FDA Approves Cannabis Drug, But Cannabis Is Still Schedule I

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If there’s any sign that the War on Drugs is a failed endeavor, it’s the fact that the Food and Drug Administration (FDA) has signed off on a cannabis-based drug. While the Attorney General still wants to crack down on cannabis users, growers, and merchants, other federal agencies are actively undermining the prohibition of cannabis.

Monday, June 25th, 2018, has become a historical day, because today today the FDA approved a drug in a move that directly counters the Schedule I classification. Schedule I drugs, by definition, pose a strong risk of abuse and also have no recognized medical use. Now, however, the FDA recognizes that cannabis-based drugs could actually have a critical medical function.

The drug in question, Epidiolex, is a product of the UK-based company GW Pharmaceuticals. It is an oral solution that contains cannabidiol (CBD), which the FDA has approved for use in patients age two or older who have Dravet syndrome or Lennox-Gastaut syndrome. Both of these diseases are extreme forms of epilepsy that impact young children.

The FDA carefully classified its approval of the drug, citing the fact that the solution is highly purified and offers a uniform strength from batch to batch. Parents of children with qualifying seizure disorders can hopefully soon access this medicine to see if CBD therapy may help their children.

Sadly, however, this approval will leave thousands of children and adults who suffer seizures at the mercy of their disorders. Those with different diagnoses, as well as those who don’t have good insurance to cover the costs of Epidiolex, could go without adequate care. There’s also the question of whether CBD alone is as effective as whole-plant, broad-spectrum cannabis oils that contain other cannabinoids and offer the understudied “entourage effect.”

While the FDA approving this drug is an encouraging step in the right direction, it still leaves far too many people with epilepsy without legal access to medicines that could save their lives. The good news is that this, combined with the government’s patent on cannabinoids as neuroprotectants, could be the basis of future lawsuits or changes in policy that force the federal government to remove cannabis from its current Schedule I classification.

 

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