States give marijuana data to Biden administration for rescheduling review

July 13, 2023 · MJ Biz Daily

At least five states with medical marijuana programs have shared key data – including the products patients are using and how they are affected – with U.S. health regulators as part of the Biden administration’s review of whether to remove marijuana from the federal government’s list of the most dangerous drugs, MJBizDaily has learned.

The state data sent to the U.S. Food and Drug Administration and the Department of Health and Human Services (HHS) offers federal researchers a wider and deeper look into marijuana use and its medical potential than most peer-reviewed studies available to researchers, experts told MJBizDaily.

In sharing the data, officials hope to influence the ongoing federal review of cannabis’ status under the Controlled Substances Act (CSA), which still serves as an immovable barrier to long-awaited federal marijuana reform, including interstate commerce and tax relief.

President Joe Biden ordered the review last fall.

The process ultimately could lead to lower federal taxes for cannabis companies and better access to traditional financial services as well as legal interstate commerce and, possibly, federal marijuana legalization – although the final outcome is far from clear.

So far, Illinois, Maryland, Massachusetts, Minnesota and Utah have shared information with federal health regulators about marijuana use gleaned from their state programs, officials from those markets confirmed.

“This is going to be some of the most important data considered,” predicted Jahan Marcu, a published researcher who earned a Ph.D. examining the endocannabinoid system and is serving as scientific adviser to the Coalition for Cannabis Scheduling Reform (CCSR).

The CCSR is a collection of major multistate operators seeking to encourage rescheduling or descheduling marijuana.

States shared the insight into marijuana use and MJ products at the encouragement of the Cannabis Regulators Association, an organization comprised of government officials overseeing state programs.

The revelation that states are participating in the administrative rescheduling review offers a rare peek into that process, which federal health officials have kept a near secret so far, observers in Congress and on Capitol Hill said.

Asked previously what studies or data officials are weighing, spokespeople for the federal health agencies have declined to elaborate.

Separately, a spokesperson from the U.S. Food and Drug Administration did not respond to an MJBizDaily request for comment this week.

“So much money has been put into understanding the risks of illicit cannabis,” Marcu noted.

By comparison, there’s been very little research into legal commercial marijuana.

“With state-level data, you’re talking about what products people are using, any health effects – that information is so important,” he added. “In some ways, that’s what Big Pharma does.”

Surveys say

“We shared a subset of our data – minus any identifying information – with the FDA,” David Rak, the research manager at the Minnesota Department of Public Health’s Office of Medical Cannabis, told MJBizDaily via email.

“We collect data from our patients every time they go to make a purchase at a dispensary (Patient Self Evaluation), and offer an optional survey at fixed intervals (Patient Experience Survey).

“So, we have a fair amount of data to analyze.”

Minnesota’s data also includes reports of adverse events, such as prescription-drug interactions.

“In general, we’ve had very few adverse events reported,” Rak said.

According to Rak, the FDA has yet to respond to the states that shared information.

Massachusetts officials “submitted data and information to the U.S. Food and Drug Administration as part of its review of cannabis’s scheduling status, including conditions approved for medicinal cannabis use, cannabinoid profiles of medical-use products, and frequency and quantity of medical patient purchases from the medical-use market,” a spokesperson for the state Cannabis Control Commission told MJBizDaily via email.

“We look forward to continuing to work with our partners at the state and federal level to encourage additional research and data-sharing, and ultimately impact nationwide policy.”

Unique source

In an ongoing paradox that Congress has yet to untangle, current federal drug laws thwart and discourage research into cannabis.

The marijuana research bill that Biden signed into law last fall – drafted by one of the country’s most prominent anti-legalization organizations – has not yielded new research protocols nor new sources of research-grade cannabis.

Critics have told MJBizDaily that the research bill is failing by design.

Meanwhile, federal officials have repeatedly said more research is necessary before marijuana prohibition can be weakened or undone.

The little marijuana research that does go on in the U.S. typically examines cannabis grown by U.S. Drug Enforcement Administration-approved suppliers.

Experts agree this supply does not bear much resemblance to the marijuana available in state-legal medical dispensaries.

When determining a drug’s appropriate classification under the CSA, the FDA employs what’s called an “eight-factor analysis.”

The eight factors considered are:

  • The drug’s actual or relative potential for abuse.
  • Scientific evidence of the drug’s pharmacological effect, if known.
  • The state of current scientific knowledge regarding the drug or other substance.
  • Its history and current pattern of abuse.
  • The scope, duration and significance of abuse.
  • What, if any, risk there is to the public health.
  • Its psychic or physiological dependence liability.
  • Whether the substance is an immediate precursor of a substance already controlled.

In another demonstration of how marijuana’s legal status stymies research that could change that status, there are a limited number of peer-reviewed academic studies that the FDA would traditionally rely on for the eight-factor analysis process, said Gillian Schauer, executive director of the Cannabis Regulators Association.

“A number of state medical cannabis programs have rich data sources around patient use of cannabis, clinical recommendations for medical cannabis, adverse events (or lack thereof), and more,” she said via email.

“These data are typically not collected for academic or research purposes but rather for consumer safety, program improvement, and regulatory reasons.”

Those states that haven’t yet shared data are encouraged to do so, Schauer added.

“It is imperative that these data are shared with the FDA so they can conduct the 8-factor analysis with data not only from academia, but from what is happening in practice on the ground in states and territories.”

‘Nobody can really say’

In announcing his administration’s rescheduling review last October, Biden noted in a statement that federal law “currently classifies marijuana in Schedule 1 of the Controlled Substances Act, the classification meant for the most dangerous substances.

“This is the same schedule as for heroin and LSD, and even higher than the classification of fentanyl and methamphetamine – the drugs that are driving our overdose epidemic.”

For most laypeople as well as Biden – and many lawmakers and officials who have decried the conflict between state and federal MJ laws as well as the Nixon-era declaration that marijuana is more dangerous than heroin – the idea that cannabis should be reclassified from Schedule 1 is obvious.

Schedule 1 is the category reserved for drugs with a high potential for abuse and no medical value.

Less obvious is how far federal health officials will go in their recommendation, which is due to the DEA by the end of the year, and whether law enforcement officials will take heed.

“What nobody can really say is what the scientists (at the FDA and HHS) are going to look at and what will be persuasive,” said Andrew Freedman, a senior vice president at influential Washington DC-based law and lobbying firm Forbes Tate and the executive director of the Coalition for Cannabis Policy, Education, and Regulation.

That’s also true of scientific studies. “How persuasive they will find anecdotes at the state level, I think, will be harder to determine,” Freedman added.

“The other thing that’s going to confuse this analysis is, well, what ‘cannabis’ are we talking about?” he added.

“Are we talking about someone who uses shatter three times a day, or someone who smokes half a joint with a friend on a Friday night?

“Those are two different versions of risk. Cannabis is not one thing, even though it’s scheduled as one thing.”

Most experts agree that health officials are unlikely to remove marijuana from the Controlled Substances Act entirely.

That might satisfy some major cannabis companies, as the notorious Section 280E of the federal tax code – which bars marijuana operators from taking basic deductions for business expenses – does not apply to drugs classified Schedule 3 or lower.

But it won’t satisfy advocates or many regulators, whose state frameworks aren’t set up for drugs controlled at that level, which are typically sold at pharmacies.

“This data is going to be used to support some sort of showing that there is a medical benefit,” said Griffen Thorne, a Los Angeles-based attorney at Harris Bricken.

“Everybody knows there is some medical benefit, at least for pain if for nothing else.”

But will that convince federal regulators? It’s still anyone’s guess.

“It’s hard to deduce what the federal government is doing,” Thorne noted. (Full Story)

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