FDA Approves Marketing Of Plant-Derived Marijuana Medicine
Washington, DC: Regulators at the US Food and Drug Administration on Monday granted market approval to Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD) for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.
The proprietary extract formulation - developed by the British biotechnology firm GW Pharmaceuticals - had demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials. It is the fourth marijuana-based medicine to receive US FDA approval - joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). However, Epidiolex is the first FDA-approved medicine containing plant-derived, non-synthetic cannabinoids.
Commenting on the agency's decision, NORML Deputy Director Paul Armentano said: "We anticipate that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis - a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states."
Federal agencies have 90 days to determine the scheduling of Epidiolex under the US Controlled Substances Act. According to the New York Times, analysts expect Epidiolex to cost patients between $2,500 and $5,000 a month.
Despite the FDA's approval of Epidiolex, the agency acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is "prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims." FDA Commissioner Scott Gottlieb further added: "This is the approval of one specific CBD medication for a specific use. ... [T]his is not an approval of marijuana or all of its components."
Oklahoma Becomes 31st State To Legalize Medical Marijuana Access
Oklahoma City, OK: A majority of Oklahomans voted on Tuesday to enact State Question 788 - a statewide voter-initiated measure that permits doctors to use their discretion to recommend medical cannabis to patients who may benefit from it. Oklahoma is the 31st state to legalize and regulate the use of medical cannabis under state law.
State Question 788 permits licensed medical marijuana patients to cultivate up to six mature plants and to possess personal use quantities of marijuana flowers, edibles, or infused concentrates. It also establishes a regulatory framework for the retail production and dispensing of medical cannabis at licensed facilities. Under the act, the state Department of Health has a 30-day timeline in which to establish an online license application process for eligible patients.
Oklahoma voters endorsed the plan despite organized opposition from law enforcement, political leaders, and other groups. Opponents of the measure spent an estimated $500,000 in the final week of the campaign on an advertising blitz that falsely claimed that "SQ 788 was not about medical marijuana," a mischaracterization that was previously determined to be purposely misleading by the state Supreme Court.
Republican Gov. Mary Fallin, who publicly opposed SQ 788, said that she intends to call lawmakers back for a special session to address the law's implementation and to consider changes to some of its provisions.
Under existing Oklahoma laws, the possession of any amount of cannabis is classified as a criminal offense - punishable by up to a year in prison. Engaging in cannabis cultivation or sales may be punishable by up to life in prison. According to a study released earlier this month, Oklahoma's incarceration rate is 1,079 per 100,000 people - the highest rate in the United States.
Survey Data: No Increase In Youth Marijuana Use In Colorado Post-Legalization
Atlanta, GA: The self-reported use of marijuana by young people in Colorado is largely unchanged in the years following the enactment of adult use legalization, and remains slightly below the national average, according to federal data provided.
According to the latest edition of the US Centers for Disease Control and Prevention's Youth Risk Behavior Survey, the percentage of high school students who acknowledge having used cannabis in the past 30 days fell 11 percent between the years 2011 and 2017, and remains just below the national average. The percentage of high-schoolers reporting having ever tried marijuana also fell 11 percent during this period.
The CDC data is consistent with various other data sets finding that neither the enactment of medical cannabis legalization nor the passage of adult use regulation is associated with significant upticks in marijuana use or access among young people.
Study: Maternal Marijuana Exposure Not Independently Associated With Lower Birthweight In Newborns
Atlanta, GA: Cannabis exposure during pregnancy is not independently associated with lower birthweight among infants, according to data published in the journal Drug and Alcohol Dependence.
Researchers from the US Centers for Disease Control and Prevention assessed the relationship between maternal marijuana exposure and birthweight. They reported that infants, on average, weighed no less than controls after researchers controlled for cofounders, particularly the maternal tobacco use. Investigators also failed to observe "significant effects of marijuana use during pregnancy and preterm birth or healthcare utilization."
Overall, they reported that the prevalence of marijuana use during pregnancy was "low."
The study's findings are consistent with prior data suggesting "that the increased risk for adverse neonatal outcomes reported in women using marijuana in pregnancy is likely the result of coexisting use of tobacco and other cofounding factors and not attributable to marijuana use itself."
Full text of the study, "Marijuana use during and after pregnancy and association of prenatal use on birth outcomes: A population-based study," appears in Drug and Alcohol Dependence. NORML's fact-sheet, "Maternal Marijuana Use and Childhood Outcomes," appears online.