This year marks another milestone, FDA approval for cannabis distribution.
The U.S. Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the nation's food supply, cosmetics, and products that emit radiation.
The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. But cannabis distribution has been largely absent from federal oversight... until now.
In January 2017, PhytoPain Pharma, a subsidiary of Tetra Bio-Pharma Inc., a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions, announced that it completed its pre-IND meeting with the USA Food and Drug Administration. The meeting was held with the Division of Anesthesia, Analgesia, and Addiction Products ("DAAAP"), and Center for Drug Evaluation and Research ("CDER").
The FDA provided all the necessary guidance on the design of the Phase I trial in healthy volunteers and the overall product development program, including quality, nonclinical and the medical device, and on marketing requirements. Dr. Chamberland, the Chief Scientific Officer, commented: "We could not be more pleased, as the FDA guidance gave us a clear path to progress from early to late phase clinical development. Adhering to the US FDA regulations is part of Tetra Bio-Pharma's dedication to the commercialization of cannabis as a prescription controlled drug and the corporations plan to seek reimbursement by insurers for patients."
This was important for two reasons: the first was that the FDA previously announced that they had not approved marijuana use, and second, because this would lead to federal oversight--and most likely--regulation. "The FDA understands that caregivers and patients are looking for treatment options for unmet medical needs," the FDA claimed on their website. "In some instances, patients or their caregivers are turning to marijuana in an attempt to treat conditions such as seizures and chemotherapy-induced nausea."
Over the last few decades, there has been significant interest in the potential utility of marijuana for a variety of medical conditions, including those that already have FDA-approved therapies. More recently, several states have also passed laws that remove state restrictions on health care professionals using marijuana as a medical treatment for a variety of conditions. A number of other states are considering similar legislation regarding the use of marijuana in medical settings.
Previously, the FDA had not approved marijuana as a safe and effective drug for any indication. The agency did, however, approve two drugs containing a synthetic version of a substance present in the marijuana plant and one other drug containing a synthetic substance that acts similarly to compounds from marijuana. Although the FDA has not approved any drug product containing or derived from botanical marijuana, 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.
All of this is a step in the right direction to maintain a fair delivery of the drug once it is legalized.