The Food and Drug Administration approved a plant-derived medicine from marijuana. The prescription drug, known as Epidiolex, for the treatment of severe seizure disorders.
GW Pharmaceutical has long been licensed by the U.K. government to privately grow strains of cannabis for the purpose of drug development.
Unfortunately there is no such plan in the United States. This is due to the regulation that products from privately owned/grown may not be used in the course of an FDA trial. It must all come from one source, that is The University of Mississippi. It holds the only licence to cultivate cannabis for research, and has done since 1968. However there are limited strains that are not a true reflection of the THC and CBD levels that are now available.
These strains range from between zero percent THC to 6.7 percent THC, far below the average potency of available products in legal states or on the black market. Furthermore, none of the available products contain even close to one percent CBD – a therapeutic compound of growing interest to scientists
In 2015 the report from the Brookings Institution stated “Statutory, regulatory, bureaucratic, and cultural barriers have paralysed science and threatened the integrity of research freedom in this area.”
The irony of the issue is that it has very little to do with marijuana. This policy problem involves medical research and scientific freedom. This same conversation would be had if such barriers hindered the study of morphine or diazepam or Propofol or any other drug. Yet, of all the controlled substances that the federal government regulates, cannabis is treated in a unique manner in ways that specifically impede research.”
Members of Congress for the first time took action to undo this unduly restrictive and irrational policy. Members of the House Judiciary Committee voted in favor of legislation (HR 6534: The Medical Cannabis Research Act of 2018) to facilitate federally-approved clinical trials assessing the efficacy of whole-plant cannabis by mandating the government begin the process of licensing private marijuana growers. The vote marks the first time that lawmakers have ever decided in favor of easing existing federal restrictions which limit investigators ability to clinically study marijuana in a manner similar to other controlled substances.
Specifically, H.R. 6534, sponsored by Rep. Matt Gaetz (R-Fla.) and 40 cosponsors, mandates the U.S. Attorney General to take action on some 25 pending federal applications from private entities seeking to grow cannabis for research purposes, and to approve at least two additional marijuana manufacturers within a year.
Congress must act to better facilitate and fund efforts to better explore cannabis’ therapeutic applications and impact on health, and passage of H.R. 6534 is a significant and necessary first step in this direction.
Image – Brookings