Pages tagged "FDA"


ASA Submits Recommendations to FDA for International Rescheduling of Cannabis

This week, we submitted comments relating to the efficacy and medical usefulness of cannabis as a medical treatment. In early April, the Food and Drug Administration (FDA) issued a notice in the federal register asking for public comments on cannabis and its derivatives. These comments will help inform the response of the United States to the World Health Organization in potentially reclassifying cannabis.

Read ASA’s Comments Here

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Congress Must Act to Reclassify Cannabis Under Federal Law

Acting DEA Administrator RosenbergToday, the Drug Enforcement Administration (DEA) released its decision to keep cannabis in its current Schedule 1 status. This decision will have substantial implications for the two million patients that currently have access to medical cannabis and cannabis products under state laws. Schedule I status means that the DEA sees no accepted medical use of cannabis.  

The Controlled Substances Act requires an 8-Factor Analysis from the HHS upon which the DEA makes it determination for all scheduling, or rescheduling, decisions. Previous efforts to reschedule cannabis have also been blocked by the DEA, who remain the most steadfast in maintaining their opposition to cannabis reform under the Obama administration.

Pictured: Acting DEA Administrator Chuck Rosenberg 

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ASA’s “8-Factor Analysis” Calls for the Federal Removal of Cannabis from Schedule I

ASA reportcoverToday, Americans for Safe Access (ASA) disseminated copies of an independent 8-Factor Analysis conducted in support of current petitions requesting removal of cannabis (marijuana) from Schedule I status in the Controlled Substances Act (CSA). The document was sent to all members of Congress, as well as heads of the United States Department of Justice (DOJ), the Department of Health and Human Services (HHS), the Office of National Drug Control Policy (ONDCP), the DEA, and the Food and Drug Administration (FDA).

The Drug Enforcement Administration (DEA) is about to make a very important decision regarding whether or not to reschedule cannabis from its Schedule I status. This decision will have substantial implications for the two million patients that currently have access to medical cannabis and cannabis products under state laws. Cannabis has been listed as a Schedule I substance - defined as a drug with high potential for abuse and no accepted medical use - along with heroin and LSD since the 1970’s. This Schedule I status makes it illegal to grow, possess, use, or distribute under federal law. While many other drugs have been rescheduled, cannabis has stayed in Schedule I for 46 years. 

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California Medical Association Says U.S. Has “Failed Public Health Policy” on Medical Marijuana, Urges Rescheduling



The first broad marijuana policy statement by a state medical association has become a hot topic of conversation, repeatedly referring to the current federal approach as a “failed public health policy.” Indeed, the October 14, 2011 official policy statement by the California Medical Association (CMA) is gathering significant interest from medical marijuana advocates as well as the broader reform movement. While certain portions of the statement focus on full legalization, the CMA has geared its policy recommendations for those in Washington with the power to reschedule medical marijuana under the Controlled Substances Act (CSA).

The prevailing theme of the CMA policy is that marijuana’s current placement under Schedule I of the CSA has directly and severely hindered researchers from fully establishing marijuana’s medical value. Specifically, the CMA states without equivocation that:
[C]annabis must be moved out of its current Schedule I status.

Notably, the CMA points out that Schedule I classification of cannabis is the principle reason the growing body of international evidence in favor of medical marijuana’s efficacy has been limited in the U.S. to approximately one dozen clinical trials. The CMA ultimately recommends that:
Rescheduling cannabis will allow for further clinical research to determine the utility and risks of cannabis.

By urging the federal government to reclassify marijuana out of Schedule I, the CMA are in effect stating that marijuana does in fact have medical value. While some may choose to play up the reference to “risks,” the CMA was confident enough in medical marijuana’s safety to have issued an August 2011 “Physician Recommendation of Medical Cannabis,” which provides guidance to doctors on how they may treat their sick and dying patients with medical marijuana. In other words, the CMA has asserted that marijuana, even in the absence of FDA approval, is safe enough for physicians to recommend to their patients.

The CMA policy recommendation to reclassify marijuana is one that ASA not only supports, but has also been actively working to implement. As part of the Coalition for Rescheduling  Cannabis (CRC), ASA has appealed a July 2011 denial by the DEA of the CRC rescheduling petition. With this policy statement by the CMA, patients and advocates have gained an important champion on the critical issue of federal rescheduling of marijuana. The question now becomes, will Washington officials listen to doctors' orders?

Research Approved to Study Effects of Medical Marijuana on PTSD



 

 

 

 

 

 

 

 

 

 

 

After a lengthy approval process, the Food and Drug Administration (FDA)  has granted research to study the effects of medical marijuana on people living with Post Traumatic Stress Disorder (PTSD). This summer, the research group MAPS was given the go-ahead by FDA to conduct a:
Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Five Different Potencies of Smoked or Vaporized Marijuana in 50 Veterans with Chronic, Treatment-Resistant [PTSD].

The effects of medical marijuana on PTSD has been a growing area of inquiry given the difficulty of treating the condition and its prevalence among U.S. troops coming back from Iraq and Afghanistan, as well as others. PTSD affects as many as 7.8 percent of Americans and according to the New York Times:
Currently, nearly a third of the 4,982 patients approved for medical marijuana in New Mexico suffer from post-traumatic stress disorder, more than any other condition, according to the state’s health department.

Preceding final approval by the federal government to conduct PTSD research using medical marijuana, the Journal Frontiers in Behavioral Neuroscience published an article in June 2011 on “The role of cannabinoids [the compounds found in the marijuana plant] in modulating emotional and emotional memory processes in the hippocampus.”

Unfortunately, MAPS still needs approval from the National Institute on Drug Abuse (NIDA) before it can begin trials, but Americans for Safe Access looks forward to the eventual completion of this research and the greater acceptability of using marijuana to treat a debilitating condition that affects millions of people in the U.S.