How Medical Marijuana Works

To some, medical marijuana is a contradiction in terms, immoral or simply illegal. But to Aldrich and numerous people in the United States and around the world, marijuana, or cannabis, represents an essential medicine that alleviates debilitating symptoms. Without it, these people wouldn't be able to treat their conditions. Aldrich thinks he would be dead without marijuana. Others, like Dr. Kevin Smith, who was also featured in these pro-medical marijuana ads, can't treat their conditions for fear of breaking the law. Smith says that, save for a trip to Amsterdam where he tried marijuana, the autoimmune disorders he suffers from have prevented him from sleeping soundly through the night for the last 20 years. Among them are nausea (especially as a result of chemotherapy), loss of appetite, chronic pain, anxiety, arthritis, cancer, AIDS, glaucoma, multiple sclerosis, insomnia, ADHD, epilepsy, inflammation, migraines and Crohn's disease. The drug is also used to ease pain and improve quality of life for people who are terminally ill. So how, exactly, does medical marijuana work to treat these conditions? Why, if this medicine is so effective for some people, does it remain controversial and, in many places, illegal? In this article, we'll take a look at the medical, legal, and practical issues surrounding medical marijuana in the United States. We'll examine why some people, like Burton Aldrich, depend on it to live normally. We'll also examine some of the intriguing intersections between pharmaceutical companies, the government and the medical marijuana industry.

Step 4: If the selected BRM or drug substance manufacturer holds a Drug Master File (DMF), the sponsor must obtain a Letter of Authorization (LOA) to reference CMC and BRM information. Alternatively, an IND submission would need to contain all necessary CMC data characterizing their study drug and ensuring it is safe for use in humans. The sponsor sends a copy of the IND and clinical protocol, including a LOA (if applicable), to FDA. FDA reviews the submitted IND. The sponsor must wait 30 calendar days following IND submission before initiating any clinical trials, unless FDA notifies the sponsor that the trials may proceed sooner. During this time, FDA has an opportunity to review the submission for safety to assure that research subjects will not be subjected to unreasonable risk. If the IND is authorized by FDA as “safe to proceed” the sponsor may then submit their clinical protocol registration application, including referenced IND number, to DEA to obtain the protocol registration. Once this is received, the sponsor contacts NIDA or another DEA-registered source to obtain the cannabis and/or cannabis-derived substances and they can then begin the study.

For nonclinical research, including research conducted under an INAD file submitted established with CVM, there is no requirement of prior authorization of the protocol by FDA before the investigators may proceed with a protocol registration application submitted to DEA. For these nonclinical protocols, investigators may immediately pursue investigator and study site licensure, and protocol registration with DEA, so they may then obtain their Schedule I cannabis-derived study drug from supplier. Sponsor obtains pre-IND number through CDER review division to request a pre-IND meeting. For new animal drug research, a sponsor may engage with CVM to establish an INAD file. A pre-IND meeting with CDER is optional, and an opportunity to obtain FDA guidance on sponsor research plans and required content for an IND submission. Sponsor provides all applicable chemistry, manufacturing, and controls (CMC) and botanical raw material (BRM) information in the IND for review by FDA, including hemp cultivars. If the selected hemp manufacturer holds a Drug Master File (DMF), the sponsor must obtain a Letter of Authorization (LOA) to reference CMC and BRM information.

Alternatively, an IND submission would need to contain all necessary CMC data characterizing their study drug and ensuring it is safe for use in humans. The sponsor sends a copy of the IND and clinical protocol, including a LOA (if applicable), to FDA. FDA reviews the submitted IND. The sponsor must wait 30 calendar days following IND submission before initiating any clinical trials, unless FDA notifies the sponsor that the trials may proceed sooner. During this time, FDA has an opportunity to review the submission for safety to assure that research subjects will not be subjected to unreasonable risk. The FDA’s role in the regulation of drugs, including cannabis and cannabis-derived products, also includes review of applications to market drugs to determine whether proposed drug products are safe and effective for their intended indications. The FDA’s drug approval process requires that clinical trials be designed and conducted in a way that provides the agency with the necessary scientific data upon which the FDA can make its approval decisions. Without this review, the FDA cannot determine whether a drug product is safe and effective. It also cannot ensure that a drug product meets appropriate quality standards.