FDA Enters the Cannabis Industry
The Food and Drug Administration (FDA) has reviewed and approved cannabis clinical trials before but this is the first time FDA enters the cannabis industry and any State law has directed the State to create a cannabis clinical trial and involve growers, health care systems, and cannabis patients. The Commonwealth of Pennsylvania is the most recent State to join the list of medical marijuana States. Governor Wolf signed Senate Bill 3 into law on April 17, 2016. The date alone fascinates me. The signing of the bill into law occurred one day before my birthday and three days before 4/20. A close second is FDA’s involvement with a section of the law that is unprecedented in the industry.
Quantum 9‘s FDA Cannabis Consultant Steve Goldner stated the following “This is not surprising to me because running clinical trials through the FDA system ensures the patients are protected and the data is solid. Companies that want to excel in the cannabis industry will follow FDA guidelines. Quantum 9 has a team of FDA attorneys and grant writers to help guide companies down the FDA path. This is our attempt to give structure to the marijuana industry where federal guidelines do not currently exist.”
Here is a link to the Bill: Senate Bill 3
In Chapter 19 of Pennsylvania Senate Bill 3, it covers the responsibility of a Research Program. The FDA was mentioned for the first time in medical marijuana law. One of the five vertically integrated Pennsylvania medical marijuana license holders is to participate in a research study. This includes the petitioning of the FDA to start a research study. The research program is being created to: …STUDY THE IMPACT OF MEDICAL MARIJUANA ON THE TREATMENT AND SYMPTOM MANAGEMENT OF SERIOUS MEDICAL CONDITIONS. Page 152.
The Bill states “(3) WHEN THE DATABASE CONTAINS 25 OR MORE PATIENTS WITH THE SAME SERIOUS MEDICAL CONDITION, PETITION THE UNITED STATES FOOD AND DRUG ADMINISTRATION AND THE UNITED STATES DRUG ENFORCEMENT ADMINISTRATION FOR APPROVAL TO STUDY THE CONDITION AND THE IMPACT OF MEDICAL MARIJUANA ON THE CONDITION. (4) CONCURRENT WITH THE REQUEST TO THE UNITED STATES FOOD AND DRUG ADMINISTRATION AND UNITED STATES DRUG ENFORCEMENT ADMINISTRATION, PUBLICLY ANNOUNCE THE FORMATION OF A RESEARCH STUDY TO WHICH A VERTICALLY INTEGRATED HEALTH SYSTEM AND A UNIVERSITY WITHIN THIS COMMONWEALTH MAY SUBMIT A REQUEST TO PARTICIPATE.” Page 151.
As a marijuana consulting firm this is huge news for the industry, petitioning the FDA is a small start but a huge move by the Commonwealth of Pennsylvania.
This means once the FDA approves the study, Pennsylvania program administrators will select one of the five vertically integrated license holders to conduct the research study and “DESIGNATE THE FORM OR FORMS OF MEDICAL MARIJUANA WHICH WILL BE USED TO TREAT THE SERIOUS MEDICAL CONDITION.” The best thing about this research study is that it has an alternative or “plan B”.
If the FDA rejects the petition for the research study the Pennsylvania State administration will do it anyway and try to fund it themselves. Cannabis provisioned for the study will be free for the patient! Please sign me up. The research study requires that the vertically integrated company keep daily logs dispensed to the patient. This Research Study is a huge step in the right direction. The project does not directly involve the FDA. However, the petitioning could mean the approval from the federal government to research cannabis.
About Quantum 9
Quantum 9 has been at the forefront of marijuana law since the first 2009’s for-profit model in Colorado. The firm is lead by expert marijuana consultant Michael Mayes. The Quality Assurance and FDA division are lead by Steve Goldner. Mr. Mayes has successfully obtained 24 licenses including cannabis cultivation, processing, and dispensing legal marijuana. Mr. Goldner has successfully obtained FDA approval for 244 products including his formulation, Methadone.
Quantum 9 is an international marijuana consulting firm. It has practiced in 12 countries including US territories like Puerto Rico and Guam. If you are looking for help obtaining a license or are looking to bring your facility to FDA standard, please contact us at firstname.lastname@example.org or call 888-716-0404. You can also fill out the form below.