RE:RE:DEA HHS ignoring Medical Cannabis Law action The lawmakers sent the letter after HHS missed a Dec. 2, 2023, deadline to provide Congress with a report on the federal barriers to cannabis research, as directed in the law, according to Blumenauer’s office.
“We are deeply troubled by recent reporting that the Medical Marijuana and Cannabidiol Research Expansion Act is not being implemented in line with congressional intent. It is unacceptable that researchers continue to face harmful barriers to cannabis research after Congress expressly encouraged research into this substance,” Blumenauer and Harris wrote. “More than 150 pending research applications for studies into cannabis and related products have yet to receive an approval or denial from the U.S. Food and Drug Administration (FDA), and many more researchers are excluded through the U.S. Drug Enforcement Administration’s (DEA) licensing process, which has not been adequately updated.”
Under the act, the Attorney General has no more than 60 days after receiving a “complete” research application to approve the application or request additional information from the applicant. The Attorney General then has no more than 30 days to approve or deny an application after receiving the additional information requested.
“Additionally, Congress has yet to receive a report on the potential therapeutic effects of cannabis and barriers to research on state- or locally legalized marijuana despite the law mandating this report be sent a year after enactment,” the congressmen wrote.
The act states that “Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in coordination with the Director of the National Institutes of Health and the heads of other relevant Federal agencies, shall submit to the Caucus on International Narcotics Control, the Committee on the Judiciary, and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce and the Committee on the Judiciary of the House of Representatives a report on” various therapeutic and other effects of marijuana (and delta-9 THC) and cannabidiol as well as on “the barriers associated with researching marijuana or cannabidiol in States that have legalized the use of such substances” and recommendations for removing those barriers.
The congressmen noted the barriers that exist (but have not been reported by the DEA and HHS) “signal ineffective implementation” of the act, and they are requesting from Becerra and Milgram the following additional details regarding the implementation, as outlined in the letter:
- What is the standard timeline for FDA to issue a decision to approve or deny cannabis-related research applications?
- How does this compare to timelines for research that is not cannabis-related?
- How many research licensing applications are pending before DEA?
- What is the average timeline for DEA to approve or deny license applications related to cannabis?
- What caused the Department of Health and Human Services (HHS) to miss the Dec. 2, 2023, deadline to report to Congress on potential impacts of cannabis and barriers to research?
- What is HHS’ target deadline to transmit this report to Congress?
- What specific steps are HHS and the DEA taking to ensure that congressional intent to streamline research registration and expand research on cannabis is reflected in updated processes for research application processing and approvals?
“While Congress works to address the impacts of the federal-state gap on cannabis policy, the urgency of improved implementation of our Medical Marijuana and Cannabidiol Research Expansion Act must inform the Administration’s engagement with researchers,” Blumenauer and Harris wrote. “Congress passed this legislation with robust bipartisan, bicameral support because increasing research into the impacts of cannabis requires timely action. We look forward to your response and to your proactive engagement to reflect congressional intent in the implementation of the law.”
CBT contacted the DEA and HHS for comments but had not received a reply as of press time.