FDA Approves First Cannabis-based Drug

FDA Approves First Cannabis-based Drug

There has been a tremendous amount of discussion (if not actual movement) at the Federal level with cannabis classification. As a Schedule 1 drug, it has been difficult for researchers to test cannabis and its derivatives for possible medicinal uses.  However, that appears to be changing. The Food and Drug Administration (FDA) just recently approved the first-ever prescription drug containing cannabinol (CBD).

The medication called Epidiolex, delivered in syrup form, is used to treat two forms of childhood epilepsy. Researchers are not entirely sure of the cause, but CBD has been shown to reduce seizures. It’s important to note that CBD retains the medicinal properties of cannabis, but will not get the user high.

“This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients,” said FDA Commissioner Scott Gottlieb in a statement.

Gottlieb added, “But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use.”

However, the approval of Epidiolex is just the first step in what will most likely be a contentious battle at the federal level. Though the results look promising, the Drug Enforcement Agency (DEA) has refused to act on two dozen applications by companies looking to produce cannabis for scientific research.

Cannabis (and CBD) remains a Schedule 1 drug, which states that as such it has no medical value and a high likelihood of abuse. Other Schedule 1 drugs include heroin, LSD, cocaine. The approval of a medication containing CBD by the FDA will most likely weaken that assumption and help add momentum to recent efforts to decriminalize the drug at a Federal level.

There have been multiple efforts by members of the House and Senate to decriminalize the drug, most recently the Marijuana Freedom and Opportunity Act put forth by Senator Chuck Schumer at the end of June. Originally announced in April, Schumer’s bill would de-schedule the drug, essentially making it fully legal in all states which currently allow it.

This follows similar efforts by Sen. Cory Booker and Elizabeth Warren in the Senate and Reps. Barbara Lee and Ro Khanna of California in the House of Representatives. Currently, there are 27 marijuana-related bills in the House and 14 in the Senate.

However, none of the current bills have been given the opportunity to vote by the Republican leaders in either house of Congress. Additionally, Attorney General Jeff Sessions has made clear his reversal of the Obama-Era “hands off” policy on state-level drug enforcement.  

However, the approval of Epidiolex provides an opportunity for additional drug manufacturers to begin testing and searching for approval for other cannabis-derived chemicals.

If you have additional questions about greater cannabis legalization and how it may affect your business, please feel free to check out our Cannabis Industry page, call me at my office at 626.703.1556, or just email me at ctobin@boltonco.com.

About Corey Tobin

With close to a decade of industry experience, Corey has worked with a number of small and medium-sized businesses and is knowledgeable about property and casualty, life and health insurance. Corey specializes in working with elevator contractors, manufacturing, distributing, healthcare and construction. Additionally, he is focused on the unique needs and challenges facing cannabis related business, including dispensaries, cultivators, extractors, developers and much more.

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