Why Some Activists Are Fearful Of Marijuana Rescheduling: Replying To Former FDA Officials' Dismissal of Our Concerns. (Op-Ed).

It’s surreal to see our fears manifest in real time. It’s strange to see our fears come true in real-time .”

By Debtharp, NuggMD

Politico recently released a Q&A that was conducted with Howard Sklamberg. He is a former FDA official and currently works for the law firm Arnold and Porter. Sklamberg says that many advocates of legalization and restorative Justice are concerned about the rescheduling cannabis to Schedule III, a move that he believes is “alarmist and ill-informed.”

As a long-time advocate, I can’t say I agree with that opinion. Since rescheduling recommendations were made last year, the worrying absence of transparency from regulatory agencies has been a major concern. Although we are not always correct, our record in drug policy is superior to that of policymakers and regulatory agencies who pushed for, created, and perpetuated the so-called “war on drugs”.

Regulators, officials and their representatives could benefit by listening to and taking seriously concerns raised by advocates about the rescheduling of cannabis. Below, I have tried to summarize some of the concerns.

Sklamberg:

“I find that it is a strange and difficult to understand myth that the enforcement of cannabis laws would increase when it was rescheduled to Schedule III from Schedule I.”

Why would you say, “Oh, and by the way, cannabis is less risky than we thought” when you launch a enforcement initiative? You would go after it under Schedule I.”

Schedule III is not just about no-knock raids, but it is still of great concern. Rescheduling does not remove criminal penalties. The impending regulatory mess is also a concern for activists. The excessive regulations of the state are already causing cannabis businesses to fail by a large margin. Big Pharma drug patent lawsuits and increased FDA involvement will drive out the few surviving businesses–businesses built by the fearless activists who paved the way for legalization. The inevitable is the case, and it doesn’t matter if this result was intended or not. The result will always be the same.

I don’t believe that drug companies would spend years developing and patenting their products without trying to corner the market.

The FDA will be regulated by cannabis as if it were a pharmaceutical drug if the FDA moves cannabis to Schedule III. Why else would they have it listed under the Controlled Substances Act. It’s the same as saying “I’ve got this axe, but I only intend to use it for peeling your apples and not to chop down your trees.”

In the absence of congressional protection, state-legal cannabis operators face a dire threat. The Rohrabacher-Blumenauer amendment prohibits the Justice Department from spending funds to interfere with the implementation of state medical cannabis laws, but it has to be renewed every year. It is urgently needed to pass legislation that will make it permanent and apply to recreational markets in states that have legalized cannabis. The first session of this 118th Congress has been the least productive one in recent U.S. History. It is unlikely that legislative action will be forthcoming, along with the rescheduling.

Sklamberg:

FDA regulations apply to them now. FDA does not enforce these regulations. Why would FDA suddenly want to enforce them when it didn’t do so in the past, under Schedule I?”

FDA doesn’t “choose” to be anti-enforcement. The agency lacks the clarity and public support it needs to interfere in state-legal markets. Take a look at FDA’s position on psychoactive hemp. Recently, it asked Congress for clarity on how to regulate these products. That’s a big clue to me.

Sklamberg:

The FDA does not have the resources to deal with cannabis.

It’s like saying that the raccoon who was in your garden yesterday hasn’t yet ruined it because he is down the street, looking through garbage. This may be true but is not very comforting. Do activists like the fact that FDA allegedly doesn’t have any resources for cannabis use? Yes, sure. We don’t believe this is a guarantee or a guideline on the Agency’s position if cannabis was rescheduled.

FDA will have broad powers and resources to enforce and regulate against commercially unapproved cannabinoids. This is not the current plan. If it was, they would deschedule instead of reschedule, and FDA-controlled Big Pharma-driven marijuana is the wrong approach. Why would anyone want to trust this essential herb to the same actors that created the opioid epidemic and then fought against cannabis legalization in order to stop competition from a safer option? This is not an unfounded medical claim. Cannabis use is clearly safer than opiate usage.

The FDA will also be required to enforce its privileges if cannabis is reclassified as a Schedule III Drug under FDA jurisdiction instead of being an agricultural crop. There are currently dozens cannabis-based pharmaceuticals who have applied for orphan status. You can check it out yourself by typing “canna” into the “product name search” box in FDA’s Orphan Drug Designations and Approvals Database.

The state-legal market will not be allowed to continue in the same way it is with dozens newly patented products fighting for their share of the market. I don’t believe that drug companies will spend years developing and patenting their products without trying to corner the market. This is not the way that the pharmaceutical industry operates. This is not how any industry really works.

Sklamberg:

The DEA would be the most likely agency to enforce if there was a new administration. They would also face the same problem: if you take only symbolic enforcement actions, you will be open to criticism that it is arbitrary and favoritism, which agencies cannot do.

Since we’re all grown-ups, I’ll be honest: every administration and state government has engaged in symbolic enforcement of cannabis laws since Nixon. Around half of all adults have tried cannabis, but this hasn’t deterred the government from waging this futile war. Why would we expect them to accept their limitations after nearly a half century of futile war against the American people.

Financial incentives are used to encourage both FDA and DEA enforcement. Financial incentives are also provided to state agencies for enforcement. We still have hundreds of thousands marijuana arrests each year, despite our efforts to convince regulators and law-enforcement to take a rational approach.

Arrests are a source of profit. The arrests drive profits. Sklamberg asks what their motivation is to enforce. What is their motivation to stop?

Even if the enforcement of these laws is not intended to harm society, the result is still the same. Even the data about cannabis and race enforcement speaks for itself. Over the last decade, the racial disparity in enforcement has grown, even though total arrests have decreased. The fear of criticism has not stopped these misguided organizations yet, and Schedule III is unlikely to change that.

Sklamberg:

“It is an expensive and lengthy process to conduct clinical trials for cannabis drugs and file new drug applications. In practice, the medical cannabis industry would continue to exist. The approved drug would convince agencies to take actions against some medical cannabis companies.

It reads like an acknowledgement of our fears. The article admits two things: an FDA enforcement agenda, and that activists were right to worry about drug companies suing cannabis operators until they disappear under Schedule III.

A patent is useless if the intention is to monopolize intellectual property. The drug companies aren’t known for doing a good job. They are also pursuing patents for cannabis.

Epidiolex was given orphan drug status and rolled out with a price tag of $30,000 per year. All this for a CBD product that may not work as well or as safely as the concentrates that activists are already producing in the state-legal market. Concentrates that they provide for a fraction of the cost. The lawsuits against GW for its overpriced pills have just begun.

It is not necessary to guess what will happen to THC-approved drugs in Schedule III. CBD is a good example of this.

Cannabis operators, who are already struggling to pay for legal and regulatory fees, would suffer a severe blow if the pharmaceutical industry brought a patent-related lawsuit. Section 280E tax savings under Schedule III will not help cannabis operators if they have to spend their savings on legal and regulatory defense.

Politico:

Would moving marijuana from Schedule III to Schedule III facilitate research?

Sklamberg:

“It depends on who you are asking. It’s not without debate. Even though it can be easier, clinical trials still cost money, even when dealing with substances that are not scheduled.

For it to be a good business decision, it would require a company that is willing to invest and the resources necessary to do so. This is something you should spend time on. “I don’t think that’s likely.

In a few years, we will be able see who was right.

Schedule III will bring a flood of cannabis-related litigation, and the industry as it is now will be drowned in a tsunami of lawsuits. Sklamberg has also said that the DEA might lose interest in criminal prosecution if they let this scenario play out for the sake of progress.

It’s the Judgment Day we all predicted in the dark days before prohibition, while smoking a joint with a conspiracy. It’s strange to see our fears come true in real-time.

Schedule III: The Outlook

Sklamberg no longer has the job of providing basic transparency to FDA, but I do agree that it would be a great help in alleviating some of the concerns activists have. I enjoy his interviews, and appreciate the fact that he views this issue from a different perspective. Cannabis advocates have heard these empty assurances before. I was accused of being alarmist and heard a similar voice during the Proposition 64 campaign, which legalized marijuana in California. What are the results? A poorly written law has suffocated the very people who created California’s industrial base. So perhaps I’m jaded.

Here is my basic view of cannabis under Schedule III in the absence of a decisive Congress action to protect state-legal market:

Patent litigation will bankrupt many companies
Big Pharma is attempting to weaponize the justice system as it competes for a share of a $100 billion dollar industry.
There is confusion among consumers about which cannabis products and services are legal.
FDA campaigns of enforcement against operators are based on various theories
More lives destroyed by continued criminal enforcement (over a quarter of a million cannabis arrests were made last year; 92 percent for possession).
An even greater explosion in black market activity
The congressional calendar is a giant blank where cannabis legislation should be.

Cannabis advocates are ready to engage in a meaningful dialogue with regulators on why declassifying cannabis and regulating under the USDA or already existing, safe and tested state market is the only option that makes sense. New cannabis regulations must balance individual liberties with the mandates of regulatory agencies to protect public safety and health. We can’t even have this conversation with ourselves.

Deb Tharp, head of NuggMD’s legal and policy research department, is the company’s largest cannabis telehealth provider.