Does the FDA Approve of Medical Marijuana in Ohio?
Medical cannabis is now legal in some shape or form in 33 states and the District of Columbia. In spite of the progress being made by individual states, the DEA and Food and Drug Administration (FDA) still view cannabis as a substance without any therapeutic value and a high potential for addiction. The Federal government’s position on cannabis is slowing the progression of knowledge regarding the benefits of cannabis as medication and keeping potential patients across the USA from accessing a substance that could very well benefit their health and well-being. Our quick eligibility survey can help determine if you pre-qualify to become a medical cannabis patient. At your first appointment, you can talk to an Ohio Medical Cannabis Physician to discuss the best treatment options for your needs.
As it stands today, Cannabis Sativa is still classified by the Federal Government as a Schedule I substance, which lumps it together with heroin, peyote, LSD, methaqualone, and Ecstasy as having no therapeutic or medicinal value and a high risk of addiction. (1)
The FDA requires documentation proving the benefits of a drug in order to approve it for use, but they are putting up roadblocks to studying cannabis by making it almost impossible to get approved for a study, and even more difficult to obtain the product needed to conduct the research once the study has been approved.
While all other Schedule I drugs can be produced in private labs for research purposes, the DEA has only allowed one facility, located at the University of Mississippi, to grow cannabis for research. The National Institute on Drug Abuse (NIDA), whose mission is to “research the harmful effects of controlled substances and stop drug abuse.”(2), is responsible for selling cannabis to approved researchers. Requirements for obtaining cannabis from NIDA for federally-approved studies include the following:
“….the agency can provide research-grade marijuana to projects that have received funding from the National Institutes of Health (NIH), or to a non-NIH-funded project that has an approved Investigational New Drug application on file with the FDA; has proper DEA registration; and has been approved as scientifically valid by a Health and Human Services scientific review panel.” (2)
Even when an applicant is approved by the FDA, NIDA can and does refuse to sell cannabis to researchers for any one of a number of reasons. Prior reasons for rejection in one study included the size of the study group, questions about how the researchers were going to control the dietary intake of the participants, and how the study would monitor the exact time, dose, and route of cannabis used by the study group during the 2-week interim between assessments. Even when the researchers provided updated information and protocols to meet updated requirements, NIDA rejected their application. It is interesting to note that currently, only 16.5% of NIDA’s yearly cannabis budget goes toward exploring its therapeutic benefits. (4)
One of the biggest obstacles to acceptance of cannabis as medicine is the lack of research proving its benefits to patients suffering from illnesses ranging from arthritis to cancer. Since 1972, just two years after the Controlled Substances Act placed cannabis in the Schedule I category, petitions have been filed requesting a re-scheduling by NORML, patient groups, politicians, and the Alliance for Cannabis Therapeutics among others. All of these petitions have been denied, partly because no research has been done on the benefits and possible drawbacks of cannabis as medication. Unfortunately, as long as it is a Schedule I drug, widespread studies cannot be legally conducted.
In 2016, the DEA said it was implementing a new policy to allow more facilities to grow cannabis for research purposes, but to date none of the 30 licensing requests submitted have been approved. After a federal lawsuit was filed by one of the applicants earlier this year, the government announced it will begin processing the applications they have received. If some of these facilities are approved to grow cannabis for research, the monopoly currently held by NIDA and the University of Mississippi will be ended, providing options for obtaining cannabis in order to study its benefits as medicine. (3)
Unfortunately, many influential organizations favor the arduous process of FDA approval of cannabis.
- The American Medical Association: 1) believes that scientifically valid and well-controlled clinical trials conducted under federal investigational new drug applications are necessary to assess the safety and effectiveness of all new drugs, including potential cannabis products for medical use; (2) opposes the legalization of cannabis for medicinal use through the state legislative, ballot initiative, or referendum process; (3) will develop model legislation requiring the following warning on all cannabis products not approved by the U.S. Food and Drug Administration: ‘Marijuana has a high potential for abuse. This product has not been approved by the Food and Drug Administration for preventing or treating any disease process.’”
- Biotechnology Innovation Organization issued this statement: “We are concerned that a lack of enforcement against unsupported medical claims by dietary supplement manufacturers will reduce incentives to study and invest in more targeted drug products in this similar ingredient category …This could rob patients of the potential for new treatments that may evolve from intensive and thorough research…..”
- Amyris, a company providing sustainable ingredients for health, wellness, beauty, and fragrance, said this: “The US market needs affordably priced CBD product solutions. The biotech industry urges FDA to provide clarity of all potential regulatory pathways to market …We think that appropriate controls are critical to ensure that the ingredients and products are safe.”
- The Child Neurology Foundation says “…We advocate for emerging treatments to be studied properly to ensure their safety and effectiveness. Moreover…..we urge for greater access to and promotion of research studies utilizing rigorous scientific methodology.” (5)
A hearing held May 31, 2019 revealed the FDA may be concerned that de-regulating cannabis could affect the incentive to do more research on cannabis as medicine. This seems to be a misguided vie since applications for new studies continue to be filed in spite of legalization for medical and/or recreational purposes not only in a majority of US states, but around the world. Holding back researchers may drive more patients to the black market instead of purchasing approved and safe products. (6)
The refusal of the DEA, NIDA, HHS (Health and Human Services), and FDA to allow timely and thorough research into the benefits of cannabis as medicine has caused a Catch-22 situation to emerge. The Federal government will not consider rescheduling cannabis without research proving its medical benefits, but its current Schedule I status severely limits and, in most cases, prevents studies that can provide the necessary information. In spite of the results of studies performed in other countries and published worldwide, the FDA and its cooperating agencies seem determined to continue to deny Americans the legal right to use cannabis to treat their medical conditions. Even if studies can be approved here in the USA, the approval process can take decades to complete.
The FDA seems determined to continue to view cannabis as a dangerous drug and to do all in its power to stop access to the plant for research purposes. Legalization by vote may be the only recourse US citizens have in guaranteeing access to cannabis to those who need it as part of their medical regimen without fear of prosecution or negative actions by employers, landlords, or healthcare providers.