DEA Denies Marijuana Rescheduling Petition, Eases Research Restrictions
- DEA will not reschedule marijuana unless the FDA determines the drug has a medical use.
- DEA’s new research policy will hopefully facilitate future necessary medical research.
Ending months of speculation, the Drug Enforcement Administration announced yesterday that it declined to down-classify marijuana from Schedule I of the Controlled Substances Act for the fifth straight time. In making its decision, DEA relied heavily on the recommendations made by the Food and Drug Administration, namely that marijuana has no “currently accepted medical use” because: the drug's chemistry is not known and reproducible; there are no adequate safety studies; there are no adequate and well-controlled studies proving efficacy; the drug is not accepted by qualified experts; and the scientific evidence is not widely available.” FDA further noted in its recommendation that marijuana lacks accepted safety for use under medical supervision, because there are no marijuana products approved by the FDA, nor is marijuana under a New Drug Application evaluation at the FDA for any indication. In a separate statement, Acting DEA Director Rosenburg explained that “[t]his decision isn’t based on danger. This decision is based on whether marijuana, as determined by the FDA, is a safe and effective medicine.”
As we noted previously, rescheduling marijuana could open the door to additional medical research using the drug and its derivatives by easing restrictions for researchers. Although DEA did not reschedule the drug, it has taken a novel approach of reducing some of the barriers to researching marijuana and its derivatives. In a separate notice, the DEA published a Policy Statement outlining how it intends to treat future applications under the CSA to become registered to grow marijuana for medical research, with the intent of increasing the availability of marijuana to better facilitate future medical research efforts. The Policy Statement notes the following considerations related to such future applications:
- Each application for registration that DEA receives will be evaluated individually based on its own merit;
- DEA will consider whether the applicant has previous experience handling controlled substances in a lawful manner and whether the applicant has engaged in illegal activity involving controlled substances (in this context, illegal activity includes any activity in violation of the CSA (regardless of whether such activity is permissible under State law) as well as activity in violation of State or local law.
- Applicants should anticipate that, in addition to the information requested in the application itself, they will be asked to submit other information germane to the application, including, in part, detailed information regarding an applicant’s past experience in the manufacture of controlled substances.
- Applicants will also be asked to provide a written explanation of how they would be able to augment the nation's supply of research-grade marijuana in compliance with the CSA.
- Approved applicants may only grow marijuana to supply DEA-registered researchers.
So, it seems that DEA will not reschedule marijuana unless the FDA determines the drug has a medical use. Yet FDA cannot determine that the drug has a medical use, in part because of the onerous research restrictions imposed by DEA. Hopefully, DEA’s new research policy will facilitate the much-needed medical research.
Arent Fox will continue to follow and report on developments involving state and federal regulation of cannabis and related regulatory and safety issues. Please contact James R. Ravitz, Emily M. Leongini, or James H. Hartten for further assistance.