Laura M. Nagel
Deputy Assistant Administrator
Office of Diversion Control
Drug Enforcement Administration
House Committee on Government Reform: Subcommittee on Criminal Justice, Drug Policy and Human Resources
March 27, 2001
Note: This document may not reflect changes made in actual delivery.
Chairman Souder, Ranking Member Cummings, and Members of the Subcommittee, good afternoon and thank you for the opportunity to address this subcommittee on the effects certain state laws have on the enforcement of federal narcotics laws. Mr. Chairman, on behalf of Administrator Marshall, I would like to thank the subcommittee for its unwavering support of the DEA in carrying out our mission of enforcing the nation's drug laws.
Let me begin with a discussion of the Controlled Substances Act (CSA) and the scheduling process. The CSA, Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is the legal foundation for the United States' fight against abuse of drugs and other substances. The CSA was passed to minimize the quantity of abuseable substances available to those likely to abuse them, while providing for legitimate medical, scientific and industrial needs of those substances in the United States. The Drug Enforcement Administration (DEA) is the agency within the Department of Justice primarily responsible for the administration and enforcement of the provisions of the CSA.
The CSA places substances with a substantial potential for abuse into one of five schedules. Both legitimately produced drugs and clandestinely manufactured substances are included in the list of substances controlled under the CSA. This placement is based on the substance's accepted medical use, safety, potential for abuse, and/or dependence liability; Schedule I is the most restrictive and Schedule V is the least restrictive schedule. The Act also provides a mechanism for (1) substances to be controlled or added to a schedule, (2) decontrolled or removed from a schedule, and (3) rescheduled or transferred from one schedule to another. Proceedings to add, change, or remove a substance from the schedules listed in the CSA can be initiated either (1) by the Attorney General or Administrator of DEA (after reports from DEA field offices, state control authorities, treatment clinics, or other sources regarding the diversion or abuse problems associated with a substance), (2) at the request of the Secretary of Health and Human Services (HHS), or (3) by petition from any interested party (including a pharmaceutical company, advocacy group, or private citizen).
The CSA, and its subsequent amendments, establishes several procedures for the control of substances that create or have the potential to create significant abuse problems. Specific procedures to administratively control or decontrol substances under the CSA include (1) traditional scheduling, (2) temporary (emergency) scheduling, (3) the scheduling of immediate precursors, and (4) the control actions required by international treaty obligations. Additionally, Congress may add, delete or transfer substances under the CSA by legislative process. I am going to restrict my statement to the traditional administrative scheduling procedures.
The CSA provides roles for both the law enforcement and scientific and medical communities in making drug scheduling decisions pursuant to the traditional scheduling provisions (21 U.S.C. 811-812). The Administrator of the DEA, by authority of the Attorney General, has the ultimate authority for the decision as to whether or not a substance should be controlled under this provision of the CSA. The DEA Administrator's decision, however, must be based on all available evidence and can be made only after a scientific and medical evaluation of those data are received by DEA from the Assistant Secretary for Health of HHS, who is the Federal government's representative of the scientific and medical community. Recommendations of the Secretary of HHS regarding the scientific and medical aspects of scheduling are binding on DEA; in cases where a substance is not controlled, if the Secretary of HHS recommends that a substance cannot be controlled, the DEA Administrator may not control the substance. Ultimately, DEA decides the appropriate schedule of a controlled substance.
The administrative scheduling process relies on scientifically sound, legally-defensible and timely data relevant to each substance considered for placement into one of the five schedules. One of the responsibilities of the DEA in this process is to collect the necessary data and write a comprehensive review that documents all aspects of a drug or substance, including data regarding its abuse and dependence liability, pattern, history and significance of its actual abuse, its pharmacology, chemistry, and legitimate medical use. This document is sent to the HHS along with a request for a scientific and medical evaluation and a scheduling recommendation. The request is sent to the Assistant Secretary for Health of HHS, who solicits information from the Commissioner of the Food and Drug Administration (FDA), evaluations and recommendations from the National Institute on Drug Abuse (NIDA), and occasionally from the scientific and medical community. The Assistant Secretary for Health, by authority from the Secretary, compiles these data and transmits back to DEA a scientific and medical evaluation regarding the drug or other substance, a recommendation as to whether the substance should be controlled, and in what schedule it should be placed.
Once DEA has received the scientific and medical evaluation from HHS, the Administrator evaluates all available data and makes a final decision whether to propose that a drug or substance be controlled and into which schedule it should be placed.
The threshold issue for determining scheduling is whether the drug or substance has potential for abuse. If a substance does not have potential for abuse then it cannot be controlled. Although the term "potential for abuse" is not defined in the CSA, there is much discussion in the legislative history of the Act and its predecessor laws. The indicators that a drug or other substance has a potential for abuse include evidence that individuals are taking the drug or other substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community, evidence of significant diversion of the drug or other substance from legitimate channels, evidence that individuals are taking the drug or other substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs; or the substance is new and is related to a substance already listed and likely to have the same potential for abuse as the listed substance. In fact, the evidence of actual abuse of a substance indicates that the drug has a potential for abuse.
In order to determine in which schedule a drug or other substance should be placed, or whether a controlled substance should be decontrolled, or rescheduled, certain factors must be considered. These eight factors are listed in Section 201(c) of the CSA (21 U.S.C., Section 811 (c)) and include data on the drug's actual or relative potential for abuse, the scientific evidence and knowledge of abuse, the scope, duration, and significance of abuse, its risk to the public health, the drug's psychic or physiological dependence liability, and whether it is an immediate precursor of a substance already controlled.
Once the above listed eight factors are evaluated by DEA and HHS and a scheduling recommendation is received from the Secretary of HHS, the DEA Administrator must make specific findings concerning the drug or other substance. This will determine into which schedule the drug or other substance should be placed. The criteria for each schedule are established by the CSA and involve making findings on those criteria.
For Schedule I substances, the criteria that need to be considered are whether the substance has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision.
For substances in Schedule II, the criteria that need to be considered are its high potential for abuse, whether it has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions and whether abuse of the substances may lead to severe psychological or physical dependence.
A substance is placed in one of Schedules III through V based on its potential for abuse relative to substances in other schedules, whether it has a currently accepted medical use in treatment in the United States, and its relative potential to produce physical or psychological dependence.
If the DEA Administrator determines that a substance meets the criteria for control in one of the five schedules of the CSA or that it should be decontrolled or transferred into another schedule, a proposal to do so is published in the Federal Register. The proposal invites all interested persons to comment on the proposed action. Relevant comments must be considered by DEA and addressed in the final order. Affected parties may also request a hearing with DEA. If no hearing is requested, DEA will publish a final order in the Federal Register. The final order will set the effective dates for imposing the various requirements of the CSA.
If a hearing is held, it is held before an Administrative Law Judge (ALJ). The ALJ takes evidence on factual issues and hears arguments on legal questions regarding the control of the substance. The ALJ prepares findings of fact and conclusions of law and a recommended decision which is submitted to the DEA Administrator. The DEA Administrator is not required to follow the recommendations of the ALJ. The Administrator reviews the entire record, including documents and legal briefs submitted, background materials, and the recommendations of the ALJ, then publishes his decision as a final rule in the Federal Register.
Once the final order is published in the Federal Register, interested parties have 30 days to appeal to a U.S. Court of Appeals to challenge the order. Findings of fact of the Administrator are deemed conclusive if supported by "substantial evidence." The order imposing controls is not suspended during the appeal, unless so ordered by the Court.
The DEA has used the administrative scheduling process to place substances under control and to transfer substances among schedules. Specifically, the DEA has also transferred two tetrahydrocannabinol (THC) related substances (the natural psychoactive ingredient found in marijuana) from Schedule I to Schedule II. In 1985, the FDA approved a new drug application for a product called Marinol, which contains specific amounts of a synthetic THC called dronabinol suspended in sesame oil. Marinol was approved for use in treatment of nausea and vomiting produced by cancer chemotherapy. Also in 1985, the FDA approved a new drug application for another synthetic cannabinoid-like substance called Nabilone. The Nabilone product Cesamet was approved for use in treatment of nausea and vomiting produced by cancer chemotherapy, however, this product has never been marketed in the United States. These products were approved for marketing by the FDA and found to have an accepted medical use in treatment in the United States. Therefore, Nabilone and the Marinol product were transferred from Schedule I to Schedule II.
In 1999, the Marinol product was transferred from Schedule II to Schedule III in response to a company's petition to the Administrator. Following the administrative scheduling procedure, the Administrator evaluated all the available data and found that Marinol met the criteria for inclusion in Schedule III. The decision was based on a scientific and medical evaluation from HHS and DEA's independent evaluation that demonstrated that the specific product formulation reduced the potential for abuse of the THC contained in the product, and thus met the criteria for inclusion in Schedule III.
In 1995, DEA received a petition to transfer marijuana and THC from Schedule I control, and Marinol and Nabilone from Schedule II control. This petition was based on the assertion that these substances had lower abuse potentials than other substances in Schedules I or II. The accepted medical use issue was not addressed in the petition. Following the administrative scheduling process, exhaustive reviews and evaluations of the scientific and medical literature and other data were conducted independently by HHS and DEA. On March 20, 2001, the DEA denied the petitioner's request for rulemaking on marijuana on both legal and scientific grounds.
Research can be and has been successfully conducted using Schedule I controlled substances. Currently DEA has registered 577 researchers to handle Schedule I substances. Of these, 158 are registered to conduct research using marijuana or THC. DEA also has registered 157 researchers conducting studies with LSD, 105 researchers are registered to conduct studies with MDMA, and 44 researchers are registered to conduct studies with GHB.
There are instances when Schedule I substances remain in Schedule I while products containing them are placed in Schedule II or III. In these cases the specific product is formulated in such a way that it has a lower abuse potential than the substance, and it has accepted medical use. The synthetic THC substance dronabinol remains in Schedule I while the dronabinol-containing product, Marinol, was transferred to Schedule II and subsequently to Schedule III. Diphenoxin is in Schedule I while combination products containing diphenoxin are in Schedules IV and V. The most recent example of this type of scheduling is gamma hydroxybutyric acid (GHB). Congress directed DEA to place the substance GHB in Schedule I, but if or when the FDA approves the drug for marketing, Congress directed that only the FDA approved product will be placed in Schedule III. There are ongoing clinical studies of this Schedule I substance to support a company's FDA submission.
There are also a number of other substances that were placed in Schedule I while clinical studies were ongoing to determine their accepted medical use. Once these substances were approved for marketing and found to have accepted medical use the substances were transferred to Schedule II. Examples of these transfers include the narcotic treatment drug LAAM, and the narcotic analgesics sufentanil and alfentanil.
It should be noted that the majority of controlled substances are in Schedules II through V. Some drug substances were placed in Schedule I by Congress in 1970 and others added in subsequent years because of their high potential for abuse and lack of medical safety and use in the United States. These actions have withstood the test of time and scientific scrutiny and remain there today. These control actions have saved an indeterminable number of lives within the United States. However, the CSA has proved to be a dynamic law that has allowed for the evolution of science and technology to progress to the point in which some Schedule I substances have been developed for medical use and the CSA has been modified from its original listings to bring new drug products to the general medical community.
I would now like to address the impact state laws such as California's Proposition 215 have had on federal law enforcement. These state laws purport to legalize marijuana for "medical" use. These so-called "medical marijuana laws" work as follows: If a doctor "recommends" that a patient use marijuana for any ailment, then it is legal for the patient to grow and use marijuana. At present, Alaska, California, Colorado, Hawaii, Maine, Nevada, Oregon, and Washington have passed such laws. Arizona has passed a law that allows doctors to prescribe any Schedule I drug. Contrary to these laws, marijuana remains an illegal drug under federal law. Actually "medical" marijuana is actually a misnomer since marijuana is in fact a Schedule I drug. As such, it has not been scientifically proven safe and effective in accordance with the Food, Drug, and Cosmetic Act and cannot be used except in research approved by the FDA and registered with DEA. Under federal law, there is really no basis to distinguish "medical" marijuana trafficking from marijuana trafficking generally.
Historically, DEA has directed its investigative resources at major trafficking organizations without regard to whether the traffickers might claim to have a "medical" excuse for violating the law. This is not to say that these current state laws have not caused conflict and confusion throughout the law enforcement community. California's Attorney General publicly announced his unwillingness to enforce the state's drug laws against traffickers who claim to be involved with "medical" marijuana. He has left it to the individual counties and municipalities to arrive at their own criteria for implementation of Proposition 215. The California localities that have taken a public position on Proposition 215 have issued vague guidelines, all of which send a clear message that anyone who has a "recommendation" from a doctor is permitted to grow and possess certain amounts of marijuana. The City of Oakland for example allows each person to possess up to six pounds of marijuana. Since there is a complete lack of state government oversight, each grower is on his or her honor not to exceed these vague guidelines.
California has now become the home of several "cannabis" clubs that openly distribute marijuana to anyone who the club owners decide has a "medical" need for the drug. In some jurisdictions, local sheriffs have given groups advance permission to grow marijuana while state judges have ordered law enforcement officials to return marijuana seized from criminal defendants who claim to be handling the drug for "medical" reasons. Even where local police have made arrests and seizures, there have been numerous instances where local district attorneys have been unwilling to prosecute because the defendants supposedly complied with the "spirit" of Proposition 215.
An example of how marijuana trafficking is occurring under the guise of medicine is illustrated in one particular case in 1999. A local television station in New Orleans informed law enforcement officials that it had discovered an Internet web site advertising the sale of "medical" marijuana. The web site was established by an individual who distributed marijuana from his home in Anaheim, California. After the United States Attorney's Office for the Eastern District of Louisiana advised DEA that it would prosecute the case, DEA undercover agents placed orders which resulted in marijuana being shipped to the agents in New Orleans. In September 1999, agents from the DEA and IRS together with the Anaheim Police Department executed a search warrant at the defendant's home. During the execution of the warrant, the defendant advised that he had been selling "medical" marijuana for nearly three years. Records revealed that he had distributed more than 50 pounds to 149 different customers in 35 different states. On February 11, 2000, the defendant was indicted by a federal grand jury in New Orleans on charges of distribution of marijuana and advertising the distribution of a Schedule I controlled substance. During the execution of the search warrant, agents also seized numerous "recommendation" letters that appear to have been issued by doctors in various states to customers.
The resulting dilemma has been further viewed as jeopardizing the historical cooperation between federal, state, and local drug enforcement officials. For example, local officers assigned to a federally funded task force might find themselves in the situation of having to seize marijuana in order to enforce federal law, knowing that the local prosecutor will refuse to prosecute or the local judge will order the marijuana returned to the grower. In essence, allowing traffickers to carry on with impunity in this manner simply undercuts enforcement of the Controlled Substances Act and allows an unproven and potentially dangerous drug to be sold to the public as "medicine".
Two pending lawsuits have developed from law enforcement efforts to keep this situation in check. In United States vs. Oakland Cannabis Buyers' Cooperative the U.S. sought an injunction ordering this "cannabis club" to stop growing and distributing marijuana in violation of federal law. The club claimed a "medical necessity" defense that allowed it to distribute marijuana. The Ninth Circuit Court of Appeals recognized that this was a legally cognizable defense. The United States Supreme Court will hear argument on this case on March 28th, 2001. In Conant vs. ONDCP, DOJ, DEA, and HHS a group of Californians sued the Government claiming that doctors have a "free speech" right to "recommend" that their patients use marijuana in violation of federal law. The federal district court agreed and issued an injunction that prohibits DEA from investigating doctors who "recommend" marijuana or revoking their DEA registrations.
Lastly, I would like to point out that the United States is a party to several international treaties to control international and domestic traffic in controlled substances. These are expressly recognized by Congress in the Controlled Substances Act. Most notable are: the 1961 Single Convention on Narcotic Drugs; the 1971 Convention on Psychotropic Substances; and the 1988 Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. Most of the provisions of the CSA must be in force in order for the United States to meet its obligations under these treaties. Treaty obligations that are relevant are as follows: the United States must enact and carry out legislation disallowing the use of Schedule I drugs outside of research; make it a criminal offense, subject to imprisonment, to traffic in illicit or to aid and abet such trafficking; and prohibit cultivation of marijuana except by persons licensed by, and under the direct supervision of the federal government.
There is no doubt that Proposition 215 and similar state initiatives provide an obstacle to the United States meeting its obligations under these treaties. In addition, allowing these state marijuana initiatives to remain in force potentially undermines diplomatic efforts by the United States to persuade other countries like Mexico and Colombia to enact and vigorously enforce their drug laws.
In conclusion, I would again like to thank this committee for the opportunity to comment on this highly controversial but very important topic and look forward to addressing any questions.