Am. for Safe Access v. Drug Enforcement Admin.

• Decision Date: 11 March 2013
• Docket Number: No. 11–1265.,11–1265.
• Parties: AMERICANS FOR SAFE ACCESS, et al., Petitioners v. DRUG ENFORCEMENT ADMINISTRATION, Respondent Carl Eric Olsen, Intervenor.
• Court: U.S. Court of Appeals — District of Columbia Circuit

706 F.3d 438

AMERICANS FOR SAFE ACCESS, et al., Petitioners

v. DRUG ENFORCEMENT ADMINISTRATION, RespondentCarl Eric Olsen, Intervenor.

No. 11–1265.

United States Court of Appeals,District of Columbia Circuit.

Argued Oct. 16, 2012.

Decided Jan. 22, 2013.

Rehearing En Banc Denied March 11, 2013.

On Petition for Review of a Final Order of the United States Drug Enforcement Administration.

Joseph D. Elford argued the cause and filed the briefs for petitioners.

Carl E. Olsen, pro se, filed briefs for intervenor.

Lena Watkins, Senior Trial Attorney, U.S. Department of Justice, argued the cause for respondent. With her on the briefs were Lanny A. Breuer, Assistant Attorney General, and Anita J. Gay, Senior Trial Attorney.

Before: HENDERSON and GARLAND, Circuit Judges, and EDWARDS, Senior Circuit Judge.

Opinion for the Court filed by Senior Circuit Judge EDWARDS.

Dissenting opinion filed by Circuit Judge HENDERSON.

EDWARDS, Senior Circuit Judge:

There is a serious debate in the United States over the efficacy of marijuana for medicinal uses. Although marijuana has been legalized in a number of states, it is classified as a “Schedule I” drug by the Drug Enforcement Administration (“DEA”), pursuant to its authority under the Controlled Substances Act of 1970 (“CSA” or “Act”). The DEA has maintained this listing because it has determined that marijuana “has no currently accepted medical use in treatment in the United States.” 21 U.S.C. § 812(b)(1)(B). Because Schedule I is the most restricted drug classification under the CSA, the production, sale, and use of marijuana are largely banned by federal law. Petitioners in this case—Americans for Safe Access, the Coalition to Reschedule Cannabis, Patients Out of Time, and several individuals—challenge DEA's denial of its petition to initiate proceedings to reschedule marijuana.

The CSA permits the DEA to reclassify drugs to less restrictive schedules according to various statutory criteria, and interested parties can petition the DEA for such action. See21 U.S.C. §§ 811, 812. In October 2002, the Coalition to Reschedule Cannabis petitioned the DEA to reschedule marijuana as a Schedule III, IV, or V drug. SeeDenial of Petition to Initiate Proceedings to Reschedule Marijuana (“ Denial ”), 76 Fed.Reg. 40,552, 40,552 (July 8, 2011). The DEA denied the petition on July 8, 2011, finding that “[t]here is no currently accepted medical use for marijuana in the United States,” and that “[t]he limited existing clinical evidence is not adequate to warrant rescheduling of marijuana under the CSA.” Id. at 40,552, 40,567. On July 22, 2011, Petitioners filed a timely petition for review of the DEA action.

Petitioners claim that “[n]umerous peer-reviewed scientific studies demonstrate that marijuana is effective in treating various medical conditions, but the DEA simply ignores them to conclude that marijuana should remain in Schedule I.” Pet'rs' Br. at 20. Petitioners thus contend that the DEA's denial of their petition was arbitrary and capricious and ask this court to remand the case to the agency for further consideration.

The Government, in turn, argues that we should dismiss the petition for review on jurisdictional grounds because Petitioners and Intervenor lack Article III standing. The Government also asserts that, even if the court determines that Petitioners or Intervenor have standing, the petition for review should be denied on the merits. According to the Government, in the record reviewed by the DEA, “there was no available evidence of adequate, well-controlled studies demonstrating marijuana's safety and effectiveness as a medicine and no consensus among experts as to these issues. The enactment of state laws allowing the use of marijuana for medical purposes did not constitute the required science-based evidence.” Br. for Resp't at 23.

We deny the Government's jurisdictional challenge because we find that at least one of the named Petitioners, Michael Krawitz, has standing to challenge the agency's action. Krawitz, who is a disabled veteran, is entitled to medical care through the U.S. Department of Veterans Affairs (“VA”). Krawitz has suffered injury-in-fact because he must shoulder a financial cost for services he could otherwise obtain free of charge from the VA. There is a causal connection between the DEA's continuing decision to classify marijuana as a Schedule I drug and the VA's policy of refusing to provide referrals for state medical marijuana programs. And a favorable decision from this court would likely redress Krawitz's injury because, if the DEA rescheduled marijuana, the VA could no longer use the CSA to justify its policy of refusing to complete medical marijuana referral forms. Krawitz thus satisfies the requirements of Article III standing. See Lujan v. Defenders of Wildlife, 504 U.S. 555, 560–61, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992).

On the merits, the question before the court is not whether marijuana could have some medical benefits. Rather, the limited question that we address is whether the DEA's decision declining to initiate proceedings to reschedule marijuana under the CSA was arbitrary and capricious. These questions are not coterminous. “The scope of review under the ‘arbitrary and capricious' standard is narrow and a court is not to substitute its judgment for that of the agency.” Motor Vehicle Mfrs. Ass'n of the U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983). On the record before us, we hold that the DEA's denial of the rescheduling petition survives review under the deferential arbitrary and capricious standard. The petition asks the DEA to reclassify marijuana as a Schedule III, IV, or V drug, which, under the terms of the CSA, requires a “currently accepted medical use.” The DEA's regulations, which we approved in Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C.Cir.1994), define “currently accepted medical use” to require, inter alia, “adequateand well-controlled studies proving efficacy.” Id. at 1135. We defer to the agency's interpretation of these regulations and find that substantial evidence supports its determination that such studies do not exist.

I. Background

A. The Controlled Substances Act

We have previously described marijuana's listing as a Schedule I drug under the CSA as follows:

The [CSA] places hazardous drugs in five categories, or schedules, which impose varying restrictions on access to the drugs. See21 U.S.C. § 812 (1988). Marijuana is assigned by statute to Schedule I, the most restrictive of these. Schedule I drugs may be obtained and used lawfully only by doctors who submit a detailed research protocol for approval by the Food and Drug Administration and who agree to abide by strict recordkeeping and storage rules.

The CSA allows the Attorney General to reschedule a drug if he finds that it does not meet the criteria for the schedule to which it has been assigned. 21 U.S.C. § 811(a). The Attorney General has delegated this authority to the [DEA] Administrator. In rescheduling a drug, the Administrator must consider, inter alia, “[s]cientific evidence of [the drug's] pharmacological effect, if known,” and “[t]he state of current scientific knowledge regarding the drug or other substance.” 21 U.S.C. § 811(c)(2), (3).

A drug is placed in Schedule I if (1) it “has a high potential for abuse,” (2) it has “no currently accepted medical use in treatment in the United States,” and (3) “[t]here is a lack of accepted safety for use of the drug ... under medical supervision.” 21 U.S.C. § 812(b)(1) (1988) (emphasis added).

Alliance for Cannabis Therapeutics, 15 F.3d at 1133.

A criterion for Schedule III, IV, and V drugs is the existence of “a currently accepted medical use in treatment in the United States.” 21 U.S.C. § 812(b)(3)–(5). To assess whether there is a “currently accepted medical use,” the DEA looks for five necessary elements: “(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 drug must be accepted by qualified experts; and (5) The scientific evidence must be widely available.” See Denial, 76 Fed.Reg. at 40,579. Unlike Schedule I drugs, federal law permits individuals to obtain Schedule II, III, IV, or V drugs for personal medical use with a valid prescription. See21 U.S.C. § 829(a)–(c).

Under the CSA, “any interested party” may petition the DEA to reschedule a drug. 21 U.S.C. § 811(a). In reaching a final scheduling decision, the DEA must request from the Department of Health & Human Services (“DHHS”) a “scientific and medical evaluation,” as well as a recommendation for the drug's appropriate schedule. 21 U.S.C. § 811(b). These recommendations are binding on the DEA insofar as they rest on scientific and medical determinations. Id.

B. Procedural History

As noted above, Petitioners in this case include three advocacy organizations and several individuals. On September 1, 2011, Carl Olsen intervened on behalf of Petitioners. He asserts a religious interest in the use of marijuana.

On October 9, 2002, the Coalition to Reschedule Cannabis petitioned the DEA to reschedule marijuana as a Schedule III, IV, or V drug. See Petition to Reschedule Cannabis (Marijuana), reprinted in Joint Appendix (“J.A.”) 46–162. Petitioners assert that marijuana's Schedule I status is inappropriate because, inter alia, it “has an accepted medical use in the United States.” The petition to reschedule supported this assertion with citations to alleged peer-reviewed, published studies on the potential medical applications of marijuana. See, e.g., id. at 38–56, reprinted in J.A. 86–104. The DEA submitted Petitioner's rescheduling request to DHHS. Denial, 76 Fed.Reg. at 40,552.

In its scientific and medical evaluation, DHHS concluded that marijuana lacks a currently accepted medical use in the United States. In reaching this conclusion,...