From: carlolsen@dsmnet.com (Carl E. Olsen) Newsgroups: talk.politics.drugs Subject: Olsen v. DEA (1 of 7) Date: Sat, 27 Aug 1994 13:18:45 Message-ID: Post Office Box 4091 Des Moines, Iowa 50333 July 21, 1992 Robert C. Bonner, Administrator Drug Enforcement Administration Washington, D.C. 20537 Dear Mr. Bonner: I just finished reading your decision on the Marijuana Rescheduling Petition, 57 FR 10499 (March 26, 1992). Your explanation of the scheduling criteria in the Controlled Substances Act (CSA) left me confused. By your definition, a substance in Schedule II is a scientifically established chemical compound capable of reproduction in standardized dosages. Of course, marijuana is not such a substance, it is a plant, not a drug. Although you made no mention of the fact, the coca plant, from which cocaine is made, and the opium plant, from which morphine and heroin are made, are both in Schedule II of the CSA. As I was reading your decision, I wondered how these two plants can be in Schedule II. These plants are subject to the same variances in chemistry as the marijuana plant. It seems like you are treating marijuana unfairly. If Congress intended to rely on scientifically established chemistry and reproducible dosages, why did Congress include the coca and opium plants in Schedule II? It seems to me that these plants should not be included in the CSA at all, because they will never fit into your definition of drugs, and I think your definition is correct as far as it goes. However, since Congress has decided to include them in the CSA, your definition is inadequate to explain them. I hope you will correct your definition, and not simply ignore this apparent inconsistency. Thank you for your attention. Sincerely, Carl Eric Olsen (515) 243-7351 August 17, 1992 Dear Mr. Olsen: This is in response to your letter of July 21, 1992, regarding my decision with respect to the Marijuana Rescheduling Petition. Your letter correctly states that one of the factors to be considered in determining whether a substance has a currently accepted medical use in treatment is that it is a scientifically established chemical compound capable of reproduction is standardized dosages. While you are also correct in noting that Congress placed coca and opium plant materials in Schedule II, your attempt to analogize those substances to marijuana, and to find inconsistency in their scheduling, fails. In placing coca leaves and opium plant material in Schedule II, Congress was very much aware that these plant materials have historically been recognized as the source for a variety of accepted and useful medications. Neither of these plants are used medicinally as plant material. In both instances, the medically active alkaloids are extracted from the plant material after which pharmaceutical compounds capable of reproduction in standardized dosages are produced. These compounds are the medications which may then be lawfully marketed in the United States. While indigenous populations in various parts of the world brew coca teas, chew coca leaves, and smoke opium for various purposes, these practices are not permitted in the United States under the Controlled Substances Act. Unlike pharmaceuticals derived from opium and coca leaves, the petition to reschedule marijuana did not involve the scheduling of any medically useful compound to be extracted from the plant material. Instead, the petition involved unsupported claims for the medical use of smoked marijuana. There is, therefore, no inconsistency in my finding that such claims did not make a case for accepted medical use in treatment in the United States. Very truly yours, Robert C. Bonner Administrator of Drug Enforcement ============================================================================= From: carlolsen@dsmnet.com (Carl E. Olsen) Newsgroups: talk.politics.drugs Subject: Olsen v. DEA (2 of 7) Date: Sat, 27 Aug 1994 13:22:02 Message-ID: Post Office Box 4091 Des Moines, Iowa 50333 September 6, 1992 Robert C. Bonner, Administrator DrugEnforcement Administration Washington, D.C. 20537 Dear Mr. Bonner: Carl Eric Olsen hereby petitions the Administrator to reschedule marijuana from Schedule I to Schedule II of the Controlled Substances Act (CSA) pursuant to Section 201 of the CSA, Public Law 91-513, 21 U.S.C. § 811 and 21 C.F.R. § 1307.03. Attached hereto and constituting a part of this petition is a statement of the grounds upon which petitioner relies for the proposed rescheduling. Five copies of this petition are provided pursuant to 21 C.F.R. § 1308.44(b). All notices regarding this petition should be addressed to: Carl Eric Olsen Post Office Box 4091 Des Moines, Iowa 50333 (515) 243-7351 Sincerely yours, Carl Eric Olsen (515) 243-7351 PETITIONER'S STATEMENT OF GROUNDS FOR RESCHEDULING The Controlled Substances Act (CSA), 21 U.S.C. §§ 801 et seq., contains five schedules, the first of which (Schedule I) contains substances which have no medical use in treatment in the United States, and the final four of which (Schedules II through V) contain substances which have medical use in treatment in the United States but which are available only by a physician's prescription. Marijuana is currently in Schedule I of the CSA. On March 26, 1992, the Administrator made a final decision in a marijuana rescheduling petition, DEA No. 86-22, rejecting the finding of an administrative law judge that marijuana has medical use in treatment in the United States, and rejecting the administrative law judge's recommendation that marijuana be moved to Schedule II of the CSA. 57 FR 10499. The essence of the decision was that marijuana is a plant and not a drug. The Administrator argued that the chemistry of the marijuana plant is complex, varies from plant to plant, and is incapable of reproduction in standardized dosages (attributes common to all plants), and that a drug is a scientifically established chemical compound capable of reproduction in standardized dosages. The Administrator's decision has been appealed to the United States Court of Appeals for the District of Columbia by several parties seeking medical access to marijuana plants. According to the Administrator, "the petition to reschedule marijuana did not involve the scheduling of any medically useful compound to be extracted from the plant material." The Administrator went on the say, "the petition involved unsupported claims for medical use of smoked marijuana." See Exhibit A. As for other plants in Schedule II, the Administrator said, "In placing coca leaves and opium plant material in Schedule II, Congress was very much aware that these plant materials have historically been recognized as the source for a variety of accepted and useful medications." The Administrator went on to say, "Neither of these plants are used medicinally as plant material." See Exhibit A. It must follow from the Administrator's explanation that marijuana need not have an accepted medical use in treatment in the United States in order to be rescheduled from Schedule I to Schedule II of the CSA, it only needs to be shown that marijuana is a source for an accepted and useful medication. On October 11, 1985, the Administrator proposed to reschedule dronabinol to Schedule II of the CSA. 50 FR 42186 (October 18, 1985); 21 C.F.R. § 1308.12(f)(1) (1991). Dronabinol is the synthetic equivalent of the isomer of delta-9- tetrahydrocannabinol which is the principle psychoactive substance present in Cannabis Sativa L., marijuana. 50 FR 42186 (October 18, 1985). Dronabinol is the U.S. Adopted Name (USAN) for the substance (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H- dibenzo [b,d] pyran-1-ol or (-)-delta-9-(trans)- tetrahydrocannabinol, the principle psychoactive substance in Cannabis sativa L., marijuana. 50 FR 42186 (October 18, 1985). It has the empirical formula C21H30O2 with molecular weight of 314.45. 1989 Physician's Desk Reference, page 1859. On May 24, 1991, the United Nations Economic and Social Council (ESCOR) rescheduled delta-9-tetrahydrocannabinol from Schedule I to Schedule II of the 1971 Convention on Psychotropic Substances. U.N. Doc. E/CN.7/1991/26. Report of the Commission on Narcotic Drugs on its thirty-fourth session, U.N. Doc. E/1991/24, Supp. No. 4. The United States is a party to that international convention pursuant to the Psychotropic Substances Act of 1978 (Pub. L. 95-633, November 10, 1978). 50 FR 42186 (October 18, 1985). Since marijuana is now a source for an accepted and useful medication, it must now be moved from Schedule I to Schedule II of the CSA. Respectfully submitted, Carl Eric Olsen Post Office Box 4091 Des Moines, Iowa 50333 (515) 243-7351 October 23, 1992 Dear Mr. Olsen: This is in response to your petition to reschedule marijuana from Schedule I to Schedule II of the Controlled Substances Act. The crux of your petition is that marijuana itself need not have an accepted medical use in treatment in the United States if it is shown that marijuana is the source of an accepted and useful medication. To that end, you argue that marijuana should be rescheduled as a source of delta-9-tetrahydrocannabinol because dronabinol, the synthetic form of the same isomer, is controlled in Schedule II. 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. Accordingly, pursuant to 21 C.F.R. § 1308.44(c), your petition to reschedule marijuana is not accepted. 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. As you are well aware, the issue of whether marijuana itself has any accepted medical use is pending before the United States Court of Appeals for the District of Columbia Circuit. We are confident that the Court will find no merit in the petition and that it will affirm my ruling in that case. Very truly yours, Robert C. Bonner Administrator of Drug Enforcement Article 29166 of talk.politics.drugs: Path: news.claremont.edu!nntp-server.caltech.edu!news.cerf.net!usc!cs.utexas.edu!howland.reston.ans.net!wupost!udel!news.sprintlink.net!dsm6.dsmnet.com!slip5.dsmnet.com!carlolsen From: carlolsen@dsmnet.com (Carl E. Olsen) Newsgroups: talk.politics.drugs Subject: Olsen v. DEA (3 of 7) Date: Sat, 27 Aug 1994 13:25:22 Organization: Des Moines Internet Lines: 52 Message-ID: NNTP-Posting-Host: slip5.dsmnet.com X-Newsreader: Trumpet for Windows [Version 1.0 Rev A] July 13, 1993 Dear Mr. Olsen: This replies to your May 13, 1993, letter asking several questions about drugs. It is true that a good many drugs useful in therapeutics can be extracted from herbs. Some drugs have an animal origin, e.g., many hormones. A synthetic drug is a drug that is made by chemically combining various starting materials to make the desired product. The product is then identical in all respects to the product isolated from a plant source. Such a product can be marketed under the same name. For example, cortisone is synthesized from a yam that grows in Mexico and it is identical to cortisone extracted from adrenal tissue. A synthetic drug would be in the same schedule as its naturally occurring twin. For example, synthetic lysergic acid amide is in the same schedule as lysergic acid amide derived from the plant source. Please let me know if I can be of further assistance on drug matters. Sincerely yours, Harold Davis Consumer Safety Officer CDER Executive Secretariat Staff (HFD-8) Center for Drug Evaluation and Research December 2, 1993 Dear Mr. Olsen: This replies to your July 21, 1993, letter concerning synthetic dronabinol (delta-9-THC). In respect to the naturally extracted and synthetically manufactured dronabinol, the Drug Enforcement Agency has promulgated the enclosed regulation. Please note that tetrahydrocannabinol is a Schedule I substance, but dronabinol, synthetic, in sesame oil and in a soft gelatin capsule, is a U.S. Food and Drug Administration approved drug product and is a Schedule II substance. Both marijuana and tetrahydrocannabinol are Schedule I substances. With respect to your other questions on marijuana, the original chemical researcher was Dr. Roger Adams of the University of Illinois chemistry department. The pharmacology of the compounds was investigated by Dr. Seigried Lowe of the University of Utah. A review of marijuana is given on page 549- 553 of Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th Edition, Pergamon Press, 1990. Sincerely yours, Harold Davis Consumer Safety Officer CDER Executive Secretariat Staff (HFD-8) Center for Drug Evaluation and Research ============================================================================= From: carlolsen@dsmnet.com (Carl E. Olsen) Newsgroups: talk.politics.drugs Subject: Olsen v. DEA (4 of 7) Date: Sat, 27 Aug 1994 13:29:02 Message-ID: MOTION FOR REMAND The Drug Enforcement Administration, respondent in the above-captioned appeal, hereby moves this Court to remand the action to the Administrator of the Drug Enforcement Administration. In support of this motion and as the basis therefore, respondent states as follows: 1. On September 6, 1992, appellant Olsen filed a petition with the Administrator requesting that marijuana be rescheduled from Schedule I to Schedule II of the Controlled Substances Act. In support of this petition, appellant filed a statement of grounds for rescheduling in compliance with 21 C.F.R. § 1308.44(b)(B). 2. On October 23, 1992, the Administrator responded to appellant's petition by refusing to accept that petition for filing. Prior to rejecting the petition for filing the Administrator took no action to review the grounds upon which appellant relied in that petition. 3. Pursuant to the 21 C.F.R. § 1308.44(c), respondent is required to accept the petition for filing absent some defect in format. As this requirement was not met, respondent now requests this Court to remand the matter so that respondent may accept appellant's petition for filing and review that petition in accordance with regulations. See NORML v. Ingersoll, 497 F.2d 654 (D.C. Cir. 1974). 4. Respondent makes this motion in the interests of fairness and judicial economy and not with the intent of causing unnecessary delay. Therefore, respondent respectfully requests this Court to order the Administrator upon remand to accept appellant's petition for filing and to make a ruling upon the matter within 90 days of the date of this Court's final order in the related cases of Alliance for Cannabis Therapeutics v. Drug Enforcement Administration, No. 92-1168 and Drug Policy Foundation v. Drug Enforcement Administration, No. 92-1179. Both of these cases are scheduled for oral argument on October 1, 1993. Respectfully submitted, Lena D. Mitchell Trial Attorney Narcotic and Dangerous Drug Section Criminal Division, P.O. Box 27312, Washington, D.C. 20530 RESPONSE TO MOTION FOR REMAND I, Carl Eric Olsen, petitioner in the above-captioned petition for review of a final administrative order, hereby respond to the respondent's Motion for Remand to the Administrator of the Drug Enforcement Administration, and state as follows: 1. On September 6, 1992, I filed a petition with the Administrator requesting that marijuana be rescheduled from Schedule I to Schedule II of the Controlled Substances Act. In support of this petition, I filed a statement of grounds for rescheduling in compliance with 21 C.F.R. § 1308.44(b)(B). 2. On October 23, 1992, the Administrator responded by refusing to accept my petition for filing and by ruling on its merits. Contrary to what the respondent says in paragraph two of the Motion for Remand, the Administrator did review the grounds upon which I relied and did make a ruling on the merits of my petition. 3. Pursuant to the 21 C.F.R. § 1308.44(c), respondent is required to accept a petition for filing absent some defect in format. As the respondent now admits, this requirement was not met, and respondent now claims it is requesting this Court to remand the matter so that it may accept my petition for filing in accordance with regulations. However, since the respondent ruled on the merits of my petition, it is questionable whether the respondent actually refused to accept my petition for filing. 4. Respondent claims to make the Motion for Remand in the interests of fairness and judicial economy and not with the intent of causing unnecessary delay. However, the respondent fails to mention that the Drug Enforcement Administration (DEA) has been developing a pattern of unfairness, waste of judicial resources and unnecessary delay. The respondent mentions one example in the Motion for Remand, NORML v. Ingersoll, 497 F.2d 654 (D.C. Cir. 1974), but fails to mention another case where a petition was not accepted for filing, Carl Eric Olsen v. Drug Enforcement Administration, 878 F.2d 1458 (D.C. Cir 1989). Between 1983 and 1985, I filed several petitions which the DEA refused to accept, until a mandamus action was filed in the U.S. District Court. Id. 878 F.2d at 1459. Then, after review of the DEA's denial of the petition on its merits was sought, the DEA asked this Court "to remand the matter for renewed agency consideration." Id. 878 F.2d at 1460. This is exactly what the DEA is doing now. 5. Since the DEA has already ruled on the merits of my petition, the only possible reason for a remand would be because the DEA didn't make a reasonable decision on the merits of my petition and now wants to hold an administrative hearing before an administrative law judge to correct its error. If the DEA simply plans to deny the petition again after it is accepted for filing, then there is no reason for a remand, because a final ruling has already been made and such a remand would simply be a waste of judicial resources and an unnecessary delay. 6. Respondent now requests this Court to order the Administrator upon remand to accept my petition for filing and to make a ruling upon the matter within 90 days of the date of this Court's final order in the related cases of Alliance for Cannabis Therapeutics v. Drug Enforcement Administration, No. 92-1168 and Drug Policy Foundation v. Drug Enforcement Administration, No. 92-1179. Both of these cases are scheduled for oral argument on October 1, 1993. I strongly oppose my case being delayed for these two cases. The grounds upon which I seek rescheduling are entirely unrelated to the grounds relied upon in these two cases, and, if this Court decides to remand this matter, I think this Court should set a time frame that is unrelated to them. Respectfully submitted, Carl E. Olsen, pro se Post Office Box 4091 Des Moines, Iowa 50333 ============================================================================= From: carlolsen@dsmnet.com (Carl E. Olsen) Newsgroups: talk.politics.drugs Subject: Olsen v. DEA (5 of 7) Date: Sat, 27 Aug 1994 13:32:19 Message-ID: November 17, 1993 Dear Senator Harkin: This is in response to your letter of October 12, 1993, on behalf of your constituent, Mr. Carl E. Olsen. Pursuant to 21 U.S.C. § 811, and interested party can petition the DEA to reschedule a controlled substance. When such a petition is filed with the Drug Enforcement Administration, it is carefully evaluated to determine whether the petition meets the requirements of 21 C.F.R. § 1308.44. Section (b) of that regulation requires that the petition conform to the format provided and also specifies that four copies be filed. If the petition is accepted for filing, the Administrator will evaluate the petition on its merits. If the petition is not accepted for filing, because it is either lacking in the regulatory requirements or not readily understood, the Administrator will notify the petitioner of his decision and reasons thereof. 21 C.F.R. § 1308.44(c). A copy of the regulation has been provided for your convenience. As you are aware, your constituent has appealed the DEA's nonacceptance of his petition to the United States Court of Appeals for the District of Columbia. In that case, the DEA has asked for a remand of the action in order that the Administrator may accept Mr. Olsen's petition for filing and review that petition on its merits. The DEA is constrained from commenting further on the merits of Mr. Olsen's case since it is currently pending before the court of appeals. I hope the foregoing will assist you in responding to your constituent. Sincerely, Stephen H. Greene Acting Administrator of Drug Enforcement November 23, 1993 Dear Senator Grassley: This is in response to your letter of October 25, 1993, on behalf of your constituent, Mr. Carl E. Olsen. As you are aware, your constituent has appealed the Drug Enforcement Administration's (DEA) nonacceptance of his petition to reschedule marijuana from Schedule I to Schedule II of the Controlled Substances Act to the United States Court of Appeals for the District of Columbia. Pursuant to 21 U.S.C. § 811, and interested party can petition the DEA to reschedule a controlled substance. When such a petition is filed with the Drug Enforcement Administration, it is carefully evaluated to determine whether the petition meets the requirements of 21 C.F.R. § 1308.44. Section (b) of that regulation requires that the petition conform to the format provided and be readily understood. If the petition is accepted for filing, the Administrator will evaluate the petition on its merits. If the petition is not accepted for filing, the Administrator will notify the petitioner of his decision and reasons thereof. 21 C.F.R. § 1308.44(c). A copy of the regulation has been provided for your convenience. Despite Mr. Olsen's contentions, the Administrator did not review the grounds upon which Mr. Olsen relied in his petition before refusing to accept his petition. However, DEA has recognized that the requirement that a petition be accepted for filing absent some ambiguity or some defect in format was not met in this matter. Therefore, in the pending case before the Court of Appeals, DEA has asked for a remand of the action in order that the Administrator may accept Mr. Olsen's petition for filing and review that petition on its merits. The DEA is constrained from commenting further on the merits of Mr. Olsen's case since it is currently pending before the court of appeals. I hope the foregoing will assist you in responding to your constituent. Sincerely, Stephen H. Greene Acting Administrator of Drug Enforcement ============================================================================= From: carlolsen@dsmnet.com (Carl E. Olsen) Newsgroups: talk.politics.drugs Subject: Olsen v. DEA (6 of 7) Date: Sat, 27 Aug 1994 13:34:29 Message-ID: FINAL ORDER This order is issued pursuant to an Order dated December 9, 1993, from the United States Court of Appeals for the District of Columbia Circuit which remanded the matter of a petition from Carl Eric Olsen to the Drug Enforcement Administration (DEA) for a ruling by the agency. On September 6, 1992, Carl Eric Olsen (Petitioner) of Des Moines, Iowa, submitted a petition requesting that the controlled substance marijuana, be rescheduled from Schedule I to Schedule II of the Controlled Substances Act of 1970 (CSA). The Petitioner's grounds were based on his evaluation of two prior rescheduling actions by the Administrator. See Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules, 51 Fed. Reg. 17476 (1986) and Marijuana Rescheduling Petition, 57 Fed. Reg. 10499 (1992). On October 23, 1992, the-Administrator of Drug Enforcement, Robert C. Bonner, declined to accept his petition. The Petitioner subsequently filed for review of then-Administrator Bonner's decision with the United States Court of Appeals for the District of Columbia Circuit. The matter was remanded by Order of that Court to the DEA for a ruling. Pursuant to that Court's Order, and 21 C.F.R. § 1308.44(c), the Deputy Administrator of the Drug Enforcement Administration has considered the matters before him and thereby renders his final decision. In his Petition for rescheduling, the Petitioner alleged that marijuana need not have an accepted medical use in treatment in the United States in order to be rescheduled from Schedule I, but "it only needs to be shown that marijuana is a source for an accepted and useful medication". This contention was based on Petitioner's own analogies drawn from an earlier DEA marijuana rescheduling case, 57 Fed. Reg. 10499 (1992), and subsequent written statements made to the Petitioner by then-Administrator Bonner regarding coca leaves and opium plant material; and the Petitioner's incorrect contention that the DEA proposed to reschedule dronabinol in a proposed rulemaking. See Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules, 50 Fed. Reg. 42186 (1985). It appears that Petitioner contends that this rescheduling action included delta- 9-tetrahydrocan-nabinol (delta-9-THC), an ingredient in marijuana, and concluded that "since marijuana is now a source for an accepted and useful medication, it must now be rescheduled from Schedule I to Schedule II of the CSA". The Deputy Administrator finds, for the reasons stated herein, that the grounds upon which the Petitioner relies are not sufficient to justify the initiation of proceedings for the transfer of marijuana from Schedule I to Schedule II of the CSA. In July 1992, the Petitioner wrote then-Administrator Bonner regarding his final order of March 26, 1992, (57 Fed. Reg. 10499), in which the Administrator declined to reschedule marijuana to Schedule II, and the apparent "unfair" classification of the marijuana plant as a Schedule I substance, while coca and opium plants remained in Schedule II. Then- Administrator Bonner replied by letter on August 17, 1992, and distinguished the pharmaceuticals or derivative compounds from each plant. Apparently, the Petitioner then created a theory, that given that the Schedule II opium and coca plants were a source for accepted medication, then if marijuana plants were a source for accepted medications it should also be a Schedule II substance. To further his argument, the Petitioner pointed to the rescheduled drug, which he called dronabinol, as having its source in marijuana. The Petitioner also alluded to inconsistencies of scheduling of delta-9-THC, a component of marijuana, between the CSA and certain multilateral international agreements. When the CSA was created, Congress specified the initial scheduling of controlled substances and the criteria by which controlled substances could be rescheduled. 21 U.S.C. §§ 811- 812. The DEA is bound, by law, to follow this mandate. Congress placed both the tetrahydrocannabinols, which includes delta-9- THC, and the plant marijuana into Schedule I when it enacted the CSA. See Pub. L. 91-513, § 202(c), Schedule I (c)(17) and (c)(10). Similarly, Congress placed opium poppy and straw and coca leaves into Schedule II. See Pub. L. 91-513, § 202(c), Schedule II (a)(3) and (a)(4). The legislative history indicates that marijuana was placed into Schedule I on its own merits and not because delta-9-THC could be extracted from it. H.R. Rep. No. 1444, 91st Cong., 2d Sess., pt. 1, at 12 (1970). Whether or not marijuana is a source of delta-9-THC is irrelevant to the status of marijuana under the CSA. With regard to the classification of controlled substances, the Attorney General may, by rule, add to the established schedules or transfer between such schedules and drug or other substance if [s]he finds that such drug or other substance has a potential for abuse, and makes with respect to such drug or other substance the findings prescribed by subsection (b) of Section 812 for the schedule in which such drug is to be placed. 21 U.S.C. § 811(a)(1). The Attorney General has delegated this authority to the Administrator, who has redelegated it to the Deputy Administrator. See 28 C.F.R. §§ 0.100(b) and 0.104. (59 Fed. Reg. 23637 (May 6, 1994)). In order for a substance to be placed into Schedule II, the Attorney General must find that: "(A) The drug or other substance has a high potential for abuse. (B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. (C) Abuse of the drug or other substance may lead to severe psychological or physical dependence." 21 U.S.C. § 812(b)(2). Then-Administrator John C. Lawn previously determined that marijuana does not have a currently accepted medical use in treatment in the United States and as a result must remain in Schedule I. See Marijuana Rescheduling Petition, 54 Fed. Reg. 53767 (1989). Then-Administrator Lawn's final order was appealed to the United States Circuit Court of Appeals for the D.C. Circuit which returned the matter to the DEA for an explanation of the factors relied upon in determining "currently accepted medical use". See Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991). In response to the remand, then-Administrator Bonner issued a final order in which he determined that for a substance to have a "currently accepted medical use" the following must exist: a. the drug's chemistry must be known and reproducible; b. there must be adequate safety studies; c. there must be adequate and well-controlled studies proving efficacy; d. the drug must be accepted by qualified experts; and e. the scientific evidence must be widely available. Then-Administrator Bonner concluded that marijuana failed to meet all elements of the five-part test and, therefore, did not meet the statutorily prescribed criteria for a Schedule II substance. Marijuana Rescheduling Petition, 57 Fed. Reg. 10499 (1992); See Alliance for Cannabis Therapeutics v. DEA, et al., 15 F.3d 1131 (D.C. Cir. 1994) upholding the Administrator's decision. Accordingly, the Deputy Administrator concludes that the Petitioner's contention that marijuana need not have an accepted medical use in treatment in the United States in order to be rescheduled from Schedule I to Schedule II of the CSA is not in accordance with law. DEA may only move a drug from Schedule I if there is a finding of "currently accepted medical use in treatment in the United states". Although delta-9-THC is the principle psychoactive ingredient in marijuana, it can be synthesized and exist as a chemical. Delta-9-THC is a generic term which refers to four separate chemicals and two mixtures of chemicals, i.e., four stereochemical variants of the parent substance and two racemates. One of the stereochemical variants, the (-) delta-9- trans-THC isomer, is the principle psychoactive ingredient in Cannabis sativa, L., or marijuana. That isomer is also the ingredient in a pharmaceutical product which has been shown to be safe and effective as an anti-emetic for certain patients receiving cancer chemotherapy, and is identified chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H- dibenzo[b,d]-pyran-1-ol. The International Nonproprietary name (INN) and the U.S. Adopted Name (USAN) for that isomer of delta- 9-THC is dronabinol. With the development of scientific and medical evidence that demonstrated that a pharmaceutical product which contained dronabinol was safe and effective for the treatment of nausea and vomiting associated with cancer chemotherapy in certain patients, then-Administrator John C. Lawn rescheduled this pharmaceutical product from Schedule I to Schedule II. See 51 Fed. Reg. 17476 (1986). Only the pharmaceutical product was transferred from Schedule I to Schedule II, i.e., "dronabinol (synthetic) in sesame oil and encapsulated in soft gelatin capsules in a U.S. Food and Drug Administration approved drug product". No rescheduling action was taken with regard to (-) delta-9-trans- THC, i.e., dronabinol, which remains in Schedule I of the CSA. Tetrahydrocannabinols, including delta-9-THC, one of the synthetic equivalents of the substances contained in the plant or resinous extractives of Cannabis (marijuana) are listed at 21 C.F.R. § 1308.11(d)(25). Tetrahydrocannabinols and all their isomers, including delta-9-THC, are also the subject of control by international agreement under the United Nations Convention on Psychotropic Substances, 1971, February 21, 1971, 32 U.S.T. 543, T.I.A.S. 9725, 1019 U.N.T.S. 175. Cannabis, cannabis resin and extracts and tinctures of cannabis are regulated as Schedule I substances under the United Nations Single Convention on Narcotic Drugs, 1961, March 30, 1961, 18 U.S.T. 1407, T.I.A.S. 6298, 520 U.N.T.S. 204. The United States is a party to both conventions. Then-Administrator Lawn also discussed the United States international obligations in his Dronabinol in Sesame Oil and Encapsulated in a Soft Gelatin Capsule, rescheduling action. See 51 Fed. Reg. 17476 (1986). Since Article 7 of the Convention on Psychotropic Substances, 1971 has strict prohibitions on activities involving Schedule I drugs, in 1987, the United States Government initiated an action to have delta-9-THC transferred to Schedule II to allow the pharmaceutical product to be marketed. See U.N. Doc. E/CN.7/1990/4. Such a transfer was not inconsistent with the substance delta-9-THC remaining in the CSA Schedule I. Under Article 23 of the Convention on Psychotropic Substances, 1971, a party may adopt more strict or severe measures of control if desirable or necessary for the protection of the public health and welfare. Under the CSA, the regulation of chemicals and the plant material are distinct from each other. The classification of delta-9-THC has no bearing on the classification of marijuana. Under the CSA, a proposed change in the schedule of either a tetrahydrocannabinol or the plant marijuana requires the Attorney General to proceed independently. Petitioner apparently does not wish to look to the clear construct of the Controlled Substances Act, but to pose alternative theories of the Act. Under the CSA, drugs or other substances may be treated and classified differently, according to the enumerated statutory criteria. 21 U.S.C. § 812(b). The Deputy Administrator reaffirms that marijuana does not have a currently accepted medical use in treatment in the United States and is thus appropriately listed as a Schedule I controlled substance. The Deputy Administrator finds nothing to support the petitioner's contention that since marijuana, coca, and opium are all plant materials they must be treated alike in the CSA. The Deputy Administrator further finds that the rescheduling of the pharmaceutical product "dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved drug product", which contains the synthetic chemical ingredient (-) delta-9-trans-THC, did not require that either the plant marijuana or substance delta-9-THC be similarly rescheduled. The Petitioner's request is denied. Stephen H. Greene Deputy Administrator Dated: May 16, 1994 ============================================================================= From: carlolsen@dsmnet.com (Carl E. Olsen) Newsgroups: talk.politics.drugs Subject: Olsen v. DEA (7 of 7) Date: Sat, 27 Aug 1994 13:36:34 Message-ID: PRELIMINARY DRAFT OF PETITIONER'S RESPONSE On May 16, 1994, the Deputy Administrator of the Drug Enforcement Administration (DEA) erroneously denied my petition to have marijuana transferred from Schedule I to Schedule II of the Controlled Substances Act (CSA), 21 U.S.C. §§ 801 et seq. The DEA Deputy Administrator erred by erroneously ruling that: (1) marijuana must have a medical use in treatment in the United States before it can be transferred to Schedule II of the CSA; (2) only synthetic dronabinol in sesame oil and encapsulated in soft gelatin capsules, not dronabinol itself, was transferred to Schedule II of the CSA; and (3) whether or not marijuana is a source of delta-9-tetrahydro-cannabinol (THC) is irrelevant to the status of marijuana under the CSA. In my petition for rescheduling, I alleged that marijuana need not have an accepted medical use in treatment in the United States in order to be rescheduled from Schedule I, but "it only needs to be shown that marijuana is a source for an accepted and useful medication". In his final ruling, the DEA Deputy Administrator said, "This contention was based on Petitioner's own analogies drawn from an earlier DEA marijuana rescheduling case, 57 Fed. Reg. 10499 (1992), and subsequent written statements made to the Petitioner by then-Administrator Bonner regarding coca leaves and opium plant material;..." FINAL ORDER, at page 2 (May 16, 1994). The DEA Deputy Administrator cites the case of Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994) to support his theory that marijuana may only be moved from Schedule I if there is a finding of "currently accepted medical use in treatment in the United States." The parties agreed that nothing which has a currently accepted medical use in treatment can be included in Schedule I, and the question of whether marijuana has a currently accepted medical use in treatment was the sole issue in that case. The question of whether marijuana could be moved from Schedule I without a currently accepted medical use in treatment was not an issue in that case. In 1977, the United States Court of Appeals for the District of Columbia Circuit considered this exact question when it ruled, "[P]lacement in Schedule I does not appear to flow inevitably from lack of currently accepted medical use. ...The legislative history of the CSA indicates that medical use is but one factor to be considered, and by no means the most important one." National Organization for the Reform of Marijuana Laws v. DEA, 559 F.2d 735, 748 (D.C. Cir. 1977). In my petition for rescheduling, I also allege that the DEA proposed to reschedule dronabinol in a proposed rulemaking. See Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules, 50 Fed. Reg. 42186 (1985). In his final ruling the DEA Deputy Administrator said, "It appears that Petitioner contends that this rescheduling action included delta-9-tetrahydrocannabinol (delta-9-THC), an ingredient in marijuana, and concluded that 'since marijuana is now a source for an accepted and useful medication, it must now be rescheduled from Schedule I to Schedule II of the CSA'". FINAL ORDER, at page 2. Although the DEA Deputy Administrator points out that I have incorrectly identified dronabinol as delta-9-THC, the Deputy Administrator admits that the correct ingredient, the (-) delta- 9-trans-THC isomer of delta-9-THC, is the principle psychoactive ingredient in Cannabis sativa, L., or marijuana. The Deputy Administrator argues that dronabinol was not transferred to Schedule II of the CSA, and that only "dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved drug product" has been transferred to Schedule II of the CSA. This is a distinction that the Deputy Administrator does not have the authority to make. FDA marketing approval is not a prerequisite for the rescheduling of a drug. Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 939-40 (D.C. Cir. 1991); Grinspoon v. DEA, 828 F.2d 881, 887 (1st Cir. 1987). Certainly, the Deputy Administrator would not make the claim that sesame oil and soft gelatin capsules, by themselves, belong in any schedule of the CSA. Is the Deputy Administrator saying that the addition of sesame oil and soft gelatin capsules to dronabinol create therapeutic value in dronabinol where none existed before, or that synthetic dronabinol has therapeutic value while its twin obtained from the plant material has none? The DEA Deputy Administrator points out that both delta-9- THC and marijuana are subject to international control, delta-9- THC under the United Nations Convention on Psychotropic Substances, 1971, February 21, 1971, 32 U.S.T. 543, T.I.A.S. 9725, 1019 U.N.T.S. 175, and marijuana under the United Nations Single Convention on Narcotic Drugs, 1961, March 30, 1961, 18 U.S.T. 543, T.I.A.S. 6298, 520 U.N.T.S. 204, and that the United States is a party to both conventions. In 1977, The United States Court of Appeals for the District of Columbia Circuit ruled that the United States may place marijuana in either Schedule I or Schedule II of the CSA without violating its international obligations. National Organization for the Reform of Marijuana Laws v. DEA, 559 F.2d 735, 757 (D.C. Cir. 1977). The DEA Deputy Administrator admits, "Since Article 7 of the Convention on Psychotropic Substances, 1971 has strict prohibitions on activities involving Schedule I drugs, in 1987, the United States Government initiated an action to have delta-9- THC transferred to Schedule II to allow the pharmaceutical product to be marketed. See U.N. Doc. E/CN.7/1990/4." FINAL ORDER, at page 8. The United States could have sought only the transfer of "dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved drug product," but instead chose to seek the transfer of all delta-9-THC isomers and racemates, whether obtained synthetically or from the plant material itself. In his final ruling, the DEA Deputy Administrator said, "the regulation of chemicals and the plant material are distinct from each other." FINAL ORDER, at page 8. However, in a letter dated August 17, 1992, then DEA Administrator Robert C. Bonner said, "In placing coca leaves and opium plant material in Schedule II, Congress was very much aware that these plant materials have historically been recognized as the source for a variety of accepted and useful medications." Then Administrator Bonner recognized, as the U.S. Supreme Court did in 1984, "If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. ...[I]f the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute." Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842- 843, 104 S.Ct. 2778, 2781-2782, 81 L.Ed.2d 694 (1984). It is clear that Congress placed coca and opium into Schedule II because they were sources for accepted and useful medications, and it is equally clear that, "Neither of these plants are used medicinally as plant material." See DEA Administrator Bonner's letter of August 17, 1992. Clearly, marijuana, like coca and opium, could be placed in Schedule II without having a currently accepted medical use in treatment in the United States and without violating international treaty obligations. It only needs to be shown that marijuana is the source of accepted and useful medicines. Investigations have also shown that other drugs, other than (-) delta-9-trans-THC, in the marijuana plant may have therapeutic value, but the placement of marijuana in Schedule I makes such investigations difficult, if not impossible, which is why Congress chose to place coca and opium in Schedule II rather than Schedule I. In his final ruling, the DEA Deputy Administrator said, "Whether or not marijuana is a source of delta-9-THC is irrelevant to the status of marijuana under the CSA." FINAL ORDER, at page 4. In 1975, the United States Court of Appeals for the District of Columbia Circuit gave detailed consideration to this question in the case of United States v. Walton, 514 F.2d 201 (D.C. Cir. 1975). The court said, "Looking at the history of this latter law [the Marijuana Tax Act of 1937], we find that the definition of marijuana was intended to include those parts of marijuana which contain THC and to exclude those parts which do not." Id. 514 F.2d at 203. "The legislative history is absolutely clear that Congress meant to outlaw all plants popularly known as marijuana to the extent those plants possessed THC." Id. 514 F.2d at 203-204. Although the Deputy Administrator said, "The classification of delta-9-THC has no bearing on the classification of marijuana." [FINAL ORDER, at page 8], the court has already ruled otherwise. Carl E. Olsen May 24, 1994 ============================================================================= From: carlolsen@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 Message-ID: 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. § 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. § 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. § 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. § 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. §§ 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. § 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. § 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. § 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. § 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. § 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. § 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. § 811 and 21 C.F.R. § 1307.03, in the form prescribed by 21 C.F.R. § 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) ============================================================================= From: carlolsen@dsmnet.com (Carl E. Olsen) Newsgroups: talk.politics.drugs Subject: OLSEN v. DEA, Legal Brief (2 of 2) Date: Tue, 30 Aug 1994 21:36:34 Message-ID: (continued from previous message) SUMMARY OF ARGUMENT By definition, a synthetic drug is the same as its natural occurring twin. Delta-9-THC is only one substance, not two. In 1986, Health and Human Services (HHS) recognized that synthetic delta-9-THC is the same as its naturally occurring twin. The DEA must accept this scientific and medical findings of HHS. The DEA is trying to do something with delta-9-THC that it doesn't do with any other drug, placing the synthetic drug in a different schedule than its naturally occurring twin. The DEA is not authorized to make such distinctions. The DEA must defer to HHS for scientific and medical findings. Neither can the DEA rely on FDA marketing approval of Marinol, synthetic dronabinol "in sesame oil and encapsulated in soft gelatin capsules," as a reason for keeping all other forms of delta-9-THC in Schedule I. Sesame oil and gelatin capsules are simply foods, which are not subject to control under the CSA. It is delta-9-THC which is in Schedule II, not just the FDA approved product Marinol. In 1986, when marijuana became the source of an accepted and useful medication, delta-9-THC, it should have been transferred into the same schedule of the CSA, Schedule II, as the other plants, coca and opium, which are the sources of the accepted and useful medications cocaine and morphine. ARGUMENT 1. SYNTHETIC AND NATURAL DELTA-9-THC ARE THE SAME. The Administrator's decision that synthetic delta-9-THC in sesame oil and encapsulated in soft gelatin capsules, but not delta-9-THC itself, has been rescheduled, and that delta-9-THC is not obtained from marijuana, is beyond the scope of the DEA's authority. This Court must review the DEA's decision to schedule delta- 9-THC simultaneously in two different schedules in light of the guidelines set forth by the Supreme Court in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). In Chevron, the Court explained that a reviewing court must employ a two-step analysis that focuses initially on the intentions of Congress: First, always, is the question whether Congress had directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. Id. at 842-43, 104 S.Ct. at 2781 (emphasis supplied). In the absence of congressional intent, however, the court must proceed to a second inquiry: If ... the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute. Id. at 843, 104 S.Ct. at 2781-82 (footnote omitted; emphasis supplied). In enacting the CSA, "Members of the House repeatedly stated that the Department of Justice should make judgments based on law enforcement considerations, while HEW should have the final say with respect to medical and scientific determinations." NORML v. DEA, 559 F.2d at 746. The Department of Justice "may not schedule a substance under the CSA without first obtaining the recommendation of the FDA, through its parent agency, HHS, 21 U.S.C. § 811(b), and providing an 'opportunity for a hearing pursuant to rulemaking procedures prescribed by [the Administrative Procedures Act].' 21 U.S.C. § 811(a)." Grinspoon v. DEA, 828 F.2d 881, 890 (1st Cir. 1987). "This request is filed with the Commissioner of FDA, who has the responsibility for coordination of activities within [HHS]." NORML v. DEA, 559 F.2d at 749 n.59. As this Court stated in 1977: Our interpretation of Section 201(d) ensures proper allocation of decisionmaking responsibility between the Attorney General and the Secretary of HEW, in accordance with their respective spheres of expertise. Section 201(d) directs the Attorney General, as an initial matter, to make a legal judgment as to controls necessitated by international commitments. He then establishes a minimum schedule or level of control below which placement of the substance may not fall. Determination of a minimum schedule ensures that the Secretary's recommendation, which ordinarily would be binding as to medical and scientific findings, does not cause a substance to be scheduled in violation of treaty obligations. However, once that minimum schedule is established by the Attorney General, the decision whether to impose controls more restrictive than required by treaty implicates the same medical and scientific considerations as do scheduling decisions regarding those few substances not controlled by treaty. The Secretary of HEW is manifestly more competent to make these nonlegal evaluations and recommendations. NORML v. DEA, 559 F.2d at 747. Although the FDA has approved a New Drug Application (NDA) for Marinol, synthetic delta-9-THC in sesame oil and encapsulated in soft gelatin capsules, this does not qualify as a recommendation to the DEA for purposes of scheduling. FDA has never recommended that delta-9-THC remain in Schedule I while Marinol is in Schedule II, nor has it said that synthetic delta- 9-THC is better than delta-9-THC itself. [App., p. 15] This is not the first time the DEA has tried to follow verbatim text of FDA marketing approval for a New Drug Application (NDA) in making a scheduling determination. As this Court stated in 1991: The First Circuit in Grinspoon v. Drug Enforcement Administration, 828 F.2d 881, 891-92 (1st Cir. 1987), upon which petitioners rely, had held that earlier criteria the Administrator had employed to define "currently accepted medical use" were contrary to the statute because they were a carbon copy of those used by the FDA in licensing new drugs. The present criteria, it is argued, duplicate a number of those original criteria. But the criteria challenged in Grinspoon included several elements, such as the availability of patent information or FDA-required labeling, which were necessary only to market the drug in interstate commerce. These criteria are clearly relevant to the FDA's mission, but not the DEA's, see Grinspoon, 828 F.2d at 887. The First Circuit never suggested the DEA Administrator was foreclosed from incorporating and relying on those standards employed by the FDA that are relevant to the pharmaceutical qualities of the drug. The court merely held that while FDA approval is sufficient to establish the existence of an accepted medical use, the converse in not true -- that absent FDA approval, commonly accepted medical use cannot be proven. Id. at 890. Nor can we conceive of a reason the Administrator should be barred from employing notions developed by a sister agency insofar as those notions serve the missions of both agencies. ACT v. DEA, 930 F.2d at 939-40. In 1987, the First Circuit said, [W]e find no necessary linkage between failure to obtain FDA interstate marketing approval and a determination that the substance in question is unsafe and has no medical use. Indeed, the FDCA does not even mention the term 'medical use.' In short, it is plainly possible that a substance may fail to obtain interstate marketing approval even if it has an accepted medical use. Grinspoon, 828 F.2d at 887. "Thus, it is possible that a substance may have both an accepted medical use and safety for use under medical supervision, even though no one has deemed it necessary to seek approval for interstate marketing." Id. A synthetic drug is the same as its naturally occurring twin, by definition. Under this Court's order of June 4, 1982, in NORML v. DEA, No. 79-1660, the Department of Health and Human Services (DHHS) was required to submit reports on the status of its recommendations for the scheduling of THC and marijuana plants. In reference to the DEA's rescheduling order of May 13, 1986 (51 Fed. Reg. 17,476) the DHHS stated that, "Dronabinol is structurally the same as THC." [App., p. 8] The Administrator says that marijuana is not the source of an accepted and useful medication, but there is considerable evidence to the contrary. In his final order on NORML's petition, the Administrator adopted in their entirety the findings of the former Administrator. 57 Fed. Reg. at 10,507. The former Administrator, in his final order on NORML's petition, stated, "There is no difference in the pharmacological effect between the THC isolated from cannabis and the synthetically produced THC which is now marketed in the United States." 54 Fed. Reg. at 53,774. As this Court noted in 1991, "The First Circuit never suggested the DEA Administrator was foreclosed from incorporating and relying on those standards employed by the FDA that are relevant to the pharmaceutical qualities of the drug." ACT v. DEA, 930 F.2d at 939. The former Administrator, in agreement with HHS, recognized that the pharmaceutical qualities of synthetic delta-9-THC are the same as those of delta-9-THC itself. In his final order on NORML's petition, the Administrator stated, "There are scientific studies showing pure THC (Delta-9- Tetrahydrocannabinol), one of the many chemicals found in marijuana, has some effect in controlling nausea and vomiting. Pure THC is pharmaceutically made in clean capsule form, called Marinol, and is available for use by the medical community. More information on Marinol can be found in the 'Physicians' Desk Reference,' available in most libraries." 57 Fed. Reg. at 10,500. The 1993 Physician's Desk Reference describes Marinol as follows: "Dronabinol, commonly known as delta-9-THC, is one of the major active substances in marijuana." Id. at p. 2076. Synthetic delta-9-THC is an exact duplicate of its naturally occurring twin, delta-9-THC. "Following the isolation and characterization of delta-9-THC as the major active component of marijuana by Mechoulam and colleagues, a technique for producing synthetic material was developed." Plasse, T.; Gorter, R.; Krasnow, S.; Lane, M.; Shepard, K.; Wadleigh, R. Recent Clinical Experience With Dronabinol. Pharmacology Biochemistry & Behavior, Vol. 40, pp. 695-700; 1991 (Gaoni, Y.; Mechoulam, R. The isolation and structure of 1-tetrahydrocannabinol and other neutral cannabinoids from hashish. J. Am. Chem. Soc. 93:217-224; 1971) (Petrzilka, T.; Haefliger, W.; Sikemeier, C. Synthesis of hashish components. Part 4. Helv. Chim. Acta 52:1102-1134; 1969). In a letter dated July 13, 1993, the FDA states that, "A synthetic drug ... is identical in all respects to the product isolated from a plant source. Such a product can be marketed under the same name.... A synthetic drug would be in the same schedule as its naturally occurring twin." Letter from the FDA, July 13, 1993 [App., p. 16]. Clearly, delta-9-THC itself was approved for medical use by the FDA when it approved Marinol. "[T]he [DEA] does not have the authority to impose Schedule I controls on a drug which has been approved by the [FDA] for medical use." Grinspoon, 828 F.2d at 890 (citing, 1984 U.S. Code Cong. & Admin. News 540, 543). When the Economic and Social Council of the United Nations moved delta-9-THC from Schedule I to Schedule II of the Convention on Psychotropic Substances, it made no distinction between synthetic delta-9-THC and delta-9-THC itself. In 1986, then Administrator John C. Lawn improperly took upon himself the authority to define synthetic delta-9-THC and delta-9-THC itself as two separate substances under the CSA. In the course of rescheduling synthetic dronabinol to Schedule II of the CSA, the original proposal submitted by the DEA defined it as "the principle psychoactive substance in Cannabis sativa L., marijuana," 50 Fed. Reg. 42,185 (October 18, 1985) (proposed rule), but this definition was changed to "the synthetic equivalent of the isomer of delta-9- tetrahydrocannabinol (THC) which is the principle psychoactive substance in Cannabis sativa L., marijuana" in the final rule, 51 Fed. Reg. 17,476 (May 13, 1986) (final rule). Whether this change was accidental or intentional is hard to discern, but it clearly exceeded the Administrator's authority. Although it is true that "[a]ppellate courts have neither the expertise nor the resources to evaluate complex scientific claims," this is not a complex scientific claim. Grinspoon, 828 F.2d at 896 (citing, Thompson Medical Co. v. FTC, 791 F.2d 189, 196 (D.C. Cir. 1986)). A synthetic drug must be the same as the naturally occurring twin before it can receive FDA marketing approval for distribution in interstate commerce. As a matter of law, delta-9-THC itself was rescheduled to Schedule II of the CSA at the same time as synthetic delta-9-THC, and this Court should so find. 2. MARIJUANA IS IN SAME SCHEDULE AS DELTA-9-THC. As this Court noted in 1991, "As is apparent, one salient concept distinguishing the two schedules is whether a drug has 'no currently accepted medical use in treatment in the United States.'" ACT v. DEA, 930 F.2d at 938. "However, placement in Schedule I does not appear to flow inevitably from lack of currently accepted medical use." NORML v. DEA, 559 F.2d at 748. "The legislative history of the CSA indicates that medical use is but one factor to be considered, and by no means the most important one." Id. Moreover, DEA's own scheduling practices support the conclusion that substances lacking medical usefulness need not always be placed in Schedule I. At the hearing before ALJ Parker DEA's Chief Counsel, Donald Miller, testified that several substances listed in CSA Schedule II, including poppy straw, have no currently accepted medical use. Tr. at 473-474, 488. He further acknowledged that marihuana could be rescheduled to Schedule II without a currently accepted medical use. Tr. at 487-488. Neither party offered any contrary evidence. Id. The explanation given by the Administrator for the placement of coca and opium poppy plants in Schedule II is that coca and opium poppy plants have been "recognized as the source for a variety of accepted and useful medications." Petition, Exhibit A. According to this explanation, marijuana should be transferred to Schedule II, because it has now become the source of an accepted and useful medication, after its initial placement in Schedule I of the CSA in 1970. In the final order under review in this case, the Administrator stated that, "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." Final Order, October 23, 1992. Again, the standard of review is that of Chevron, 467 U.S. 837. It is apparent from reading the CSA that Congress intended to include coca and opium poppy plants in Schedule II because useful medications were being derived from these plant sources when the CSA was created in 1970. The apparent distinction that Congress made between marijuana and coca and opium poppy plants when the schedules were created in 1970 was that coca and opium poppy plants were the sources of useful and accepted medications, while marijuana was not. The Administrator has provided his interpretation of the statute by stating "Congress was very much aware that these plant materials [coca and opium poppy] have historically been recognized as the source for a variety of accepted and useful medications." Petition, Exhibit A. The Administrator's interpretation reinforces what is apparent from the face of the statute, that plants which are the source of accepted and useful medications cannot be placed in a schedule higher than Schedule II. For example, peyote, a plant which contains the Schedule I drug mescaline, is also in Schedule I, while opium poppy, a plant which contains the Schedule II drug morphine, is in Schedule II. To quote the Administrator, "Those who insist marijuana has medical uses would serve society better by promoting or sponsoring more legitimate scientific research, rather than throwing their time, money and rhetoric into lobbying, public relations campaigns and perennial litigation." 57 Fed. Reg. at 10,503. Since marijuana belongs in Schedule II of the CSA, the DEA should not even be involved in the debate on marijuana's medical use. Congress intended the FDA to handle this debate. Scientific research will be promoted by treating marijuana exactly the same as coca and opium poppy plants, the DEA will be removed from the debate on marijuana's medical use, clearing the way for the FDA to take over, and needless perennial litigation will cease. Since accessibility for research purposes is exactly the same under either Schedule I or Schedule II, there is no reason for the DEA not to move marijuana into Schedule II, since DEA's only legitimate concern under the CSA is drug diversion. "Congress was particularly concerned with the diversion of drugs from legitimate channels to illegitimate channels." United States v. Moore, 423 U.S. 122, 135 (1972). 3. THE PETITION MUST BE ACCEPTED BEFORE IT IS DENIED. Another question presented is whether the Administrator followed proper procedure in refusing to accept the petition by denying the petition on its merits. Pursuant to 21 C.F.R. § 1308.44(c): Within a reasonable period of time after the receipt of a petition, the Administrator shall notify the petitioner of his acceptance or nonacceptance of the petition, and if not accepted, the reason therefor. The Administrator need not accept a petition for filing if any of the requirements prescribed in paragraph (b) of this section is lacking or is not set forth so as to be readily understood. If the petitioner desires, he may amend the petition to meet the requirements of paragraph (b) of this section. If accepted for filing, a petition may be denied by the Administrator within a reasonable period of time thereafter if he finds the grounds upon which the petitioner relies are not sufficient to justify the initiation of proceedings. The Administrator's streamlined procedure in this case appears to be in conflict with DEA regulations. This Court dealt with a similar procedural question in 1974: [T]he rejection of a filing is a "peremptory" response "which classically is used not to dispose of a matter on the merits but rather as a technique for calling on the filing party to put its papers in proper form and order. Its use is not limited to defects of form. It may be used by an agency where the filing is so patently a nullity as a matter of substantive law, that administrative efficiency and justice are furthered by obviating any docket at the threshold rather than opening a futile docket." 146 U.S.App.D.C. at 299, 450 F.2d at 1346. NORML v. Ingersoll, 497 F.2d at 659 n.10. My petition was not such a patent nullity, as matter of law, to justify either refusal to accept the petition for filing, or denial of the petition on its merits. I was denied the opportunity to present additional evidence to support my petition, and I am objecting to this streamlined approach. CONCLUSION Based on the foregoing, I respectfully request this Court to rule that: (1) as a matter of law, delta-9-THC itself is in Schedule II of the CSA; (2) as a matter of law, marijuana is in Schedule II of the CSA; and (3) such other or further relief be granted as this Court may deem necessary under the circumstances. Respectfully submitted, Carl Eric Olsen, pro se Post Office Box 4091 Des Moines, Iowa 50333 (515) 243-7351 Dated: August 4, 1993 carlolsen@dsmnet.com