FDA Supports Medical Marijuana Research
On June 20, 2014, the FDA released a statement indicating its support of research into the use of marijuana for medical purposes. Currently, marijuana is classified as a Schedule I drug by the Drug Enforcement Agency (DEA). Schedule I drugs are defined as “drugs with no currently accepted medical use and a high potential for abuse.”
Despite the DEA classification and the lack of FDA approval of marijuana for any reason, an ever-increasing number of states are legalizing the use of marijuana as a legitimate treatment for a variety of health conditions, many of which involve chronic pain. I suspect the fact that so many states are “going rogue” is what motivated the newly-released statement.
The FDA Statement
The FDA's statement begins, “The FDA understands that caregivers and patients are looking for treatment options for unmet medical needs. In some instances, patients or their caregivers are turning to marijuana in an attempt to treat conditions such as seizures and chemotherapy-induced nausea.”
Following warnings about the dangers of using untested drugs and an explanation of the FDA's role in the drug approval process, the statement addresses the FDA's position regarding medical marijuana research.
“The FDA also has an important role to play in supporting scientific research into the medical uses of marijuana and its constituents in scientifically valid investigations as part of the agency’s drug review and approval process. As a part of this role, the FDA supports those in the medical research community who intend to study marijuana.
“The FDA also supports research into the medical use of marijuana and its constituents through cooperation with other federal agencies involved in marijuana research. Conducting clinical research using marijuana involves interactions with other federal agencies:
The FDA reviews the IND [investigational new drug] application and the research protocol submitted by the applicant.
The Drug Enforcement Administration (DEA) reviews the registration application filed by the researcher.
The National Institute on Drug Abuse (NIDA) within the National Institutes of Health operates pursuant to the Single Convention on Narcotic Drugs. NIDA has been designated the responsible agency to supply research-grade marijuana to researchers.”
What Does the Statement Actually Mean?
It should be noted that there have been no changes to the federal rules regarding marijuana research. And these rules are precisely why there has been very little quality research into the use of medical marijuana in humans. The multiple legal and administrative hoops researchers must jump through to gain approval is extremely expensive and time-consuming.
According to Forbes magazine, the cost of developing and successfully getting one new drug approved and to market is about $5 billion. Only the large pharmaceutical companies with their deep pockets can afford to make that kind of investment. And one of the main reasons they can afford to do so is because they then have exclusive rights to sell that drug for several years, which allows them to recoup their costs and hopefully make a profit.
The problem with researching marijuana is that individuals can grow and process their own, making it all but impossible for pharmaceutical companies, or anyone else for that matter, to even cover their expenses for research, let alone make a profit. Plus, the additional restrictions involved in studying a Schedule I drug only add to the cost and headaches involved.
So what does the FDA statement really mean? Probably very little. Even if they loosen the reins some and allow more research to be done, who is going to pay for it? Until the government is willing to not only approve but also fund marijuana research, it's doubtful much will change on the federal level.
“Drug Schedules.” United States Drug Enforcement Administration. Retrieved 6/27/2014.
Herper, Matthew. “The Cost of Creating a New Drug Now $5 Billion, Pushing Big Pharma to Change.” Forbes. 8/11/2013.