Kiyoshi Kuromiya, et al.,           )
            Plaintiffs,             )       Civil Action No. 98-3439 MK
      v.                            )
United States of America,           )
            Defendants.             )


        This Court has asked defendant to consider whether to accept the Court's proposal to settle this case by agreeing to establish a "carefully monitored," "scientifically controlled" program that would distribute marijuana to individuals whose medical conditions could be improved by it, and that would provide useful scientific research results that would help decide whether marijuana was medically beneficial or not.  After careful consideration, the government wishes to inform this Court that it must respectfully decline the Court's settlement proposal for three principal reasons.
        First, Congress has already prescribed methods by which the Executive Branch may review proposals to perform research with Schedule I drugs such an marijuana.1   Indeed, Congress has recently reaffirmed its commitment to these procedures.   New legislation passed on October 21, 1998 makes clear that "Congress continues to support the existing Federal legal process for determining the safety and efficacy of drugs."  Pub. L. No. 105-277, 1998 H.R. 4328 (Div'n F)(11) (emphasis added).  Moreover, Congress also "opposes efforts to circumvent this process by legalizing marijuana, and other Schedule I drugs, for medicinal use without valid scientific evidence and the approval of the Food and Drug Administration."  Id.   Congress also expressed its sense that marijuana, like other Schedule I drugs, is dangerous.  Id. at (1)-(2).  It has not been approved by the Food and Drug Administration ("FDA") to treat any disease or condition, id. at (5), and before any drug -- including marijuana -- can be approved as a medication, it must meet the "extensive scientific and medical standards established by the Food and Drug Administration to ensure it is safe and effective."  Id. at (4); see also id. at (6).
        These congressionally mandated review procedures are designed to ensure that any research with controlled substances is conducted in a safe and effective manner with adequate safeguards to prevent diversion into the illegal drug market.  Under these procedures, "practitioners wishing to conduct research with controlled substances in schedule I," such as marijuana, must submit "[r]egistration applications" that are to be referred to the Secretary of Health and Human services ("HHS").  21 U.S.C. 823(f).  The Secretary is to review the practitioners' qualifications and competency and the merits of their proposed research protocols, see 21 U.S.C. 823(f), a responsibility that the Secretary has delegated to the Commissioner of Food and Drugs, see 21 C.F.R. 5.10(a)(9).2  The Secretary must also consult with the Drug Enforcement Administration ("DEA") regarding the effectiveness of procedures to safeguard against diversion of the drugs from research to illicit use.  See 21 U.S.C. 823(f) (requiring consultation with Attorney General); 28 C.F.R. 0.100(b) (delegation of this responsibility from Attorney General to the Administrator of DEA).
        In addition to the extent that research is funded by HHS through the National Institutes of Health ("NIH"), such research must be approved by outside scientific peer review prior to funding.  See 42 U.S.C. 284(b)(1)(B), 284(b)(2)(B), 284a, 289a; 42 C.F.R. Part 52h.   Moreover, NIH-funded research projects involving human beings must comply with human subject protection requirements, see 42 U.S.C. 289, 45 C.F.R. Part 46, and such projects involving the administration of investigational drugs to human beings must meet FDA requirements, see 21 C.F.R. Part 50.
        In light of these congressionally prescribed procedures, the United States cannot agree to establish some new, ad hoc method of distributing marijuana and conducting research on plaintiffs for the sale purpose of settling this litigation.  Congress has carefully delineated the procedures to be used in reviewing applications to conduct marijuana research, procedures aimed at protecting the public, producing sound scientific research, and preventing diversion into illicit markets.  If bona fide researchers wish to propose a research protocol regarding marijuana, defendant stands ready to review it under established statutory and regulatory requirements.  However, bypassing those procedures simply to settle a single case would be inconsistent with this congressionally established, uniform system of research review.
        Second, defendant previously allowed for the use of government-supplied marijuana by individuals whose doctors believed they might benefit from it, but the program proved so unsatisfactory that it had to be discontinued in 1992.  Indeed, for this reason, HHS expressly chose not to reopen the program in 1994 despite the urging of several members of Congress.  See July 13, 1994 Letter to the Honorable Dan Hamburg from Dr. Philip R. Lee, HHS, with attachments; March 22, 1994 Letter to Dr. Philip R. Lee, HHS from the Honorable Dan Hamburg and seven other representatives (Attachment 1).
        The program began in 1978 upon the settlement of Randall v. United States, Civil No. 78-0817 (D.D.C.), an action brought by a glaucoma patient seeking to enjoin the enforcement of federal drug laws relating to marijuana.  See Notice of voluntary Dismissal; Notice of withdrawal of Plaintiff's Motion for a Temporary Restraining Order (Attachment 2).  Following that case, marijuana cigarettes were distributed to a small number of individuals with a variety of medical disorders.  See Attachment 1.  By 1991, about 15 individuals had received marijuana, and the number of applicants was increasing.  See Attachment 1.
        The program was discontinued in March 1992 when it became clear that the potential widespread use of marijuana for "medical" purposes under the program -- especially when effective alternative treatments were available and when the program failed to provide evidence of any therapeutic benefit from the use of marijuana -- was bad public policy and bad medical practice.  See Attachment 1.  Accordingly, physicians for individuals who had applied to the program were counseled on alternative therapies, and only the individuals who were already in the program were allowed to continue receiving marijuana but were encouraged to cease doing so and to find alternative therapies.  See Attachment 1.
        The decision to discontinue the program was based in part on the recognition that the program failed to provide scientific evidence that marijuana might be beneficial for the conditions for which it was being requested.   In addition, there was evidence that smoked marijuana might be actually harmful to those using it for "medical" purposes and could even worsen a patient's underlying condition.  In particular, evidence showed that chemical components of marijuana could cause lung problems in AIDS patients who were prone to pneumonia and other lung infections.  At the same time, alternative medicines such as Marinol -- a synthetic form of marijuana's active ingredient -- were becoming available.  (Marinol currently is approved by the FDA for anorexia associated with weight loss in patients with AIDS and for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments.)  Finally, the program was not designed to produce sound scientific results.  See Attachment 1.  Thus, establishing a similar program now, as proposed, would be contrary to the government's policies of promoting good public health policy and sound medical and scientific practice.
        Finally, settlement is inappropriate because plaintiffs' claims in this case are exceptionally weak.  The named plaintiffs -- who number over 160 and who purport to represent a class of "at least" 97 million people, see Second Amended Complaint at 1 -- apparently seek to enjoin the enforcement of the provisions of the Controlled Substances Act ("CSA") that regulate the manufacture, distribution, and possession of marijuana.  Yet, it is well settled that the CSA is a valid exercise of Congress' Commerce Clause powers, and none of plaintiffs' various constitutional challenges to the CSA can succeed as a matter of law.3  Thus, far from meriting some accommodation by the government, plaintiffs' case is so weak that their lawsuit should be dismissed.
        For these reasons, defendant is in no position to offer concessions and respectfully declines to accept the Court's proposal of settlement.

Dated:  January 12, 1999

Respectfully submitted,

Assistant Attorney General

United States Attorney


Department of Justice
Civil Division, Room 1086
901 E St., N.W.
Washington, D.C. 20530
Tel: (202) 616-8299

Attorneys for Defendant



1        Controlled substances are placed in one of five schedules depending on their potential for abuse, the extent to which they may lead to psychological or physical dependence, and whether they have a currently accepted medical use in treatment in the United States.  21 U.S.C. 812(b).  Controlled substances in Schedule I have been determined to have a "high potential for abuse," "no currently accepted medical use in treatment in the United States," and a "lack of accepted safety for use ... under medical supervision."  Id. 812(b)(1).  Given these characteristics, Congress has mandated that substances in Schedule I be subject to the most stringent regulation.  When it passed the Controlled Substances Act in 1970, Congress placed marijuana in Schedule I, where it remains today.  Id. 812 Schedule I(c)(10).

2        Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-395, new drugs may not be introduced or delivered for introduction in interstate commerce unless the Secretary of HHS approves a new drug application supported by substantial evidence of the drug's efficacy and by adequate tests showing that the drug is safe under the proposed conditions of use.  21 U.S.C. 355(a).  (The HHS Secretary has delegated this authority to Commissioner of Food and Drugs.  See 21 C.F.R. 5.10(a)(1).)  Drugs "intended solely for investigational use by experts qualified by scientific training and experience to investigate (their) safety and effectiveness" may be exempted from that requirement, if certain specified requirements are met.  21 U.S.C. 355(1).  The FDA's regulations relating to investigational new drug applications ("INDs") accomplish this purpose.  See 21 C.F.R. Part 312.

3        In its Memorandum in support of Defendant's Motion to Dismiss Or, in The Alternative, to Strike Second Amended Complaint, which is filed today, defendant addresses the Second Amended Complaint in more detail.