On Oct. 6, 2022, President Joe Biden issued a public statement on cannabis policy reform, indicating a potentially seismic shift in how the substance may be treated under federal law. Among President Biden’s directives was a request that the secretary of Health and Human Services (“HHS”) and the attorney general initiate an administrate process to review cannabis’s classification under federal law. While this has the potential to lead to sweeping changes by way of rescheduling or even descheduling cannabis, this process is often time intensive and does not easily achieve quick results.
Since 1970, cannabis has been classified as a Schedule I substance under the Controlled Substances Act (“CSA”), which delineates six categories of substances from Schedule I to unscheduled. Schedule I drugs are considered the most dangerous, with “no currently accepted medical use in treatment in the United States” and having the “highest potential for abuse.” Other substances classified as Schedule I include heroin and LSD, whereas cocaine and methamphetamine are currently classified as Schedule II.
While this certainly is not the first time efforts have been made to reschedule cannabis, the latest of which was denied by the Food and Drug Administration (“FDA”) in 2016, it does indicate further progress toward removing barriers that have long restricted the cannabis industry.
But expectations surrounding this progress should remain tempered, particularly given the lengthy and often arduous process of rescheduling or descheduling substances under the CSA. Before a drug may be reclassified, the CSA contemplates a formal on-the-record, trial-like rulemaking spearheaded by the attorney general, who has delegated his authority to the Drug Enforcement Administration (“DEA”), a process that requires participation from numerous federal agencies and the public.
Before the DEA may initiate proceedings to control a drug or substance or to remove a drug or substance from the CSA schedules, the DEA must request a scientific and medical evaluation from the secretary of HHS, as well as the secretary’s recommendations as to whether the drug should be so controlled or removed as a controlled substance. The HHS secretary has in turn delegated the authority to prepare this scientific and medical evaluation to the FDA.
This scientific and medical evaluation required under the CSA involves consideration of several factors, including scientific evidence of the substance’s pharmacological effect, the state of current scientific knowledge regarding the substance, any public health risk posed by the substance, the substance’s potential for abuse and dependence, and liability for the substance’s psychic or physiological dependence.
Once the FDA engages in this evaluation, the HHS secretary then provides recommendations as to the substance’s appropriate schedule. The binding evaluation and recommendations of the secretary must be made in writing and submitted to the DEA within a reasonable time, which in actuality could be many years. In other words, if the HHS Secretary recommends that a substance not be controlled, the DEA cannot schedule the substance.
If the DEA concludes that the relevant data constitutes substantial evidence of potential for abuse such as to warrant control of the drug or substantial evidence that the drug should be removed entirely from the schedules, it must then initiate proceedings for control or removal, as the case may be, under a formal hearing process governed by the Administrative Procedures Act.
As the steps and science required by the process illustrate, rescheduling or descheduling a substance under the CSA is no easy feat. Indeed, past efforts to reschedule or deschedule drugs shed light on how this process can often take up to a decade to yield a result.
For instance, in 2004, the DEA received a petition to reclassify hydrocodone combination products (“HCPs”) from Schedule III to Schedule II. The FDA did not complete its scientific and medical evaluation until 2008, four years after receiving the request from the DEA. The FDA’s initial evaluation recommended that HCPs remain classified as Schedule III, but in 2009, the DEA requested that the FDA re-evaluate its recommendation. It was not until 2013 that the FDA recommended HCPs be reclassified as a Schedule II drug, which did not become official until 2014, a decade after the DEA first fielded the petition animating the process.
Although HCPs faced a protracted rescheduling process, other substances have fared relatively better as far as timing. For example, a pharmaceutical company submitted a petition to the DEA in 1995 for the reclassification of Marinol, a drug geared toward the treatment of anorexia associated with weight loss in patients with AIDS, from Schedule II to Schedule III. After conducting its own analysis, the DEA submitted a request to the HHS secretary for a scientific and medical examination in 1997, which was completed in 1998. Once the reclassification went through the formal rulemaking process, Marinol was officially deemed a Schedule III drug in 1999.
The completed rescheduling of HCPs and Marinol demonstrates the wide variation in timeline, ranging anywhere from four to 10 years. Other substances, such as a cocaine derivative currently being considered by the DEA, continue to move forward toward reclassification with no end in sight. A petition was submitted in 2018 to remove this cocaine derivative, which is used by patients with suspected Parkinsonian syndromes, as a Schedule II drug. The DEA did not receive a scientific and medical recommendation until April 2021. Although a notice of proposed rulemaking was issued in November 2021, there appears to be no update in that rulemaking. Thus, it remains to be seen whether this particular drug will be successful declassified and, if so, when.
Through these examples, it becomes clear that President Biden’s directive to examine the federal classification of cannabis may face a long path. And of course, in light of this drawn-out process, Congress could well supersede the president’s initiative through cannabis legislation. As the cannabis industry waits for federal policymakers in Congress and the executive branch to address issues relating to the status of cannabis under federal law, our attorneys are ready to help these businesses continue to navigate this complex legal landscape.
This document is intended to provide you with general information regarding the process to reschedule or deschedule a drug under the Controlled Substances Act. The contents of this document are not intended to provide specific legal advice. If you have any questions about the contents of this document or if you need legal advice as to an issue, please contact the attorneys listed or your regular Brownstein Hyatt Farber Schreck, LLP attorney. This communication may be considered advertising in some jurisdictions. The information in this article is accurate as of the publication date. Because the law in this area is changing rapidly, and insights are not automatically updated, continued accuracy cannot be guaranteed.