To ban or not to ban - That is the question: The constitutionality of a moratorium on consumer drug advertising

Food and Drug Law Journal

Volumn 63, Issue 1, 2008, Pages 1-33

  Schwartz, Mark I ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CITALOPRAM; ESCITALOPRAM; FLUOXETINE; FLUVOXAMINE MALEATE; NAPROXEN; PAROXETINE; ROFECOXIB; ROSIGLITAZONE; SEROTONIN UPTAKE INHIBITOR; SERTRALINE; TELITHROMYCIN;

ARTHRITIS; COMMUNITY ACQUIRED PNEUMONIA; CONSUMER; DRUG APPROVAL; DRUG MARKETING; DRUG USE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH HAZARD; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; INTERPERSONAL COMMUNICATION; LAW; LIVER FAILURE; LIVER INJURY; NON INSULIN DEPENDENT DIABETES MELLITUS; PAIN; PUBLIC HEALTH; REVIEW; SINUSITIS; SUICIDAL BEHAVIOR; TREATMENT CONTRAINDICATION;

ADVERTISING AS TOPIC; CIVIL RIGHTS; CONSUMER PARTICIPATION; DRUG INDUSTRY; DRUG THERAPY; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL AGENCIES; LEGISLATION, DRUG; PATIENT EDUCATION AS TOPIC; PHARMACEUTICAL PREPARATIONS; SUPREME COURT DECISIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 40749093699     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (239)

1. H.R. 1561, The Enhancing Drug Safety and Innovation Act of 2007 (introduced in the House of Representatives on Mar. 19, 2007) and S. 1082, The Prescription Drug User Fee Amendments of 2007 (reported in the Senate on Apr. 10, 2007).
2. This article does not seek to determine whether a moratorium constitutes good public policy separate and apart from whether a moratorium would be constitutional.
3. The author considers the constitutionality of a moratorium under each of the prongs of the Central Hudson test.
4. See, for instance, Barnaby Feder, Merck's Actions on Vioxx Face New Scrutiny, New York Times, (Feb. 15,2005), available at http://www.nytimes.com/2005/02/15/business/15merck.html?ei=5088&en= a7f4f42cbcd0541e&ex=1266123600&adxnnl=1&partner=rssnyt&adxnnlx= 1128682912-zmTlgrz5NiRXd-saIb59XTQ;
5. and Brooke Masters and Marc Kaufman, Painful Withdrawal/or Makers of Vioxx - Pulling of Arthritis Drug Raises Questions on Marketing, Safety Risks, WASHINGTON POST, (Oct. 18, 2004), at A1.
6. See, for instance, Gardiner Harris, FDA Warns of Liver Failure with Antibiotic, NEW YORK TIMES, (June 30, 2006), available at http://www.nytimes.com/2006/06/30/health/30fda.html;
7. Gardiner Harris, Halt is Urged for Trials of Antibiotic in Children, NEW YORK TIMES, (Jun. 8, 2006), available at http://www.nytimes.com/2006/06/08/science/08drug.html;
8. Andrew Bridges, Advisers Suggest Restricting Antibiotic, WASHINGTON POST, (Dec. 15, 2006), available at http://www.washingtonpost.com/wp-dyn/content/article/2006/12/15/AR2006121501703. html.
9. See, for instance, Steven Reinberg, Diabetes Drug Avandia Boosts Heart Attack, Death Risk: Study, WASHINGTON POST, (May 21, 2007), available at http://www.washingtonpost.com/wp-dyn/ content/article/2007/05/21/AR2007052100753.html;
10. Marilynn Marchione, FDA Risk Said to Show Avandia Risk, WASHINGTON POST, (May 24, 2007), available at http://www.washingtonpost.com/wp-dyn/content/article/2007/05/24/AR2007052402427. html;
11. and Gardiner Harris, Report Backs up Warnings about Drug Avandia, NEW YORK TIMES, (Jul. 27, 2007), available at http://www.nytimes.com/2007/07/27/health/27avandia.html.
12. See, for instance, Gardiner Harris, Debate Resumes on the Safety of Depression's Wonder Drugs, NEW YORK TIMES, (Aug. 7, 2003), available at http://query.nytimes.com/ gst/fullpage.html?res=9E0DE4DD1731F934A3575BC0A9659C8B63&sec=&spon= &pagewanted=2;
13. and Erica Goode, British Ignite a Debate on Drugs and Suicide, NEW YORK TIMES, (Dec. 16, 2003), available at http://query.nytimes.com/gst/fullpage.html?sec=health&res= 9b04e6df113cf935a25751c1a9659c8b63.
14. "[A]lmost every morning's newspaper and each evening's television newscasts include a new and more disturbing episode of pharmacological crisis and medical mayhem in the United States ...," from a prepublication copy of The Future of Drug Safety - Promoting and Protecting the Health of the Public, Institute of Medicine of the N ational Academies, at 1-1 (2006), quoting Markel, available at http://www.nap.edu/catalog.php?record_id= 11750#toc.
15. Also, see The Public has Doubts about the Pharmaceutical Industry's Willingness to Publish Safety Information about their Drugs in a Timely Manner, WALL STREET JOURNAL, (Jan. 18, 2005), available at http://www.harrisinteractive.com/news/printerfriend/index. asp?NewsID=882.
16. See, for example, Julie Donohue et al., A Decade of Direct-to-Consumer Advertising of Prescription Drugs, NEW ENGLAND JOURNAL OF MEDICINE, 357:7 (2007);
17. and Francis Palumbo et al., The Development of Direct-to-Consumer Prescription Drug Advertising Regulation, 57 FOOD & DRUG L. J. 423 (2002).
18. See, for example, AMA calls for temporary moratorium on direct-to-consumer advertising of new prescription drugs, (Jun. 14, 2005), available at http://www.ama-assn.org/ama/pub/category/16467.html.
19. The Future of Drug Safety - Promoting and Protecting the Health of the Public, supra note 8, at 5-9.
20. Also, see, Christopher Rowland, Senate Leader Attacks Drug Ads, BOSTON GLOBE, (Jul. 2, 2005), available at http://www.boston.com/business/articles/2005/07/02/ senate_leader_attacks_drug_ads/.
21. The Future of Drug Safety - Promoting and Protecting the Health of the Public, supra note 8, at 5-9 to 5-10. Bristol-Meyers Squibb's moratorium is one year, and Pfizer's is six months.
22. Id. at 5-15.
23. Anna Wilde Mathews and Stephanie Kang, Media Industry Helped Drug Firms Fight Ad Restraints, WALL STREET JOURNAL, (Sept. 21, 2007), at B1.
24. Id.
25. Id.
26. Section 901(d) of FDAAA added section 503B to the FDCA. FDAAA was signed into law by President Bush in Sept. 2007.
27. This has included the American Medical Association (AMA), and the Consumers Union. See, for example, AMA Calls for Temporary Ban on DTC Drug Ads, (Jun. 15, 2006), available at https://www.aef.com/industry/ news/data/2006/6050/:pf_printable?;
28. and The Impact of Direct-to-Consumer Drug Advertising on Seniors' Health and Health Care Costs, Statement of Consumers Union Bill Vaughan to the Senate Committee on Aging, (Sept. 29, 2005), available at http://www.consumersunion.org/pub/2005/09/002745print/html.
29. 81% of Physicians Support Direct-to-Consumer Advertising Moratorium for New Prescription Medications, (Sept. 21, 2005), available at http://www.hraresearch.com/L3-about-Press1.html.
30. "Democratic presidential hopeful John Edwards said Sunday that prescription drug companies should wait two years to begin advertising their new products to consumers ...," Holly Ramer, Edwards: Two Year Ban on New Drug Ads, THE GUARDIAN, (Oct. 28, 2007), available at http://www.guardian.co.uk/worldlatest/story/0.,-7031085,00.html.
31. OECD is an international organization of thirty countries that accept the principles of representative democracy and a free market economy.
32. The Future of Drug Safety - Promoting and Protecting the Health of the Public, supra note 8, at 5-6: "In 2006, the United States and New Zealand were the only nations that permitted DTC advertising of prescription drugs. However, the European Medicines Agency has for some time considered allowing DTC advertising for three disease categories (HIV/AIDS, diabetes and asthma and other respiratory conditions)."
33. 44 Liquormart v. Rhode Island, 517 U.S. 484, at 495 (1996).
34. Daniel Troy, Advertising: Not 'Low Value' Speech, 16 YALE J. REG. 85, at 95 (1999).
35. Id.
36. Troy, supra note 24, at 93. Indeed, Benjamin Franklin authored his early defense of the free press in support of his decision to print, of all things, an advertisement promoting trips to Barbados. See, for instance, 44 Liquormart, 517 U.S. 484, at 495-496.
37. Daniel Troy, Do We Have a Beef With the Court? Compelled Commercial Speech Upheld, but it Could Have Been Worse, published in CATO SUPREME COURT REVIEW, 2004-2005, Washington, D.C., Cato Institute, 2005.
38. Id.
39. Id.
40. Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976).
41. Id. at 762-763.
42. Id. at 763. See, also, 44 Liquormart, 517 U.S. at 496: "In accord with the role that commercial messages have long played, the law has developed to ensure that advertising provides consumers with accurate information about the availability of goods and services."
43. Virginia State Board of Pharmacy, 425 U.S. at 764-765. "So long as we preserve a predominantly free enterprise economy, the allocation of our resources in large measure will be made through numerous private economic decisions. It is a matter of public interest that those decisions, in the aggregate, be intelligent and well informed. To this end, the free flow of commercial information is indispensable."
44. Id. at 770. "There is, of course, an alternative to ... [a] ... highly paternalistic approach. That alternative is to assume that this information is not in itself harmful, that people will perceive their own best interests if only they are well enough informed, and that the best means to that end is to open the channels of communication rather than to close them ... It is precisely this kind of choice, between the dangers of suppressing information, and the dangers of its misuse if it is freely available, that the First Amendment makes for us. Virginia is free to require whatever professional standards it wishes of its pharmacists; it may subsidize them or protect them from competition in other ways. But it may not do so by keeping the public in ignorance of the entirely lawful terms that competing pharmacists are offering."
45. Ohralik, v. Ohio State Bar Association, 436 U.S. 447, 456 (1978). Also see, Martin Redish, Money Talks: Speech, Economic Power, and the Values of Democracy, New York, NEW YORK UNIVERSITY PRESS, (2001), at 15.
46. Id.
47. Bates v. State Bar of Arizona, 433 U.S. 350 (1977). Also, see, In re RMJ, 455 U.S. 191 (1982).
48. Central Hudson Gas and Electric Corporation v. Public Service Commission of New York, 447 U.S. 557, at 566 (1980).
49. Id. at 566-567.
50. Id. at 568.
51. Id. at 569-570.
52. For an overarching critique of the First Amendment protection of commercial speech, see, Roger A. Shiner, Freedom of Commercial Expression, New York, OXFORD UNIVERSITY PRESS, (2003).
53. "This inquiry [i.e., the fourth prong] is heavily spiced with reasonableness considerations, leading to great subjectivity in analysis and the risk of inconsistent results ... ," Troy, supra note 24, at 132.
54. Redish, supra note 35, at 15.
55. Bolger v. Youngs Drug Products Corp., 463 U.S. 60 (1983).
56. Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471, U.S. 626, at 651 (1985). For more recent Supreme Court cases on commercial speech mandates, see, Glickman v. Wileman Brothers & Elliott, 521 U.S. 457 (1997); United States v. United Foods, 533 U.S. 405 (2001), and Johanns v. Livestock Marketing Association, 544 U.S. 550 (2005).
57. Posadas de Puerto Rico Associates v. Tourism Co. of Puerto Rico, 478 U.S. 328, at 348 (1986).
58. Compelled speech has received decidedly more mixed protection during this period of time. See, for example, Wileman Brothers & Elliott, Inc., 521 U.S. 457;
59. United Foods, 533 U.S. 405, and Livestock Marketing Association, 544 U.S. 550.
60. City of Cincinnati v. Discovery Network, 507 U.S. 410 (1993).
61. Edenfield v. Fane, 507 U.S. 761 (1993).
62. Id. at 771. "The Board has not demonstrated that, as applied in the business context, the ban on CPA solicitation advances its asserted interests in any direct and material way. It presents no studies that suggest personal solicitation of prospective business clients by CPA's creates the dangers of fraud, overreaching, or compromised independence that the Board claims to fear. The record does not disclose any anecdotal evidence, either from Florida or another State, that validates the Board's suppositions."
63. Ibanez v. Florida Department of Business and Professional Regulation, 512 U.S. 136 (1994).
64. Rubin v. Coors Brewing Company, 514 U.S. 476 (1995).
65. 44 Liquormart v. Rhode Island, 517 U.S. 484 (1996).
66. Greater New Orleans Broadcasting Association v. U.S., 527 U.S. 173 (1999).
67. Lorillard Tobacco v. Reilly, 533 U.S. 525 (2001).
68. Thompson v. Western States Medical Center, 535 U.S. 357 (2002).
69. The other one is United States v. Edge Broadcasting Company, 509 U.S. 418 (1993).
70. Florida Bar v. Went For It, Inc., 515 U.S. 618 (1995).
71. See, Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976), where prescription drug price advertising was deemed commercial speech, and Thompson v. Western States Medical Center, 535 U.S. 357 (2002), where the advertising of compounded drugs was deemed commercial speech.
72. In which case the false advertisement would be enforceable under section 502 FDCA.
73. See, Pearson v. Shalala, 164 F.3d 650, at 656 (D.C. Cir. 1999), where the court acknowledged that had the matter involved drugs, as opposed to dietary supplements, the legal analysis might have been somewhat different.
74. Id. at 655, where the Court added: "It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled. We think this contention is almost frivolous."
75. Id.
76. See, for instance, In re R.M.J, 455 U.S. 191, at 203 (1982), stating: "... [T]he Court in Bates suggested that the remedy in the first instance is not necessarily a prohibition but preferably a requirement of disclaimers or explanation." Also, see, Shapero v. Kentucky Bar Association, 486 U.S. 466, at 479 (1988), stating: "... [T]he First Amendment limits the State's authority to dictate what information an attorney may convey in soliciting legal business. 'The States may not place an absolute prohibition on certain types of potentially misleading information ... if the information may also be presented in a way that is not deceptive,' unless the State 'asserts a substantial interest' that such a restriction would directly advance.'"
77. The Future of Drug Safety - Promoting and Protecting the Health of the Public, supra note 8, at 5-10.
78. Id. at 5-7 to 5-8.
79. Id. Also, see, Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising, United States Government Accountability Office (GAO), (Nov. 2006), at 15: "The studies we reviewed also suggest that DTC advertising increases prescribing by prompting some consumers to request the drugs from their physicians, and that physicians are generally responsive to the patient requests ... ,"
80. and Richard Kravitz, et al., Influence of Patients' Requests for Direct-to-Consumer Advertised Antidepressants, 293 JAMA 1995 (2005).
81. Thompson v. Western States Medical Center, 535 U.S. 357, at 368 (2002).
82. Troy, supra note 24, at 131.
83. Id. Also, see, International Dairy Foods Association v. Amestoy, 92 F3d 67 (2d Cir. 1996).
84. Greater New Orleans Broadcasting Association v. U.S., 527 U.S. 173, at 188 (1999).
85. See, for instance, David Brown, Congress Seeks to Balance Drug Safety, Quick Approval, WASHINGTON POST, (Jul. 5, 2007), at A4, citing the problems with Vioxx, Ketek and Avandia as a principal reason for the then pending legislation,
86. and John Calfee, Reform without Reason: What's Wrong with the FDA Amendments Act of 2007, American Enterprise Institute, (2007), citing the problems with Vioxx, Ketek, Avandia and SSRIs as the principal reason for passage of FDAAA.
87. See, for instance, Barnaby Feder, Merck's Actions on Vioxx Face New Scrutiny, NEW YORK TIMES, (Feb. 15, 2005), available at http://www.nytimes.com/2005/02/15/business/15merck.html?ei= 5088&en=a7f4f42cbcd0541e&ex=1266123600&adxnnl=1&partner= rssnyt&adxnnlx=1128682912-zm-Tlgrz5NiRXdsaIb59XTQ;
88. and Brooke Masters and Marc Kaufman, Painful Withdrawal for Makers of Vioxx - Pulling of Arthritis Drug Raises Questions on Marketing, Safety Risks, WASHINGTON POST, (Oct. 18, 2004), at A1.
89. See, for instance, Gardiner Harris, FDA Warns of Liver Failure with Antibiotic, NEW YORK TIMES, (Jun. 30, 2006), available at http://www.nytimes.com/2006/06/30/health/30fda.html;
90. Gardiner Harris, Halt is Urged for Trials of Antibiotic in Children, NEW YORK TIMES, (Jun. 8, 2006), available at http://www.nytimes.com/2006/06/08/science/08drug.html;
91. Andrew Bridges, Advisers Suggest Restricting Antibiotic, WASHINGTON POST, (Dec. 15, 2006), available at http://www.washingtonpost.com/wp-dyn/content/article/2006/12/15/AR2006121501703. html.
92. See, for instance, Steven Reinberg, Diabetes Drug Avandia Boosts Heart Attack, Death Risk: Study, WASHINGTON POST, (May 21, 2007), available at http://www.washingtonpost.com/wp-dyn/ content/article/2007/05/21/AR2007052100753.html;
93. Marilynn Marchione, FDA Risk Said to Show Avandia Risk, WASHINGTON POST, (May 24, 2007), available at http://www.washingtonpost.com/wp-dyn/content/article/2007/05/24/AR2007052402427. html;
94. and Gardiner Harris, Report Backs up Warnings about Drug Avandia, NEW YORK TIMES, (Jul. 27, 2007), available at http://www.nytimes.com/2007/07/27/health/27avandia.html.
95. See, for instance, Gardiner Harris, Debate Resumes on the Safety of Depression's Wonder Drugs, NEW YORK TIMES, (Aug. 7, 2003), available at http://query.nytimes.com/ gst/fullpage.html?res=9E0DE4DD1731F934A3575BC0A9659C8B63&sec=&spon= &pagewanted=2;
96. and Erica Goode, British Ignite a Debate on Drugs and Suicide, NEW YORK TIMES, (Dec. 16, 2003), available at http://query.nytimes.com/gst/fullpage.html?sec=health&res= 9b04e6df113cf935a25751c1a9659c8b63.
97. Timeline of Vioxx related events from CBS News, available at http://www.cbsnews.com/stories/2006/04/05/health/main1476188.shtml
98. Id.
99. It is far from clear that Vioxx, and its competing Cox-2 inhibitors, are significantly riskier than much older non-steroidal anti-inflammatory drugs. See, for instance, Patricia Kearney et al., Do Selective Cyclo-Oxygenase-2 Inhibitors and Traditional Non-Steroidal Anti-Inflammatory Drugs Increase the Risk of Atherothrombosis? BRITISH MEDICAL JOURNAL, 332:1302-1308 (2006).
100. This matter was also complicated by issues surrounding clinical trial # 3014 for Ketek, as a physician who treated many of the patients in this trial eventually pled guilty to fabricating patient data, and is currently serving a 57-month sentence in federal prison. See, for example, David B. Ross, M.D., The FDA and the Case of Ketek, NEW ENGLAND JOURNAL OF MEDICINE, 356:16 (2007);
101. and Janice Soreth, et al., Ketek - The FDA Perspective, NEW ENGLAND JOURNAL OF MEDICINE, 356:16 (2007).
102. See, for example, Revised Boxed Warning Ordered for Avandia, Dickinson's FDA Webview, (Nov. 14, 2007);
103. and Gardiner Harris, After Debate, FDA Backs Sale of Diabetes Medicine, NEW YORK TIMES, (Nov. 15, 2007), available at http://www.nytimes.com/2007/11/15/washington/15drug.html?ex= 1352782800&en=236a430cee30a766&ei=5089&partner=rssyahoo&emc=rss.
104. Antidepressants Get Suicidality Boxed Warning, Dickinson's FDA Webview, (Oct. 2, 2007).
105. Id.
106. See, for example, Alex Berenson et al., Experts Question Study on Youth Suicide Rates, NEW YORK TIMES, (Sept. 14, 2007), available at http://www.nytimes.com/2007/09/14/us/14suicide. html?ex=1347422400&en=74641353eafdffd6&ei=5088&partner= rssnyt&emc=rss;
107. Robert Gibbons et al., Early evidence on the effects of regulators' suicidality warnings on SSRI prescriptions and suicide in children and adolescents, AMERICAN JOURNAL OF PSYCHIATRY 164: 1356-1363, (2007);
108. Jeffrey Bridge, et al., Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: A meta-analysis of randomized controlled trials, 297 JAMA 1683-1696, (2007);
109. David Brett, Antidepressants and suicidal behavior: Cause or cure? AMERICAN JOURNAL OF PSYCHIATRY 164: 989-991 (2007);
110. and Jens Ludwig et al., Anti-depressants and suicide, NBER Working Paper No. 12906, National Bureau of Economic Research, (2007).
111. An additional test, which need not be undertaken in this article, is whether the regulatory regime is irrational, or is so pierced by exceptions and inconsistencies, that the government cannot hope to exonerate it. See, for instance, Rubin v. Coors Brewing Company, 514 U.S. 476, at 488 (1995), and Greater New Orleans Broadcasting Association v. U.S., 527 U.S. 173, at 190 (1999).
112. Greater New Orleans Broadcasting Association, 527 U.S. 173, at 188.
113. Id.
114. Lorillard Tobacco v. Reilly, 533 U.S. 525, at 556 (2001).
115. Edenfield v. Fane, 507 U.S. 761, at 771 (1993).
116. Rubin v. Coors Brewing Company, 514 U.S. 476, at 490 (1995).
117. 44 Liquormart v. Rhode Island, 517 U.S. 484 at 506-507 (1996). Even though the standard enunciated by Justice Stevens was only joined by three other Justices (Kennedy, Souter and Ginsburg), it is the most detailed and objective description we have seen of the scope of the evidentiary requirement for the third prong to be advanced by a Justice of the Supreme Court, and hence is worthy of serious consideration here.
118. Florida Bar v. Went For It, Inc., 515 U.S. 618, at 640 (1995).
119. Under this third prong, we are looking at whether a DTC advertising moratorium would be unconstitutional as-applied to individual drugs, not whether a moratorium would be facially unconstitutional.
120. Principally, these drugs are Vioxx, Ketek, Avandia and SSRIs. See, for instance, David Brown, Congress Seeks to Balance Drug Safety, Quick Approval, WASHINGTON POST, (Jul. 5, 2007), at A4, citing the problems with Vioxx, Ketek and Avandia as a principal reasons for the pending legislation;
121. and John Calfee, Reform without Reason: What's Wrong with the FDA Amendments Act of 2007, American Enterprise Institute, (2007), citing the newly discovered health problems associated with Vioxx, Ketek, Avandia and SSRIs as the principal reasons for passage of FDAAA.
122. Other drugs that have also received substantial media attention of late concerning previously undiscovered health risks, include Trasylol, Fosamax, Zelnorm, and Prempro. It is worth noting that if these four drugs were added to the analysis above, the author's results would not change substantially. For example, for Trasylol (Aprotinin), manufactured by Bayer, see William Hiatt, M.D., Observational Studies of Drug Safety - Aprotinin and the Absence of Transparency, NEW ENGLAND JOURNAL OF MEDICINE, 355:2171-2173 (2006), stating: "Aprotinin was approved by the FDA in 1993 as a means of reducing perioperative blood loss and the need for blood transfusion in patients undergoing coronary-artery bypass grafting. Neither the clinical trial database that led to approval nor the numerous randomized, controlled trials conducted after approval identified an association between aprotinin and any short-term increase in the risk of death or nonfatal cardiovascular events or any serious renal toxic effects ... However, in early 2006, two observational studies were published that raised serious concerns about the drug's safety."
123. For Fosamax, see Robert E. Marx et al., Bisphosphonate-Induced Exposed Bone (Osteonecrosis/Osteorpetrosis) of the Jaws: Risk Factors, Recognition, Prevention, and Treatment, JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY, 63:1567-1575 (2005). Fosamax, manufactured by Merck, was approved by FDA in 1995, however, it was not until Dec. 13, 2004, that doctors at the Long Island Jewish Medical Center announced they had discovered a link between bisphosphonate drugs (such as Fosamax) and a serious bone disease called osteonecrosis of the jaw. This discovery, published in the above-captioned article of the Journal of Oral and Maxillofacial Surgery, prompted FDA and Novartis to issue warnings to physicians and dentists about the risk for the potential adverse effect.
124. Zelnorm was approved by FDA in July 2002, for short term treatment of irritable bowel syndrome. In Feb. 2007, Novartis, Zelnorm's manufacturer, reported an increased risk of cardiovascular adverse events with Zelnorm, and on Mar. 30, 2007, Novartis stops marketing Zelnorm. See comments of Dr. John Jenkins, Director of the Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), FDA, Transcript of FDA Press Conference on the Discontinued Marketing of Zelnorm, (Mar. 30, 2007), available at http://www.fda.gov/bbs/transcripts/transcript033007.pdf. "We looked at the data when the original NDA was reviewed in 2002. And then we looked at the data again in 2004 when the indication was added for chronic constipation. At both of those times the actual number of cardiovascular adverse events in the database were very small while there were imbalances between Zelnorm and placebo, they were not such that you could really draw the inferences of a finding. It really took pooling together all 29 of the studies that have been conducted over the entire life of the product to see this level of signal ... We requested - we first heard about the signal from Novartis on Feb. the 22nd (2007). We met with them on Mar. the 28th (2007) and at that meeting asked that they voluntarily withdraw. The next day, Mar. the 29th, yesterday, they agreed and we're announcing it today. So, there was no long lag between our request and their agreement to follow up on our request."
125. Prempro (estrogen plus progestin), manufactured by Wyeth, was approved by FDA in Jan.,1998 for treatment of symptoms associated with menopause, and for prevention of osteoporosis. See National Institutes of Health News Release, NHLBI Stops Trial of Estrogen Plus Progestin Due to Increased Breast Cancer Risk, Lack of Overall Benefit, (Jul. 9, 2002), available at http://www.nhlbi.nih.gov/new/press/02-07-09.htm. In 2000 and again in 2001, Women's Health Initiative (WHI) investigators complied with a recommendation from the study's Data and Safety Monitoring Board (DSMB) to inform participants of a small increase in heart attacks, strokes, and blood clots in women taking hormones. The DSMB, an independent advisory committee charged with reviewing results and ensuring participant safety, found that the actual number of women having any one of these events was small and it did not cross the statistical boundary established to ensure participant safety. Therefore, the group recommended continuing the trial due to the still uncertain balance of risks and benefits. Then, at the DSMB's regularly scheduled meeting on May 31, 2002, the data review revealed for the first time that the number of cases of invasive breast cancer in the estrogen plus progestin group had crossed the boundary established as a signal of increased risk. 'In designing the trial and following the results, the safety of the patients was of the utmost importance,' said Garnet Anderson, Ph.D., a biostatistician who led the analysis at the Fred Hutchinson Cancer Research Center, Seattle, Washington. 'Because breast cancer is so serious an event, we set the bar lower to monitor for it. We pre-specified that the change in cancer rates did not have to be that large to warrant stopping the trial. And the trial was stopped at the first clear indication of increased risk,' she added. She also noted that, at that point, there was no indication of increased risk for breast cancer in the estrogen-only group."
126. Section 901 of FDAAA, adding subsection 505(o)(3)(B) FDCA, explains that a post-approval study or clinical trial may be required to "... assess signals of serious risk related to the drug." Also under section 901 of FDAAA, adding subsection 505-1(b)(6) FDCA, Congress has defined the term "signal of a serious risk" to mean information related to a serious adverse drug experience associated with use of a drug, and derived from any of the following: a clinical trial, adverse event reports, a post-approval study, peer-reviewed biomedical literature, data derived from the post-market risk identification and analysis system, or other scientific data deemed appropriate by the Secretary.
127. The bill language states "... may require that for a fixed period after initial approval ..." which does not preclude the imposition of a moratorium at some point other than at the initial approval of the drug. However, Congress' objective in drafting subsections 505(o)(4)(G) and (H) in H.R. 1561 was to limit the use of certain drugs that had questionable risk profiles during the initial three-year period post-approval, before the public learned about the drug's benefits. If an advertising moratorium is imposed, for example, 5 years after initial FDA approval, it is unlikely to have much of an effect on sales (though adverse media attention might), as most consumers would have already learned about the drug's purported benefits. It is for this reason that this article focuses on a moratorium being imposed immediately after a drug is approved.
128. Subsection 505(o)(4)(H) of H.R. 1561, reads, in part: "... if the Secretary determines that ... such prohibition is necessary to protect public health and safety while additional information about serious risks of the drug is collected, considering ... the extent to which clinical trials used to approve the drug may not have identified serious risks that might occur among patients expected to be treated with the drug."
129. Arthritis Advisory Committee Meeting of Nov. 29, 2006, slide presentation of Sharon Hertz, M.D., Deputy Director, Division of Analgesia, Anesthesia, and Rheumatology Products, CDER, FDA, Cardiovascular Risk and NSAIDs, available at www.fda.gov/ohrms/dockets/ac/06/slides/2006-4252s1-01-02-FDA-Hertz.ppt.
130. Jennifer Couzin, Drug Safety: Gaps in the Safety Net, SCIENCE, 307:5707:196 (2005).
131. Greater New Orleans Broadcasting Association v. U.S., 527 U.S. 173, at 188 (1999).
132. Id.
133. David B. Ross, M.D., The FDA and the Case of Ketek, NEW ENGLAND JOURNAL OF MEDICINE, 356:1601-1604, (2007).
134. Id.
135. Janice Soreth, et al., Ketek - The FDA Perspective, NEW ENGLAND JOURNAL OF MEDICINE, 356:1675-1676, (2007).
136. Where, according to Justice Stevens and three other justices, the state failed the third prong for not having identified what price level would lead to a material reduction in alcohol consumption, nor the amount that prices would decrease without a ban on liquor prices.
137. Part of the calculus that the Court would need to consider in evaluating the constitutionality of a DTC advertising moratorium is that, unlike the cases of Coors., 44 Liquormart and Lorillard Tobacco, a consumer of a prescription drug, like Ketek, must convince a physician to prescribe such medication. Hence, a DTC advertisement convincing a consumer to consider a medication might be a necessary condition, but is not a sufficient condition, to the consumer taking the drug. Because the physician acts as a gatekeeper of sorts between the consumer and the prescription medication, bringing to bear his independent medical judgment, a court would need to consider whether this intervention tips the balance towards the speech being useful in most instances, as it cannot, per se, cause the harms that the government seeks to avoid under its asserted interest, though it can inform the consumer's decision. This is discussed in greater detail under the 4th prong of Central Hudson.
138. This is assuming Dr. Ross' previously stated conclusions are accurate.
139. Lorillard Tobacco v. Reilly, 533 U.S. 525, at 555 (2001).
140. Greater New Orleans Broadcasting Association v. U.S., 527 U.S. 173, at 188 (1999).
141. http://www.ketek.com/
142. Steve Nissen and Robert Califf, A Conversation about Rosiglitazone, Medscape DIABETES AND ENDOCRINOLOGY, (Aug. 21, 2007), available at http://www.medscape.com/viewarticle/561666.
143. Clifford Rosen, M.D., The Rosiglitazone Story - Lessons from an FDA Advisory Committee Meeting, NEW ENGLAND JOURNAL OF MEDICINE, 357:844-846, (2007);
144. Robert Temple, M.D. et al., Rosiglitazone and the FDA, NEW ENGLAND JOURNAL OF MEDICINE, 357:1775-1777, (2007).
145. Where, according to Justice Stevens and three other justices, the state failed the third prong for not having identified what price level would lead to a material reduction in alcohol consumption, nor the amount that prices would decrease without a ban on liquor prices.
146. Lorillard Tobacco, 533 U.S. 525, at 555.
147. Greater New Orleans Broadcasting Association, 527 U.S. 173, at 188.
148. The language of subsections 505(o)(4)(G) and (H) in H.R. 1561 does not appear to contemplate a moratorium being imposed on an entire class of drugs. Because members of a class receive FDA approval in staggered fashion over a period of many years or decades, there would be little benefit to imposing such a restriction unless the moratorium were imposed on the entire class at some time many years subsequent to initial FDA approval of all the drugs in the class. Furthermore, a moratorium on only one or a few drugs in a class would not materially reduce the relevant risks unless these few drugs in the class had the overwhelming majority of market sales. Clearly, in the case of an entire class of drugs, like SSRIs, for a moratorium to materially reduce the risk to the public, it would either need to be imposed for substantially longer than three years, or it would need to be imposed many years after initial FDA approval of the first drug in its class, and on the vast majority of the drugs in the class.
149. Greater New Orleans Broadcasting Association, 527 U.S. 173, at 188.
150. Id.
151. Central Hudson Gas and Electric Corporation v. Public Service Commission of New York, 447 U.S. 557, at 565 (1980). Stated differently, the regulatory technique may extend only as far as the interest it serves.
152. Id.
153. Thompson v. Western States Medical Center, 535 U.S. 357, at 377 (2002). (Emphasis added)
154. See, Lorillard Tobacco v. Reilly, 533 U.S. 525 at 561-562 (2001): "The broad sweep of the regulations indicates that the Attorney General did not 'carefully calculate[e] the costs and benefits associated with the burden on speech imposed' by the regulations. The outdoor advertising regulations prohibit any smokeless tobacco or cigar advertising within 1,000 feet of schools or playgrounds. In the District Court, petitioners maintained that this prohibition would prevent advertising in 87 percent to 91 percent of Boston, Worcester, and Springfield, Massachusetts ... The Attorney General disputed petitioners' figures but 'concede[d] that the reach of the regulations is substantial.'... The substantial geographical reach of the Attorney General's outdoor advertising regulations is compounded by other factors. 'Outdoor' advertising includes not only advertising located outside an establishment, but also advertising inside a store if that advertising is visible from outside the store. The regulations restrict advertisements of any size and the term advertisement also includes oral statements. In some geographic areas, these regulations would constitute nearly a complete ban on the communication of truthful information about smokeless tobacco and cigars to adult consumers."
155. The issue of whether the moratorium would unnecessarily prohibit advertising for an excessive amount of time will not be considered separately in this section, as it would be duplicative of the analysis that is being performed throughout the entire article.
156. Subsection 505(o)(4)(H) of H.R. 1561.
157. This is not equivalent to the Learned Intermediary doctrine, which states that a manufacturer of a product has fulfilled his duty of care when he provides all of the necessary information to a learned intermediary, such as a physician, who then interacts with a consumer of the product. This doctrine is used primarily by pharmaceutical and medical device manufacturers in defense of tort suits. See, for example, Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652 (1st Cir. 1981).
158. See, for instance, Direct-to-Consumer Prescription Drug Advertising - Overview and Recommendations, National Health Council, (Jan. 2002), at 9: "Clearly, there is concern among some physicians and academic researchers that DTC advertising puts pressures on physicians to prescribe medications because they believe patients expect it in situations where they might otherwise have waited to see whether the condition resolved itself or suggested a different non-drug or drug therapy."
159. Also, see, The Future of Drug Safety - Promoting and Protecting the Health of the Public, supra note 8, at 5-8.
160. Kathryn Aikin, et al., Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs - Summary of FDA Survey Research Results, Final Report, FDA, CDER, (Nov. 19, 2004), at 91, available at http://www.fda.gov/cder/ddmac/Final%20Report/FRfinal111904. pdf.
161. Also, see, John Calfee, Public Policy Issues in Direct-to-Consumer Advertising of Prescription Drugs, American Enterprise Institute, (Jul. 8, 2002).
162. "No studies that we know of have specifically addressed the issue of appropriate pharmaceutical prescribing relative to DTC pharmaceutical ads ...," Direct-to-Consumer Prescription Drug Advertising - Overview and Recommendations, supra note 128, at 9.
163. It is well established that the party seeking to uphold a restriction on commercial speech carries the burden of justifying it. See, for instance, Thompson v. Western States Medical Center, 535 U.S. 357, at 373 (2002).
164. Subsection 505(o)(4)(G) and (H) from H.R. 1561 does not distinguish among types of DTC advertising.
165. Subsection 505(o)(4)(H) from H.R. 1561 states that the moratorium is "... not to exceed 3 years ...," so it could conceivably be shorter than three years.
166. Florida Bar v. Went For It, Inc, 515 U.S. 618 (1995).
167. This dissent was joined by Justices Stevens, Souter and Ginsburg.
168. Florida Bar, 515 U.S. 618 (1995) at 635-645. The dissent also seems skeptical of the "substantial interests" that the government proffers for the second prong. Id. at 636-640.
169. Although the ban applied to all accident injuries, whatever their gravity, unlike the DTC advertising moratorium, which would be applied on a case by case basis. Id. at 633-634.
170. Id. at 634. (Emphasis added)
171. See, for instance, Miriam Shuchman, M.D., Drug Risks and Free Speech - Can Congress Ban Consumer Drug Ads?, NEW ENGLAND JOURNAL OF MEDICINE, 356:2236-39, (2007).
172. Also, see, The Future of Drug Safety - Promoting and Protecting the Health of the Public, supra note 8, at 5-8: "[V]iewers of television prescription drug advertisements may learn more about the benefits than about the risks."
173. The Future of Drug Safety - Promoting and Protecting the Health of the Public, supra note 8, at 5-7. Also, see 21 CFR 202.1(e)(1) "Advertisements broadcast through media such as radio, television, or telephone communications systems shall include information relating to the major side effects and contraindications of the advertised drugs in the audio or visual parts of the presentation and unless adequate provision is made for dissemination of the approved or permitted package labeling in connection with the broadcast presentation shall contain a brief summary of all necessary information related to side effects and contraindications."
174. Also, see, Guidance for Industry: Consumer-Directed Broadcast Advertisements, (Aug. 1999), available at http://www.fda.gov/cder/ Guidance/1804fnl.htm,
175. and Draft Guidance for Industry: Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements, (Jan. 2004), available at http://www.fda.gov/CDER/GUIDANCE/5669dft.pdf.
176. Section 901(d) of FDAAA, adding section 503B FDCA.
177. Recall earlier discussion that the IOM Report cites studies showing that such advertising increases exposure to the new drugs among patients who may not be good candidates for them, and also cites studies suggesting that viewers of DTC drug advertising may learn more about the benefits than the risks of new drugs.
178. The changes brought about by FDAAA do not change the " overbroad" portion of the fourth prong analysis.
179. Central Hudson Gas and Electric Corporation v. Public Service Commission of New York, 447 U.S. 557, at 565 (1980): "... nor can it completely suppress information when narrower restrictions on expression would serve its interest as well." Also, see, Thompson v. Western States Medical Center, 535 U.S. 357, at 371 (2002): "... if the Government could achieve its interests in a manner that does not restrict speech, or that restricts less speech, the Government must do so."
180. 44 Liquormart v. Rhode Island, 517 U.S. 484, at 507 (1996), (opinion of Justice Stevens, joined by Justices Kennedy, Souter and Ginsburg). (Emphasis added) Also, see, Id. at 529, the opinion of Justice O'Connor, joined by Chief Justice Rehnquist, and Justices Souter and Breyer, their agreement with Justice Stevens, that Rhode Island's goal of temperance could be achieved more successfully without prohibiting the advertising of liquor prices.
181. Western States Medical Center, 535 US. 357, at 372. (Emphasis added)
182. H.R. 1561, subsection 505(o)(4)(G)(i) and (ii).
183. See, for instance, In re R.M.J, 455 U.S. 191, at 203 (1982), stating: "... [T]he Court in Bates suggested that the remedy in the first instance is not necessarily a prohibition but preferably a requirement of disclaimers or explanation." Also, see, Shapero v. Kentucky Bar Association, 486 U.S. 466, at 479 (1988), stating: "... [T]he First Amendment limits the State's authority to dictate what information an attorney may convey in soliciting legal business. 'The States may not place an absolute prohibition on certain types of potentially misleading information ... if the information may also be presented in a way that is not deceptive,' unless the State 'asserts a substantial interest that such a restriction would directly advance."
184. Pearson v. Shalala, 164 F.3d 650, at 658 (D.C. Cir. 1999). The court acknowledged that had the matter involved drugs, as opposed to dietary supplements, the legal analysis might have been somewhat different.
185. According to H.R. 1561, subsections 505(o)(4)(G)(i) and (ii), only the last two disclosures are intended to cure an advertisement's potentially misleading nature. The first two are described as intending to protect the public health and safety.
186. H.R. 1561, subsection 505(o)(4)(H).
187. Section 901(a) of FDAAA, adding section 505(o) FDCA.
188. Id.
189. Section 901(b) of FDAAA, adding section 505-1 FDCA.
190. Id.
191. Id.
192. Section 901(d) of FDAAA, adding section 503B FDCA.
193. See, for example, Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), where the organization, Abigail Alliance, sought access to potentially life-saving post-phase I investigational new drugs on behalf of mentally competent, terminally ill adult patients who had no alternative government-approved treatment options.
194. The Future of Drug Safety - Promoting and Protecting the Health of the Public, supra note 8, at 5-14 to 5-15: "In the United Kingdom, a black triangle marks every newly marketed drug approved by the Medicines and Health products Regulatory Agency. The black triangle signifies that a pharmaceutical product is under intense scrutiny of regulatory authorities ...". Also, see, Thompson v. Western States Medical Center, 535 U.S. 357, at 376 (2002), where the majority stated that consumer confusion about drug risks could be dealt with by requiring each compounded drug to be labeled with a warning that the drug has not undergone FDA testing, and that its risks were unknown.
195. Western States Medical Center, 535 U.S. 357, at 373: "The Government has not offered any reason why these possibilities, alone or in combination, would be insufficient to prevent compounding from occurring on such a scale as to undermine the new drug approval process. Indeed, there is no hint that the Government even considered these or any other alternatives. Nowhere in the legislative history of the FDAMA or petitioners' briefs is there any explanation of why the Government believed forbidding advertising was a necessary as opposed to merely convenient means of achieving its interests."
196. Id. at 373: "Yet 'it is well established that the party seeking to uphold a restriction on commercial speech carries the burden of justifying it.' The Government simply has not provided sufficient justification here. If the First Amendment means anything, it means that regulating speech must be a last - not first resort. Yet here it seems to have been the first strategy the Government thought to try."
197. Id.
198. Id. at 374: "... [T]his concern rests on the questionable assumption that doctors would prescribe unnecessary medications ..."
199. Id.
200. Id. at 375, quoting Virginia State Board of Pharmacy: "There is, of course, an alternative, to this highly paternalistic approach. That alternative is to assume that this information is not in itself harmful, that people will perceive their own best interests if only they are well enough informed, and that the best means to that end is to open the channels of communication rather than to close them...But the choice among these alternative approaches is not ours to make or the Virginia General Assembly's. It is precisely this kind of choice, between the dangers of suppressing information, and the dangers of its misuse if it is freely available, that the First Amendment makes for us."
201. Id. at 376.
202. The Future of Drug Safety - Promoting and Protecting the Health of the Public, supra note 8, at 5-7 to 5-8: "One concern is that advertising may lead to more rapid uptake of a new drug, which, in cases where the drug in question is later found to present greater risks than older drugs in the same class, could potentially dramatically increase the exposure to that particular drug, even among patients who are not good candidates for it. That exemplifies the continuing tension between safety concerns and benefits that outweigh the risks for certain patients ... On a potentially more negative note, viewers of television prescription drug advertisements may learn more about the benefits than about the risks."
203. See, also, Julie Donohue, et al., A Decade of Direct-to-Consumer Advertising of Prescription Drugs, NEW ENGLAND JOURNAL OF MEDICINE, 357:673-681 (2007).
204. The Supreme Court has not rendered any decisions on First Amendment protection of commercial speech since Justices Roberts and Alito joined the Court.
205. Bates v. State Bar of Arizona, 433 U.S. 350, at 404 (1977).
206. Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748, at 781 (1976); Central Hudson Gas & Electric Corporation v. Public Service Commission of New York, 447 U.S. 557, at 583 (1980).
207. These more recent votes upholding the 1st Amendment protection of commercial speech appear to be a recognition of the principle of stare decisis more so than any intellectual transformation on his part.
208. In Posadas de Puerto Rico Associates v. Tourism Company of Puerto Rico, 478 U.S. 328 (1986), the Court concluded that the power to regulate conduct logically includes the lesser power to regulate expression promoting that conduct.
209. Id. at 351.
210. Id. at 344.
211. Cases, since Central Hudson, where Rehnquist voted in favor of 1st Amendment protection for commercial speech: In re RMJ; Youngs Drug Products; Edenfield; Coors Brewing Company; 44 Liquormart; Greater New Orleans Broadcasting Association; Wileman Brothers & Elliott; United Foods, Inc. and Lorillard Tobacco. Cases, since Central Hudson, where Rehnquist voted against 1st Amendment protection for commercial speech: Zauderer; Posadas; Shapero; Fox; Discovery Network; Edge Broadcasting; Ibanez; Florida Bar; Livestock Marketing Association and Western States Medical Center.
212. Cases where Justice O'Connor voted in favor of 1st Amendment protection for commercial speech: In re RMJ; Youngs Drug Products; Discovery Network; Coors Brewing Company; 44 Liquormart; Greater New Orleans Broadcasting Association; Lorillard Tobacco; and Western States Medical Center. Cases where Justice O'Connor voted against 1st Amendment protection for commercial speech: Zauderer; Posadas; Shapero; Fox; Edenfield; Edge Broadcasting; Ibanez; Florida Bar; Wileman Brothers & Elliott; United Foods, Inc. and Livestock Marketing Association.
213. Edenfield v. Fane, 507 U.S. 761, at 778-780 (1993).
214. Lorillard Tobacco v. Reilly, 533 U.S. 525 (2001). The regulations prohibited outdoor advertising of smokeless tobacco or cigars within 1000 feet of a school or playground, and also prohibited indoor, point-of-sale advertising of tobacco or cigars lower than five feet from the floor of a retail establishment located within 1000 feet of a school or playground.
215. Id. at 561.
216. Id. at 566.
217. Id. at 567.
218. This determination is made by tabulating the votes cast in favor and against First Amendment protection in individual commercial speech cases, an admittedly crude measure.
219. Florida Bar v. Went For It, Inc., 515 U.S. 618 (1995).
220. Randall v. Sorrell, 126 S.Ct. 2479 (2006)
221. Justice Alito also joined the majority on the Supreme Court in FEC v. Wisconsin Right to Life, 127 S.Ct. 2652 (2007), in holding that section 203 of the Bipartisan Campaign Reform Act of 2002 was an unconstitutional restriction on speech; and he filed an opinion concurring with the majority in Morse v. Frederick, 127 S.Ct. 2618 (2007), holding that the Principal of a high school did not violate the free speech rights of a student by confiscating a banner that the Principal reasonably believed was promoting illegal drug use.
222. Alito was a judge on the 3rd Circuit Court of Appeals for 16 years.
223. It is acknowledged that, while he was on the 3rd Circuit Court of Appeals, he was required to adhere to Supreme Court precedent.
224. Pitt News v. Pappert, 379 F.3d 96 (3rd Cir. 2004). Judge Alito also participated in the decision of Rappa v. New Castle County, 18 F.3d 1043 (3rd Cir. 1994), though the commercial speech issues in that case are somewhat less germane to this article.
225. Pitt News, 379 F.3d 96, at 101.
226. While the Supreme Court has already rendered decisions on alcohol content bans on product labels (Coors Brewing Company), and liquor price advertising bans (44 Liquormart), it has yet to directly confront the issue of bans for the payment of liquor advertising, or for related commercial speech. See, for example, Justice Thomas' dissenting opinion, in Glickman v. Wileman Brothers & Elliott, 521 US 457, at 506 (1997): "What we are now left with, if we are to take the majority opinion at face value, is one of two disturbing consequences: Either 1) paying for advertising is not speech at all, while such activities as draft card burning, flag burning, armband wearing, public sleeping, and nude dancing are, or 2) compelling payment for third-party communication does not implicate speech, and thus the Government would be free to force payment for a whole variety of expressive conduct that it could not restrict."
227. For more of a discussion on the relationship between money and speech (specifically, political speech), see, Buckley v. Valeo, 424 U.S. 1 (1976); McConnell v. FEC, 540 U.S. 93 (2003) and FEC v. Wisconsin Right to Life, 127 S.Ct. 2652 (2007).
228. Pitt News, 379 F.3d, at 105-106.
229. Id at 107.
230. Id.
231. Id. at 108.
232. Id. at 109.
233. Judge Roberts did concur, without comment, in the decision of Whitaker v. Thompson, 353 F.3d 947 (D.C. Cir. 2004), in which the court concluded that FDA did not violate a manufacturer's commercial speech rights.
234. Pub. Int. L. Rev. 107 (1994).
235. Federal Election Commission v. Wisconsin Right to Life, 127 S.Ct. 2652 at 2669 (2007). Chief Justice Roberts also stated, at 2674: "McConnell held that express advocacy of a candidate or his opponent by a corporation shortly before an election may be prohibited, along with the functional equivalent of such express advocacy. We have no occasion to revisit that determination today. But when it comes to defining what speech qualifies as the functional equivalent of express advocacy subject to such a ban - the issue we do have to decide - we give the benefit of the doubt to speech, not censorship. The First Amendment's command that 'Congress shall make no law ... abridging the freedom of speech' demands at least that."
236. Chief Justice Roberts also wrote for the majority in two other decisions involving speech, first in Rumsfeld v. Forum for Academic and Institutional Rights, 547 U.S. 47 (2006), where the Court held that the Solomon Amendment, requiring the Department of Defense to deny federal funding to institutions of higher education that prohibit military representatives access to recruiting, did not violate schools' freedom of speech, or association, rights; and then in Morse v. Frederick, 127 S.Ct. 2618 (2007), where the Court held that the Principal of a high school did not violate the free speech rights of a student by confiscating a banner that the Principal reasonably believed was promoting illegal drug use. Chief Justice Roberts joined with the majority in Randall v. Sorrell, 126 S.Ct. 2479 (2006), holding that Vermont's stringent restrictions on the amounts that candidates for state office could spend on their campaigns, and on the amounts that individuals, organizations and political parties could contribute to those campaigns, violated the First Amendment's free speech guarantees.
237. If no moratorium is imposed on the drugs that do not signal a risk at the time of initial FDA approval, then there is obviously no First Amendment issue. The First Amendment issue arises when a moratorium is imposed on a drug that exhibits no risk signal at the time of initial approval, as it is exceedingly likely that this restriction on speech would fail the 3rd prong of Central Hudson, given that evidentiary support is needed to achieve the third prong. It is not satisfied by mere speculation or conjecture.
238. See, for instance, Rubin v. Coors Brewing Company, 514 U.S. 476 (1995) and 44 Liquormart v. Rhode Island, 517 U.S. 484 (1996).
239. Available at, http://www.discus.org/industry/code/code.htm