Off-label Prescription of Medication

in European Journal of Health Law
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Off-label use of medication refers to prescribing a registered medicine outside its approved marketing authorization, purpose, target group, or indication. Off-label prescription is a widely accepted practice. However, no or little regulation can be found. In this article, the legal status of off-label prescription will be examined. Does off-label prescription fall under the therapeutical freedom and is it free from regulation? Or should we equalize off-label prescription with a therapeutical experimentation and should it follow the rules of experimentation? I will also examine whether the patient can give an informed consent. Whether or not this is possible leads to intense discussions. Finally, the potential liability of the prescribing physician is of great importance.

Off-label Prescription of Medication

in European Journal of Health Law

Sections

References

9

L. Noah‘Informed consent and the elusive dichotomy between standard and experimental therapy’Am. J.L. & Md. 28(4) (2002) 397-398; Johns supra note 6 968; Raine supra note 4 p. 16; G. Conko ‘Hidden truth: the perils and protection of off-label drug and medical device promotion’ Health Matrix 21 (2011) 152-153.

10

Molyneux and Bogaertsupra note 5 13.

14

R. Harding and E. Peel‘‘He was like a zombie’: off-label prescription of antipsychotic drugs in dementia’Medical Law Review 21(2) (2013) 245.

15

M.L. Harness‘What is ‘experimental’ medical treatment?: a legislative definition is needed’Clev. St. L. Rev. 44(67) (1996) 72-73; Salbu supra note 11 193-194; V. Henry ‘Off-label prescribing. Legal implications’ J. Legal. Med. 20 (1999) 379-383; M. Kane ‘Off-label use: pros and cons’ Alb. L.J. Sci. & Tech. 19(3) (2009) 581-582; R. Dresser and J. Frader ‘Off-Label prescribing: a call for heightened professional and government oversight’ J. Law Med. & Eth. 37(2) (2009) 476; Kesselheim supra note 8 234-235; T. Mackey and B.A. Liang ‘Off-label promotion reform: a legislative proposal addressing vulnerable patient drug access and limiting inappropriate pharmaceutical marketing’ U. Mich. J.L. Reform 45(1) (2011-2012) 16-18; R.C. Ausness ‘‘There’s danger here Cherie!’ — Liability for the promotion and marketing of drugs and medical devices for off-label uses’ Brookl. L. Rev. 73(4) (2007-2008) 1255.

17

Harnesssupra note 15 72-73; Salbu supra note 11 193-194; Henry supra note 15 379-383; Kane supra note 15 581-582; Dresser and Frader supra note 15 476; Kesselheim supra note 8 234-235; Mackey and Liang supra note 15 16-18 (children: 75% pregnant: 90%); Ausness supra note 15 1255.

18

Kesselheimsupra note 8 234-235; Mackey and Liang supra note 15 2.

19

P.M. Rosoff and D. Lambelet Coleman‘The case for legal regulation of physician’ off-label prescribing’Notre Dame L. Rev. 86(2) (2011) 650.

20

Ausnesssupra note 15 1254; M. Gilhooley ‘Commercial speech and off-label drug uses: what role for wide acceptance general recognition and research incentives?’ Am. j.l. & Med. 37(2-3) (2011) 261; P. Bogaert and A. Schwabl ‘Cost considerations should not drive off-label drug use in the euScript Regulatory Affairs (2012) 7. See also Turner et al. supra note 16 966.

23

Kanesupra note 15 584.

25

Henrysupra note 15 371.

26

Gilhooleysupra note 20 269.

27

Kidr‘Rilatine helpt mogelijk tegen stotteren’De Standaard2 July 2014 http://www.standaard.be/cnt/dmf20140702_01164204.

28

Evg‘Malariageneesmiddel helpt bij kanker’De Standaard11 August 2014 http://www.standaard.be/cnt/dmf20140811_01213332.

30

Salbusupra note 11 204.

31

Rosoff and Lambelet Colemansupra note 19 654.

32

Ibid. 680.

33

Ibid. 662.

34

Salbusupra note 11 204. See also D. Holley ‘Balancing on the edge: the implications and acceptability of off-label drug use’ Alb. J.L. Sci. & Tech. 19(3) (2009) 644.

35

Definitions: Beck and Azarisupra note 7 81.

36

Holleysupra note 34 639.

37

Salbusupra note 11 193.

38

Mehlmansupra note 88 2.

39

Dresser and Fradersupra note 15 479.

40

Beck and Azarisupra note 7 83 85.

41

See J. Ter HeerdtHet experiment beproefd: een juridische analyse van medische experimenten met mensen (Antwerp: Maklu2000) pp. 41-57. 1) Every medical treatment is experimental; 2) teleological aspect objective or subjective; 3) methodological aspects; 4) material aspects: deviation of standard treatment new treatment insufficiently tested technique degree of risk interest of others and pragmatic view. The following survey is based on this author.

42

Ter Heerdtsupra note 41 p. 58.

45

Holleysupra note 34 644.

46

N.M.P. King‘The line between clinical innovation and human experimentation’Seton Hall Law Review 32(3) (2002) 573.

47

Noahsupra note 9 363 388.

48

Ter Heerdtsupra note 41 p. 74.

49

Harnesssupra note 15 95-96.

50

Holleysupra note 34 639 and notes there. See also Noah supra note 9 391.

52

Rosoff and Lambelet Colemansupra note 19 660.

53

Kingsupra note 46 574; Ter Heerdt supra note 41 p. 76.

54

Cowansupra note 51 621-622.

55

Ter Heerdtsupra note 41 p. 76.

56

Kingsupra note 46 574-575.

57

Salbusupra note 11 197.

58

Ibid. 218.

59

Cowansupra note 51 623-624; Ter Heerdt supra note 41 p. 76. See also Noah supra note 9 391.

60

S.H. Johnson‘Polluting medical judgment? False assumptions in the pursuit of false claims regarding off-label prescribing’Minn. J.L. Sci. & Tech. 9(1) (2008) 68.

61

Ter Heerdtsupra note 41 p. 76.

62

Holleysupra note 34 654-655; Noah supra note 9 363.

63

Ter Heerdtsupra note 41 p. 76.

64

Johnssupra note 6 1008.

65

Salbusupra note 11 222-223.

66

See Rosoff and Lambelet Colemansupra note 19 651.

67

Ibid. 652.

70

Beck and Azarisupra note 7 72 85 87.

71

Henrysupra note 15 370-371; Johns supra note 6 967 1012-1019; Dresser and Frader supra note 15 481; Rosoff and Lambelet Coleman supra note 19 673 682 691; Harding and Peel supra note 14 268. By analogy: Ter Heerdt supra note 41 p. 405. Contra: Salbu supra note 11 190-191; Beck and Azari supra note 7 91; O’Reilly and Dalal supra note 21 299.

72

Johnssupra note 6 1015.

73

Beck and Azarisupra note 7 89; Noah supra note 9 375. See also Karp v. Cooley 349 F. Supp. 827 835 (s.d. Tex. 1972); Gaston v. Hunter 588 P.2d 351 (Ariz. Ct. App. 1978); Estrada v. Jaques 321 S.E.2d 253-254 (n.c. Ct. App. 1984).

74

Johnssupra note 6 1013-1016.

75

Ibid. 1018-1019.

76

Holleysupra note 34 651.

77

Mackey and Liangsupra note 15 20.

78

Rb ‘s-Hertogenbosch 22 February 2008awb 07/2632 ecli:nl:rbshe:2008:bc8849 www.rechtspraak.nl.

85

Rosoff and Lambelet Colemansupra note 19 651.

87

Article 68 Medicines Act; F. Brandsma108 Vragen en antwoorden over de geneesmiddelenwet wat huisartsen moeten weten (Bohn: Stafleu van Loghum2007) pp. 22-23.

90

Rainesupra note 4 p. 18.

91

Rainesupra note 4 p. 18.

93

Holleysupra note 34 (633) 650.

94

Klasa and Schwablsupra note 92 80. See also Holley ibid. 656.

95

C.A. Moyer‘Off-label use and the medical negligence standard under Minnesota law’Wm. Mitchell L. Rev. 31(3) (2004-2005) 928.

96

Molyneux and Bogaertsupra note 5 14. See also Johns supra note 6 1024; Brandsma supra note 87 pp. 22-23.

97

Klasa and Schwablsupra note 92 79.

98

Molyneux and Bogaertsupra note 5 14; L’Ecluse et al. supra note 12 2.

99

Beck and Azarisupra note 7 72.

100

Holleysupra note 34 640.

101

Salbusupra note 11 218-219; Conko supra note 9 160.

102

Holleysupra note 34 640.

103

M. Buhay‘Off-label drug promotion is lost in translation: a prescription for a public health approach to regulating the pharmaceutical industry’s right to market and sell its products’J. Health Care L. & Pol.’y 13(2) (2010) 466. See also Johns supra note 6 968.

104

Kanesupra note 15 584-585; Johnson supra note 60 62; Conko supra note 9 149.

105

Rosoff and Lambelet Colemansupra note 19 653. See also Washington Legal Foundation v. Friedman 13 F. Supp. 2d 51 56-57 (d.d.c. 1998). See S. Greene ‘False claims act liability for off-label promotion of pharmaceutical products’ Penn. St. L. Rev. 110(1) (2006-2007) 46.

106

Oatessupra note 8 1307.

107

Rainesupra note 4 p. 18; Molyneux and Bogaert supra note 5 16.

108

Rosoff and Lambelet Colemansupra note 19 659.

109

Rainesupra note 4 p. 19; O’Reilly and Dalal supra note 21 317.

110

O’Reilly and Dalalsupra note 27 317.

112

Ter Heerdtsupra note 41 p. 408 and notes.

113

Kanesupra note 15 579.

115

Ter Heerdtsupra note 41 p. 405.

116

Rainesupra note 4 p. 18.

117

Dresser and Fradersupra note 15 476.

118

Rainesupra note 4 p. 18; Rosoff and Lambelet Coleman supra note 19 675-676.

119

Rosoff and Lambelet Colemansupra note 19 668.

120

Cass. 4 October 1973jt 1974 296; Paris 22 January 1913 and 26 June 1919 Dallozii 73. See Ter Heerdt supra note 41 p. 408.

121

Dresser and Fradersupra note 15 481.

123

Henrysupra note 15 371.

124

Johnssupra note 6 970; Mehlman supra note 29 2.

125

Ter Heerdtsupra note 41 p. 413. See also Medisch Tuchtcollege Eindhoven 24 August 1987 T.v.GR. (1989) 53.

127

Ter Heerdtsupra note 41 pp. 405 415.

128

Ter Heerdtibid. pp. 409-410 411-413. See also Slater v. Optical Radiation Corp. 961 F. 2d 1330 (7th Circ. 1992); Schneider v. Revici 817 F.2d 987 (2nd Circ. 1987); Blanton v. United States 428 F. Supp. 360 (1977).

129

Delforgesupra note 59 C. Delforge ‘La responsabilité civile du médecin au regard de la prescription de médicaments’ (note under Antwerp 18 June 2001) tbbr 6 (2003) 371-372.

130

Conkosupra note 9 154; Holley supra note 34 644.

131

Noahsupra note 9 363.

133

Ter Heerdtsupra note 41 pp. 416-417.

134

Henrysupra note 15 383; Noah supra note 9 399; Johns supra note 6 976; Johnson supra note 60 68; Holley supra note 34 634; Conko supra note 9 154-155.

135

O’Reilly and Dalalsupra note 21 319.

137

Laudesupra note 81 256.

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