You may be wondering, with all of these changes in marijuana laws occurring around the country, is anybody monitoring these products? In terms of medical marijuana especially, is the government keeping tabs on them? Recently, as was reported previously in this newsletter, the Food and Drug Administration (FDA) approved for the first time a drug called Epidiolex which contains a purified drug substance cannabidiol. It was approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. That means the FDA has concluded that this particular drug product is safe and effective for its intended indication.
Yet that is the only prescription drug derived from the actual cannabis plant to go through the FDA approval process, which means it went through clinical trials to determine its efficacy and safety just like any other drug on the market. Three other drugs based on synthetic forms of delta-9- tetrahydrocannabinol (THC) have also been approved: Marinol and Syndros for the treatment of anorexia associated with weight loss in AIDS patients, as well as a drug called Cesamet.
The FDA does not take sides when it comes to approving a particular drug. If the data shows that a new drug is safe and effective, then there is no reason to stop an FDA approval. So why have so few drugs made it to market? The issue is with other federal agencies, such as the Drug Enforcement Agency (DEA) and the National Institute for Drug Abuse (NIDA). And there lies the problem.
Marijuana is a Schedule I drug, meaning that it is considered to have no medicinal purpose. Heroin and LSD are also Schedule I (interesting tidbit, cocaine is Schedule II drug because it has numbing properties and can be used as a local anesthetic). Research on marijuana or any of its chemicals, such as THC and cannabinol, is very difficult for scientists. It is costly and requires increased scrutiny by the DEA. Furthermore, researchers are limited to government-grown pot from either NIDA or the University of Mississippi, the lone government-sponsored lab the US to grow marijuana. Hence, many potential medications utilizing marijuana-derived compounds are just not making their way down the pike.
So what about marijuana itself, does the FDA have an issue with that? The answer is no. The FDA will approve any legitimate drug or botanical that meets its strict criteria for market approval. And just because it’s a plant does not mean that it cannot be approved. In 2004 the FDA finalized its guidelines for botanical drug products. Witchhazel is an example of an approved plant substance.
So when can we see FDA approval of marijuana? Well, if the science supports its efficacy and safety than it has no reason to bar approval. The FDA is not involved in legality issues. The main problem is there are just too many regulations and restrictions for researchers, both academic and commercial, to bother with developing a drug or studying cannabis itself as a medicinal product. The research required by the FDA is very costly and can take up to 20 years. Many developers are hesitant to invest so much time and money on these drugs only to see them fail at the end. The FDA definitely has the mandate to do that.