Thursday, May 05, 2016 by fdanews
http://www.fda.news/2016-05-05-its-time-to-deschedule-not-reschedule-marijuana.html
A recent memorandum from the US Drug Enforcement Administration to several United States Senators indicates that the agency is prepared to respond in the coming months to a five-year-old petition seeking to amend the plant’s status as a schedule I prohibited substance.
(Article by J, republished from http://www.theweedblog.com/its-time-to-deschedule-not-reschedule-marijuana/)
Under the US Controlled Substances Act of 1970, the cannabis plant and its organic cannabinoids are classified as schedule I prohibited substances — the most restrictive category available under the law. As summarized by the DEA, “Schedule I drugs are the most dangerous drugs of all the drug schedules with potentially severe psychological or physical dependence.”
Explicitly, substances in this category must meet three specific inclusion criteria: The substance must possess “a high potential for abuse”; it must have “no currently accepted medical use” in the United States; and the substance must lack “accepted safety for use … under medical supervision.” Substances that do not meet these criteria must, by law, be categorized in less restrictive federal schedules (schedule II through schedule V) and are legally regulated accordingly. (For example, schedule II substances like morphine or methadone are available by prescription.) Alcohol and tobacco, two substances that possess far greater dangers to health than does cannabis, are not subject to federal classification under the CSA.
Federal law grants power to the US Attorney General to reclassify a controlled substance if the available scientific evidence no longer supports that drug’s classification. In practice, however, this power has been delegated to the DEA, with input from both FDA and the US Department of Health and Human Services. Federal law also allows third parties to petition these agencies to consider reclassifying controlled substances.
The petition now before the DEA was filed in 2011 by then-governors Christine Gregoire of Washington and Lincoln Chafee of Rhode Island. Other recent rescheduling petitions, such as a 2002 petition filed by a coalition of marijuana law reform and health advocacy organizations, have been rejected outright by the agency. In 1990, the DEA set aside the decision of its own administrative law judge, who had responded in 1988 to a petition effort initiated by NORML, after he called for reclassifying the plant.
While it remains unknown at present time if the DEA will respond favorably to this current rescheduling effort, it has become apparent in recent years that reclassifying cannabis from schedule I to schedule II – the same category as cocaine – falls well short of the sort of federal reform necessary to reflect America’s emerging reefer reality. Specifically, reclassifying the pot plant from I to II (or even to schedule III) continues to misrepresent the plant’s safety relative to other controlled substances such as methamphetamine (schedule II), anabolic steroids (schedule III), or alcohol (unscheduled), and fails to provide states with the ability to fully regulate it free from federal interference.
Further, the federal policies in place that make clinical trial work with cannabis more onerous than it is for other controlled substances — such as the requirement that all source material be purchased from NIDA’s University of Mississippi marijuana cultivation program — are regulatory requirements that are specific to cannabis, not to Schedule I drugs in general. Simply rescheduling cannabis from I to II does not necessarily change these regulations, at least in the short-term.
In addition, the sort of gold-standard, large-scale, long-term Phase III safety and efficacy trials that are typically necessary prior to bringing therapeutic drugs to market are prohibitively expensive. As a result, trials of this kind are typically are funded by private pharmaceutical companies aspiring to bring a new product to market. In some cases, the federal government may assist in sharing these costs, such as was the case with the research and development of the synthetic THC pill Marinol (dronabinol). However, political reality dictates that neither entity is likely to pony up the tens of millions of dollars necessary to conduct such trials assessing the efficacy of herbal cannabis any time soon, if ever, regardless of the plant’s federal scheduling.
This is not to say that rescheduling cannabis would not have any positive tangible effects. At a minimum, it would bring an end to the federal government’s longstanding intellectual dishonesty that marijuana ‘lacks accepted medical use.’ It would also likely permit banks and other financial institutions to work with state-compliant marijuana-related businesses, and permit employers in the cannabis industry to take tax deductions similar to those enjoyed by other businesses. Rescheduling would also likely bring some level of relief to federal employees subject to random workplace drug testing for off-the-job cannabis consumption.
But ultimately, such a change would do little to significantly loosen federal prohibition or to make herbal cannabis readily accessible for clinical study. These goals can arguably only be accomplished by federally decsheduling cannabis in a manner similar to alcohol and tobacco, such as is proposed by US Senate Bill 2237, The Ending Federal Marijuana Prohibition Act. Doing so will finally provide states the power to establish their own marijuana policies free from federal intrusion.
Read more at: http://www.theweedblog.com/its-time-to-deschedule-not-reschedule-marijuana/