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FDA Intends to Look into Medical Marijuana Claims

FDA Intends to Look into Medical Marijuana Claims
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Good news, if it’s true. Food and Drug Administration (FDA) Commissioner Scott Gottlieb might start looking into medical marijuana’s many claims.

“I see people who are developing products who are making claims that marijuana has antitumor effects in the setting of cancer,” said Gottlieb at a hearing before Congress this week. “It’s a much broader question about where our responsibility is to step into this.”

OK, let’s do this. May we suggest, Dr. Gottlieb, that you get in touch with a few scientists and colleagues to help you out with this important job?

How about Dr. Orrin Devinsky, who is working on cannabis-based anti-epilepsy drugs for children at New York University Langone Medical Center?

Just a thought. Surely, as a physician and public health advocate yourself, you’re looking for reasonable people.

“And I think reasonable people can ask reasonable questions about whether marijuana is a chemotherapeutic agent,” said Gottlieb, formerly the FDA’s Deputy Commissioner for Medical and Scientific Affairs.

“We’ll have some answers to this question very soon, because I think we do bear responsibility to start to address these questions,” he said, responding to queries from GOP Congressman Buddy Carter, who thinks the federal government is “putting their head in the sand” about medical cannabis.

The Truth About Medical Marijuana Shall Set You Free

Dr. Orrin Devinsky: “The positive outcome in this second trial of Epidiolex in patients with Lennox-Gastaut Syndrome demonstrates the effectiveness of this product in this particularly difficult to treat, childhood-onset epilepsy.”

Devinsky was referring to GW Pharmaceuticals’ cannabis-derived therapy that was recently filed with U.S. regulators after cutting monthly convulsive seizures by 39 percent in children with Dravet syndrome.

Gottlieb, reported Bloomberg, said there were about 20 active investigational new drug projects the FDA is reviewing for marijuana products, pointing out that most of them are for extracts.

“Delivering an active pharmaceutical ingredient through inhalation isn’t always the most efficient route,” noted Gottlieb.

Without revealing when or how the FDA would begin to review and comment on medical cannabis claims, Gottlieb said, “We will address the sweep of these questions in time.”

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