We believe it; scientists believe it; health care professionals, doctors, and nurses believe it; so why doesn’t the federal government seem to believe that cannabis can be used for medicinal purposes and should not be classified as a criminal drug? It’s the DEA that needs to reclassify marijuana in order to make it federally legal, or at least less punishable by federal law; they proved they are against that process this summer. The DEA prosecutes and decides which drugs and substances are illegal to possess, consume, buy, and sell, but the Federal Drug Administration (FDA) approves medicines for public use, sale, and safety. Could the FDA’s stance help persuade the federal government and the DEA to change theirs? Let’s take a little look into how the Federal Drug Administration (FDA) feels about marijuana, since they could have a large part in approving cannabis-based medications if the November election proves that the majority of Americans approve medical and recreational cannabis.
The DEA and Marijuana
Last year, several politicians brought the question of rescheduling marijuana to the DEA’s attention, essentially forcing the traditionally anti-cannabis organization to make a public decision that it wasn’t yet ready for. Predictably but sadly the DEA refused to reschedule marijuana so that lesser penalties could be assigned for its consumption, possession and use across the United States. Part of the DEA’s argument that cannabis shouldn’t be rescheduled was the fact that it was actually approving cannabis studies on a case-by-case basis after much review – that’s just how the government does things, really. Since then, the DEA has approved cannabis for a PTSD study, and there is a dim light shining at the end of the federal cannabis approval tunnel: the November elections. The DEA repeatedly noted that it was not ready to make a quick decision regarding the rescheduling of cannabis, pending further investigation and probably public and federal support for increased legalization of the plant. Since its hand was forced, it said no – but the election’s outcome may determine its future decisions. For now, states are generally making their own laws regarding penalties for possession, consumption, sale, and purchases of marijuana and marijuana-based products, anyhow, so unless you are trying to take marijuana across state or national borders, you can safely consume it in a variety of states if you are over the age of 21.
What Does the FDA Say About Marijuana?
According to their website, the FDA “understands that caregivers and patients are looking for treatment options for unmet medical needs.” The FDA doesn’t mention the pharmaceutical addiction epidemic sweeping the nation, but does note a few of the many, many illnesses and disorders that marijuana has been proven helpful for (epilepsy, cancer, schizophrenia, CTE, and PTSD, to name a few). The FDA is actually closer to full medical marijuana approval than the DEA, and is a crucial part of the federal legalization puzzle. It has approved two synthetic marijuana substances, and synthetic copies of marijuana substances – essentially, the FDA is playing it really, really, safe while still supporting the exploration of marijuana-based medicines and synthetic marijuana-based medicines. After the November election, we may see the federal government review its position on marijuana as a medicine, and the FDA and DEA along with them. Although the fight is far from over, the election may be a significant turning point for medical marijuana in the United States’ federal government.
How Can Cannabis-Based Drugs Start Clinical Trials?
Note that drug companies can get around FDA approval (and must for a new drug like one containing cannabis) to conduct drug testing on humans with a little something called an investigational new drug (IND) application, which is carefully reviewed by the FDA. The FDA only approves these IND clinical trials after they are determined to present no unreasonable risk of harm to participants and to be safe and effective for “intended indications.” Essentially, the FDA is worried about the purity and potency of marijuana-based pharmaceuticals and medicines (a real concern in medicines of all types) – there is no previous example for them to follow, and inventing new regulations is a tedious, long-term process. This is not to say that the FDA never approves new drugs (obviously) or that it does not support any alternative treatments; it does, working with “medical and patient communities, and our federal partners when necessary, to allow access to experimental treatments through the expanded access provisions.”
What is Expanded Access?
Expanded access is the same as compassionate use according to the FDA, and they encourage these clinical trials so that they will have data to base future drug approval decisions on. So don’t give up on marijuana as medicine and the FDA – it’s coming, and not slowly. Expanded access makes experimental (read: “alternative”) treatments available to patients who have exhausted traditional options even if there is not a clinical trial the patient can enroll in. Patients can enroll in expanded access if their physicians are willing to participate, they have exhausted all options, and the FDA determines that the “experimental” or “investigational” product is not too risky for the patient. (There is no indication as to how the FDA decides this, however.) The company developing the cannabis-based drug must submit the patient treatment plan, and it has to match up with the FDA’s rules and regs. The FDA also approves alternative medical devices through the same process. Check out this page for widespread use, meaning that more than one patient would be approved for a particular alternative treatment.
The Rest of Us and Medical Marijuana
While recreational (read: self-treatment) marijuana has been approved in five states, and kind of in Washington D.C., and we know it’s on the ballot for many more states next month – if you’re desperately in need of medical marijuana, you can travel to a legal state, and consume it there, but then you can never leave with your medicine; at least not legally. That’s a problem for people in non-legal states, people with illnesses like cancer, epilepsy, PTSD, and other chronic issues that may not have the time or the knowledge to access the cannabis therapies they need. It explains Colorado’s surge in population, and it explains the emails I receive often from people in other states asking me how to navigate the medical marijuana licensure world in their state, when it exists. The truth is, though, that the federal government is coming around, but it’s as imperceptible as the turning if the earth for most of us. Presidential candidates discuss marijuana, the FDA is trying to get the word out on its expanded access program, and even the DEA has greenlighted some medical marijuana studies for PTSD and other chronic illnesses. There is no doubt that the coming election will help determine the federal government’s path concerning medical marijuana, and progress at a snail’s pace is still progress.