Hostname: page-component-76fb5796d-x4r87 Total loading time: 0 Render date: 2024-04-25T15:36:01.842Z Has data issue: false hasContentIssue false
  • English
  • Français

Off-Label Marketing's Audiences: The 21st Century Cures Act and the Relaxation of Standards for Evidence-Based Therapeutic and Cost-Comparative Claims

Published online by Cambridge University Press:  06 January 2021

Sam F. Halabi
Sam F. Halabi*
Affiliation:
University of Ottawa, Ontario; University of Missouri-Columbia; O'Neill Institute for National and Global Health Law at Georgetown University; J.D. Harvard, MPhil Oxford (St. Antony's College), B.A., B.S., Kansas State University
Get access Rights & Permissions [Opens in a new window]

Abstract

An abstract is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.
Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Articles
Information
American Journal of Law & Medicine , Volume 44 , Issue 2-3 , May 2018 , pp. 181 - 196
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2018

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 See Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(d) (2012).

2 See Katz, Russell, FDA: Evidentiary Standards for Drug Development and Approval, 1 NeuroRx 307, 307 (2004)CrossRefGoogle ScholarPubMed (“[The FDA] must determine that a drug product is both safe and effective before it may be approved for marketing.”).

3 See Dresser, Rebecca & Frader, Joel, Off-Label Prescribing: A Call for Heightened Professional and Government Oversight, 37 J. L. Med. & Ethics 476, 480 (2009)CrossRefGoogle Scholar.

4 See Formulary Management, Acad. of Managed Care Pharmacy (2009), http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=9298 [https://perma.cc/W3XE-7HRA].

5 U.S. Food & Drug Admin., Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions and Answers Guidance for Industry and Review Staff 9-11 (2017), https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm537347.pdf.

6 21st Century Cures Act, Pub. L. No. 114-255, § 3037, 130 Stat. 1033 (2016).

7 Id.

8 Id.

9 See United States ex rel. Polansky v. Pfizer, 822 F.3d 613, 619-20 (2d Cir. 2016).

10 Katz, supra note 2.

11 Food, Drug, and Cosmetic Act, 21 U.S.C § 355(d) (2012).

12 21 C.F.R. § 312.20.

13 Surrey M. Walton et al., Effective Health Care Research Report, No. 12, Developing Evidence-Based Research Priorities for Off-Label Drug Use (2009); Joshua Cohen et al., Off-Label Use Reimbursement, 64 Food & Drug L.J. 391, 393 (2009) (“Sponsors may focus their initial clinical development on narrowly defined subgroups within a given disease population that is expected to accrue the greatest benefit from the drug,” but “[o]nce the drug is approved for the narrow indication, its real-world use is typically much broader than the clinical trial population.”); Mark Ratner & Trisha Gura, Off-Label or Off-Limits?, 26 Nature Biotechnology 867, 870 (2008) (quoting Sara Radcliffe, vice president of Science & Regulatory Affairs for the Biotechnology Industry Organization, saying “[y]ou develop every drug knowing that medicine will advance and physicians may then use it for many other things”).

14 21 C.F.R. § 202.1(e)(4)(i)(a); see Ex rel. Polansky 822 F.3d 613.

15 O'Reilly, James & Dalal, Amy, Off-Label or Out of Bounds? Prescribers and Marketer Liability for Unapproved Uses of FDA-Approved Drugs, 12 Annals Health L. 295, 296 (2003)Google ScholarPubMed.

16 Dresser & Frader, supra note 3.

17 O'Reilly & Dalal, supra note 15, at 298.

18 Abbott, Ryan & Ayres, Ian, Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices, 64 Duke L.J. 377, 388 (2014)Google Scholar.

19 O'Reilly & Dalal, supra note 15, at 298.

20 Elissa P. Gentry, Relinquishment of Inappropriate Off-Label Uses: The Effect of the False Claims Act 9 (working paper) (Dec. 4, 2016).

21 Abbot & Ayres, supra note 18, at 379.

22 Id. at 389.

23 Id.

24 Gentry, supra note 20, at 7.

25 Abbot & Ayres, supra note 18, at 389.

26 Gentry, supra note 20, at 7.

27 Id.

28 Stafford, Randall S., Regulating Off-Label Drug Use—Rethinking the Role of the FDA, 358 New Eng. J. Med. 1427, 1427-28 (2008)CrossRefGoogle Scholar.

29 The manufacturers hold an extraordinary amount of information about their products. See U.S. Food & Drug Admin., Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices 2 (2011).

30 O'Reilly & Dalal, supra note 15, at 301.

31 Press Release, U.S. Dep't of Justice, Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing (Sept. 28, 2007), https://www.justice.gov/archive/opa/pr/2007/September/07_civ_782.html [https://perma.cc/X37J-5UF8].

32 Press Release, U.S. Dep't of Justice, Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa (Jan. 15, 2009), https://www.justice.gov/archive/opa/pr/2009/January/09-civ-038.html [https://perma.cc/6PW8-RAJ3]

33 Office of Pub. Affairs, GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data, U.S. Dep't of Justice (July 2, 2012), https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report [https://perma.cc/7F6N-9EWD].

34 Food and Drug Administration Modernization Act § 401, 21 U.S.C. § 301 (1997).

35 O'Reilly & Dalal, supra note 15, at 302.

36 Dresser & Frader, supra note 3, at 2.

37 See Jerry Avorn, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (2004); Rosoff, Philip M. & Coleman, Doraine L., The Case for Legal Regulation of Physicians' Off-Label Prescribing, 86 Notre Dame L. Rev. 649, 653 (2011)Google Scholar.

38 O'Reilly & Dalal, supra note 15, at 300.

39 Id. at 310-14; see Wash. Legal Fund v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998); Wash. Legal Fund v. Henney, 56 F. Supp. 2d 81 (D.D.C. 1999).

40 Food and Drug Administration Modernization Act of 1997 § 114, 21 U.S.C. § 301 (1997).

41 Amanda K. Sarata, The 21st Century Cures Act (Division A of P.L. 114-255) 40 (2016).

42 U.S. Food & Drug Admin., supra note 5, at 2 n.8.

43 Id.

44 Id. at 4.

45 Food and Drug Administration Modernization Act § 114.

46 Sarata, supra note 41, at 40.

47 Perfetto, Eleanor M. et al., FDAMA Section 114: Why the Renewed Interest?, 21 J. Managed Care & Specialty Pharmacy 368, 371 (2015)CrossRefGoogle ScholarPubMed.

48 Scheineson, Marc J. & Cuevas, Guillermo, United States v. Caronia: The Increasing Strength of Commercial Free Speech and Potential New Emphasis on Classifying Off-Label Promotion as “False and Misleading,” 68 Food & Drug L.J. 201, 201 (2013)Google Scholar.

49 See Amarin Pharm., Inc. v. U.S. Food & Drug Admin., 119 F. Supp. 3d 196 (S.D.N.Y. 2015).

50 See United States ex rel. Polansky v. Pfizer, 822 F.3d 613, 619-20 (2d Cir. 2016); Complaint, Pacira Pharm., Inc. v. U.S. Food & Drug Admin. (S.D.N.Y. Sept. 8, 2015) (No. 15-7055).

51 Sam F. Halabi, Collective Corporate Knowledge, the Federal False Claims Act, and the Future of Federal Health Programs, 68 Baylor L. Rev. 265 (2016).

52 Id.

53 U.S. Food & Drug Admin., supra note 5, at 2 n.8.

54 Peter J. Neumann & Elle Pope, Cures Act, FCA Draft Guidance Suggest Flexibility on Communication of Real-World Drug Impacts, Though Questions Remain, Health Aff. Blog (Feb. 2, 2017), http://healthaffairs.org/blog/2017/02/02/cures-act-fda-draft-guidance-suggest-flexibility-on-communication-of-real-world-drug-impacts-though-questions-remain/ [https://perma.cc/ZHA3-GWVE].

55 Id.

56 Id.

57 See 21 U.S.C. §352(a)(2)(A) (2016).

58 Food and Drug Administration Modernization Act § 114, 21 U.S.C. § 301 (1997).

59 21st Century Cures Act, Pub. L. No. 114-255, § 3037, 130 Stat. 1033, 1105 (2016).

60 Neumann & Pope, supra note 54.

61 Id.

62 U.S. Food & Drug Admin., supra note 5.

63 21st Century Cures Act § 3037.

64 Neumann & Pope, supra note 54.

65 Id.

66 21st Century Cures Act § 3037.

67 Id.

68 U.S. Food & Drug Admin., supra note 5, at 4.

69 Formulary Management, supra note 4.

70 U.S. Food & Drug Admin., supra note 5, at 4.

71 Neumann & Pope, supra note 54.

72 U.S. Food & Drug Admin., supra note 5, at 4-5.

73 See id. at 5 (stating § 3037 is not intended to permit the provision of medical information).

74 See Alix Spiegel, How to Win Doctors and Influence Prescriptions, NPR (Oct. 21, 2010), https://www.npr.org/templates/story/story.php?storyId=130730104 [https://perma.cc/3UKW-RCGF].

75 Id.

76 Id.

77 Deborah Mazer & Gregory Curfman, 21st Century Cures Act Lowers Confidence in FDA-Approved Drugs and Devices, Health Aff. Blog (Feb. 14, 2017), http://healthaffairs.org/blog/2017/02/14/21st-century-cures-act-lowers-confidence-in-fda-approved-drugs-and-devices/ [https://perma.cc/UY56-95VT].

78 Id.

79 U.S. Food & Drug Admin., supra note 5, at 6.

80 Id.

81 Id.

82 Id.

83 Id.

84 Id.

85 Id.

86 Id.

87 Id.

88 Id. at 6-7.

89 Id. at 6.

90 Id. at 7.

91 Id.

92 Id.

93 Id. at 8.

94 Id.

95 Id.

96 Id.

97 Id.

98 Id.

99 FDA Official Offers Interpretation of FDAMA 114 Standard for Health Care Economic Information (HCEI), Hogan Lovells (June 6, 2012), https://www.hlregulation.com/2012/06/06/fda-official-offers-interpretation-of-fdama-114-standard-for-health-care-economic-information-hcei/ [https://perma.cc/8EPZ-BV4S].

100 U.S. Food & Drug Admin., supra note 5, at 8.

101 Id.

102 Id.

103 Id., at 9.

104 Id.

105 Id.

106 Id.

107 Id.

108 Spurling, Geoffrey K. et al., Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review, 7 PLoS Med. 1, 2 (2010)CrossRefGoogle ScholarPubMed.

109 Id. at 3.

110 Id. at 4.

111 Id. at 3.

112 Id.

113 Id. at 4-6.

114 Id. at 4.

115 Id.

116 Id.

117 Id.

118 Id.

119 Id. at 5.

120 Id.

121 Formulary Management, supra note 4, at 29.

122 Neumann, Peter J., What Ever Happened to FDAMA Section 114? A Look Back After 10 Years, 12 Value in Health 189, 189 (2009)CrossRefGoogle ScholarPubMed.

123 John Coates, Luncheon Speech at the Food and Drug Law Journal Symposium (Oct. 30, 2015) (transcript on file with author).

124 Id.

125 Id.

126 Id.

127 Id.

128 Id.

129 Id.

130 Id.

131 Id.

132 Gentry, supra note 20, at 52.

133 Id.

134 Id. at 56.

135 Id.

136 Id. at 52.

137 See Universal Health Servs., Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989, 2003-04 (2016).

138 Mazer & Curfman, supra note 77; see United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) (overturning a conviction of conspiracy to introduce misbranded drug into interstate commerce because the government prosecuted defendant for his speech, violating his First Amendment rights); see also Amarin Pharm., Inc. v. U.S. Food & Drug Admin., 119 F. Supp. 3d 196 (S.D.N.Y. 2015) (granting preliminary injunction for pharmaceutical manufacturer against FDA for violating its right to free speech by threatening to bring a misbranding action for the company's promotion of a drug for non-FDA-approve uses).

139 Mazer & Curfman, supra note 77.

140 Neumann & Pope, supra note 54.

141 Id.

142 Id.