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 that he has concerns about other areas of the bill but his approach is “patient-centered and provides access to medications of known content and dose” and could be operational within months.
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.
Under Scott’s plan, the “Office of Compassionate Use” could create a network of state universities and medical centers and apply to the FDA or a drug manufacturer for a study. The House measure also includes $1 million for the clinical studies.
House sponsor Matt Gaetz said the clinical trials preferred by Scott are a good addition to his bill but an inadequate substitute for allowing anyone whose physician deems they would benefit from the low-THC treatment to get it.
Apart from the language proposed by Scott, the House proposal (HB 843) adopted Monday edged closer to the Senate’s approach (SB 1030) to the issue.
Parents of children with intractable epilepsy, which does not respond to other treatments, believe a strain of the marijuana produced in Colorado and known as “Charlotte’s Web” is their best hope of reducing the hundreds of seizures, some of them fatal, affected children can experience each day.