Attention has shifted from state legislation to Congress and candidates running for federal office. While rumors have been spreading around that the DEA is going to reschedule marijuana in July of 2016, on July 6, Congressman David Young became the first federal elected official from Iowa to co-sponsor H.R. 1538: the CARERS Act of 2015.
Although the CARERS Act is overly complex, it would remove marijuana from federal schedule 1 and recognizes that marijuana does have medical use. I have asked Congressman Young to file an amendment to the CARERS Act that would simply remove marijuana from federal schedule 1 and require the federal administrative agencies to work with the states to come up with reasonable regulations.
On July 4, I wrote Senator Chuck Grassley asking him why his prediction that the DEA would reclassify cannabidiol in the first half of 2016 had not materialized. On July 5, I got a call from David Bleich in Senator Grassley’s DC office. What I learned is that the DEA is telling Senator Grassley that they will rule on the marijuana rescheduling petition filed in November of 2011 by the states of Washington and Rhode Island within the next couple of weeks.
Mr. Bleich referred to a series of letters from Senator Elizabeth Warren requesting updates on the status of pending FDA reviews on cannabis and cannabidiol. Letter of July 9, 2015; Letter of October 15, 2015; Letter of December 21, 2015; Letter of April 4, 2016; Letter of June 23, 2016.
Recent editorials from John Hudak and Grace Wallack at the Brookings Institution on May 27, 2016, and from Jacob Sullum at Reason Magazine on July 4, 2016, explain why they think rescheduling of marijuana by the DEA is very unlikely.
Mr. Bleich also mentioned a new bill being introduced in the Senate Judiciary Committee that seems to have strong bipartisan support, S. 3077: the MEDS Act. When I wrote to Congressman David Young to thank him for cosponsoring the CARERS Act, I also suggested that he cosponsor the companion bill in the U.S. House of Representatives, H.R. 5549: the Medical Marijuana Research Act of 2016. Again, H.R. 5549 is overly complex and could simply be amended to remove marijuana from federal schedule 1 and instruct the federal agencies to work with the states to come up with reasonable regulations.
What these two bills scream out is that there is something wrong with the way cannabis is classified under federal law. Congress seems to be trying to bend over backward to avoid addressing the issue. S. 3077 and H.R. 5549 would create a slew of exceptions to schedule 1 for marijuana. For example, it would allow a doctor who has a license to prescribe drugs in schedule 5 to conduct research with marijuana without having a schedule 1 license. I’m asking my representatives in Congress to support these bills, even though they are extraordinarily complex, because something is better than nothing. But, I have also asked them to file amendments to simplify these bills.
Finally, Mr. Bleich said he did not expect the FDA review of cannabidiol to be completed before the end of the year. The FDA is still doing safety studies and it will take them an additional 6 months to analyze the 8 factors in 21 U.S.C. § 811(c). Mr. Bleich agrees there is no precedent for rescheduling a molecule and this is the first time the FDA has considered rescheduling a molecule that is not contained in a drug product being submitted for commercial marketing approval. Mr. Bleich said this FDA review was in response to a request from Senator Grassley and Senator Feinstein and was considered to be a petition for rescheduling of CBD. Mr. Bleich said clinical trials with Epidiolex are going well and that pharmaceutical grade CBD may be avaible from GW Pharmaceuticals in the next year or two. And, finally, Mr. Bleich said a company in the southwestern United States is working on manufacturing synthetic CBD.
FYI: For those interested, the company is Insys Therapuetics and they received FDA orphan drug status for synthetic CBD two years ago:
They also have a synthetic alternative THC drug (aka Syndros) that recently gained FDA approval: http://www.marketwatch.com/story/insyss-stock-soars-after-cannabis-based-oral-drug-gets-fda-approval-2016-07-05?siteid=yhoof2 joining a handful of other synthetic THC analogues in the market.
This is not an OTT stock but a larger US-based biotech.