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By: Judith Cassel and Melissa Chapaska
At just five years old, Jackson was diagnosed with Intractable-Epilepsy, a condition marked by chronic, uncontrollable seizures. Prescribed medications were not effective enough and caused harmful side effects. Despite credible research on the effectiveness of medical marijuana for children like Jackson, at that time, Jackson’s doctors were prohibited from discussing the possibility of using medical marijuana to alleviate Jackson’s symptoms.
As a parent, what do you do when your child is suffering, prescription medications are not providing relief, and doctors are prohibited from discussing a possible, safer alternative?
This question plagued Jackson’s parents, and the parents of countless other children suffering from serious medical conditions throughout the Commonwealth. Despite the emergence of medical marijuana as a possible treatment for chronic illness in children, medical marijuana remained an illegal drug in Pennsylvania. That is, until members of both parties in the Pennsylvania legislature joined together to legalize set forms and uses of marijuana for specific chronic illnesses and conditions.
Pennsylvania’s Medical Marijuana – a Bipartisan Success Story
In order to help patients like Jackson, the Pennsylvania legislature passed the Medical Marijuana Act on April 13, 2016. Praising both democrats and republicans for working together to provide “long overdue medical relief to patients and families,” Governor Wolf signed the Medical Marijuana Act into law on April 17, 2016.
In addition to legalizing medical marijuana for the treatment of 17 specific acute medical conditions, the Medical Marijuana Act acknowledged the growing need for medical marijuana research by establishing a research program.[1] The Medical Marijuana Act provides for 30% of the revenue in the Medical Marijuana Program Fund to be dedicated to “research into the treatment of those serious medical conditions for which medical marijuana is available for treatment within this Commonwealth and for research into the use of medical marijuana to treat other medical conditions for which medical marijuana may have legitimate medicinal value.”[2]
As part of the medical marijuana research program, the Medical Marijuana Act seeks to “engage universities within this Commonwealth to participate in the collection, collation, analysis and conclusive findings of the research studies.”[3] To become part of Pennsylvania’s medical marijuana research program, the Department of Health will publically announce the formation of the research study and interested universities and vertically integrated health systems within the Commonwealth will be permitted to submit requests to participate in the study.
Medical Marijuana Research and Federal Law
It is noteworthy that, unlike other provisions of the Medical Marijuana Act, the scientific research of medical marijuana is not prohibited under Federal law. Therefore, universities and health systems will not be in violation of federal law for their participation in Pennsylvania’s medical research program, so long as they adhere to federal and state regulations governing medical marijuana research.
Although the United States Food and Drug Administration (FDA) has yet to approve marijuana as a medical treatment, the FDA “supports researchers who conduct adequate and well-controlled clinical trials which may lead to the development of safe and effective marijuana products to treat medical conditions.” The FDA is responsible for reviewing medical marijuana research applications. In addition to the FDA, the medical marijuana research application must undergo review by the Drug Enforcement Administration (DEA). Following approval of the application, the National Institute on Drug Abuse (NIDA) is responsible for supplying research-grade marijuana to researchers.
However, despite the need for medical marijuana research, the path to FDA approval of a medical marijuana research study is not as straightforward as it may seem. In fact, House Representative Andy Harris recently acknowledged the regulatory hurdles faced by medical marijuana researchers. Representative Harris is attempting to clear away these hurdles through his introduction of the Medical Marijuana Research Act of 2016 on June 21, 2016. This bill aims to make marijuana more accessible for use by qualified medical marijuana researcher institutions. However, because the Medical Marijuana Research Act is still in the very early stages of the legislative process, qualified medical marijuana researchers still face the arduous process of FDA and DEA approval for the foreseeable future.
Located in the heart of Pennsylvania, Cannabis Law Solutions is experienced in navigating complex state regulatory schemes and perfectly situated to assist medical marijuana researchers in achieving their goals. Be sure to subscribe to the Cannabis Law Solutions blog for up-to-date information as the Medical Marijuana Research Act of 2016 continues to move through the legislative process. If you are a university or integrated health system looking to participate in medical marijuana research, contact us for more information on how Cannabis Law Solutions can help guide you through the regulatory process.
[1] Medical Marijuana Act at §301(a)(9).
[2] Medical Marijuana Act at §902(c)(3).
[3] Medical Marijuana Act at §1903(a).
