From: [c--o--n] at [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 (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. ñ 811(b), and providing an 'opportunity for a hearing pursuant to rulemaking procedures prescribed by [the Administrative Procedures Act].' 21 U.S.C. ñ 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. ñ 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 [c--o--n] at [dsmnet.com]