Pharmaceutical Regulatory Affairs: Open Access

There is only one legally-competent authority in the United States (US) that can determine what is and what isn’t medicine – the Food & Drug Administration. In 2018, under US and International statutes, marijuana is not medicine. Individual states have approved the cultivation, sale, and distribution of a Schedule I controlled substance in direct violation of International and U.S. drug control statutes. The current administration of the US allows the daily violation and nullification of 3 International United Nation treaties as well as the US Comprehensive Drug Abuse and Control Act (1970). In a search for nirvana, a growing subculture has emerged that has taken the hallucinogen, Δ9- tetrahydrocannabinol (THC), of the 1960s to “infinity and beyond”. Techniques to “boost” or potentiate the actual THC content of marijuana by agricultural refinement, fertilization, and hybrid cultivation of “home grown” or medical advocate suppliers for the “medicinal marijuana” market has dramatically changed the subjective experience of smoked product. More disturbing is the intentional adulteration of bulk harvested materials (spicing), the development of “kitchen-based” extraction techniques (dabbing), and the processes of dose administrations that have grown almost exponentially over the last decade that sets the stage for a new chimera to drug safety in the US. These cottage industries are poised and waiting for national drug control policies to be further weakened to the point of a public health crisis. While legislators debate the drug control issue, a whole subliminal industry has developed in anticipation of free farming of cannabis, with the intent of delivering hybrid dosing of THC concentrations not believed to be possible just a few years ago.

Delivery of therapeutic agents directly to the central nervous system can be critical to address a number of diseases. Intraventricular administration of drugs has been used for over 50 years. Despite a substantial number of drugs routinely administered to the central nervous system in the course of medical practice, very few medical devices are appropriately cleared in the US for this route of administration. This review explores the regulatory challenges, the supplementary testing and more stringent acceptance criteria required for combination products and medical devices intended for CNS therapies. A case study of the recent Brineura^® combination product approval is also presented.

Federally unregulated, marijuana growth organizations (MGOs) have now provided a path to exposures to the neurotoxicity of heavy metals. The lack of US Food and Drug Administration (FDA) and US Environmental Protection Agency (EPA) testing and oversight of the MGOs now threatens the public health. Agribusiness and botany experts proclaim the value of cannabis as a perfect rotating plant for phytoremediation programs to help scavenge heavy metals from soils prior to seeding the land for food product. Cannabis has a high affinity for soil contaminants without affecting its own heartiness. However, “legal” marijuana plots have burgeoned in the “Emerald Triangle” of Northern California, Oregon and Washington. According to the FDA’s toxicology program, the largest sources of heavy metals (HMs) are the environments surrounding abandoned or active mines. The history of gold, platinum, coal, and copper mining in these grow areas now threatens the end-user; the plants ability to “scrub the earth” of these highly toxic HMs provides main stream smoke contamination to the consumer. Published reports of cannabis users showing hearing loss and neurological changes to temporal lobe structures involved in audition as well as learning and memory. The apoptotic cascade of cytotoxic events initiated by heavy metals is linked to the progression of Alzheimer’s and Parkinson’s disease, as well as hearing loss related to brain stem and temporal lobe neurotoxicity.