The Food and Drug Administration is reviewing the medical evidence surrounding the safety and effectiveness of marijuana, a process that could lead to the agency downgrading the drug's current status as a Schedule I drug, the most dangerous classification.
"FDA conducts for Health and Human Services a scientific and medical analysis of the drug under consideration, which is currently ongoing," Ventura said. "HHS then recommends to DEA that the drug be placed in a given schedule. DEA considers HHS’ analysis, conducts its own assessment, and makes a final scheduling proposal in the form of a proposed rule."
The FDA could not confirm how long the review process would take.
The U.S. has five "schedules" for drugs or chemicals that can be used to make drugs. Schedule I is reserved for drugs that the DEA considers to have the highest potential for abuse and no "current accepted medical use." Marijuana has been classified as Schedule I for decades, along with other substances like heroin and LSD. Rescheduling marijuana would not make it legal, but a lower schedule could potentially ease restrictions on research into the drug and make banks less wary of offering financial services to state-legal marijuana businesses. It could also allow those businesses to make some traditional tax deductions.
"While DEA is the lead federal agency responsible for regulating controlled substances and enforcing the Controlled Substances Act, FDA, working with NIDA, provides scientific recommendations about the appropriate controls for those substances," FDA Deputy Director Doug Throckmorton said Friday in testimony delivered during the House Committee on Oversight and Government Reform hearing.
"To make these recommendations, FDA is responsible for preparing what's called an eight-factor analysis, which is a document that is used to assess how likely a drug is to be abused," Throckmorton said.
Here are the eight factors the FDA will consider about marijuana when deciding which schedule it should go under, according to the CSA:
- Its actual or relative potential for abuse
- Scientific evidence of its pharmacological effect, if known
- The state of current scientific knowledge regarding the drug or other substance
- Its history and current pattern of abuse
- The scope, duration, and significance of abuse
- What, if any, risk there is to the public health
- Its psychic or physiological dependence liability
- Whether the substance is an immediate precursor of a substance already controlled under this subchapter
This isn't the first time the DEA has asked the FDA to reconsider marijuana, Throckmorton said Friday. In 2001 and 2006, the DEA requested an analysis of the drug after receiving other public petitions requesting that the agency reschedule it. But both times, federal regulators determined that marijuana should remain a Schedule I substance. At the time, the FDA said there simply wasn't enough research about marijuana's efficacy in treating various ailments.
Part of the lack of cannabis science in the U.S. has to do with the federal stranglehold on marijuana research. There's only one federally legal marijuana garden in the U.S., at the University of Mississippi. The National Institute on Drug Abuse oversees the operation, and it's the only source of marijuana for federally sanctioned studies on the drug.
To date, NIDA has conducted about 30 studies on the potential benefits of marijuana. Since 2003, it has approved more than 500 grants for marijuana-related studies, with a marked upswing in recent years, according to McClatchy. In 2003, 22 grants totaling $6 million were approved for cannabis research, McClatchy reported. In 2012, that number had risen to 69 approved grants totaling more than $30 million.
Federal authorities have long been accused of only funding marijuana research that focuses on the potential negative effects of the substance. The DEA has also been accused of not acting quickly enough when petitioned to reschedule marijuana, and for obstructing science around the drug.
Meanwhile, a number of recent studies have added to the growing body of research showing the medical potential of cannabis. Purified forms may attack some forms of aggressive cancer. Studies have tied marijuana use to blood sugar control and slowing the spread of HIV. One study found that legalization of the plant for medical purposes may even lead to lower suicide rates.
Currently, 22 states and the District of Columbia have legalized marijuana for medical use, with New York state poised to be the 23rd. About ten other states have also legalized CBD-oil, a non-psychoactive ingredient in marijuana frequently used to treat epilepsy, for research or limited medical purposes.
According to a recent CBS News poll, a vast majority of Americans -- over 80 percent -- approve of medical marijuana legalization.
While the FDA isn't ready to get on board with legalization, it does seem more interested in the medical benefits of the drug.
"The FDA has not approved marijuana as a safe and effective drug for any indication," the FDA stated in its latest guidelines regarding marijuana, posted Friday. "The FDA is aware that there is considerable interest in its use to attempt to treat a number of medical conditions, including, for example, glaucoma, AIDS wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders."
source: huffingtonpost.com by Matt Ferner