Compliance – for the regulators and regulated.

“Compliance” is a term that is thrown around – often without a clear definition of what it means, and how it matters.

I initially worked with “compliance” matters in my first job as a healthcare consultant.  Compliance plans are ubiquitous in healthcare, largely developing after audit and anti-fraud initiatives of the federal government in the 1990’s.  Today – most industries have ongoing compliance activities, compliance officers, and compliance plans.  Compliance can simply be a catch-all position to reduce risk for a company, and often uses employees without specialized compliance experience.  I am particularly partial to “How to get a job in compliance with little or no experience.”  At least they’re being transparent about it.

But true compliance needs are growing.  The Wall Street Journal thinks a Compliance Officer is one of the hottest jobs in America.  I’ll take WSJ’s word for it, but the topic itself tends to be boring and fall on deaf ears.

The truth is, compliance matters and should be taken seriously – especially in the developing cannabis industry with the variety of security, laboratory testing, packaging, record keeping, product tracking, and other regulatory requirements.  Compliance services are an increasing trend in the industry – most recently leading two of the country’s better known cannabis-focused law firms to jointly create their own compliance software for businesses.

While we’re at it, compliance matters not only for those being regulated, but for the regulators themselves.

Think of it as akin to the issue of “who is policing the police?”

When we were developing the Illinois medical cannabis program, there were dozens of issues to address every day of the week.  We dealt with the crises, but we were left with precious little time to consider how the implementation was going.

How would we establish benchmarks for success of the Illinois medical cannabis program?  How would we improve and modify the program moving forward?  How would cannabis businesses be able to share valid suggestions without the government disregarding them as self-serving?  How could Illinois learn from best practices of other states, and fix unanticipated problems, in the face of constant political, fiscal, and bureaucratic pressures?

“Compliance,” you say?  Indeed.

Some common compliance elements include effective communication, clear policies and procedures, monitoring program success and failures, appropriately responding to unforeseen or negative incidents, and general good management principles.  Of course these aspects are beneficial to a private cannabis business.

I would go so far as to say these elements are even more critical, and less common for government regulators and programs enforcing cannabis laws.  Government regulators don’t often have the time or training to implement successful compliance tools – that’s what outside consultants and compliance experts are for (here’s lookin’ at you, Wall Street Journal!).

Some states are already diligently tracking compliance markers for their medical and adult-use cannabis programs. Washington and Colorado have produced annual reports measuring a variety of benchmarks for their programs. Arizona went a step further with their medical program and hired a compliance consultant to conduct a comprehensive review of strengths and weaknesses of their medical marijuana system:

“The [Beacon-ID consulting] report recommends a state inventory tracking system, expanding patient registry systems to include faster and better sharing between physicians, regulators and dispensaries, standardized rules for packaging including child-proofing and increased inspections including unannounced ones.”

All state cannabis regulators should ensure a rational review of the successes and failings of their respective programs – especially those like Illinois where the program automatically sunsets January 1, 2018 without legislative renewal or expansion. We can all benefit from taking into account extensive data about the business, health, security, and quality of the state’s cannabis industry. The various state agencies must incorporate the tenets of compliance for us all to effectively evaluate next steps – we can’t just wing it and make emotional decisions about the future of these programs. A compliance plan is just one way for the regulators to track the successes and failures, and I hope such preparation and self-analysis paves the way for the continuation and expansion of the Illinois medical cannabis program.

Maryland Med Cann is Delayed Again – Where is the Outrage?

I want to share something with all of you: I don’t like waiting.

I don’t like to wait for service at a restaurant, I loathe waiting in lines for roller coasters (but love getting to the front seat of Great America’s American Eagle), and I have a visceral reaction whenever government takes longer to make decisions than it reasonably should.

Whether it is my local city hall staff taking weeks to decide whether I can cut down a tree on my own property, or a state government waiting to announce who has been selected for limited medical cannabis licenses – my blood pressure spikes and I want to take action to push the decision along using any (legal) means possible.Backyard

The tree on the right was saved by local government staff…but I will find a way to get you, tree.  I will find a way…

So you can imagine how I reacted today when the Maryland Medical Cannabis Commission (“MMCC”) again punted on announcing who will be selected for growing, processing, and dispensing medical cannabis in The Old Line State.  The MMCC met and announced that, although applications were received on November 6, 2015, they do not expect to announce selected businesses until at least August 2016.  A total of 10 months waiting – or more.  On top of the fact that Maryland has been tweaking its medical cannabis law since 2013, this is an unacceptable delay.  This is perhaps more striking because my interactions with the MMCC commissioners and Maryland Department of Health and Metal Hygiene staff have been very good – they are capable and compassionate.

Maryland’s program implementation has been relatively slow and below the radar.  The state’s Republican Governor waited three months to appoint a new director of the MMCC when the previous director had stepped down:

“Gov. Larry Hogan (R) has tapped a former state trooper and Republican political candidate as Maryland’s top medical marijuana regulator.

Patrick Jameson started Monday as executive director of the Maryland Medical Cannabis Commission, a spokesman for Hogan said.”

Okay – how does 10 months compare to other medical cannabis states that have a competitive, merit-based selection process?  Maryland is at the bottom of the pack.

Hawaii, Minnesota and New York announced licenses within 3 months of receiving applications, Illinois took approximately 3 months (discounting for a 3 month political delay), and Florida and Massachusetts needed roughly 6 months.

Why the delay?  No one knows.  It could be due to the large number of applications, but Maryland instituted a strict page limit reducing the size of the applications compared to the other preceding states.  You could chalk it up to the transition to a new Executive Director, but by his own admission, he doesn’t have a vote in the license selection.  I presume the delay is due to Maryland’s contracted application scorers: Towson University’s Economic Studies Institute, and its subject matter expert sub-contractors.  Could the sub-contractors have over-promised their skill-sets?  Could unknown conflicts have arisen?  It does not particularly matter – the delay has been too long. 

What is perhaps most surprising is the lack of vocal anger by potential Maryland patients.  To date I have only seen a solitary Baltimore Sun letter to the editor on the topic from parents of potential patients:

“The Natalie LaPrade Medical Cannabis Commission has made strides to move forward the process to bring safe medical cannabis as a treatment option in the state of Maryland. But now that a new executive director has been appointed, the time to finish the job started in 2014 is long past. Families in Maryland are pleading with our elected officials and the commission to implement the medical marijuana program.

The electrical firestorms in our kid’s brain, and in those of every other epileptic child in Maryland, loom every day. Thus, every day, we must have available all the tools to do anything — including medical cannabis — to stop the seizures.”

The fact that bureaucratic delays are keeping these patients at bay from the medicine they need is unacceptable.  Hopefully MMCC will find a way to surprise everyone and expedite the timeline for license announcements.  Until then, it’s time for all of us to be outraged…

E-Cigs, Cannabis Vaporizers, and the FDA: The Beginning of the End?

Walking down the street in any urban area today, you will see people smoking e-cigarettes and using vaporizers.  If you are like me, you’ve wondered whether they are smoking a tobacco-based product, or cannabis-related product.  There is no easy way to tell.

vaping

When I worked for the Illinois Department of Public Health, I was surprised that e-cigarettes were not regulated at the federal or state level.  It appeared to be a huge loophole.  The obvious difference is that smoking tobacco without the combustion of a cigarette is most certainly less harmful for the smoker and those around them.  But no one really knows how safe it is, and that question is part of why it took so long for the Food and Drug Administration to intervene.

That all ended this week when the FDA put their foot down:

E-cigarettes and other tobacco products like premium cigars and hookahs will be regulated in the same way the government regulates traditional cigarettes and smokeless tobacco.

Secretary of Health and Human Services Sylvia Burwell and the commissioner of the Food and Drug Administration, Dr. Robert Califf, made the announcement about their final rule Thursday.

Predictably, public health advocates are ecstatic, and the vaping industry is enraged.  My only question is: where’s John Boehner when you need him?

The impact on cannabis users could be interesting.  To my earlier point, there are many that use vaporizers for their cannabis, and some medical cannabis states only allow liquid cannabis products (particularly in the Southeast states), so what does this mean for those patients?

For starters, we are not necessarily talking apples to apples.  As Leafly notes:

When it comes to legislation, the difference between the cannabis and e-cigarette industries is that the former is desperate for regulations while the latter is doing everything it can to avoid them. There are many different viewpoints, but the vast majority of those in the cannabis industry seek regulation because they know that it will add standards and legitimacy to their business. But many e-cigarette makers and consumers see attempts to regulate e-cigarettes as just a way to take away their newfound freedoms and get them hooked on smoking again.

Valid point, but how will cannabis users be impacted by the new FDA rule?  It is far from certain, but here is a good rundown:

Many cannabis consumers have had the experience of visiting a head shop and being scolded to describe bongs clearly intended for marijuana consumption as “tobacco water pipes” in order to avoid violating drug paraphernalia laws. But thanks to the new FDA rules and rapidly changing public attitudes and laws surrounding cannabis, consumption device manufacturers and retailers may begin to advertise such products as “for marijuana use only.”

The federal drug statutes contain an exemption for “any person authorized by local, state or federal law to manufacture, possess or distribute” paraphernalia, but explicitly advertising vape products as for cannabis consumption could be risky for companies without a clear state or local license to manufacture marijuana devices or who operate in or distribute products to states without legalization.

As with any new federal regulation of this magnitude, expect some Congressional outrage (sans Boehner), public outcries by e-cig users, and likely lawsuits.  The impact on the cannabis industry will play out over time, but keep an eye out for changes to vaporizer marketing…

*Photo courtesy Flickr user Lindsay Fox at EcigaretteReviewed.com.

Springfield, Illinois – Oh how I’ve missed, thee…

I am often asked if I miss working for State of Illinois government (“State”).  I do.  Sometimes.

I worked for the State for 5 and 1/2 years, and in full disclosure I truly loved it – the crisis management, the public policy debates and decisions, and the asbestos-ridden ceilings.

My first State job was as a Springfield-based attorney for the group health insurance program for state employees and retirees.  In truth, I got the job more for my willingness to relocate from Chicago to Springfield, IL, than for my exceptional healthcare law chops (though I had some of those too).

I spent the next 16 months living in Springfield (initially on a borrowed inflatable mattress, later on a borrowed full-sized mattress, and then upgrading to my own apartment), and the experience was roughly what you might expect.  When the legislature was in town, Springfield had an unmistakable electricity.Ghost Town

When they were out of town – it looked something like this===>

Fine – Springfield has less tumbleweeds than that.

For the following four years I worked for the State out of a Chicago office, but frequently headed down I-55 South towards the State Capitol.  I really do hold some fond memories of S-patch (it’s too small for a field, so it’s more like spring-patch, get it?).  Perhaps most of all, I miss the exceptionally gracious people that live there year-round, and very much long for the days of eating authentic buffalo chicken horseshoe sandwiches (see below – YUM!).  If that surprises you, you must not have read my earlier post about Olive Garden.

horseshoe sandwhich

This week I will return to Springfield after a hiatus from traveling there.  My emotions have varied between nostalgic excitement, to deep thoughts on how to advance progressive policy issues, to sadness to have to be away from my family – even for one night.

I will use this trip to start rekindling my long-lost Springfield friendships and legislative advocacy – so look for me in the halls of the Capitol, and perhaps at my old horseshoe sandwich haunts.  It’s time to get back in the game.  Springfield, here I come.