The psychedelic boom is definitely underway, and it’s going full steam ahead. Prompted perhaps by the success of the cannabis industry, which paved the way, psychedelics were much more quickly brought into the limelight and gained acceptance. While still mostly illegal at the federal level, recent breakthrough therapeutic designations given by the FDA indicate that at least one government agency is pushing for legal psychedelics.
The FDA may not have explicitly stated it, but its breakthrough therapeutic designations granted to companies studying psilocybin and MDMA make a pretty big statement, and it looks like the FDA wants legal psychedelic drugs. We cover everything important in the burgeoning field of psychedelics, so subscribe to The Cannadelics Newsletter for more stories like this and to stay up to date with big news coming out of the industry.
What is Breakthrough Therapy?
The FDA – Food & Drug Administration, is the US federal agency that governs and regulates all drugs that can be marketed and sold in the United States. The FDA falls under the Department of Health and Human Services and is responsible for more than drugs, also regulating the food industry, tobacco products, dietary supplements, over-the-counter drugs, biopharmaceuticals, blood transfusions , vaccines, medical devices, electromagnetic products, radiation emitting products, animal feed, veterinary products and cosmetics.
In order to get a drug approved, a compound must go through different rounds of testing in clinical trials. After passing this part, a company must submit a New Drug Application to the FDA, and then the FDA decides whether the drug should be approved or not. The FDA is the only body that does so, so if they don’t approve, a drug can’t be legally sold.
When a drug is in testing, the company that created it and puts it through trials can submit it to the FDA for a “breakthrough therapy” designation. This goes for whether the drug is specifically illegal according to the controlled substances list or not. The term “breakthrough therapy” is defined this way by the FDA, as:
“…a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement in one or more clinically significant parameters compared to available therapies.”
What is this designation for? According to the FDA, the “breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.” Suppose a new drug goes through tests that could be used instead of chemotherapy and show promise as a better option in preliminary tests for treating cancer. Then, the company that made the drug can apply for a “breakthrough therapy” designation to get its product to market faster, in hopes that this in turn could save lives.
So it’s basically to speed things up. If the FDA gives this designation, it wants to put the drug through trials and put it on pharmacy shelves. This, of course, becomes all the more interesting when the drugs in question are Schedule I drugs, deemed dangerous by the federal government and of no medical value. That said, we all know the government can be wrong because they also have cannabis on Schedule I.
How does the Breakthrough Therapy designation apply to psychedelics?
The FDA has now officially assigned three breakthrough therapeutic designations to three different companies studying psilocybin or MDMA. All of this has happened over the past few years. Which companies got it? And what are they studying?
A company to obtain such designation is Compass Pathways which received designation in 2018 for research into psilocybin for use with treatment-resistant major depression. The following year, Usona Institute also applied for and received this designation for its research on psilocybin for treatment-resistant depression.
It doesn’t stop at psilocybin. In fact, before Compass or Usona got their designations, a breakthrough therapy title in 2017 was awarded to the organization MAPS (Multidisciplinary Association for Psychedelic Studies) for its research on MDMA for PTSD. And in this case, the FDA went further than just giving it the title of speeding things up.
When it came time for the MAPS Phase III trials, they were designed with help from the FDA. The two organizations proposed a “special protocol assessment” to ensure that the trial results would comply with the regulations. So not only did the FDA basically say it was cool that these drugs were being studied to be used as drugs, but it actually helped one of the companies make sure that if the study results were positive , there would be no problem with them breaking the regulations. Maybe it’s just me, but it seems to outwardly imply that the FDA wants the drugs approved.
Are all psychedelics illegal?
The recent moves by the FDA to give breakthrough therapeutic designations to psilocybin and MDMA are just another part of a general trajectory when it comes to psychedelics. In 2019, the FDA very quietly (as in, under the guise of quietly overnighting) legalized a form of ketamine for use with treatment-resistant depression, called esketamine. It’s odd when you consider how much of a debate there is with the legalization of cannabis, or when it comes to the legalization of almost any drug. Why was this done without discussion or without the public knowing about it?
The US government is not keen on explaining its decisions, but it seems that the most likely reason for this change, was related to the rapid expansion of the gray market ketamine industry that relies on off-label prescription. Because ketamine is Schedule III, this is possible under general regulations, but creates a market that is not federally taxed, at least beyond standard taxation. Think how much taxes are applied to the cannabis industry. It would be foolish to think that a psychedelic industry wouldn’t have the same, so ketamine presents a problem for the US government.
If this booming market was the reason for legalizing esketamine, the government failed on many levels. For one thing, it also requires taking a regular antidepressant, which defeats the purpose of using esketamine for treatment, while making it more susceptible to drug interactions. And second, it has only been licensed for treatment-resistant depression despite the large amount of evidence for it being used for pain. This is odd considering the current opioid epidemic and ketamine’s ability to treat not only pain issues but possibly the Dependencies that have developed around opioids. In fact, the U.S. government made no mention of esketamine being used in this way, while 75,000+ people die each year from an opioid overdose.
Besides esketamine, there is another psychedelic that has been legal for some time: DXM – dextromethorphan. DXM is a dissociative psychedelic that belongs to the class of morphinans, and not only has it been legal since 1958, but despite its known abuse, it has always been an over-the-counter drug. And one that can be viewed by anyone of any age. DXM can be found in tons cold medicine, and the US government has actually rejected moves to make it a prescription drug, although some states like California and Oregon have passed their own regulations to stop the sale of DXM to minors.
State rights and psychedelics
Everything I just went through is about federal guidelines, but there’s a caveat here, and it’s the same reason we have legal cannabis in 18 States: everything that is not explicitly covered by the constitution falls under the “rights of the States”, which are also “personal rights”. For this reason, psychedelics are not illegal everywhere.
Multiple locations across the United States have instituted decriminalization measures, including: Denver, Colorado; Oakland, Santa Cruz and Arcata in California; Ann Arbor, Washtenaw and Detroit County, Michigan; Washington D.C.; Somerville, Cambridge, Northampton and Easthampton in Massachusetts; and Seattle, Washington.
Not only that, but starting with the 2020 election, the entire state of Oregon decriminalized psychedelics, while legalizing them for medical use. Three other states are looking to up the ante with comprehensive state recreation legalization policies: California, Michigan, and Washington. Although they propose different measures in their respective bills, in all cases legalizations would be made for the recreational use of at least some psychedelics, usually in the form of entheogenic plants (plants with psychedelic compounds).
Right now, psychedelics are on the cusp of a major growth spurt, helped in part by groundbreaking therapeutic designations from the FDA, the momentum of the cannabis industry, and the brightening mood of the population. towards these two classes of drugs. I tend to think that when there is so much rallying, you can expect change to come. So even if the current three states don’t get their bills this time around, something will pass soon enough. One thing is for sure, psychedelics are coming.
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Warning: Salvation, I am a researcher and writer. I am neither a doctor, nor a lawyer, nor a businessman. All information in my articles is sourced and referenced, and all opinions expressed are my own. I do not give advice to anyone, and while I am more than happy to discuss topics, if anyone has another question or concern they should seek advice from a competent professional.
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