Prepared Statement by Senator Chuck Grassley of Iowa
Chairman, Senate Judiciary Committee
Subcommittee on Crime and Terrorism
Hearing on “Researching the Potential Medical Benefits and Risks of Marijuana”
Wednesday, July 13, 2016
Today’s hearing continues an important and timely discussion about researching the potential medical benefits of the marijuana plant and its constituent parts.
Thousands of children throughout the United States suffer from rare, extreme forms of intractable epilepsy. In many of these cases, parents have reason to fear that their child’s next seizure may be his or her last. These children are often treated with powerful drugs with strong side effects, which may also further incapacitate them. But in recent years, evidence has come to light suggesting that a substance called cannabidiol, or CBD, may help these children. CBD is a compound derived from the marijuana plant that can be administered in the form of an oil. It’s not smoked, and it can’t be used to get high.
I’ve had Iowans come to my Iowa office and my county meetings, praising CBD oil because they say it has greatly reduced seizures and in some cases has eliminated them completely. So it appears CBD oil can have positive effects. But it’s concerning that many of the CBD products that these parents must turn to are of unknown quality. So even though leading medical organizations typically reject the idea of smoked marijuana as medicine, many of them have called for further research into the potential medical use of CBD.
To the extent possible, I believe we should be encouraging responsible, FDA-approved research on CBD and other parts of the marijuana plant, to unlock whatever potential medical benefit may lie within them – for children with intractable epilepsy and any other patients who may benefit.
But legitimate, medical research shouldn’t be confused at all with smoking marijuana for recreational purposes, which the science tells us can be harmful and addictive, especially for young people.
I’ve been pushing to remove unnecessary barriers to this research for a few years now. Senator Feinstein and I held a hearing on this topic in the Senate Caucus on International Narcotics Control last year, and our efforts have helped bring about important changes.
In October 2014, and then again in May of last year, Senator Feinstein and I wrote to the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) about this issue.
First, we asked these agencies to consider revising regulations that may be inhibiting research into the potential medical applications of CBD. Some, but not all, of these regulations are related to CBD’s status as a Schedule I substance. Our letter made a difference on this front. In June of last year, HHS announced that it was eliminating the extra layer of review for non-government funded CBD research that it previously required its Public Health Service (PHS) to complete. Doing away with the PHS review, which wasn’t required for any other Schedule I substance, was a step in the right direction.
Then in December, DEA announced that it would ease some of the regulatory requirements for those conducting FDA-approved clinical trials on cannabidiol by permitting waivers that will let research proceed seamlessly if the researcher requires more CBD than was initially approved by the DEA. This change represents another step in the right direction.
Second, through our letter last May we asked these agencies to evaluate CBD using the appropriate scientific and medical factors to make a scheduling determination for it that is separate from the whole marijuana plant. If it turns out that CBD may be classified on a lower schedule than the entire marijuana plant, then research on it may proceed somewhat more easily. In response, DOJ and HHS agreed to undertake this evaluation at our request. This was a significant breakthrough, and I wrote to these agencies recently to seek an update as to where the evaluation stands.
In the meantime, it’s also worth recognizing that research on CBD is proceeding, even under the current regulations. A CBD-based drug called Epidiolex is currently undergoing FDA-approved clinical trials to treat rare forms of pediatric epilepsy. I’m glad that one of the sites at which it’s being tested is the University of Iowa. In addition, hundreds of children are currently being treated with Epidiolex through Expanded Access Investigational New Drug programs.
So far, the data emerging from these efforts is promising. So even though more research is needed, there is reason to hope that at least one FDA-approved CBD medicine may be more widely available soon.
I look forward to continuing this discussion on ways we can work together to facilitate even more scientific research on marijuana and its constituent parts, especially to help children who suffer from these rare conditions.
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