Opinion ID: 815698
Heading Depth: 2
Heading Rank: 2

Heading: The DEA’s Denial of the Petition to Initiate

Text: Proceedings to Reschedule Marijuana On the merits, Petitioners claim that the DEA’s final order denying their request to initiate proceedings to reschedule marijuana was arbitrary and capricious. Under the terms of the CSA, marijuana cannot be rescheduled to Schedules III, IV, or V without a “currently accepted medical use.” 21 U.S.C. § 812(b)(3)-(5). To assess whether marijuana has such a medical use, the agency applies a five-part test: “(1) The drug’s chemistry must be known and reproducible; (2) There must be adequate safety studies; (3) There must be adequate and well-controlled studies proving efficacy; (4) The 22 drug must be accepted by qualified experts; and (5) The scientific evidence must be widely available.” See Denial, 76 Fed. Reg. 40,552, 40,579. The DEA’s five-part test was expressly approved by this court in Alliance for Cannabis Therapeutics, 15 F.3d at 1135. Because the agency’s factual findings in this case are supported by substantial evidence and because those factual findings reasonably support the agency’s final decision not to reschedule marijuana, we must uphold the agency action. Under the Administrative Procedure Act, a court may set aside an agency’s final decision only if it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). “We will not disturb the decision of an agency that has ‘examine[d] the relevant data and articulate[d] a satisfactory explanation for its action including a rational connection between the facts found and the choice made.’” MD Pharm. Inc. v. DEA, 133 F.3d 8, 16 (D.C. Cir. 1998) (quoting Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)). Furthermore, the agency’s interpretation of its own regulations “must be given controlling weight unless it is plainly erroneous or inconsistent with the regulation.” Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 512 (1994). The CSA also directs this court to review the agency’s findings of fact for substantial evidence. See 21 U.S.C. § 877. Under this standard, we must “ask whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.” Dickinson v. Zurko, 527 U.S. 150, 162 (1999). Petitioners do not seriously dispute the propriety of the five-part test approved in Alliance for Cannabis Therapeutics. Thus, they are left with the difficult task of showing that the DEA has misapplied its own regulations. Petitioners challenge the agency’s reasoning on each of the five factors. However, 23 “[a] drug will be deemed to have a currently accepted medical use for CSA purposes only if all five of the foregoing elements are demonstrated.” Denial, 76 Fed. Reg. at 40,579. In this case, we need only look at one factor, the existence of “adequate and well-controlled studies proving efficacy,” to resolve Petitioners’ claim. In its scientific and medical evaluation, DHHS concluded that “research on the medical use of marijuana ha[d] not progressed to the point that marijuana [could] be considered to have a ‘currently accepted medical use’ or a ‘currently accepted medical use with severe restrictions.’” Id. at 40,560. As noted above, DHHS’ recommendations are binding on the DEA insofar as they rest on scientific and medical determinations. 21 U.S.C. § 811(b). After an exhaustive examination of the issue, the DEA, adhering to DHHS’ recommendation, reached the following conclusion: To establish accepted medical use, the effectiveness of a drug must be established in well-controlled, welldesigned, well-conducted, and well-documented scientific studies, including studies performed in a large number of patients (57 FR 10499, 1992). To date, such studies have not been performed. The small clinical trial studies with limited patients and short duration are not sufficient to establish medical utility. Studies of longer duration are needed to fully characterize the drug’s efficacy and safety profile. Scientific reliability must be established in multiple clinical studies. Furthermore, anecdotal reports and isolated case reports are not adequate evidence to support an accepted medical use of marijuana (57 FR 10499, 1992). The evidence from clinical research and reviews of earlier clinical research does not meet this standard. 24 Denial, 76 Fed. Reg. at 40,579. Petitioners contest these findings, arguing that their petition to reschedule marijuana cites more than two hundred peer-reviewed published studies demonstrating marijuana’s efficacy for various medical uses, and that those studies were largely ignored by the agency. As we explain below, Petitioners’ singular reliance on “peer-reviewed” studies misses the mark. It is also noteworthy that Petitioners’ brief to this court fails to convincingly highlight any significant studies allegedly ignored by DHHS or the DEA. Petitioners’ argument focuses at length on one study – the March 1999 report from the Institute of Medicine (“IOM”) – that was clearly addressed by the DEA. The IOM report does indeed suggest that marijuana might have medical benefits. See, e.g., INST. OF MEDICINE, MARIJUANA AND MEDICINE: ASSESSING THE SCIENCE BASE 177 (Janet E. Joy et al. eds., 1999), reprinted in J.A. 208 (“For patients such as those with AIDS or who are undergoing chemotherapy, and who suffer simultaneously from severe pain, nausea, and appetite loss, cannabinoid drugs might offer broad-spectrum relief not found in any other single medication.”). However, the DEA fairly construed this report as calling for “more and better studies to determine potential medical applications of marijuana” and not as sufficient proof of medical efficacy itself. Denial, 76 Fed. Reg. at 40,580. In other words, “while the IOM report did support further research into therapeutic uses of cannabinoids, the IOM report did not ‘recognize marijuana’s accepted medical use’ but rather the potential therapeutic utility of cannabinoids.” Id. At bottom, the parties’ dispute in this case turns on the agency’s interpretation of its own regulations. Petitioners construe “adequate and well-controlled studies” to mean peer25 reviewed, published studies suggesting marijuana’s medical efficacy. The DEA, in contrast, interprets that factor to require something more scientifically rigorous. In explaining its conclusion that there is a lack of clinical evidence establishing marijuana’s “currently accepted medical use,” the agency said the following: [A] limited number of Phase I investigations have been conducted as approved by the FDA. Clinical trials, however, generally proceed in three phases. See 21 C.F.R. 312.21 (2010). Phase I trials encompass initial testing in human subjects, generally involving 20 to 80 patients. Id. They are designed primarily to assess initial safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary studies of potential therapeutic benefit. (62 FR 66113, 1997). Phase II and Phase III studies involve successively larger groups of patients: usually no more than several hundred subjects in Phase II and usually from several hundred to several thousand in Phase III. 21 C.F.R. 312.21. These studies are designed primarily to explore (Phase II) and to demonstrate or confirm (Phase III) therapeutic efficacy and benefit in patients. (62 FR 66113, 1997). No Phase II or Phase III studies of marijuana have been conducted. Even in 2001, DHHS acknowledged that there is “suggestive evidence that marijuana may have beneficial therapeutic effects in relieving spasticity associated with multiple sclerosis, as an analgesic, as an antiemetic, as an appetite stimulant and as a bronchodilator.” (66 FR 20038, 2001). But there is still no data from adequate and well-controlled clinical trials that meets the requisite standard to warrant rescheduling. Id. at 40,579-80. 26 The DEA interprets “adequate and well-controlled studies” to mean studies similar to what the Food and Drug Administration (“FDA”) requires for a New Drug Application (“NDA”). See id. at 40,562. DHHS found that “there have been no NDA-quality studies that have scientifically assessed the efficacy of marijuana for any medical condition.” Id. It is well understood that, under FDA protocols, “adequate and well-controlled investigations” require “clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.” 21 U.S.C. § 355(d). This is a rigorous standard. See, e.g., Edison Pharm. Co. v. FDA, 600 F.2d 831, 843 (D.C. Cir. 1979) (holding that substantial evidence supported the FDA’s conclusion that double-blind testing of a new drug was necessary before the drug could be administered to cardiac patients); Holland-Rantos Co. v. U.S. Dep’t of Health, Educ. and Welfare, 587 F.2d 1173, 1174 (D.C. Cir. 1978) (refusing to construe the requirement of a “well-controlled investigation” in a “self-defeating fashion”). Contrary to what Petitioners suggest, something more than “peer-reviewed” studies is required to satisfy DEA’s standard, and for good reason. “[S]cientists understand that peer review per se provides only a minimal assurance of quality, and that the public conception of peer review as a stamp of authentication is far from the truth.” Charles Jennings, Quality and Value: The True Purpose of Peer Review, NATURE.COM (2006), http://www.nature.com/nature/ peerreview/debate/nature05032.html; see also Lynn S. McCarty et al., Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice, 120 27 ENVTL. HEALTH PERSP. 927, 930 (2012) (“It is difficult to extract from the extensive body of work and commentary published over the last 25-30 years that scientific journal peer review is a coherent, consistent, reliable, evaluative procedure. . . . [T]he opposite conclusion may be more accurate.”). Petitioners may have cited some peer–reviewed articles in support of their position, but they have not pointed to “adequate and well-controlled studies” confirming the efficacy of marijuana for medicinal uses. If, as is the case here, “there is substantial evidence to support the [agency’s] finding that the[] studies [offered by petitioner] are not helpful, then petitioner must fail.” Unimed, Inc. v. Richardson, 458 F.2d 787, 789 (D.C. Cir. 1972). In making this assessment, we must “remind ourselves that our role in the Congressional scheme is not to give an independent judgment of our own, but rather to determine whether the expert agency entrusted with regulatory responsibility has taken an irrational or arbitrary view of the evidence assembled before it.” Id. The DEA’s construction of its regulation is eminently reasonable. Therefore, we are obliged to defer to the agency’s interpretation of “adequate and well-controlled studies.” See Thomas Jefferson Univ., 512 U.S. at 512 (deferring to “an agency’s interpretation of its own regulations”). Judged against the DEA’s standard, we find nothing in the record that could move us to conclude that the agency failed to prove by substantial evidence that such studies confirming marijuana’s medical efficacy do not exist. Finally, Petitioners suggested during oral argument that the Government had foreclosed the research that would be necessary to create sufficiently reliable clinical studies of marijuana’s medical efficacy. Because Petitioners did not properly raise this issue with the DEA and there is nothing in 28 the record to support it, we do not consider it here. We note, however, that DHHS’ recommendation explained that “[t]he opportunity for scientists to conduct clinical research with marijuana exists under the [D]HHS policy supporting clinical research with botanical marijuana.” Denial, 76 Fed. Reg. at 40,562. Thus, it appears that adequate and well-controlled studies are wanting not because they have been foreclosed but because they have not been completed.