FDA JUST UNLOCKED A DOOR FOR CANNABIS POLICY, WILL CONGRESS PUSH IT OPEN?


What just Happened

On Wednesday, Bloomberg news reported that Health and Human Services (HHS) is recommending that cannabis be rescheduled to Schedule III following the Food and Drug Administration’s (FDA) scientific review of cannabis under the direction of President Biden. Their findings were sent to the Drug Enforcement Administration (DEA) who will be performing the final review for the Department of Justice (DOJ) in response to President Biden’s request in October 2022 for HHS and DOJ to look into the scheduling of cannabis. 

As someone who has spent the last twenty plus years of my life working toward changes in the federal scheduling of cannabis, HHS recommendations are a big deal!

No matter what happens next, the FDA has confirmed that cannabis has accepted medical use in the United States. This will no doubt have an impact on attitudes about medical cannabis, reducing the stigma, increasing the acceptance of cannabis for medical professionals, employers, state regulators, and hopefully Congress.

What’s Next: Scheduling Process

The Drug Enforcement Administration (DEA) will review HHS’s findings along with other data they deem relevant, such as their interpretations of the United Nation drug treaties, abuse potential, risks to public health, scientific evidence of pharmacological effects, amongst other things, and make the final determination. There is no time requirement for DEA to issue their findings. 

It is also important to know that the DEA does have the authority to make a determination that is different than HHS’s Schedule III recommendation. However, the key difference between Schedule I and the other schedules is that Schedule I drugs are considered to have “no currently accepted medical use in treatment in the United States.” Even without seeing HHS’s findings, we can assume that HHS has made that determination that cannabis does indeed have accepted medical value. What this means is that it is unlikely that cannabis will remain in Schedule I or that the DEA will make a more liberal determination, and we should prepare for Schedule II or III.

Realities of Schedule II or III 

Scheduled substances are highly regulated, and products that are not registered with the DEA remain illegal at the federal level, which means the manufacturing and distribution carry stiff penalties. 

For example, cocaine and methamphetamine are two well known Schedule II substances.

 The protection of individuals for possessing these substances is through a prescription, and luckily for patients the federal government rarely enforces simple possession charges. Cultivating, manufacturing, and/or distributing these substances outside the regulatory process is referred to as trafficking and still holds steep penalties.

Penalties for Trafficking Schedule III drugs

Any amount First Offense: Not more than 10 years. If death or serious injury, not more than 15 yrs. Fine not more than $500,000 if an individual, $2.5 million if not an individual.

Second Offense: Not more than 20 yrs. If death or serious injury, not more than 30 yrs. Fine not more than $1 million if an individual, $5 million if not an individual. 

Impact on State Programs, Individuals, and Companies 

In good news, because state programs operate outside the CSA, medical cannabis programs will continue to be protected from federal interference of the DEA and DOJ as long as the CJS amendment is reauthorized every year. However, rescheduling alone will not change the experience of cannabis stakeholders. Cannabis in the current state supply chains would remain illegal federally. That would mean that Congress and/or individual federal agencies would still have to create a pathway for cannabis products for any stakeholder to find relief or protection from federal statutes such as benefits, taxation, ability to travel etc.  

A Change in the Scheduling of Cannabis Creates an Opportunity, Not a Solution. 

The reality is if we want to see medical cannabis advance, Congress must step in and with FDA’s findings they should feel emboldened to do so. Even if the DEA follows the recommendations, putting cannabis in Schedule III, the country still needs Congressional leadership on these issues. 

Cannabis therapeutics are helping millions of Americans, often where all traditional options have failed or as a safer treatment option. While state-level initiatives have demonstrated the potential of medical cannabis, the lack of federal laws and regulations poses challenges for patients, researchers, and medical practitioners, keeping cannabis treatments from reaching their full potential. This won’t change with Scheduling alone.

A national medical cannabis program would fill this void, ensuring uniformity in regulations, restoring rights for medical cannabis patients, creating nation-wide access for therapeutic use and research, and forging a new, purpose-built pathway for cannabis therapeutics.

Americans for Safe Access has developed a legislative framework for a national medical cannabis program that builds on the knowledge from the state level experiment, includes input from patients, regulators, researchers, medical professionals, medical cannabis providers and patient originations, and incorporates the experience of the 65 countries with federal medical cannabis programs.  

We need to embrace this opportunity, step up and demand comprehensive medical cannabis and cannabinoid legislation from Congress! This is the only way to address the gap in state and federal cannabis policies, public health concerns, and to give federal agencies the robust guidance they are seeking. 

Now is not the time to “sit back and see what happens”. We must take this opportunity to show Congress what needs to be done. If you want to see progress being made, now is your chance to help make something happen. Join us in this fight!

 

Still confused about what is happening with Scheduling? Watch a recorded version of our live discussion webinar where we dove into cannabis scheduling, what comes next, and what it means for patients.

Review our Rescheduling Factsheet for the latest on how cannabis rescheduling works and what it means for US cannabis policy

Download a Factsheet on the 2016 Cannabis Rescheduling Denial

Breaking Update: HHS report on cannabis rescheduling 

ASA's Recommendation to HHS/FDA on Approach to Scheduling Process 

 

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