HHS’ New 2-Step Classification: What It Means to Medical Cannabis

The U.S. Department of Health and Human Services (HHS) turned heads last year with a recommendation to reclassify cannabis as a Schedule III substance. The agency did so by relying on a brand new 2-step classification test for determining whether substances have medical value. Although the new test is considered novel, it seems as though the DEA is on board with it.

What does it mean for medical cannabis, both in Utah and across the country? First, it would seem that the DEA’s acceptance of the new test signals its willingness to reschedule cannabis as recommended by HHS. Second, and perhaps more importantly, rescheduling could ultimately lead to a more standardized environment for recommending medical cannabis.

Schedule I Since the 1970s

Cannabis has been a Schedule I controlled substance since the 1970s. The short list of substances on Schedule I are perceived to have a high risk of addiction but no legitimate medical purpose. The story of how cannabis made it to Schedule I is long and complicated. Needless to say, new revelations about its medical value have prompted a rethinking of its status.

The current administration directed HHS to review cannabis and its medical benefits more than a year ago. Based on what the agency found, it was understood that the DEA would then consider rescheduling cannabis. That is where we are now.

Officials at the DEA have heeded the HHS recommendation to reschedule. They are currently in the process of formal rulemaking, a procedure that will almost certainly end with rescheduling either this year or next. To understand how we got to this point, it might be beneficial to look at the new test and its older counterpart.

Out With the Old, In With the New

In order to determine whether a substance belongs on Schedule I, the DEA must determine its medical usefulness. Prior to HHS’ recommendation on cannabis, the agency relied on a 5-part test that looked at:

  1. Whether or not a drug’s chemistry is reproducible.
  2. The existence of adequate safety studies.
  3. The existence of adequate efficacy studies.
  4. Whether or not qualified experts accept the drug.
  5. The existence of widely available scientific evidence.

In fairness, medical cannabis has long failed the 5-step test for the simple fact that research on its safety and efficacy has been limited by federal regulation. Yet ever since the states began decriminalizing medical cannabis in the 1990s, the amount of anecdotal evidence in favor of its efficacy and safety has become virtually overwhelming.

Perhaps this is partially what motivated HHS to devise a new 2-step test based on two simple questions:

  1. Whether or not there exists “widespread, current experience with medical use of the substance by licensed healthcare providers” in jurisdictions where the substance has been regulated within the practice of medicine; and
  2. Whether or not there is credible scientific support for at least one medical application.

Medical cannabis ticks both boxes. That being the case, it is no surprise that HHS has recommended rescheduling it.

Things Will Change

Our industry is working on the assumption that cannabis will be reclassified as a Schedule III substance. When it happens, things will change. Yet there is no need for panic. The changes will come gradually and fairly easily.

In the end, rescheduling should be good for medical cannabis patients and the industry that supports them. As long as the states step up and continue to assert their legal right to regulate cannabis, rescheduling should result in better medications that do a better job of treating targeted conditions.