UTopiAH’s life expectancy and death rate are below the Marijuana states, which as of 2017, filled the top quintile state rankings. See Part 16. These parts contain the 2015 Drug Enforcement Agency’s response to a 2011 petition from the Governors of Washington and Rhode Island to legalize Marijuana, a DEA Schedule One Drug. The letter is viewable at https://www.deadiversion.usdoj.gov/schedules/marijuana/Incoming_Letter_Department%20_HHS.pdf#search=marijuana.

Part Thirty One. Marijuana as Schedule One of the Controlled Substances Act for abuse, no accepted medical use, high potential for abuse, and lack of accepted safety.

DHHS letter to Chuck Rosenberg

Department of Health & Human Services. Office of the Secretary

Office of the Assistant Secretary for Health, Washington, D.C. 20201

June 25, 2015

The Honorable Chuck Rosenberg

Acting Administrator
Drug Enforcement Administration U.S. Department of Justice,

8701 Morrissette Drive Springfield, VA 22152

Dear Mr. Rosenberg:

Pursuant to the Controlled Substances Act (CSA, 21 U.S.C. § 811(b), (c), and (f)), the Department of Health and Human Services (HHS) is recommending that marijuana continue to be maintained in Schedule I of the CSA.

The Food and Drug Administration (FDA) has considered the abuse potential and dependence­ producing characteristics of marijuana.

Marijuana meets the three criteria for placing a substance in Schedule I of the CSA under 21 U.S.C. 812(b)(l). As discussed in the enclosed analyses, marijuana has 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. Accordingly, HHS recommends that marijuana be maintained in Schedule I of the CSA. Enclosed are two documents prepared by FDA [FOOD AND DRUG ADMINISTRATION]’s Controlled Substance Staff (in response to petitions filed in 2009 by Mr. Bryan Krumm and in 2011 by Governors Lincoln D. Chafee and Christine 0. Gregoire) that form the basis for the recommendation. Pursuant to the requests in the petitions, FDA broadly evaluated marijuana, and did not focus its evaluation on particular strains of marijuana or components or derivatives of marijuana.

FDA [FOOD AND DRUG ADMINISTRATION]’s Center for Drug Evaluation and Research’s current review of the available evidence and the published clinical studies on marijuana demonstrated that since our 2006 scientific and medical evaluation and scheduling recommendation responding to a previous DEA petition, research with marijuana has progressed. However, the available evidence is not sufficient to determine that marijuana has an accepted medical use. Therefore, more research is needed into marijuana’s effects, including potential medical uses for marijuana and its derivatives. Based on the current review, we identified several methodological challenges in the marijuana studies published in the literature. We recommend they be addressed in future clinical studies with marijuana to ensure that valid scientific data are generated in studies evaluating marijuana’s safety and efficacy for therapeutic use. For example, we recommend that studies need to focus on consistent administration and reproducible dosing of marijuana, potentially through the use of

————–

U.S. Public Health Service

Page 2 – The Honorable Chuck Rosenberg

Administration methods other than smoking. A summary of our review of the published literature on the clinical uses of marijuana, including recommendations for future studies, is attached to this document.

FDA and the National Institutes of Health’s National Institute on Drug Abuse (NIDA) also believe that work continues to be needed to ensure support by the federal government for the efficient conduct of clinical research using marijuana. Concerns have been raised about whether the existing federal regulatory system is flexible enough to respond to increased interest in research into the potential therapeutic uses of marijuana and marijuana-derived drugs. HHS welcomes an opportunity to continue to explore these concerns with DEA.

Should you have any questions regarding these recommendations, please contact-Corinne P. Moody, Science Policy Analyst, Controlled Substance Staff, Center for Drug Evaluation and Research, FDA, at (301) 796-3152.

Sincerely yours,

Karen B. DeSalvo, MD, MPH, MSc Acting Assistant Secretary for Health

Enclosures

https://www.deadiversion.usdoj.gov/schedules/marijuana/Incoming_Letter_Department%20_HHS.pdf#search=marijuana

Enclosure 1

BASIS FOR THE RECOMMENDATION FOR MAINTAINING MARIJUANA IN SCHEDULE I OF THE CONTROLLED SUBSTANCES ACT

On November 30, 2011, Governors Lincoln D. Chafee of Rhode Island and Christine 0. Gregoire of Washington submitted a petition to the Drug Enforcement Administration (DEA) requesting that proceedings be initiated to repeal the rules and regulations that place marijuana in Schedule I of the Controlled Substances Act (CSA). The petition contends that marijuana has an accepted medical use in the United States, is safe for use under medical supervision, and has a relatively low abuse potential compared to other Schedule II drugs. The petition requests that marijuana and “related items” be rescheduled in Schedule II of the CSA. In June 2013, the DEA Administrator requested that the U.S. Department of Health and Human Services (HHS) provide a scientific and medical evaluation of the available information and a scheduling recommendation for marijuana, in accordance with the provisions of 21 U.S.C. 81l(b).

In accordance with 21 U.S.C. 811(b), DEA has gathered information related to the control of marijuana (Cannabis sativa) 1 [Footnote] [The CSA (CONTROLLED SUBSTANCES ACT) defines marihuana (marijuana) as the following:

All parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted there from), fiber, oil, or cake,] under the CSA. Pursuant to 21 U.S.C. 811(b), the Secretary of HHS is required to consider in a scientific and medical evaluation eight factors determinative of control under the CSA. Following consideration of the eight factors, if it is appropriate, the Secretary must make three findings to recommend scheduling a substance in the CSA or transferring a substance from one schedule to another. The findings relate to a substance’s abuse potential, legitimate medical use, and safety or dependence liability.

Administrative responsibilities for evaluating a substance for control under the CSA [CONTROLLED SUBSTANCES ACT]are performed by the Food and Drug Administration (FDA), with the concurrence of the National Institute on Drug Abuse (NIDA), as described in the Memorandum of Understanding (MOU) of March 8, 1985 (50 FR 9518-20).

In this document, FDA recommends continued control of marijuana in Schedule I of the CSA. Pursuant to 21 U.S.C. 811 (c), the eight factors pertaining to the scheduling of marijuana are considered below.

—

1. ITS ACTUAL OR RELATIVE POTENTIAL FOR ABUSE

Under the first factor, the Secretary must consider marijuana’s actual or relative potential for abuse. The CSA [CONTROLLED SUBSTANCES ACT]does not define the term “abuse.” However, the CSA’s legislative history suggests the following in determining whether a particular drug or substance has a potential for abuse : 2 [footnote] 2

Footnote 2 – Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 91-1444, 91^st Cong., Sess. 1 (1970) reprinted in U.S.C.C.A.N. 4566,4603.

1. There is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community.
2. There is a significant diversion of the drug or drugs containing such a substance . from legitimate drug channels.
3. Individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of his professional practice.
4. The drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.

In the development of this scientific and medical evaluation for the purpose of scheduling, the Secretary analyzed considerable data related to the substance’s abuse potential. The data include a discussion of the prevalence and frequency of use, the amount of the substance available for illicit use, the ease of obtaining or manufacturing the substance, the reputation or status of the substance “on the street,” and evidence relevant to at-risk populations.

Importantly, the petitioners define marijuana as including all Cannabis cultivated strains.

[Petitioners included Governors Chafee of Rhode Island and Gregoire of Washington, who asked the DEA to repeal rules placing Marijuana in Schedule I of the Controlled Substance Act, contending it was accepted for medical use, safe, and with low abuse potential. The DEA, in turn, received scientific and medical information with recommendations from the Secretary HHS, FDA, Controlled Substance Staff, Center for Drug Evaluation and Research, in 2015.]

Different marijuana samples derived from various cultivated strains may have very different chemical constituents, thus the analysis is based on what is known about the range of these constituents across all cultivated strains.

Determining the abuse potential of a substance is complex with many dimensions, and no single test or assessment provides a complete characterization. Thus, no single measure of abuse potential is ideal. Scientifically, a comprehensive evaluation of the relative abuse potential of a substance can include consideration of the following elements: receptor binding affinity, preclinical pharmacology, reinforcing effects, discriminative stimulus effects, dependence producing potential, pharmacokinetics, route of administration, toxicity, data on   [FDA Page 2      March] actual abuse, clinical abuse potential studies, and public health risks. Importantly, abuse can exist independently from tolerance or physical dependence because individuals may abuse drugs in doses or patterns that do not induce these phenomena. Additionally, evidence of clandestine production and illicit trafficking of a substance can shed light on both the demand for a substance as well as the ease of obtaining a substance. Animal and human laboratory data and epidemiological data are all used in determining a substance’s abuse potential. Moreover, epidemiological data can indicate actual abuse.

The petitioners compare the effects of marijuana to currently controlled Schedule II substances and make repeated claims about their comparative effects.

[Ed. Petitioners included Governors Chafee of Rhode Island and Gregoire of Washington, who asked the DEA to repeal rules placing Marijuana in Schedule I of the Controlled Substance Act, contending it was accepted for medical use, safe, and with low abuse potential. The DEA, in turn, received scientific and medical information with recommendations from the Secretary HHS, FDA, Controlled Substance Staff, Center for Drug Evaluation and Research, in 2015.]

Comparisons between marijuana and the diverse array of Schedule II substances is difficult, because of the pharmacologically dissimilar actions of substances in Schedule II of the CSA. For example, Schedule II substances include stimulant-like drugs (e.g., cocaine, methylphenidate, and amphetamine), opioids (e.g., oxycodone, fentanyl), sedatives (e.g., pentobarbital, amobarbital), dissociative anesthetics (e.g., PCP), and naturally occurring plant components (e.g., coca leaves and poppy straw). The mechanism(s) of action of the above Schedule II substances are wholly different from one another, and they are different from tetrahydrocannabinol (THC) and marijuana as well. For example, Schedule II stimulants typically function by increasing monoaminergic tone via an increase in dopamine and norepinephrine (Schmitt et al., 2013). In contrast, opioid analgesics function via mu-opioid receptor agonist effects. These differing mechanism(s) of action result in vastly different behavioral and adverse effect profiles, making comparisons across the range of pharmacologically diverse C-II substances inappropriate.

In addition, many substances scheduled under the CSA [CONTROLLED SUBSTANCES ACT]are reviewed and evaluated within the context of commercial drug development, using data submitted in the form of a new drug application (NDA). A new analgesic drug might be compared to a currently scheduled analgesic drug as part of the assessment of its relative abuse potential. However, because the petitioners have not identified a specific indication for the use of marijuana, identifying an appropriate comparator based on indication cannot be done.

[Ed. Petitioners included Governors Chafee of Rhode Island and Gregoire of Washington, who asked the DEA to repeal rules placing Marijuana in Schedule I of the Controlled Substance Act, contending it was accepted for medical use, safe, and with low abuse potential. The DEA, in turn, received scientific and medical information with recommendations from the Secretary HHS, FDA, Controlled Substance Staff, Center for Drug Evaluation and Research, in 2015.]

1. There is evidence that individuals are taking the substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community.

Evidence shows that some individuals are taking marijuana in amounts sufficient to create a hazard to their health and to the safety of other individuals and the community. A large number of individuals use marijuana. HHS provides data on the extent of marijuana abuse through NIDA and the Substance Abuse and Mental Health Services Administration (SAMHSA). According to the most recent data from SAMHSA’s 2012 National Survey on Drug Use and Health (NSDUH), which estimates the number of individuals who have used a substance within the month prior to the study (described as “current use”), marijuana is the most commonly used illicit drug among Americans aged 12 years and older, with an estimated 18.9 million Americans having used marijuana within the month prior to the 2012 NSDUH. Compared to 2004, when an estimated 14.6 million individuals reported using marijuana Within the month prior to the study, the estimated rates in 2012 show an increase of approximately 4.3 million individuals. The 2013 Monitoring the Future (MTF) survey of [page 3] 8^th , 10^th , and 12^th grade students also indicates that marijuana is the most widely used illicit substance in this age group. Specifically, current monthly use was at 7.0 percent of 8th graders, 18.0 percent of 10^th ,graders and 22.7 percent of 12^th graders. Additionally, the 2011 Treatment Episode Data Set (TEDS) reported that primary marijuana abuse accounted for 18.1 percent of non-private substance-abuse treatment facility admissions, with 24.3 percent of those admitted reporting daily use. However, of these admissions for primary marijuana abuse, the criminal justice system referred 51.6 percent to treatment. SAMHSA’s Drug Abuse Warning Network (DAWN) was a national probability survey of U.S. hospitals with emergency departments (EDs), and was designed to obtain information on ED visits where recent drug use was implicated. In 2011, there were 455,668 ED visits in which marijuana was mentioned, accounting for 36.4 percent of illicit drug related ED visits. There are some limitations related to DAWN data on ED visits, which are discussed in detail in Factor 4, “Its History and Current Patterns of Abuse.” For more information, refer to Factor 4, “Its History and Current Pattern of Abuse;” Factor 5, “The Scope, Duration, and Significance of Abuse;” and Factor 6, “What, if any, Risk There is to the Public Health.” These factors contain detailed discussions of these data.

A number of risks can occur with both acute and chronic use of marijuana. Detailed discussions of the risks are addressed in Factor 2, “Scientific Evidence of its Pharmacological Effect, if Known,” and Factor 6, “What, if any, Risk There is to the Public Health.”

1. There is significant diversion of the substance from legitimate drug channels.

There is a lack of evidence of significant diversion of marijuana from legitimate drug channels, but this is likely due to the fact that marijuana is more widely available from illicit sources rather than through legitimate channels. Marijuana is not an FDA [FOOD AND DRUG ADMINISTRATION]-approved drug product, as an [NEW DRUG APPLICATION] NDA or biologics license application (BLA) has not been approved for marketing in the United States. Numerous states and the District of Columbia have state­ level medical marijuana laws that allow for marijuana use within that state. These state-level drug channels do not have sufficient and complete data to allow for an analysis of diversion, nor is there sufficient collection of data related to medical treatment, including efficacy and safety.

Marijuana is used by researchers for nonclinical research as well as clinical research under investigational new drug (IND) applications; this represents the only legitimate drug channel in the United States. However, marijuana used for research represents a very small contribution of the total amount of marijuana available in the United States, and thus provides limited information about diversion. In addition, the lack of significant diversion of investigational supplies is likely because of the widespread availability of illicit marijuana of equal or greater amounts of delta 9 – THC. The data originating from the DEA on seizure statistics demonstrate the magnitude of the availability for illicit marijuana. DEA’s System to Retrieve Information from Drug Evidence (STRIDE) provides information on total domestic drug seizures. STRIDE reports a total domestic seizure of 573,195 kg of marijuana in 2011, the most recent year with complete data that is currently publically available (DEA Domestic Drug Seizures, n.d.).

[page 4]

1. Individuals are taking the substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such substances.

Because the FDA [FOOD AND DRUG ADMINISTRATION] has not approved an [NEW DRUG APPLICATION] NDA or [BIOLOGICS LICENSE APPLICATION] BLA for a marijuana drug product for any therapeutic indication, the only way an individual can take marijuana on the basis of medical advice through legitimate channels at the federal level is by participating in research under an [INVESTIGATIONAL NEW DRUG] IND application. That said, numerous states and the District of Columbia have passed state­ level medical marijuana laws allowing for individuals to use marijuana under certain circumstances. However, data are not yet available to determine the number of individuals using marijuana under these state-level medical marijuana laws. Regardless, according to the 2012 NSDUH data, 18.9 million American adults currently use marijuana (SAMHSA, 2013). Based on the large number of individuals reporting current use of marijuana and the lack of an FDA-approved drug product in the United States, one can assume that it is likely that the majority of individuals using marijuana do so on their own initiative rather than on the basis of medical advice from a licensed practitioner.

1. The substance is so related in its action to a substance already listed as having a potential for abuse to make it likely that it will have the same potential for abuse as such substance, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.

FDA [FOOD AND DRUG ADMINISTRATION] [FOOD AND DRUG ADMINISTRATION] has approved two drug products containing cannabinoid compounds that are structurally related to the active components in marijuana. These two marketed products are controlled under the CSA. Once a specific drug product containing cannabinoids becomes approved, that specific drug product may be moved from Schedule I to a different Schedule (II – V) under the CSA. Firstly, Marinol-generically known as dronabinol-is a Schedule III drug product containing synthetic delta-9 THC. Marinol, which is formulated in sesame oil in soft gelatin capsules, was first placed in Schedule II under the CSA [CONTROLLED SUBSTANCES ACT]following its approval by the FDA [FOOD AND DRUG ADMINISTRATION]. Marinol, was later rescheduled to Schedule III under the CSA because of low numbers of reports of abuse relative to marijuana. Dronabinol is listed in Schedule I under the CSA. FDA [FOOD AND DRUG ADMINISTRATION] approved Marinol in 1985 for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who failed to respond adequately to conventional anti-emetic ‘treatments. In 1992, FDA approved Marinol for anorexia associated with weight loss in patients with acquired immunodeficiency syndrome (AIDS). Secondly, in 1985, FDA [FOOD AND DRUG ADMINISTRATION] approved Cesamet, a drug product containing the Schedule II substance nabilone, for the treatment of nausea and vomiting associated with cancer chemotherapy. Besides the two cannabinoid-containing drug products FDA approved for marketing, other naturally occurring cannabinoids and their derivatives (from Cannabis) and their synthetic equivalents with similar chemical structure and pharmacological activity are included in the CSA as Schedule I substances.

[Continued next Part 32]

Disclaimer: The author of each article published on this web site owns his or her own words. The opinions, beliefs and viewpoints expressed by the various authors and forum participants on this site do not necessarily reflect the opinions, beliefs and viewpoints of Utah Standard News or official policies of the USN and may actually reflect positions that USN actively opposes. No claim in public domain or fair use. UTopiAH is a trade mark of the author. Utopia was written in 1516 by Sir Thomas More, Chancellor of England. © Edmunds Tucker.