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The Medical Marijuana Catch-22

How the Federal Monopoly on Marijuana Research Unfairly Handicaps the Rescheduling Movement

Published online by Cambridge University Press:  06 January 2021

Alexander W. Campbell
Alexander W. Campbell*
Affiliation:
J.D. Candidate, 2015, Boston University School of Law; M.P.H. Candidate, 2015, Boston University School of Public Health; B.A., 2012, Economics, Political Science, University of New Hampshire
*
Email: [email protected]
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Extract

As of April 2015, twenty-three states and the District of Columbia permit the therapeutic use of marijuana1 to treat various illnesses or conditions, with legalization statutes currently pending in eight other states. Despite the growing number of states that allow for the prescription and use of medicinal marijuana, the federal government still classifies the drug as a Schedule I controlled substance, the strictest classification of controlled substances and the only type healthcare providers may not legally prescribe. As states continue to deliberate the merits of allowing access to marijuana for therapeutic use, it is useful to examine the structural and political forces that have prevented a similar movement at the federal level. This Note does so, and argues that proactive changes—either legislative or administrative—are necessary to remove the handicap that the current regulatory system places on attempts to change federal marijuana policy.

Type
Notes and Comments
Information
American Journal of Law & Medicine , Volume 41 , Issue 1 , March 2015 , pp. 190 - 209
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2015

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References

1 While “cannabis” is the preferred term among the scientific community to refer to the plants of the genus cannabis and their byproducts, this paper will use “marijuana” to reference same, owing to the widespread use of this term in the statutes and case law of the United States.

2 23 Legal Medical Marijuana States and DC: Laws, Fees, and Possession Limits, ProCon.org, http://medicalmarijuana.procon.org/view.resource.php?resourceID=000881 (last updated Jan. 8, 2015, 2:50 PM).

3 8 States with Pending Legislation to Legalize Medical Marijuana, ProCon.org, http://medicalmarijuana.procon.org/view.resource.php?resourceID=002481 (last updated Apr. 2, 2015, 10:03 AM).

4 21 C.F.R. § 1308.11(d)(23) (2013).

5 21 U.S.C. § 829 (2012).

6 Americans for Safe Access v. DEA, 706 F.3d 438, 452 (D.C. Cir. 2013) (holding that reclassification by FDA must rely on “adequate and well-controlled studies”).

7 See generally Craker v. DEA, 714 F.3d 17 (1st Cir. 2013).

8 See Coal. for Rescheduling Cannabis, Petition to Reschedule Cannabis (Marijuana) 10 (Oct. 9, 2002), available at http://www.drugscience.org/PDF/Petition_Final_2002.pdf.

9 Americans for Safe Access, 706 F.3d at 452.

10 See Nat’l Inst. on Drug Abuse, Ordering Guidelines for U.S. Research Investigators/Users 1, available at http://www.drugabuse.gov/sites/default/files/files/OrderingGuidelinesUS.pdf (last visited Apr. 3, 2015).

11 See Brian Vastag, Marijuana Study of Traumatized Veterans Stuck in Regulatory Limbo, Wash. Post (Oct. 1, 2011), http://www.washingtonpost.com/national/health-science/marijuana-study-oftraumatized-veterans-stuck-in-regulatory-limbo/2011/09/30/gIQAZfYLDL_story.html; Medical Marijuana, Multidisciplinary Ass’n for Psychedelic Stud., http://www.maps.org/research/mmj (last visited Apr. 3, 2015).

12 See Gardiner Harris, Researchers Find Study of Medical Marijuana Discouraged, N.Y. Times, January 19, 2010, at A14.

13 See DEA Upholds Federal Marijuana Monopoly, Obstructing Privately-Funded FDA Research, PR NEWSWIRE (Aug. 24, 2011), http://www.prnewswire.com/news-releases/dea-upholds-federal-marijuana-monopoly-obstructing-privately-funded-fda-research-128335763.html.

14 Craker v. DEA, 714 F.3d 17, 20 (1st Cir. 2013).

15 21 U.S.C. § 823(a) (2012).

16 Craker, 714 F.3d at 27-29.

17 Controlled Substances Act, 21 U.S.C. § 812(a) (2012).

18 Id. § 811(a).

19 Id. § 812(b).

20 See Drug Scheduling, DEA, http://www.justice.gov/dea/druginfo/ds.shtml (last visited Apr. 3, 2015).

21 21 U.S.C. § 811(a).

22 Initiation of Proceedings for Rulemaking, 21 C.F.R. §1308.43 (2013).

23 Id. §1308.43(b).

24 Id.

25 Id. §1308.43(c).

26 Authority and Criteria for Classification of Substances, 21 U.S.C. § 811(b).

27 Id. § 811(c).

28 Id. § 811(b).

29 Id. § 802.

30 21 C.F.R. § 1308.02.

31 Id. §§ 1308.11–.15.

32 Id. §§ 1308.21–.35.

33 Id. §§ 1308.41–.45.

34 Id. §§ 1308.21–.35.

35 Id. §§ 1308.21–.22.

36 Id. §§ 1308.23–.24.

37 Id. §§ 1308.25–.26.

38 Id. §§ 1308.31–.32.

39 Id. §§ 1308.33–.34.

40 Id. § 1308.35.

41 The regulation specifically states “processed plant material or animal feed mixture,” perhaps indicating that its main purpose was to exempt livestock feed containing marijuana plant material. This inference is further supported by the requirement that the material not be intended for human consumption.

Id.

42 Id. § 1308.35(a)(1).

43 21 U.S.C. § 802(16) (2012).

44 21 C.F.R. §1308.35(c). THC is “the main chemical ingredient that produces the psychoactive effect” of marijuana. DEA, Drug Fact Sheet: Marijuana 1, available at http://www.dea.gov/druginfo/drug_data_sheets/Marijuana.pdf (last visited Apr. 3, 2015).

45 Id. Presumably, the scientific evidence is offered to prove that some material is chemically inert and would not have an intoxicating effect on humans.

46 Compare id. with 21 U.S.C. §§ 811-12.

47 See 21 C.F.R. §§ 1308.41–.45.

48 See id. § 1308.46.

49 See id. § 1308.49.

50 See id. § 1308.46.

51 Id. § 1308.49.

52 See id. § 1308.49(b).

53 See, e.g., Americans for Safe Access v. DEA, 706 F.3d 438 (D.C. Cir. 2013) (involving Coalition for Rescheduling Cannabis/Americans for Safe Access); Gettman v. DEA, 290 F.3d 430 (D.C. Cir. 2002) (involving High Times Magazine); Grinspoon v. DEA, 828 F.2d 881 (1st Cir. 1987) (involving Harvard Medical School faculty member and researcher); Nat’l Org. for Reform of Marijuana Laws v. Ingersoll, 497 F.2d 654 (D.C. Cir. 1974) (involving NORML).

54 See Ingersoll, 497 F.2d at 655.

55 Id. at 656.

56 Id. at 657-58.

57 21 U.S.C. § 811(d)(1) (2012).

58 Single Convention on Narcotic Drugs art. 21, Mar. 30, 1961, 18 U.S.T. 1407.

59 See Nat’l Org. for Reform of Marijuana Laws v. DEA, 559 F.2d 735, 750-51 (D.C. Cir. 1977).

60 Id. at 752.

61 See Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1133 (D.C. Cir. 1994) (“The petition to reschedule marijuana was first filed in 1972 and has been before this court on four prior occasions—National Org. for the Reform of Marijuana Laws v. Ingersoll, 497 F.2d 654 (D.C.Cir.1974); National Org. for the Reform of Marijuana Laws v. Drug Enforcement Admin., 559 F.2d 735 (D.C.Cir.1977); National Org. for the Reform of Marijuana Laws v. Drug Enforcement Admin. & Dep't of Health Education & Welfare, No. 79–1660 (D.C.Cir. Oct. 16, 1980); and most recently, ACT, 930 F.2d 936 (D.C.Cir.1991).”); see also Smith, Annaliese, Comment, Marijuana as a Schedule I Substance: Political Ploy or Accepted Science?, 40 Santa Clara L. Rev. 1137, 1151-56 (2000)Google Scholar.

62 Alliance for Cannabis Therapeutics, 15 F.3d at 1135.

63 Id. at 1137.

64 Gettman v. DEA, 290 F.3d 430, 432 (D.C. Cir. 2002).

65 Id. at 430.

66 Id. at 434.

67 Americans for Safe Access v. DEA, 706 F.3d, 438, 452 (D.C. Cir. 2013).

68 See Coal. for Rescheduling Cannabis, supra note 8, at 22-24.

69 Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 76 Fed. Reg. 40,552 (July 8, 2011).

70 See Petition for Review, Americans for Safe Access v. DEA, 706 F.3d 438 (D.C. Cir. 2011) (No. 11-1265).

71 Americans for Safe Access, 706 F.3d at 439.

72 Id. at 451-52.

73 Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).

74 Id. at 1136-37.

75 Denial of Petition To Initiate Proceedings To Reschedule Marijuana, 76 FR 40,552, 40,579 (July 8, 2011).

76 Id. at 40,562.

77 See Americans for Safe Access v. DEA, 706 F.3d 438, 450-52 (D.C. Cir. 2011).

78 Id. at 452 (citing Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 76 Fed. Reg. 40,552, 40,562 (July 8, 2011)).

79 Id.

80 Id.

81 Grinspoon v. DEA, 828 F.2d 881, 891 (1st Cir. 1987).

82 Petition for Writ of Certiorari, Americans for Safe Access, 706 F.3d 438 (2013) (No. 13-0084).

83 Id. at 16.

84 Americans for Safe Access, 706 F.3d 438, cert. denied, 134 S. Ct. 267 (2013).

85 See id.; see also Grinspoon, 828 F.2d at 891.

86 See Grinspoon, 828 F.2d at 891.

87 See Americans for Safe Access, 706 F.3d at 451-52.

88 21 U.S.C. §§ 821-31 (2012).

89 Id. § 822(a)(1).

90 Id. § 823(a).

91 Id.

92 See, e.g., discussion infra Part III.C; see generally MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215 (6th Cir. 2009); Noramco of Delaware, Inc. v. DEA, 375 F.3d 1148 (D.C. Cir. 2004).

93 See Bilz, Gregg A., The Medical Use of Marijuana: The Politics of Medicine, 13 Hamline J. Pub. L. & Pol’y 117, 132 (1992)Google Scholar.

94 21 C.F.R. §§ 312.2,.20 (2013).

95 Id. §312.22.

96 Id. § 312.40(b)(1).

97 21 U.S.C. § 828(a) (2012).

98 21 C.F.R. § 1305.03.

99 See Craker v. DEA, 714 F.3d 17, 20 (1st Cir. 2013).

100 See generally Nat’l Inst. on Drug Abuse, supra note 10.

101 See id. at 5.

102 See id.; see also Ariana Eunjung Cha, Marijuana Research Hampered by Access from Government and Politics, Scientists Say, Wash. Post (Mar. 21, 2014), http://www.washingtonpost.com/national/health-science/marijuana-research-hampered-by-access-from-government-and-politics-scientists-say/2014/03/21/6065eb88-a47d-11e3-84d4-e59b1709222c_story.html.

103 See 21 C.F.R § 1301.32; see also Cha, supra note 102.

104 See 21 C.F.R § 1301.32.

105 Id.

106 21 U.S.C. § 824(a) (2012).

107 See Craker v. DEA, 714 F.3d 17, 20 (1st Cir. 2013).

108 21 U.S.C. § 823(a).

109 See Craker, No. 05–16, at *51 (DEA Feb. 7, 2007), available at http://www.maps.org/research-archive/mmj/ALJfindings.PDF.

110 See id.

111 See id. at *3.

112 See id. at *87.

113 Single Convention on Narcotic Drugs, supra note 58, at art. 23.

114 Id.

115 See Craker, No. 05–16, at *82.

116 See id. at *85.

117 See id. at *83-*84.

118 See id. at *84-*85.

119 Id. at *87.

120 Lyle E. Craker; Denial of Application, 74 Fed. Reg. 2101 (Jan. 14, 2009).

121 Id. at 2114.

122 Id. at 2116 (“Respondent’s reliance is misplaced as it ignores several critical distinctions between what was formerly known as ‘medicinal opium’ and what it contends is ‘medicinal marijuana.’”).

123 Id. at 2118.

124 See id.

125 Id.

126 See id. at 2119.

127 Id.

128 Id. (“Indeed, the ten grams of marijuana that [MAPS] requested is less then [sic] one 100,000th of the amount of marijuana that NIDA has available to supply researchers.”).

129 Id. at 2120.

130 Id.

131 Id.

132 Id.

133 Id. at 2121.

134 Id. at 2120.

135 Id. at 2133.

136 Craker v. DEA, 714 F.3d 17, 18 (1st Cir. 2013).

137 Id. at 27

138 See id. at 26 (“In reviewing the Administrator's decision, we first address whether Congress has unambiguously spoken to the precise question that is at issue, Chevron, U.S.A. Inc. v. Natural Resources Defense Council Inc., 467 U.S. 837, 842–43, 104 S. Ct. 2778, 81 L.Ed.2d 694 (1997). If it turns out that the statute is ambiguous, then Chevron deference must be afforded; the agency’s interpretation of the statute will be upheld as long as it is ‘based on a permissible construction of the statute.’”).

139 See id. at 28.

140 See id.

141 See id. at 29 (“That the current regime may not be the most competitive situation possible does not render it ‘inadequate.’”).

142 Id.

143 See id.

144 See id.

145 See Vastag, supra note 11 (“[O]ne government agency, the National Institute on Drug Abuse, controls the nation’s supply of research marijuana. Any non-government researcher wanting access to it needs to satisfy the special HHS committee.”).

146 See Phillip Smith, Federal Appeals Court Rejects Researcher's Bid to Grow Medical Marijuana, StoptheDrugWar.org (April 17, 2013, 3:47 AM), http://stopthedrugwar.org/chronicle/2013/apr/17/federal_appeals_court_rejects_re; Chelsea Conaboy, Research into Marijuana’s Medical Benefits Limited; Scientists Cite Challenge of Studying an Illegal Drug, Boston.com (Oct. 19, 2012, 4:42 AM), http://www.boston.com/news/local/massachusetts/2012/10/18/research-into-marijuana-medical-benefits-limited-scientists-cite-challenge-studying-illegal-drug/tfBIDWRcS1e46R3wFituZP/singlepage.html.

147 See 21 U.S.C. § 812 (2012).

148 See DAVID F. (“Max”) Beach, The Legal Implications of Medical Marijuana for Licensed Health Care Providers 10-11 (2015), available at http://www.dri.org/DRI/course-materials/2015-Medical/pdfs/13_Beach.pdf.

149 See Americans for Safe Access v. DEA, 706 F.3d 438, 452 (D.C. Cir. 2013).

150 See Vastag, supra note 11.

151 See Smith, supra note 146; Conaboy, supra note 146.

152 See 21 U.S.C. § 829(a) (2012) (“Except when dispensed directly by a practitioner … to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A. § 301 et seq.], may be dispensed without the written prescription of a practitioner ….”).

153 Craker v. DEA, 714 F.3d 17 (1st Cir. 2013).

154 21 U.S.C. § 823(a).

155 See Cha, supra note 102.

156 See id.

157 Id. (“Sisley’s study got the green light from the Food and Drug Administration in 2011, and for most studies, that would have been enough. But because the study is about marijuana, Sisley faced two additional hurdles.”).

158 Letter from Sarah A. Wattenberg, Chairperson, Pub. Health Serv. Marijuana Research Review Comm., to Rick Doblin, Multidisciplinary Ass’n for Psychedelic Stud. (Mar. 12, 2014), available at http://www.maps.org/mmj/HHS-CoverLetter-Doblin-electronic-14Mar14.pdf; see also Matthew Perrone, Marijuana Study in Veterans Wins Federal Backing, Associated Press (Mar. 17, 2014), http://bigstory.ap.org/article/marijuana-study-veterans-wins-federal-backing.

159 Wattenberg, supra note 158; see also Multidisciplinary Ass’n for Psychedelic Stud., MAPS Study Outline and Synopsis (Oct. 11, 2012), available at http://www.maps.org/mmj/MJP1_FINAL_Amend2Vers2_Protocol11Oct12.pdf.

160 Astrid Galvan, Fired Professor Suzanne Sisley Isn't Giving up on Marijuana Research, Huffington Post (July 20, 2014), http://www.huffingtonpost.com/2014/07/20/suzanne-sisley-marijuana-research_n_5603547.html.

161 Id.

162 María Inés Taracena, Sue Sisley’s Medical Marijuana for PTSD Research Officially Rejected by 3 State Universities, Tucson Wkly. (Feb. 23, 2015), http://www.tucsonweekly.com/TheRange/archives/2015/02/23/sue-sisleys-medical-marijuana-for-ptsd-research-official-rejected-by-3-state-universities.

163 Compassionate Access, Research Expansion and Respect States (CARERS) Act, S. 683, 114th Cong. (2015).

164 Id. § 3.

165 Id. § 2 (“Notwithstanding any other provision of law, the provisions of this title relating to marihuana shall not apply to any person acting in compliance with State law relating to the production, possession, distribution, dispensation, administration, laboratory testing, or delivery of medical marihuana.”).

166 Id. § 7.

167 Id. § 6.

168 Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).

169 21 U.S.C. § 812(b)(1) (2012).

170 See Americans for Safe Access v. DEA, 706 F.3d 438, 450-52 (D.C. Cir. 2013).

171 Id. at 452 (citing Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 76 Fed. Reg. 40,552, 40,562 (July 8, 2011)).

172 See Cha, supra note 102 (“[M]any would-be marijuana researchers are driven to abandon projects after they discover how time-consuming and expensive it can be to obtain the drug.”).

173 See Bilz, supra note 93, at 132.

174 Craker v. DEA, 714 F.3d 17, 29 (1st Cir. 2013).

175 21 U.S.C. § 812 (2012).

176 Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).

177 See Cha, supra note 102.