Gov. Rick Scott and his surgeon general are balking at a proposal headed to the House floor that would open the door for a strain of marijuana that doesn't get users high but is believed to dramatically reduce seizures in children with a rare form of epilepsy.
Instead, Scott wants a more limited approach that would put children with "intractable" epilepsy, as well as children and adults with other diseases, into clinical trials for the drug. The trials would require cooperation with the U.S. Food and Drug Administration or drug companies.
A plan approved by the House Judiciary Committee on Monday includes language proposed by Scott that would create an "Office of Compassionate Use" within the Department of Health that would "enhance access to investigational new drugs for Florida patients through approved clinical treatment plans or studies."
"Investigational new drug" studies are the first step in laboratory testing of drugs not yet approved by the Food and Drug Administration.
Florida Surgeon General John Armstrong told the House committee Monday that he has concerns about other areas of the bill but that his approach is "patient-centered and provides access to medications of known content and dose" and could be operational within months.
But Armstrong raised questions about the measure's "plant-focused system without quality assurance for the precise chemical composition and protection from impurity."
The strain of marijuana, which is high in cannabidiol (CBD) and low in euphoria-inducing tetrahydrocannabinol (THC), would have "variable and unknown content," Armstrong said.
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"The safety is unknown and the time to establish such a (distribution system) structure is unknown, likely more than 18 months and subject to rule challenges," he went on."Your Department of Health is committed to helping children and their families managing refractory epilepsy safely. We support access to investigational new drugs with known composition and a regulated risk profile. We must be wary of unintended consequences and remember that first we must do no harm."
Armstrong also pointed to a drug called Epidiolex, a synthetic form of marijuana high in CBD but with no THC. The University of California, San Francisco, started clinical trails on the drug, manufactured by GW Pharmaceuticals, earlier this year.
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Scott administration wants more restrictions on marijuana proposal