FDA Approved Cannabis Research: What is happening behind the scenes?
As marijuana culture moves forward into a legalized future, and medical marijuana rises in demand as medical research continues, you may be wondering what happens behind the scenes. There’s a lot of push-back from the Federal Government where marijuana is concerned, and presently the ability to state that marijuana officially helps with a disease or condition is strictly limited. This is typical of a substance currently classified as schedule 1, so it's remarkable that any cannabis products have been approved at all.
The FDA has been supporting the research and development of marijuana-based substances as part of its internal process. This includes providing specific information on how to conduct sound scientific research on the effectiveness of cannabis and outlining what steps are involved in developing a drug that can be used on humans. The process is somewhat complicated, and not understanding it can lead to problems with successfully obtaining supporting research.
An important part of this process is working closely not only with the FDA, but also with the Center for Drug Evaluation and Research (CDER). Specific qualifications are needed for those performing the clinical studies, and informed consent must be obtained from those who are participating in any related studies.
Following these protocols are essential to anyone trying to produce meaningful research, a situation which is complicated due to Marijuana's schedule 1 status. This status means that other federal agencies have to be involved with the entire process, which slows down research at every step. These agencies and their requirement are as follows:
- DEA Investigator Registrations are necessary on a per-site basis, the specific details of which can be found under 21 CFR 1301.18.
- NIDA (The National Institute on Drug Abuse) provides marijuana suitable for scientific study through the Drug Supply Program. The DEA registers NIDA to oversee marijuana cultivation at appropriate secure facilities. Additional growers have the opportunity to attempt to register through the DEA.
- Either an INAD or IND application (investigational new animal drug and investigational new drug, respectively) must be filed with CDER, mentioned earlier.
The official position of the FDA is to encourage cannabis-related research provided that said research is performed through the proper methods. These methods are designed to ensure that the data collected is of the highest possible integrity and within the bounds of good practices of the scientific method. This data will be used to determine if the drugs are both safe and effective for the indicated health conditions.
In the past the FDA and DEA have been staunch enemies of marijuana culture, seeking to suppress it and any suggestion that it may be medically effective. Now, however, they are becoming allies of the process. Bureaucracy has its benefits but is also a slow and often tedious process that can impact its own professed goals. We can only hope that as the process continues we’ll see a relaxing of the laws surrounding cannabis research so that those in need of the amazing healing properties of our favorite herb can benefit from it.