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Monday, October 3, 2016

Feds Say Lack of Scientific Clinical Evidence of Safety and Efficacy re MJ Re-Classification


As part of this review, the DEA obtained from the FDA an unpublished lengthy report on the status of cannabis science as it relates to human health. This review emphasized the standards by which a new drug can gain approval. 
This includes:
  • The drug’s chemistry must be known and reproducible
  • There must be adequate safety studies
  • There must be adequate, well-controlled studies showing efficacy
  • The drug must be accepted by qualified experts
  • The scientific evidence for the safety and efficacy of the drug must be widely available
In recommending that cannabis not be descheduled, the FDA identified multiple known health issues related to cannabis use, including prenatal exposure, behavioral effects, deleterious impact on those prone to psychoses, and negative impacts on a patient’s cardiovascular, endocrine, respiratory, and immune systems. In addition, given the inconsistent quality and limited amount of controlled cannabis research, and lack of NDAs or INDAs, the FDA concluded that the current evidence did not support the rescheduling of cannabis.
In essence, in its statement, the DEA adopted the FDA’s opinion, stating that while the use of cannabis for treating a variety of conditions has seen approval at the state level, the federal government has yet to see sufficient scientific clinical evidence of safety and efficacy to warrant the reclassification of cannabis. The DEA’s letter ends with the statement, “But we will remain tethered to science, as we must, and as the statute demands.”

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