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Official websites use. Share sensitive information only on official, secure websites. Jleheste nyit. While the use of medical and recreational cannabis is rapidly expanding under state jurisdiction, the convolution of federal regulations is obstructing research progress to the detriment of healthcare equity and the protection of vulnerable populations, such as the underaged. Senate bill S. This goes together with a reinforcement of the legal protection that practitioners have acquired over years of litigation with the federal government when working with their patients. The bill passed the U. Senate on March 24, Joerg R. Keywords: Health policy, US congress, Marijuana, US senate bill S, The cannabidiol and marijuana research expansion act S , Public health, Research, Medicinal marijuana, Recreational marijuana, Developmental delays and damages, psychosis, Access of care issue, Quality of care issue. Recently, the United States has experienced groundbreaking shifts in policy and public opinion regarding the promotion and use of cannabis and its compounds. Cannabis remains illegal at the Federal level under the Controlled Substances Act CSA as a Schedule I drug, without currently accepted medical use, a high abuse potential, and a lack of accepted safety for use under medical supervision. This is true, for example, for various types of chronic pain, affecting its suitability as an adjunct or replacement for opioids. Many from the scientific community argue that the deficit of rigorous research is primarily a result of the burdensome regulations associated with obtaining a Schedule I research license through the DEA. Additionally, there are increasing reports of individuals obtaining cannabis to treat or palliate serious medical conditions for which there is little, if any, evidence of benefit. The US is amongst the nations that have expanded federal research funding considerably over the past two decades; however, the primary federal research focus remains locked on abuse rather than therapeutic potential. Analysis of project grants awarded by NIDA from to reveals that the three most funded areas of research were related to the physical, psychological, and social effects of cannabis, the treatment of cannabis use or abuse, and the endocannabinoid system. Although there has been an upward trend in federal funding for research examining the therapeutic use of cannabis there is an emphasis on its negative health effects. Projections by the computerized reporting process of the NIH, the Research, Condition, and Disease Categorization RCDC for and , are indicating small increases in cannabinoid research funding clearly earmarked for therapeutic purposes. However, the limited stratification of the RCDC precludes any further analysis along the same lines as above. Most funds focus on drug abuse and adverse mental effects. The data gathered so far also lacks practical value because the widely used strains and potencies that are available through the state dispensaries differ significantly from what has been the sole federal source of cannabis for research purposes for the past 50 years, until recent policy changes which took effect on January 19, The Drug Enforcement Agency DEA oversees the process through which scientists are certified to conduct research with cannabis and other controlled substances. Current policy dictates that to initiate a Schedule I research registration involving human subjects, an investigator must first fulfill the requirements set forth by their respective state authority e. Investigators conducting in-vitro laboratory studies or research using animal subjects are not reported to encounter the same administrative burdens or registration delays, as these protocols are subject to less scrutiny and requirements compared with those involving human subjects. As with any other drug being studied in a clinical trial, researchers must initiate an investigational new drug IND application with the FDA Center for Drug Evaluation and Research CDER , Office of New Drugs OND , in which the study drug pharmacology, preclinical data, manufacturing information, and protocol design are assessed along with investigator qualifications to ensure that the research does not pose unreasonable risks on human subjects. Investigators are also encouraged to consider submitting drug master files DMFs , which are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs are not required by statute or regulation but allow parties to reference material without disclosing DMF contents to those parties, particularly proprietary information about the product. If the desired cultivar, or plant variation, is available through the NIDA DSP or another DEA-approved manufacturer, the investigator can request information on that particular study drug in order to fulfill the IND application requirements. A researcher may proceed with a protocol 30 calendar days after the submission of an application unless otherwise notified, as in the case of a clinical hold if there are deficiencies identified in any component of the application. If a clinical hold is imposed, an investigator may address discrepancies or safety concerns. The FDA will respond within 30 days as to whether the deficiencies are resolved and the study can proceed. In the circumstance that a study sponsor or investigator is not granted an LOA, or if a detailed analysis for a specific strain is not available, researchers must first apply for a DEA registration in order to procure the drug product for the purpose of chemistry, manufacturing, and controls analysis. Once the DEA receives a complete application for a Schedule I research registration, containing investigator information, the research protocol, facility storage and security provisions, as well as notice of institutional and IND approval, an assessment of the protocol, facility, and investigator credentials can proceed. However, if the DEA administrator identifies discrepancies in the application or protocol that require the submission of supplemental information, there are no subsequent measures in place that would ensure swift remedial processing Figure 2. These complexities involving multiple protocol reviews and uncertainties regarding timelines put a bias on all Schedule I drug research which impedes scientific progress. For instance, the urgent need for more research on fentanyl, in the context of the opioid overdose crisis, was outlined in congressional testimony by Nora Volkow, MD, Director of NIDA, in which she described the Schedule I research registration process as problematic, in need of an overhaul, and confusing to even experienced researchers. The total registration process is currently divided into a pre-registration left and a registration process right. Prior to initiating a Schedule I research application with the DEA, investigators must obtain approval and documentation from their respective state authority and IRB. A researcher who seeks federal funds to conduct a study will often submit their protocol to be assessed by one of the science-focused federal institutions as part of a grant review. Obtaining drug product and a Letter of Authorization LOA has been a notable barrier for researchers as cannabis from NIDA DSP, the single federal source of cannabis before a recent DEA policy change, has been described as poor quality, of limited variety, and often available in limited or insufficient quantities. As of May , an additional six manufacturers have been licensed to manufacture cannabis for research purposes. Regulatory hurdles and delays have been reported at every step of these processes yellow , well before the DEA will consider an applicant. Currently, as the DEA evaluates the safeguards in place to prevent drug diversion, the protocol is forwarded within seven days after receipt to CDER. Within 30 days the CDER is expected to report back to the DEA and provide commentary on the merits of the protocol and researcher qualifications, as well as a recommendation as to whether a Schedule I research registration should be issued. The DEA will conduct one or more site inspections to ensure that adequate security measures are in place to prevent the diversion of cannabis. These visits are reported to create further delays in obtaining a research registration, as local field agents assess security measures at their own discretion, which may result in unforeseen modification requests. If enacted, the DEA will be bound by a day window in which federal agency review, supplement requests, and researcher certification must come to completion. Furthermore, once any supplemental materials are received, the AG would be required to issue or deny the registration within 30 days. If an application is rejected, S. This is another source of concern for investigators, as it creates delays during active and ongoing research or clinical studies. In this case, a registration would be issued within 47 days green. However, the DEA reports an average processing time of 52 days once an application is complete. Any supplemental material must be requested by the DEA within 60 days. Upon receipt of a supplemental application, the DEA would be required to grant a registration or denial with a written explanation within 30 days. Protocol amendments are processed and assumed to be accepted within 30 days of receipt by the DEA unless they involve changes in drug quantity, source, or storage conditions. If any of the latter is required, the researcher may provide supplemental information detailing the necessary safeguards taken. In these circumstances, the Attorney General AG must provide written approval or instructions to modify the protocol accordingly within 10 days of receiving an amendment. Although the DEA reports having decreased the whole approval time, including other federal and local protocol reviews, from days in to days in , researchers continue to encounter regulatory obstacles from every angle of oversight. In February , the DEA implemented an electronic application service, to which they attribute the shorter processing time of complete registration applications. Instead, the presentation cited a lack of appropriate state approval, clerical discrepancies, and record-keeping errors as the primary causes of registration delays, thereby discounting any need for reform. The increase in registrants and decreased protocol approval time may, in part, be a result of the enactment of the Improving Regulatory Transparency for New Medical Therapies Act H. Concerning redundant protocol reviews, S. Researchers have reported that the NIH, FDA, and DEA have been overly critical in reviewing study protocols, often requesting extraneous supplemental information, protocol modifications, and costly adjustments, such as instrument calibrations. Under the United Nations Single Convention on Narcotic Drugs of , only one federal agency can oversee the production and distribution of cannabis in the United States. Scientists have continually expressed that cannabis from NIDA DSP has been of limited value, as its constituents and pharmacologic properties do not represent the multitude of cannabis strains and formulations available to patients and consumers throughout the states. In the past, this has led to spoilage due to microbial contamination and additional constraints for researchers. In , the DEA issued a statement outlining a new approach to increase the number of federally authorized cannabis growers in the US. In December , after several years of interjection from the DOJ Office of Legal Counsel over concerns of treaty and CSA obligations, the DEA published a final ruling indicating that the agency would begin granting registrations to additional manufacturers for research purposes. In response to public concerns that there will be registration delays due to over 50 pending applications, the DEA administrator indicated that because of the applicant review process required for diversion control, the agency will not adhere to a time frame; at the same time where a need for further reform has been denied, as previously described. Additionally, under the new policy, there are concerns that the DEA will deny the applications of capable and experienced manufacturers who supplied state-legal dispensaries in the past. The DEA stated that such prior illegal conduct will be weighed, on a case-by-case basis, when assessing the diversion risks and trustability of a facility and its operators. To date, six applicants have been registered to bulk manufacture cannabis for research purposes. Accordingly, there are provisions in S. The Senate bill focus will also require the Attorney General to evaluate the supply of cannabis to ensure that adequate quantities and varieties are available to investigators. The recent policy changes implemented by the DEA do not remove or lessen the current federal regulatory obstacles or delays that researchers must navigate in order to obtain Schedule I research registration. Having access to relevant strains may offer incentive for researchers who are otherwise deterred by the burdensome registration process, though the researcher registration process remains status quo for now. The bill also contains provisions that permit the use of hemp as a source of cannabis and cannabis-derived compounds, with less than 0. Of the antidepressant trials and 30 antiepileptic trials, there were none examining the efficacy of cannabis or cannabinoids. Since this publication, RCTs investigating the safety and efficacy of cannabidiol in the treatment of certain seizure disorders have been executed resulting in the FDA approval of epidiolex. Federal law, specifically the CSA, prohibits healthcare providers from prescribing cannabis, as this would align with aiding or abetting the acquisition of a schedule I controlled substance. In November , the passage of Proposition The Compassionate Use Act 46 in California and Proposition Drug Medicalization, Prevention, and Control Act 47 in Arizona decriminalized the physician-recommended use or cultivation of cannabis for patients with serious illnesses. Within weeks after these initiatives were enacted, the Director of the Office of National Drug Control Policy promulgated the federal government's policy in a statement declaring that recommending or prescribing Schedule I controlled substances is a violation of federal law that will result in the revocation of physicians' DEA licenses. Walters, F. For instance, the DOJ adopted starkly different policies contrasting the Obama and Trump administrations regarding actively enforcing federal cannabis policy in states that permit its use for medicinal or recreational purposes. The agency has also launched investigations and revoked the DEA licenses of physicians who issued too many certifications for medical cannabis or recommendations for high plant counts. In , after the Ogden memo was released indicating that the Obama Administration would not interfere with state cannabis policy or prosecute individuals compliant with state law, Massachusetts physicians who were affiliated with cannabis dispensaries were targeted by the DEA and presented with the ultimatum to either sever ties with dispensaries or risk revocation of their DEA license, a consequence that could severely limit a clinician's practice. To expand treatment equity and uphold the doctor-patient relationship, S. Walters permanent injunction, creating another layer of protection for physicians who choose to recommend medical cannabis. State medical boards overseeing medical cannabis programs often provide practitioners with guidelines that aim to prevent exposure to federal law. Physicians are urged to exercise caution regarding their dialogue and recommendation of cannabis. The Medical Board of California, like other state government agencies, lays out the guidelines for physicians participating in medical cannabis programs, including qualifying conditions, informed and shared decision making, physician conflict of interest, and more. Additionally, a recommendation should never contain any instruction that directs a dispensing facility to prepare or dispense the product to their patient. Many physicians find these restrictions to be contrary to the principles and methods enforced by their medical training and often cite this discrepancy as a primary reason for not considering medical cannabis treatment options for their patients. Along with the legal and procedural hurdles practitioners encounter in these circumstances, the clinical data that could provide guidance regarding optimal and safe dosing, routes of administration, and appropriate formulations for specific conditions remains scarce. Obtaining informed consent indicating that the potential side effects, including psychomotor and cognitive impairment, have been thoroughly discussed with the patient is highly encouraged by legal experts to protect physicians against malpractice liability. Recently, there has been more of a legislative focus to enhance the doctor-patient relationship, standard of care, and medical evaluation for medical cannabis patients, particularly in jurisdictions with legal programs. Over time, states have been implementing mandatory training courses for physicians who wish to certify patients for medical cannabis. As medical knowledge on the pharmacology of cannabis and its clinical applications increases, it will be vital to step up and extend proper training and certification not only to physicians but also to all allied healthcare trainees to ensure a continuum of knowledge and good clinical decision making. At the same time, it will be important to continue to ensure best practice and patient safety by continuing to investigate physicians who may have acted in their own rather than their patient's interest by granting access to medical cannabis without fulfilling basic responsibilities as physicians. The negative health effects of cannabis have been studied to a much greater extent but even so, the accepted assessment of potential harms may be an underestimate due to the less potent variety of cannabis reserves used for research. Acute adverse effects of cannabis use include altered sensorium, cognitive deficits, psychomotor delay, tachycardia, and paranoia or psychosis. Individuals who begin using cannabis during adolescence are more vulnerable to these adverse effects and may have lower psychosocial and educational outcomes later in life. Research suggests that cannabis use may increase the risk of myocardial infarction and stroke. Cannabis use prior to operating a vehicle or machinery is known to alter a driver's abilities and judgment, increasing the risk of motor vehicle accidents — a fact that is especially problematic in young drivers. Edible products available through state markets often resemble common snacks, such as brownies and fruit chews. The packaging and branding containing these commonly sought products are also known to mimic that of common foods and candies. While the official federally sanctioned application process is slow and full of hurdles, state-level decisions on medical and recreational use of cannabis are guided significantly by popular perception and demand, leaving many individuals uninformed of the associated risks and vulnerable to negative sequelae. Due to the indecision associated with data collection across states, surveillance capacity has been constrained, as well as the reach of policymaking to mitigate outcomes such as motor vehicle crashes, psychosocial disparities, and economic burdens. Title IV of the Senate bill specifically addresses these public health concerns, mandating federal health and science agencies to research and report on the upward trend in THC potency and the adverse health effects of cannabis, particularly on adolescents and developing fetuses, as well as motor vehicle or heavy machinery operators. The critical data obtained from this mandated research can guide federal and state government officials and law enforcement agencies in establishing effective regulations and harm reduction strategies such as potency caps, labeling, and packaging requirements, and national highway safety regulations. As a library, NLM provides access to scientific literature. Lancet Reg Health Am. Find articles by John M Purcell. Find articles by Tija M Passley. Find articles by Joerg R Leheste. Collection date Oct. Open in a new tab. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel.

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