The White House has taken action to immediately remove a long-standing, bureaucratic hurdle required to research the medical benefits of marijuana.
The former process, established in May 1999, made it nearly impossible for researchers to gain access to the plant for scientific studies. It required that all privately funded marijuana studies in the United States submit a study proposal to the Food and Drug Administration (FDA) review board. Then the proposal also had to be reviewed by the Public Health Service (PHS) to determine the “scientific and ethical soundness” of the study. Next, a marijuana permit would have to be obtained from the Drug Enforcement Administration (DEA). If all of those steps were approved, the cannabis to studied must come from only one source — the drug supply program from the National Institute on Drug Abuse (NIDA).
Both review processes by the FDA and PHS shared similar goals. They aimed to guide research on drug development while assuring appropriate treatment of human subjects. Advocates of medical marijuana research often argued that the second review by PHS was unnecessary, and many requests have been made to eliminate the PHS review process.
No other Schedule I substances, including heroin and LSD, have been required to go through the extra step of being reviewed by the PHS. Since the 1961 international Single Convention on Narcotic Drugs (amended in 1972), marijuana has been listed as a Schedule I substance under the Controlled Substances Act. The Schedule I classification is reserved for substances that are deemed as having no medicinal value and the highest potential for abuse. It is strange to label a plant that has been legalized for medicinal purposes in nearly half of the United States as having no medicinal value — especially when the federal government owns a patent on marijuana “cannabinoids as antioxidants and neuroprotectants.”
Tom Angell, founder of Marijuana Majority, spoke on removing cannabis from the list of Schedule I substances:
“The next step should be moving marijuana out of Schedule I to a more appropriate category, which the administration can do without any further Congressional action. Given what the president and surgeon general have already said publicly about marijuana’s relative harms and medical uses, it’s completely inappropriate for it to remain in a schedule that’s supposed to be reserved for substances with a high potential for abuse and no therapeutic value.”
In a notice expected to be published in the Federal Register on Tuesday, June 23, the Department of Health and Human Services (HHS) notes that the secondary PHS review “overlaps in several important ways” with alternative approval processes and “is no longer necessary to support the conduct of scientifically-sound studies into the potential therapeutic uses of marijuana.”
Following the elimination of the PHS review, the Office of National Drug Control Policy (ONDCP) will now assist in facilitating marijuana-based research. It will still be required that a marijuana permit from the Drug Enforcement Administration be obtained, as well as getting medical marijuana from the Drug Supply Program run by the National Institute on Drug Abuse (NIDA). According to the notice, the removal of the PHS review phase should assist in streamlining the application and approval processes for cannabis research.
Rep. Earl Blumenauer (D-OR), a leader in Congress for marijuana reform, shared his approval of the policy change in a recent press release:
“Today’s decision by HHS is a significant step toward improving an antiquated system that unfairly targets marijuana above and beyond other substances in research. I hope this action will facilitate easier access to marijuana for medical researchers. Considering the widespread use of medical marijuana, it is absolutely essential that we allow doctors and scientists to research the therapeutic benefits and risks of its use.”
Rep. Blumenauer also stated that that he is “working on legislation to address these issues, and looks forward to working with the Administration and my colleagues in Congress to further increase research.”
Blumenauer was a part of a bipartisan group of lawmakers, including three other state Representatives, who sought out additional cosigners of a letter in May 2014 that urged the elimination of the PHS review process.
While this policy change will help promote further marijuana research, there are still more barriers for cannabis than any other drug. The NIDA monopoly on medical marijuana research in the United States does not apply to other drugs, which makes work with cocaine and heroin easier for researchers than cannabis.
Although the removal of the PHS review is a step in the right direction, Angell believes more can be done for medical marijuana research:
“The president has often said that drug policy should be dictated by unimpeded science instead of ideology, and it’s great to see the Obama administration finally starting to take some real action to back that up. But there’s more to be done. Hopefully today’s action is a sign of more to come.”
Hopefully this policy change will serve as the starting point for continued improvements in medical marijuana research, now that the extra barrier has been removed. We may be able to understand the true healing potential of cannabis in the near future.