From: [c--o--n] at [dsmnet.com] (Carl E. Olsen) Newsgroups: talk.politics.drugs Subject: OLSEN v. DEA, Legal Brief (1 of 2) Date: Tue, 30 Aug 1994 21:33:29 QUESTIONS PRESENTED FOR REVIEW I. Whether the Administrator of the Drug Enforcement Administration erred in ruling that the final rule of May 13, 1986, placing synthetic dronabinol in sesame oil and encapsulated in soft gelatin capsules in Schedule II did not included the rescheduling of delta-9-tetrahydrocannabinol itself. II. Whether the Administrator of the Drug Enforcement Administration erred in ruling that the final rule of May 13, 1986, placing synthetic dronabinol in sesame oil and encapsulated in soft gelatin capsules in Schedule II did not included the rescheduling of marijuana. III. Whether the Administrator of the Drug Enforcement Administration erred procedurally by refusing to accept the petition and ruling on its merit, simultaneously. STATUTES AND REGULATIONS The pertinent statues and regulations are set forth in an addendum bound with this brief. JURISDICTION The final order of the Drug Enforcement Administration was issued on October 23, 1992. My Petition for Review was received by this Court on November 12, 1992, and assigned Docket No. 92- 8041. My Petition for Review was subsequently filed in forma pauperis by this Court on February 8, 1993, and reassigned Docket No. 93-1109 [App., p. 17]. This Court has jurisdiction of this petition for review of a final order of the Drug Enforcement Administration pursuant to 21 U.S.C. ñ 877. STATEMENT OF THE CASE 1. THE CONTROLLED SUBSTANCES ACT. In 1970 Congress enacted the Controlled Substances Act (CSA), a comprehensive statute designed to rationalize federal control of dangerous drugs. The Act contains five categories of controlled substances, designated as Schedules I through V and defined in terms of dangers and benefits. 21 U.S.C. ñ 812(b)(1)- (5). The control mechanisms imposed on manufacture, acquisition, and distribution of substances listed under the Act vary according to the schedule in which the substance is contained. Substances in Schedules I & II are subject to the most severe restrictions, and substances in Schedule V are subject to the least severe restrictions. In drafting the CSA Congress placed marijuana in Schedule I, one of the two classifications that provides for the most severe restrictions. Recognizing that the results of continuous research might cast doubt on the wisdom of initial classification assignments, Congress created a procedure by which changes in scheduling could be effected. Pursuant to Section 201(a) of the Act, 21 U.S.C. ñ 811(a), the Attorney General "may, by rule," add a substance to a schedule, transfer it between schedules, or remove it from the schedules. A reclassification rule promulgated under this section must be made on the record after opportunity for hearing, in accordance with the rulemaking procedures prescribed by the Administrative Procedure Act, 5 U.S.C. ch. 5, subch. II. Section 201(a) further provides that rescheduling proceedings may be initiated by the Attorney General on his [or her] own motion, at the request of the Secretary of Health and Human Services (HHS), or, as in the present case, on petition of any interested party. Section 501(a) of the CSA, 21 U.S.C. ñ 871(a), authorizes the Attorney General to "delegate any of his functions under this subchapter to any officer or employee of the Department of Justice." The functions vested in the Attorney General by the CSA have been delegated to the Acting Administrator of the Drug Enforcement Administration (DEA) pursuant to 28 C.F.R. ññ 0.100(b) & 0.132(d) (1992). DEA's Acting Administrator must share his [or her] decision- making function under the Act with the Secretary of HHS. Section 201(b), 21 U.S.C. ñ 811(b), provides that, prior to commencement of reclassification rulemaking proceedings, the Attorney General must "request from the Secretary a scientific and medical evaluation, and his [or her] recommendations, as to whether such drug or other substance should be so controlled or removed as a controlled substance." The evaluation prepared by the Secretary must address the scientific and medical factors enumerated in Section 201(c), 21 U.S.C. ñ 811(c); these factors relate to the effects of the drug and its abuse potential. Pursuant to Section 201(b), the Secretary's recommendations "shall be binding on the Attorney General as to such scientific and medical matters, and if the Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance." Section 201(d) of the Act, 21 U.S.C. ñ 811(d), contains a limited exception to the referral procedures detailed in Section 201(b)-(c). Subsection (d)(1) provides: If control is required by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he [or she] deems most appropriate to carry out such obligations, without regard to the findings required by subsection (a) of this section or section 812(b) of this title and without regard to the procedures prescribed by sections (a) and (b) of this section. 2. THE SINGLE CONVENTION ON NARCOTIC DRUGS. In 1948, in order to simplify existing treaties and international administrative machinery, members of the United Nations undertook codification of a single convention on international narcotics control. In 1961, after three preliminary drafts, the Single Convention on Narcotic Drugs, 1961, 18 U.S.T. 1407 (1967), 520 U.N.T.S. 204 (1964), was opened for signature. The United States ratified the Single Convention in 1967 -- three years prior to enactment of the CSA. Like the CSA, the Single Convention establishes several classifications or "schedules" of substances, to which varying regimes of control attach. Schedule I of the Single Convention contains substances considered to carry a relatively high abuse liability; included in this category are heroin, methadone, opium, coca leaf, and cocaine. Schedule II and III contain those substances regarded as less susceptible to abuse. Finally, Schedule IV of the Single Convention -- unlike CSA schedule IV -- embraces certain Schedule I substances, such as heroin, the abuse liability of which is not offset by substantial therapeutic advantages. Marijuana (cannabis) is listed in Schedules I and IV of the Single Convention, however, delta-9-tetrahydrocannabinol (delta-9-THC) is not listed in the schedules of the Single Convention. 3. THE CONVENTION ON PSYCHOTROPIC SUBSTANCES. In 1978 Congress enacted the Psychotropic Substances Act (PSA), Pub. L. 95-633, Nov. 10, 1978, 92 Stat. 2768, to coincide with the Convention on Psychotropic Substances, signed at Vienna, Austria on February 21, 1971 [The Convention entered into force in respect to the United States on July 15, 1980], 1019 U.N.T.S. 175 (1976), Treaty No. 14,596. Section 101 of the PSA, 21 U.S.C. ñ 801a, provides, in part: The United States has joined with other countries in executing an international treaty, entitled the Convention on Psychotropic Substances and signed at Vienna, Austria, on February 21, 1971, which is designed to establish suitable controls over the manufacture, distribution, transfer, and use of certain psychotropic substances. The Convention on Psychotropic Substances contains four categories of controlled substances, designated as Schedules I through IV and defined in terms of dangers and benefits. The international control mechanisms imposed on manufacture, acquisition, and distribution of substances listed under the Convention on Psychotropic Substances vary according to the schedule in which the substance is contained. Substances in Schedule I are subject to the most severe restrictions, and substances in Schedule IV are subject to the least severe restrictions. In drafting the Convention on Psychotropic Substances the parties placed tetrahydrocannabinols in Schedule I, the classification that provides for the most severe restrictions. However, "At its 1,045th meeting, on April 29, 1991, the Commission on Narcotic Drugs, in accordance with article 2, paragraphs 5 and 6, of the Convention on Psychotropic Substances, 1971, decided, by a vote of 33 in favor and 5 against, with no abstentions, that delta-9-tetrahydrocannabinol (also referred to as delta-9-THC) and its stereochemical variants should be transferred from Schedule I to Schedule II of that Convention." Official Records of the Economic and Social Council, 1991, Supplement No. 4 (E/1991/24, Supp. No. 4), pp. 23 and 98 [App., p. 10]. The five States voting against the decision were Colombia, Ivory Coast, Egypt, France and Pakistan. Id. 4. HISTORY OF THIS CASE. There are currently two other petitions for review, seeking to have marijuana moved from Schedule I to Schedule II of the CSA, now pending before this Court. Alliance for Cannabis Therapeutics v. Drug Enforcement Administration, No. 92-1168, and Drug Policy Foundation v. Drug Enforcement Administration, No. 92-1179. The Alliance for Cannabis Therapeutics (ACT) and the Drug Policy Foundation (DPF) allege that marijuana has accepted medical use in treatment in the United States, 21 U.S.C. ñ 812(b)(2)(B), and seek rescheduling on that basis. They are seeking review of a final order of the Drug Enforcement Administration (DEA), issued on March 26, 1992, finding that marijuana does not have accepted medical use in treatment in the United States. 57 Fed. Reg. 10,499. The scheduling of marijuana under the Controlled Substances Act (CSA), 21 U.S.C. ñ 812, as well as under international obligations, has been under consideration by this Court on several prior occasions. NORML v. Ingersoll, 497 F.2d 654 (D.C. Cir. 1974); NORML v. DEA, 559 F.2d 735 (D.C. Cir. 1977); and, ACT v. DEA, 930 F.2d 936 (D.C. Cir. 1991). The issue is still pending before this Court in ACT v. DEA, No. 92-1168, and DPF v. DEA, No. 92-1179. ACT and DPF inherited their case from NORML which filed a petition to have marijuana removed from the CSA with the Bureau of Narcotics and Dangerous Drugs (BNDD) on May 18, 1972. The BNDD refused to accept the petition for filing, and this Court had to order the DEA to respond. NORML v. Ingersoll, 497 F.2d 654 (D.C. Cir. 1974). Upon remand the DEA held that international treaty obligations required it to place marijuana in Schedule I of the CSA. This Court then remanded the petition back to the DEA again, holding that marijuana can be placed in either Schedule I or Schedule II of the CSA without violating international treaty obligations, and requiring the DEA to hold hearings to determine in which of the two schedules, Schedule I or Schedule II, marijuana properly belongs. NORML v. DEA, 559 F.2d 735, 757 (D.C. Cir. 1977). In the final order for which ACT and DPF seek review, the Administrator listed five criteria for determining accepted medical use, and found that marijuana failed to satisfy all five criteria. The Administrator said, "First, marijuana's chemistry is neither fully known, nor reproducible." 57 Fed. Reg. at 10,507. The Administrator went on to explain why marijuana failed to satisfy the remaining four criteria, but these four will not be repeated here, because failure to satisfy the first criterion would almost certainly mean failure to satisfy the remaining four. After reading the Administrator's final ruling of March 26, 1992, I sent a letter to the Administrator on July 21, 1992, asking why coca and opium poppy plants are scheduled in Schedule II of the CSA, since both of these plants are subject to the same variances in chemistry as the marijuana plant (neither are reproducible in standardized dosages) [App., p. 1]. On August 17, 1992, the Administrator replied by stating that "these plant materials [coca and opium poppy] have historically been recognized as the source for a variety of accepted and useful medications." Letter from the Administrator, dated August 17, 1992 [App., p. 5]. The Administrator also stated that "the petition to reschedule marijuana did not involve the scheduling of any medically useful compound to be extracted from the plant material." Id. Interpreting the Administrator's statements regarding scheduling of coca and opium poppy plants and scheduling of a medically useful compound extracted from marijuana as general rules, I then filed my own Petition to Reschedule Marijuana based on the fact that in 1986 dronabinol, delta-9-tetrahydrocannabinol (delta-9-THC), the principle psychoactive substance in the marijuana plant, was rescheduled to Schedule II of the Controlled Substances Act, and, therefore, marijuana must be moved into the same schedule as dronabinol [App., p. 2]. See Final Order of the Drug Enforcement Administration, May 13, 1986, 51 Fed. Reg. 17,476 (placing dronabinol in Schedule II). My petition was filed on September 11, 1992, pursuant to 21 U.S.C. ñ 811 and 21 C.F.R. ñ 1307.03, in the form prescribed by 21 C.F.R. ñ 1308.44(b). The Administrator responded to my petition by stating, "In a final rule published on May 13, 1986, then Administrator John C. Lawn placed a very specific substance, synthetic dronabinol in sesame oil and encapsulated in soft gelatin capsules, in Schedule II. Administrator Lawn's action did not involve the rescheduling of delta-9-tetrahydrocannabinol itself, nor did it include any form of dronabinol other than the synthetic." Final rule of the Administrator, October 23, 1992 [App., p. 7]. The Administrator stated further, "Since I am not accepting your petition on the grounds that dronabinol is a wholly synthetic substance, not obtained from marijuana, it is unnecessary for me to consider the broader question of whether the rescheduling of marijuana would be appropriate if accepted medications were indeed obtained from that source." Id. (continued in next message)