry has not acted as though it is severely constrained in its advertising and promotion.” Vodra, supra note 8, at 587.
12 Bennigson, supra note 4, at 386-87 (contrasting cases between commercial and noncommercial speech).
13 Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 566 (1980).
14 Id.
15 See, e.g., Reno v. ACLU, 521 U.S. 844, 868-70 (1997).
16 United States v. O’Brien, 391 U.S. 367, 377 (1968).
17 See Susan H. Williams, Content Discrimination and the First Amendment, 139 U. Pa. L. Rev. 615 (1994).
18 The Court characterizes the fourth Central Hudson criterion this way. 447 U.S. at 566.
19 Stern, Nat, In Defense of the Imprecise Definition of Commercial Speech, 58 Md. L. Rev. 55, 65 (1999).Google Scholar
20 Id. at 95.
21 City of Cincinnati v. Discovery Network, Inc., 507 U.S. 410, 419 (1993).
22 Metromedia, Inc. v. City of San Diego, 453 U.S. 490, 540 (1981) (plurality opinion) (Brennan, J., concurring).
23 See Valentine v. Chrestensen, 316 U.S. 52, 54 (1942). In Valentine, an entrepreneur tried to evade New York City’s Sanitary Code prohibition on distributing commercial handbills in public by printing on the opposite side of his advertisement a statement opposing the City Dock Department’s decision to deny him a permit. See Kozinski & Banner, supra note 9, at 627-28.
24 Cammarano v. United States, 358 U.S. 498, 514 (1959) (Douglas, J., concurring).
25 Valentine, 316 U.S. at 54.
26 Kozinski & Banner, supra note 9, at 627.
27 Id. at 629 (reciting concurring and dissenting opinions as early as 1959 questioning the holding in Chrestensen in 1942).
28 The Court’s decision in Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976) formally applied the First Amendment to commercial speech, striking down a state statute prohibiting advertising of prescription drug prices. But the previous term, in Bigelow v. Virginia, 421 U.S. 809 (1975), the Court struck down a state statute banning newspaper advertisement for abortion procedures, noting that courts must account for First Amendment interests in reviewing regulation of commercial advertising.
29 Va. State Bd. of Pharmacy, 425 U.S. at 761-62, 771-72 n.24.
30 Id. at 771-72 n.24 (quoting Pittsburgh Press Co. v. Pittsburgh Comm’n on Human Relations, 413 U.S. 376, 385 (1973)).
31 Kozinski & Banner, supra note 9, at 638.
32 Va. State Bd. of Pharmacy, 425 U.S. at 762 (quoting Chaplinsky v. New Hampshire, 315 U.S. 568, 572 (1942); Roth v. United States, 354 U.S. 476, 484 (1957)).
33 Va. State Bd. of Pharmacy, 425 U.S. at 771-72 n.24.
34 Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 561 (1980).
35 Bolger v. Youngs Drug Prods. Corp., 463 U.S. 60, 66-67 (1983).
36 Id. at 67.
37 Stern, supra note 19, at 86.
38 Kozinski & Banner, supra note 9, at 628.
39 See Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 518, 526-28 (Thomas, J., concurring).
40 Stern, supra note 19, at 75-77 (summarizing others’ arguments on this point).
41 Jackson, Thomas H. & Calvin Jeffries, John Jr., Commercial Speech: Economic Due Process and the First Amendment, 65 Va. L. Rev. 1, 2 (1979).CrossRefGoogle Scholar
42 See, e.g., Bennigson, supra note 4, at 397; see generally Stern, supra note 19, at 73-75.
43 See Stern, supra note 19, at 77-79
44 Nike, Inc. v. Kasky, 533 U.S. 654 (2003).
45 Id. at 672 (Breyer, J., dissenting).
46 See generally Cal. Bus. & Prof. Code §§ 17200-17364, 17500 (West 1997).
47 Kasky v. Nike, Inc., 45 P.3d 243, 247 (2002).
48 Nike, Inc. v. Kasky, 533 U.S. 654 (2003).
49 Id. at 676-79 (Breyer, J., dissenting); see also Chemerinsky, Erwin & Fisk, Catherine, What Is Commercial Speech? The Issue Not Decided in Nike v. Kasky, 54 Case W. Res. L. Rev. 1143 (2003-04)Google Scholar (persuasively arguing that Nike’s speech was noncommercial).
50 See, e.g., Eugene Volokh, Nike and the Free-Speech Knot, Wall St. J., June 30, 2003, at A16.
51 Note that I include recent litigation over state prescription confidentiality laws in Vermont, New Hampshire, and Maine that limit the use and dissemination of prescriber data captured by data mining companies. Although the primary plaintiffs are data mining companies like IMS Health, which themselves are not regulated by the FDA, the Pharmaceutical Research and Manufacturers of America (PhRMA) is also a party to some of the litigation, or filed amicus briefs siding with the data mining companies. Note also that I do not include the much-watched case Allergan v. FDA, in which the biotech manufacturer challenged FDA’s Good Reprint Practices Guidance, see infra note 217, arguing that any restrictions on discussing off-label uses of approved drugs are unconstitutional if the speech is truthful and not misleading, and if such off-label uses are “widely accepted” and are reimbursed by government programs like Medicare. Complaint at 28-35, Allergan, Inc. v. FDA, No. 1:09-CV-01879 (D.D.C. Oct. 1, 2009). For a discussion of this case, see Osborn, infra note 216, at 338-39. Allergan agreed to drop its suit against the FDA in September 2010 as part of a settlement with the government in which Allergan paid $600 million in civil and criminal fines for promoting Botox off-label. Dep’t of Justice, Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox, U.S. Dep’t of Justice (Sept. 1, 2010), http://www.justice.gov/opa/pr/2010/September/10-civ-988.html; Allergan, Allergan Resolves United States Government Investigation of Past Sales and Marketing Practices Relating to Certain Therapeutic Uses of Botox, Allergan (Sept. 1, 2010), http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=503974.
52 See Beharry v. Bedessee Imports Inc., No. 09-CV-0077, 2010 WL 1223590 (E.D.N.Y. Mar. 23, 2010) (alleging that a newspaper article describing FDA enforcement actions against a food importer and a competitor subsequently emailing the article to potential clients violated the Lanham Act); Bracco Diagnostics v. Amersham Health, 627 F. Supp. 2d 384 (D.N.J. 2009) (alleging that peer-reviewed scientific journal articles and various print media and oral communications referring to the articles violated the Lanham Act); In re Warfarin Sodium Antitrust Litig, No. MDL 98-1232-SLR, 1998 WL 883469 (D. Del. Dec. 7, 1998) (alleging that computer software, press release, and more traditional written materials used by DuPont Merck violated the Lanham Act).
53 See IMS Health Inc. v. Sorrell, 630 F.3d 263 (2d Cir. 2010) (challenging state statute limiting the use and dissemination of prescriber data captured by data mining companies); IMS Health Inc. v. Mills, 616 F.3d 7 (1st Cir. 2010) (same); IMS Health Inc. v. Ayotte, 550 F.3d 42 (1st Cir. 2008) (same).
54 See In re Orthopedic Bone Screw Products Liab. Litig., No. MDL 1014, 1997 WL 186325 (E.D. Pa. Apr. 16, 1997) (examining speeches and presentations in seminars and other venues).
55 Although the court in Kessler cited Virginia Board of Pharmacy as giving rise to a cognizable First Amendment right for standing purposes, the court did not determine whether the Washington Legal Foundations’s physician members right to receive information from drug manufacturers deserved heightened protection or not. Wash. Legal Found. V. Kessler, 880 F. Supp. 26, 31 (D.D.C. 1995). The court did not cite either Bolger or Central Hudson.
56 See Beharry, 2010 WL 1223590, at *8; Bracco Diagnostics, 627 F. Supp. 2d at 456.
57 Richard A. Samp, Courts Are Arriving at a Consensus on Food and Drug Administration Speech Regulation, 58 Food & Drug L.J. 313, 314; See, e.g., Thompson v. W. States Med. Ctr., 535 U.S. 357 (2002).
58 See Wash. Legal Found. v. Kessler, 880 F. Supp. 26, 31 (D.D.C. 1995) (citing Va. Bd. of Pharmacy, 425 U.S. 728, but only for the standing question, not on the question of whether the speech is commercial or not); Mineral Res. Int’l v. U.S. Dep’t of Health & Human Servs., 53 F.3d 305 (10th Cir. 1995) (holding that court lacked jurisdiction and thus not considering First Amendment claims); United States v. Undetermined Quantities of Article of Device, Med. Devices Rep., Peter B. Hutt, Richard A. Merrill & Lewis A. Grossman, Food & Drug Law: Cases and Materials 71 (3rd ed. 2007) (W.D. Mich. 1982) (allowing audio recordings to be evidence of an intended therapeutic use, though not considering First Amendment possibilities).
59 See Alliance for Natural Health v. Sebelius, 714 F. Supp. 2d 48, 60-61, (D.D.C. 2010); United States v. Caputo, 517 F.3d 935, 938-39 (7th Cir. 2008); Wallach v. Crawford, No. 04-CV-216, 2005 WL 6054963, at *8 (S.D. Cal. Mar. 29, 2005); Whitaker v. Thompson, 239 F. Supp. 2d 43, 53 (D.D.C. 2003); Thompson v. W. States Med. Ctr., 535 U.S. 357, 367-68 (2002); Pearson v. Shalala, 164 F.3d 650, 655 (D.C. Cir. 1999); Nutritional Health Alliance v. Shalala, 953 F. Supp. 526, 529 (S.D.N.Y. 1997); Nat’l Council for Improved Health v. Shalala, 893 F. Supp. 1512, 1517 (D. Utah 1995); United States v. Gen. Nutrition, Inc., 638 F. Supp. 556, 562 (W.D.N.Y. 1986).
60 Alliance for Natural Health v. Sebelius; Whitaker v. Thompson; Pearson v. Shalala; Nutritional Health Alliance v. Shalala; Nat’l Council for Improved Health v. Shalala.
61 See Caputo, 517 F.3d at 937 (promotion for AbTox medical device); United States v. Caronia, 576 F. Supp. 2d 385, 389, 395-96 (E.D.N.Y. 2008) (pharmaceutical sales representative marketing activities);, Thompson v. W. States Med. Ctr., 535 U.S. 357, 366 (2002) (“The parties agree that the advertising and soliciting prohibited by the FDAMA constitute commercial speech.”).
62 See Stern, supra note 19, at 94-100 (noting “the prevalence of easy calls” and arguing that “[t]he great majority of the Court’s decisions have involved communication that qualifies as commercial speech by virtually any definition.”).
63 Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,074 (Dec. 3, 1997); Advertising and Promotion; Guidances, 61 Fed. Reg. 52,800 (Oct. 8, 1996).
64 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 62 (D.D.C. 1998).
65 Id. at 64.
66 Beharry v. Bedessee Imports Inc., No. 09-CV-0077, 2010 WL 1223590, at *1 (E.D.N.Y. Mar. 23, 2010).
67 Id.
68 Id.
69 Bracco Diagnostics v. Amersham Health, 627 F. Supp. 2d 384, 457 (D.N.J. 2009).
70 Id. at 458.
71 Id. (quoting Wash. Legal Found., 13 F. Supp. 2d at 63).
72 Id. at 458-59.
73 15 U.S.C. § 1125 (2006).
74 Bracco, 627 F. Supp. 2d at 455-56.
75 Bolger v. Youngs Drug Prods. Corp., 463 U.S. 60, 66-67 (1983).
76 Id.
77 Indeed, others have made this argument. See, e.g., Barnes, Richard L., A Call for a Value-Based Test of Commercial Speech, 63 Wash. U. L.Q. 649, 706 (1985)Google Scholar. Note also that Bill Vodra identifies six factors that FDA generally uses to distinguish promotional activities that it will regulate from educational activities that it will not: (i) the speech’s content; (ii) its context; (iii) its audience; (iv) the medium used to communicate it; (v) the purported rationale for it; and (vi) the real rationale for it. Vodra, supra note 8, at 592. He notes that the distinction between promotional and educational activities “is similar to, but not the same as, the Supreme Court’s division between commercial and noncommercial speech.” Id. at 591.
78 The modern enunciation of what has become “the Five Ws (and one H)” is most often attributed to Rudyard Kipling, “The Elephant’s Child,” in Just So Stories 63 (Doubleday Page & Co., 1912). Again, Bill Vodra suggested that FDA uses similar but not identical criteria for distinguishing promotional from educational activities. Vodra, supra note 8, at 592-96.
79 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, 12 (2007).Google ScholarPubMed
80 447 U.S. 530 (1980).
81 Id. at 533.
82 Cent. Hudson Gas v. Pub. Serv. Comm’n, 447 U.S. 557, 563 n.3 (referring to the companion holding in Consolidated Edison).
83 Id. at 557 (1980).
84 First Nat’l Bank of Boston v. Bellotti, 435 U.S. 765, 768 (1978).
85 Id. at 769.
86 Id. at 777.
87 Stern, supra note 19, at 93.
88 Edward B. Beharry & Co. v. Bedessee Imps. Inc., No. 09-CV-0077, 2010 WL 1223590, at *8 (E.D.N.Y. Mar. 23, 2010); Bracco Diagnostics v. Amersham Health, 627 F. Supp. 2d 384, 456-58 (D.N.J. 2009).
89 United States v. Harkonen, No. C 08-00164, 2009 WL 1578712, at *6 (N.D. Cal. June 4, 2009) (noting that “[t]he mere fact that Harkonen is an M.D.” did not render the speech noncommercial); Whitaker v. Thompson, 239 F. Supp. 2d 43, 53 (D.D.C. 2003) (spending little time considering whether speech is commercial or not even though plaintiffs included a physician); In re Orthopedic Bone Screw Prods. Liab. Litig., No. MDL 1014, 1997 WL 186325 (E.D. Pa. Apr. 16, 1997) (seminar presentations by physicians speaking on behalf of medical device manufacturers). In United States v. Caronia, 576 F. Supp. 2d 385, 395-96 (E.D.N.Y. 2008), a pharmaceutical sales representative adopted First Amendment defenses by a physician defendant, Dr. Gleason. Although Caronia did not argue that his speech was noncommercial, the court noted that Dr. Gleason had made such an argument before pleading guilty to misbranding under the FDCA. Id. at 390, 395-96.
90 Hall & Sobotka, supra note 79.
91 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 62 (D.D.C. 1998).
92 Id. at 65.
93 Alderman, Richard M., Commercial Entities’ Noncommercial Speech: A Contradiction in Terms, 1982 Utah L. Rev. 731, 744 (1982)Google Scholar; see also Bennigson, Tom, Nike Revisited: Can Commercial Corporations Engage in Non-Commercial Speech?, 39 Conn. L. Rev. 379, 393-96 (2006)Google Scholar (arguing that because corporations have a fiduciary duty to shareholders to pursue corporate profits, “all legitimate corporate expenditures . . . must be commercial in a sense, including expenditures to publish speech”).
94 See Greater New Orleans Broad. Ass’n v. United States, 527 U.S. 173, 191 (1999). For an argument that FDA’s restrictions on off-label promotion violate Greater New Orleans, see Hall & Sobotka, supra note 79. Note also that the Court’s recent decision in Citizens United v. FEC, 130 S. Ct. 876 (2010), expressed significant skepticism about “speech restrictions based on the identity of the speaker,” id. at 899, although the restrictions here were clearly focused on political, noncommercial speech. Id. at 886.
95 Bolger v. Youngs Drug Prods. Corp., 463 U.S. 60, 69 (1983).
96 Kordel v. United States, 335 U.S. 345, 348-52 (1948); United States v. Urbuteit, 335 U.S. 355, 357 (1948).
97 Wash. Legal Found., 13 F. Supp. 2d at 64.
98 Vodra, supra note 8, at 591 (citing a March 14, 1989 speech by Ken Feather to the Pharmaceutical Manufacturers Association Marketing Section).
99 United States v. Caronia, 576 F. Supp. 2d 385, 389, 395-96 (E.D.N.Y. 2008).
100 Wash. Legal Found., 13 F. Supp. 2d at 64.
101 Stern, supra note 19, at 89-92.
102 Id. at 121.
103 First Nat’l Bank of Boston v. Bellotti, 435 U.S. 765, 775-86 (1978); see Consol. Edison Co. of N.Y. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 530, 537-41 (1980).
104 Stern, supra note 19, at 89 (citing Riley v. Nat’l Fed’n of the Blind of N.C., Inc., 487 U.S. 781, 786 (1988)).
105 Bd. of Trs. of the State Univ. of N.Y. v. Fox, 492 U.S. 469, 474 (1989) (analyzing a university rule that prohibited commercial entities from operating on campus).
106 IMS Health Inc. v. Sorrell, 631 F. Supp. 2d 434, 447 (D. Vt. 2009).
107 IMS Health Inc. v. Ayotte, 550 F.3d 42, 52 (1st Cir. 2008).
108 Stern, supra note 19, at 127.
109 Bracco Diagnostics v. Amersham Health, Inc., 627 F. Supp. 2d 384, 457-58 (D.N.J. 2009) See Bd. of Trs. of Leland Stanford Univ. v. Sullivan, 773 F. Supp. 472, 474 (D.C. Cir. 1991) (“It is equally settled . . . that the First Amendment protects scientific expression and debate just as it protects political and artistic expression.”).
110 627 F. Supp. 2d at 457-58.
111 See, e.g., Duff Wilson, Drug Maker Hired Writing Company for Doctor’s Book, Documents Say, N.Y. Times, (Nov. 29, 2010), http://www.nytimes.com/2010/11/30/business/30drug.html.
112 See, e.g., Nat’l Comm’n on Egg Nutrition v. FTC, 570 F.2d 157 (7th Cir. 1977) (upholding FTC order that prohibited trade association from running false ads arguing that “there is no scientific evidence that eating eggs increases the risk of . . . heart [and circulatory] disease . . .”); In re R.J. Reynolds Tobacco Co., 111 F.T.C. 539 (1988) (FTC decision that advertisement titled “Of Cigarettes and Science” qualified as commercial speech under Bolger criteria).
113 Bracco Diagnostics, 627 F. Supp. 2d at 458; Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 63 (D.D.C. 1998).
114 Wallach v. Crawford, No. 04-CV-216, 2005 WL 6054963 (S.D. Cal. Mar. 29, 2005) (involving dietary supplement manufacturers distributing portions of a chapter in the Physician’s Desk Reference discussing the therapeutic uses and health effects of magnesium).
115 See Bracco Diagnostics, 627 F. Supp. 2d at 458-59; Wash. Legal Found. v. Friedman, 13 F. Supp. 2d at 65; Hamburg, Margaret A., Innovation, Regulation, and the FDA, 363 New Eng. J. Med. 2228, 2231 (2010)CrossRefGoogle Scholar (discussing studies showing that larger percentages of positive trials are published than negative ones).
116 Moreover, FDA tends to look at the content of speech only after using other criteria to determine if it is promotional or educational. Vodra, supra note 8, at 593.
117 In re Warfarin Sodium Antitrust Litig., No. MDL 98-1232-SLR, 1998 U.S. Dist. WL 883469, at *13-14 (D. Del. Dec. 7, 1998).
118 Of course, companies that recall products often do so temporarily and hope to sell them again, in which case the company would have clear commercial motives to defend its product. Pfizer, for example, vigorously defended Vioxx after it was pulled from the market.
119 Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 561 (1980).
120 Kasky v. Nike, Inc., 45 P.3d 243, 256 (Cal. 2002).
121 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d at 64.
122 Hall & Sobotka, supra note 79, at 9. For example, companies can violate their obligations under federal securities law if they fail to disclose material information about products. See, e.g., SEC v. Biopure Corp., Civil No. 05-11853 WGY (Sept. 14, 2005).
123 Vodra, supra note 8, at 592-96; Hall & Sobotka, supra note 79, at 9.
124 Vodra, supra note 8, at 594.
125 Id.
126 Id.
127 Id.
128 Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 561 (1980).
129 See Bolger v. Youngs Drug Prods. Corp., 463 60, 65-68 (1983) (stating that the fact that pamphlets are advertisements, refer to a specific product, and are economically motivated provides “strong support” that the pamphlets are “properly characterized as commercial speech”).
130 Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, 425 U.S. 748, 762 (1976).
131 Bolger, 463 U.S. at 66.
132 447 U.S. at 563 & n.5.
133 Id. at 580 (Stevens, J., concurring).
134 See Consol. Edison Co. of N.Y. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 530 (1980) (energy utility company advocating for nuclear power); Fist Nat’l Bank of Boston v. Bellotti, 435 U.S. 765 (1978) (bank objecting to proposed amendment to state constitution authorizing personal income tax).
135 See, e.g., Slane v. Emoto, 582 F. Supp. 2d 1067, 1080-83 (W.D. Wis. 2008) (reviewing a naturopath’s books discussing the therapeutic effects of water and various devices, finding that it was noncommercial speech because “[n]o statement in any of the books proposes a commercial transaction with respect to any [product]”).
136 Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, 425 U.S. 748, 761-65 (1976).
137 Kozinski & Banner, supra note 9, at 640.
138 Indeed, Vodra noted in 1989 that the purported rationale for drug industry speech often varied from its “true intent.” Vodra, supra note 8, at 595.
139 See Bolger v. Youngs Drug Prods. Corp., 463 U.S. 60, 67-68 (1983).
140 Id. at 68 (quoting Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 563, n.5 (1980)).
141 Stern, supra note 19, at 89 (citing Riley v. Nat’l Fed’n of the Blind of N.C., Inc., 487 U.S. 781, 796 (1988)).
142 Nike, Inc. v. Kasky, 539 U.S. 654, 677-78 (2003) (Breyer, J., concurring).
143 Commonwealth Brands v. United States, No. 1:09-CV-117M, 2009 WL 3754273, at *6 (W.D. Ky. Nov. 5, 2009).
144 Bd. of Trs. of the State Univ. of N.Y. v. Fox, 492 U.S. 469, 474 (1989) (analyzing a university rule that prohibited commercial entities from operating on campus).
145 In re Warfarin Sodium Antitrust Litig., No. MDL 98-1232-SLR, 1998 WL 883469, at *15 (D. Del. Dec. 7, 1998).
146 Id.
147 Id. at *14.
148 Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 64 (1998).
149 Valentine v. Chrestensen, 316 U.S. 52, 55 (1942).
150 Bolger v. Youngs Drug Prods. Corp., 463 60, 68 (1983); Consol. Edison Co. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 530, 544 (1980).
151 See, e.g. Wash Legal Found., 13 F. Supp. 2d at 64 (noting that the speech might be noncommercial if manufacturers supported “CME regardless of whether their products would ultimately be addressed”).
152 Id. at 65.
153 Genentech: Avastin Not Intended for AMD: Company Cautions on Off-Label Use of Cancer Drug, Retinal Physician (Jan. 2006), http://www.retinalphysician.com/article.aspx?article=100181.
154 Id.
155 Id. For a general discussion, see Osborn, supra note 51, at 336-38. Although Osborn questions whether Genentech “could lawfully communicate directly to physicians any safety information that related to the off-label use” of Avastin for AMD during this period, this position is exceedingly cautious and of questionable accuracy. Id. at 338 (emphasis added). Ralph Hall and Elizabeth Sobotka also take a surprisingly restrictive view of what companies could lawfully communicate about off-label uses. Hall & Sobotka, supra note 79. Obviously, there is significant uncertainty over what FDA would and would not permit. But it is highly unlikely that FDA would, as an enforcement matter, pursue companies for off-label promotion on the sole basis of communicating scientific studies or sharing concerns about the safety of off-label uses without also attempting to promote that use. See FDA, 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 (Jan. 2009), http://www.fda.gov/oc/op/goodreprint.html.
156 Hall & Sobotka, supra note 79, at 14 (doubting that a court would consider this to be a sufficient economic motivation).
157 Kozinski & Banner, supra note 9, at 640.
158 Bolger v. Youngs Drug Prods. Corp., 463 60, 66 (1983) (citing N.Y. Times v. Sullivan, 376 U.S. 254, 265-66 (1964)).
159 Note that courts have been careful in FDA contexts not to stretch FDA’s jurisdiction to books and other publications that espouse “ideas, beliefs and mental processes.” United States v. Undetermined Quantities of Article of Device, Med. Devices Rep. (CCH) ¶ 15,055 (W.D. Mich. Nov. 22, 1982) (holding that FDA could use statements in books and other materials as objective evidence of “intended use,” without asserting jurisdiction over those materials directly).
160 Commonwealth Brands, Inc. No. 1:09-CV-117-M, 2009 WL 3754273, at *6 (W.D. Ky. Nov. 5, 2009).
161 Id. at *6.
162 Id. (citing United States. v. Philip Morris USA, Inc., 566 F.3d 1095, 1121 (D.C. Cir. 2009)).
163 United States v. Harkonen, No. C08-00164 MHP, 2009 WL 1578712, at *6 (N.D. Cal. June 4, 2009).
164 Id. at *1-3.
165 Id. at *6.
166 Id.
167 Id.
168 Wallach v. Crawford, No. 04-CV-216, 2005 WL 6054963, at *1 (S.D. Cal. Mar. 29, 2005).
169 Id. at *1.
170 See id. at *8.
171 In re Warfarin Sodium Antitrust Litig., No. MDL 98-1232-SLR, 1998 WL 883469, at *11-15 (D. Del. Dec. 17, 1998).
172 See, e.g., In re Orthopedic Bone Screw Prods. Liab. Litig., 193 F.3d 781, 793 (3d Cir. 1999) (not finding enough evidence at the motion to dismiss stage to determine whether the speech was commercial or not).
173 Id. at 793; In re Orthopedic Bone Screw Prods. Liab. Litig., 1997 WL 186325, at *13.
174 In re Orthopedic Bone Screw Prods. Liab. Litig., 193 F.3d at 793. The court, however, went on to note that this was a factual dispute that the court was not prepared to resolve at the motion to dismiss stage. Id. at 794.
175 Vodra, supra note 8, at 593-94.
176 Id. at 593.
177 Pearson, 164 F.3d at 651.
178 To wit, in Bracco Diagnostics, Inc. v. Amersham Health, Inc., a Lanham Act case, the court held that an article published in the New England Journal of Medicine about x-ray contrast media was noncommercial in part because “it is a protected form of speech.” 627 F. Supp. 2d 384, 457 (D.N.J. 2009). But the court held that “secondary dissemination of the article” is commercial speech, noting that the industry uses scientific studies and articles “as an especially important and prevalent marketing tool.” Id. at 458 (quoting Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 63 (D.D.C. 1998)).
179 Vodra, supra note 8, at 594.
180 Id.
181 I owe the above observations in this paragraph to discussions with Bill Vodra. Telephone Interview with Bill Vodra, Senior Partner, Arnold & Porter LLP (Jan. 3, 2011).
182 Vodra, supra note 8, at 588.
183 For example, in Nike v. Kasky, Nike had sent letters to university presidents and athletic directors, published press releases, and published arguments about its overseas labor practices in other non-advertising forms. The outcome might have been different if Nike personnel had made statements at debates on college campuses, via television or in news interviews. Chemerinsky & Fisk, supra note 49, at 1148 (discussing Nike v. Kasky, 539 U.S. 654 (2003)).
184 Family Smoking Prevention and Tobacco Control Act of 2009, 21 U.S.C. § 387a.
185 See 21 U.S.C. § 387k(b).
186 21 U.S.C. § 387k(b)(2)(A)(iii); Commonwealth Brands v. United States, No. 1:09-CV-117M, 2009 WL 3754273, at *1-2 (W.D. Ky. Nov. 5, 2009).
187 Id. at *6.
188 Id.
189 550 F.3d 42, 52 (1st Cir. 2008).
190 Id. at 54-55.
191 631 F. Supp. 2d 434, 447 (D. Vt. 2009) (internal quotations omitted).
192 There are hints of this approach in at least one Lanham Act case, In re Warfarin Sodium Antitrust Litigation. There, the court held that speech by DuPont Merck arguing that its product Coumadin presented fewer safety risks than the new generic version was commercial, in part by focusing on the nature of the legal violation alleged—product disparagement. No. MDL 98-1232-SLR, 1998 WL 883469, at *13-14 (D. Del. Dec. 17, 1998).
193 See Request for Comment on First Amendment Issues, supra note 2, 67 Fed. Reg. at 34,943.
194 Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 761-65 (1976).
195 Kozinski & Banner, supra note 9, at 640.
196 Stern, supra note 19, at 145.
197 First Nat’l Bank of Boston v. Bellotti, 435 U.S. 765 (1978); Consol. Edison Co. of N.Y. v. Pub. Serv. Comm’n, 447 U.S. 530 (1980).
198 For example, the Mobil Corporation has long paid for ads in the New York Times and other papers advocating certain public policy positions. See, e.g., Mobil Corp., Climate Change: A Degree of Uncertainty, N.Y. Times, Dec. 4, 1997, at A31; Mobil Corp. It’s Time to Pass the Trade Bill, N.Y. Times, June 30, 1988, at A23. For a discussion of this practice, see Stern, supra note 19, at 122-23.
199 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(m) (2004); Vodra, William, Cortez, Nathan & Korn, David, The Food and Drug Administration’s Evolving Regulation of Press Releases: Limits and Challenges, 61 Food & Drug L.J. 623, 631 (2008)Google Scholar (explaining FDA’s history of notifying parties in Warning Letters that press releases qualified under the definitions of promotional labeling and advertising in 21 C.F.R. § 202.1(l), which are “labeling” under the Act).
200 Vodra, supra note 199, at 629-30 (noting that FDA sent its first letter in 1982, and sent forty such letters between 1996 and 2001). Of course, FDA’s jurisdiction over “labeling” does not automatically extend to all materials distributed by companies that refer to a particular product. Elsewhere, my coauthors and I have identified materials that would probably not be subject to FDA jurisdiction, such as materials intended for investors to meet securities law disclosure obligations, and materials provided to regulators or legislators. Id. at 633-34.
201 Nike v. Kasky, 123 S. Ct. 2554 (2003).
202 FDA Industry-Wide Letter: VNRs and PR Materials, [1990-1991 Transfer Binder] Food Drug Cosm. Law Rep. (CCH) ¶ 42484 (Jul. 24, 1991). FDA suggested that it would republish a new version of this letter as guidance document but never did so. Prescription Drug Advertising and Promotional Labeling; Development and Use of FDA Guidance Documents; Request for Comment, 62 Fed. Reg. 14,915 (Mar. 28, 1997).
203 FDA Industry-Wide Letter: VNRs and PR Materials, supra note 202, ¶ 42484.
204 See, e.g., Regulatory Letter from FDA to ICN Pharmaceuticals, Inc. (Mar. 24, 1986) (on file with author) (objecting to a VNR by ICN discussing possible uses of its drug Virazole in treating AIDS-related diseases). For a general discussion of how FDA has asserted jurisdiction over press releases by regulated firms, see Vodra, supra note 199.
205 Office of Inspector Gen., U.S. Dep’t of Health & Human Servs., Notice, Publication of OIG Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees, 70 Fed. Reg. 70,624 (Nov. 22, 2005).
206 See, e.g., Riley v. Nat’l Fed’n of the Blind of N.C., Inc., 487 U.S. 781 (1988); Sec’y of State v. Joseph H. Munson Co., 467 U.S. 947 (1984); Vill. of Schaumburg v. Citizens for a Better Environment, 444 U.S. 620 (1980).
207 Riley, 487 U.S. at 796.
208 Stern, supra note 19, at 90-91.
209 Recently, many pharmaceutical manufacturers crafted PAPs to help cover out-of-pocket expenses borne by Medicare beneficiaries enrolling in Medicare’s prescription drug benefit, which took effect in 2006. Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2066 (codified and amended in various sections of 42 U.S.C.). Before the Patient Protection and Affordable Care Act in 2010, the Medicare Part D benefit required beneficiaries to bear the full cost of drug expenses between roughly $2,700 and $4,350, known as the “coverage gap” or “doughnut hole.” Even though Medicare subsidized the cost-sharing obligations for many low-income beneficiaries, 42 C.F.R. § 423.782 (2010), pharmaceutical companies wanted to design PAPs for beneficiaries not eligible for these subsidies. Patient Assistance Programs for Medicare Part D Enrollees, 70 Fed. Reg. at 70,624. The U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) expressed concern that PAPs sponsored by drug companies would induce higher drug spending, potentially in violation of federal fraud and abuse laws, by steering enrollees to use particular drugs, increasing costs to Medicare, creating an advantage over competing drugs, and reducing enrollee’s incentives to use less expensive, but equally effective drugs. Dep’t of Health and Human Servs., Office of Inspector Gen., OIG Advisory Opinion 07-04, 7, Mar. 30, 2007, available at http://oig.hhs.gov/fraud/docs/advisoryopinions/2007/AdvOpn07-04.pdf.
210 21 C.F.R. § 202.1(e)(4) (2010).
211 21 C.F.R. § 312.7(a) (2010).
212 Draft Policy Statement on Industry Supported Scientific and Educational Activities, 57 Fed. Reg. 56,412, 56,412-14 (Nov. 27, 1992); Guidance for Industry: Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,093, 64,093-100 (Dec. 3, 1997); Advertising and Promotion; Guidances, 61 Fed. Reg. 52,800 (Oct. 8, 1996).
213 Food and Drug Modernization Act of 1997, § 401, 21 U.S.C. § 360aaa-1 (repealed 2006); 21 C.F.R. § 99 (2010); Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices, 63 Fed. Reg. 64,556 (Nov. 20, 1998).
214 See, e.g., Wash. Legal Found. v. Kessler, 128 F. Supp. 2d 11 (D.D.C. 2000); Wash. Legal Found. v. Henney, 202 F.3d 331 (D.C. Cir. 2000); Wash. Legal Found. v. Friedman, 36 F. Supp. 2d 16 (D.D.C. 1999); Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998); Wash. Legal Found. v. Kessler, 880 F. Supp. 26 (D.D.C. 1995).
215 Henney, 128 F. Supp. 2d at 15.
216 The stakes for companies go far beyond liability under the FDCA. For example, companies have paid billions to settle civil and criminal claims alleging violations of the False Claims Act, anti-kickback statute, and other laws for off-label and other forms of promotion. For a concise citation of recent cases, see 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, 302 n.3 (2010)Google ScholarPubMed.
217 Dep’t of Health and Human Servs., Office of the Comm’r, 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, Jan. 2009, available at http://www.fda.gov/oc/op/goodreprint.html.
218 See, e.g., Christopher Lee, FDA Considers Easing Curbs on Drug Makers, Wash. Post, Dec. 1, 2007 at A4, available at http://www.washingtonpost.com/wp-dyn/content/article/2007/11/30/AR2007113002300.html.
219 Letter from Representative Henry A. Waxman, Chairman of the House Comm. on Oversight and Gov’t Reform, to Honorable Andrew von Eschenbach, Comm’r of the Food & Drug Admin., (Nov. 30, 2007) available at http://online.wsj.com/public/resources/documents/waxmanletter_113007.pdf.
220 Guidance for Industry, supra note 212.
221 Id.
222 Id.
223 Id.
224 447 U.S. 530, 544 (1980); Pac. Gas & Elec. Co. v. Pub. Utils. Comm’n of Cal., 475 U.S. 1, 20 (1986) (plurality) (rejecting requirement that Pacific Gas & Electric must include statements by those with alternative viewpoints in utility bills).
225 Hall & Sobotka, supra note 79, at 13.