Things are busy in the nation’s drug agencies according to the testimony of Susan R.B. Weiss, Ph.D., director, Division of Extramural Research, National Institute on Drug Abuse (NIDA).
On July 13, Dr. Weiss testified before the Subcommittee on Crime and Terrorism, part of the Senate Judiciary Committee, on the topic of “Researching the Potential Medical Benefits and Risks of Marijuana.” Laying aside what seems like an inappropriate subcommittee to hear testimony on the science of cannabis (the focus is crime and terrorism), the testimony did release some interesting tidbits.
From Dr. Weiss we learned the following:
• In Fiscal Year 2015, the National Institute on Health (NIH) supported 281 projects with over $111 million on cannabinoid research.
• Of that figure, approximately 19 percent ($21 million) was spent examining the therapeutic properties of cannabinoids (a total of 49 projects).
• Forty-two percent of the $21 million was focused on CBD.
• Since 2011 there have been 139 clinical trials listed on clinicaltrials.gov studying the therapeutic potential of cannabis and its constituents. This included 10 NIH-supported trials.
• NIH and FDA will be cooperating on a study that will determine “the abuse liability of CBD, which would be factored into the scheduling recommendation.” The agencies are “working out the final details now.” (Remember this hearing was July 13)
• Last December the DEA informed researchers studying federally supplied CBD that they no longer needed to notify DEA of certain modifications in their research thus freeing the researchers to more aggressively pursue their studies.
• On July 7, NIDA contacted researchers and asked for feedback on “which specific strains and products are currently of greatest interest” to them.
• The DEA has been working with NIDA, Office of National Drug Control Policy (ONDCP), and the Food and Drug Administration (FDA) “to identify strategies to make marijuana available from other sources.” Dr. Weiss notes that, “drug developers would need to transition from using NIDA-supplied marijuana” before FDA approval and marketing.
There is a lot more information tucked into the eight-pages of testimony from Dr. Weiss. Analysis of the content reveals at least one thing: if NIH and FDA are finalizing the details of a CBD abuse study in July of 2016 it seems unlikely that re-scheduling, long rumored to be happening this summer, will occur any time soon. Without question some level of rescheduling must happen if for no other reason than to get epidiolex, the GW Pharmaceutical CBD-based, pediatric epilepsy drug to market. GW is currently stating they will file their New Drug Application, the last step before marketing, in early 2017.
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