Alerts and Updates
Pennsylvania Department of Health Publishes Regulations on Special Medical Marijuana Clinical Research Licenses
January 8, 2018
While other states are focused on increasing the availability of nonmedical adult-use marijuana, Pennsylvania seeks to become the leader in clinical research on the medical benefits of cannabis.
The Pennsylvania Medical Marijuana Act uniquely provides for a special class of licenses for growers and dispensaries to partner with medical schools to undertake real clinical research on medical marijuana.
On January 3, 2018, the Pennsylvania Department of Health (DOH) published for comment the final clinical registrant regulations. The process of issuing these licenses will be underway shortly. While other states are focused on increasing the availability of nonmedical adult-use marijuana, Pennsylvania seeks to become the leader in clinical research on the medical benefits of cannabis.
Standards for Medical Research
One of the significant issues in medical marijuana is the lack of peer-reviewed clinical research studies on the efficacy of various strains of cannabis in the treatment of a range of medical conditions from arthritis to epilepsy to Parkinson’s disease. Although there have been research studies in the United States, most of those studies have not met FDA standards. This is the primary reason why the FDA has refused to change the classification of marijuana from a Schedule 1 narcotic. In August 2016, the FDA reviewed existing clinical studies on the medical applications of marijuana and found that out of 85 reviewed papers, there were only 11 that met FDA standards for “adequate and well controlled studies.” Among other factors, the studies must be placebo-controlled; the subjects must be qualified as having a specific medical condition being studied; the study design must have control groups; and the assignment of people to treatment and control groups must be randomized. There must also be use of double-blind study design and the study report must contain a full protocol and primary data. Most of the studies failed in some or all of these areas.
Additionally, there is a preliminary issue with the quality and consistency of the product being studied. Unless a grow facility meets the FDA’s current good manufacturing practice (CGMP) standards, the products that are being studied will lack the consistency and quality to produce legitimate test results. CGMP facilities are far more expensive to construct and operate than the typical greenhouse model, and true CGMP facilities are rare among medical marijuana growers.
The Pennsylvania regulatory scheme is intended to address deficiencies often found in medical marijuana clinical research. Chapter 20 of the Pennsylvania Medical Marijuana Act designates as an academic clinical research center (ACRC) any medical school within the commonwealth that operates or partners with an acute care hospital licensed within Pennsylvania. An ACRC also partners with a grower/processor and dispensary operator. This grower/dispenser partner is termed a clinical registrant (CR) and will be the entity that receives the permit to grow and dispense. It must meet the same criteria as the growers and dispensers in Phase One of the state’s program. There will be eight CR licenses issued and these licenses are in addition to the other licenses permitted under the statute. Each CR can open up to six dispensaries.
The DOH draft regulations provide that ACRCs must apply to the DOH for certification. Included within the application must be evidence that the medical school is accredited by the Liaison Committee on Medical Education or the Committee on Osteopathic College Accreditation; evidence that the acute care hospital holds a valid license from the DOH; and disclosure of any payments that were made by any person affiliated with a clinical CR to obtain a relationship with the ACRC.
After the ACRC is approved, the CR then applies. The CR application must include a completed grower/processor application and dispensary application in a similar form to the ones in Phase One. Also included with the application must be a copy of the contract with the ACRC and an identification of the clinical studies that will be conducted in the dispensaries. Under the regulations, no CR dispensary may open without a clinical study at the dispensary beginning within six months of the opening of that dispensary.
As far as the studies are concerned, they must be approved by an institutional review board or internal research approval committee, as would a clinical study in any field of medicine. The study must be approved by the DOH as well. The regulations lack any specific guidance on the studies or criteria DOH will use to evaluate them. Nor is there any guidance on the subject areas of the studies.
Moreover, the overall statutory and regulatory scheme presents other challenges to clinical research. The product must be dispensed at the dispensary by the personnel authorized to do so, such as a pharmacist or medical assistant working under the pharmacist’s supervision. The doctor conducting the study cannot be the one to dispense the product. And the product cannot be administered on the premises of the dispensary, making it difficult to monitor proper dosing for the study. Potential ACRCs and CRs are working on study designs to overcome these challenges.
Pennsylvania’s CR program is a unique among state medical marijuana programs. If it is implemented as intended, Pennsylvania may become a leader in medical marijuana research. However, the regulations relating to CR program are complicated, and require thoughtful analysis as to how it can be successfully implemented, especially given the current federal prohibition of cannabis as a Schedule 1 drug under the Controlled Substances Act, 21 U.S.C. § 801 et. seq.
For More Information
If you have any questions about this Alert, please contact David E. Landau, Seth A. Goldberg, any of the attorneys in our Cannabis Practice Group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.