When the petitions get filed before the DEA the DEA is required to get information from HHS and the FDA. Not that they are required to listen to it, they do have to get it from them. This is where DEA has decided that in order to re-schedule Cannabis it must listen to the report from the FDA. The DEA interprets the law to mean they must listen but that isn’t what is written. The DEA does have discretion in this area and others.
In an alliance to keep plant medications off the market the FDA has in place a number of rules that it falls on to decide if a item has medical value. First is it currently approved by the FDA. Next is it in a IND program for clinical trials. There are a variety of other things they can fall back on but for Cannabis the fact there are no approved FDA medications and there are no IND’s for Cannabis it fails to meet their definition of “accepted medical use”. Again FDA is not required to give this result as they could look at medical use in other places in the world. They could also state they simply do not know if there is accepted medical use. There are many responses the FDA can give as this is an area of ambiguity and open for interpretation.
In order to bring a new drug to market we are all well aware of the expense for a Pharmaceutical company goes through. This has been compounded by the lack of ability for private industry to even work with Cannabis in it’s raw form. This falls on the heads of the DEA and their interpretation of the CSA and the associated Treaties they claim say Schedule I substances are for Federal Research.
Recently Senator Gillibrand got clarification from the State Department that DEA’s interpretation wasn’t correct. This forced DEA to make a statement that they would allow additional manufacturers to make “medical grade” cannabis. Released in the Federal Register the DEA said that it would, if the producer meets the requirements they set forth, expand production. They didn’t announce who the new manufactures would be or that they would approve anyone, just that rather than summarily dismiss their application they would consider it.
This now opens a new box, what is “Medical Grade” cannabis when the FDA says there isn’t accepted medical use. Who is going to decide on what “Medical Grade” cannabis is? Well that is currently a determination that is made by NIH, NIDA and the University of Mississippi Farm.
There is a lot of interpretation of the federal jumble of laws/rules/regulations regarding cannabis. When agencies are able to weasel around by their own interpretations of the laws or until someone figures it out and brings the right petitions before the proper agencies/courts the state of Cannabis will remain in complete confusion.