The FDA: MIA on Marijuana?

The U.S. Food and Drug Administration (FDA), with an annual budget of $5.9 billion, is the world’s top regulator of prescription drugs, with hundreds of scientists and experts focused on swiftly and efficiently approving safe and effective drug treatments.

But when it comes to marijuana, a drug that tens of millions of Americans use every day for recreational and medicinal purposes, the FDA seems missing in action.

Accordingly, an increasing number of policymakers, lawmakers, marijuana advocates, and publicly traded pharmaceutical companies are working diligently to get the FDA to loosen up its clinical procedures and oversight in regard to marijuana.

Case in point: In a paper recently published by the National Cancer Institute, a team of six research scientists, drawn from federal agencies such as the National Institute on Drug Abuse (NIDA), and National Institutes of Health (NIH), sharply criticized marijuana regulatory systems in the U.S., asserting that bureaucratic obstacles and red tape impede vital study into marijuana’s potential health benefits.

The article, published in the Journal of the National Cancer Institute Monographs, states:

“Conflicting federal and state cannabis regulations hinder research in several ways, including the inability of researchers to access products that are legal in their state, a lack of standardization and quality control of cannabis and cannabis-derived products within and across states, and no national oversight of this standardization and quality control or the industry. The most obvious regulatory hurdle in conducting cannabis and cannabinoid research is the schedule I status of cannabis.”

You may be surprised to learn that the FDA has rarely approved weed for medical treatment.

Only a select few…

The FDA has approved one plant-based marijuana drug called Epidiolex, which contains a purified form of cannabidioil (CBD).

A prescription medication, Epidiolex is approved for treating seizures associated with two rare and severe forms of epilepsy, as well as seizures associated with a rare genetic disorder called tuberous sclerosis complex.

The FDA also has approved three medicines, Marinol, Syndros, and Cesamet, that are made from a synthetic or lab-made chemical that mimics tetrahydrocannabinol (THC). These medicines are used to treat nausea in patients with cancer who are undergoing chemotherapy treatment, and to increase appetite in individuals with AIDS. These FDA-approved cannabis medicines are only available with a prescription.

Other than these few drugs, there are currently no other FDA-approved uses for cannabis or its derivatives.

Drug companies, large and small, are frustrated with the FDA. The following tweet is indicative of this sentiment:

A tailwind for the mainstreaming of marijuana as medicine is the increasing use of weed among the American populace. Marijuana is the most commonly used federally illegal drug in the U.S. The Centers for Disease Control and Prevention estimates that 48.2 million people, or about 18% of Americans, used it at least once last year.

Watch This Video: The Weekly Weed Report

Many pharmaceutical companies of all sizes, from start-ups to Big Pharma, are currently researching and developing ways to synthesize cannabis for medical and recreational purposes.

Synthetic CBD is chemically identical to plant-based CBD, but the synthetic version confers enormous scientific and commercial advantages. It’s also a convenient way to skirt around the legal and regulatory hassles of growing natural weed.

Creating CBD in the lab, versus growing plants, also makes it easier and cheaper to increase the scale of manufacturing capacity. Companies aren’t subject to the vagaries of growing seasons or the risk of losing crops.

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John Persinos is the editorial director of Investing Daily.

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