THE CAPITAL, TALLAHASSEE, March 2, 2015……Health regulators are on the defensive about their latest attempt to get the state's medical-marijuana industry up and running, rejecting criticism from a legislative oversight panel while trying to assuage concerns of parents of sick children.
At a hearing Monday, the Florida Department of Health's Office of Compassionate Use Director Patricia Nelson fielded questions from investors and nursery owners eager to become one of five operators authorized to grow, process and dispense non-euphoric cannabis believed to eliminate or dramatically reduce life-threatening seizures in children with rare forms of epilepsy.
Parents of children who suffer from hundreds of seizures daily made tearful pleas for regulators to move as quickly as possible to get on the market what many believe are life-saving types of marijuana that are low in euphoria-inducing tetrahydrocannabinol, or THC, and high in cannabadiol, or CBD.
Under a law passed last year, the department was supposed to have chosen the five nurseries to grow, extract and distribute the substance, usually delivered in oil or paste form, by Jan. 1. But a handful of nurseries and others challenged the department's initial proposed rule for carrying out the law. An administrative law judge then tossed the plan, which would have used a lottery to select the "vertically-integrated" businesses called "dispensing organizations."
Monday's hearing came just days after Nelson gave a terse response to one of the Legislature's lawyers, who asked 14 pages of questions regarding a revamped rule developed during a rare "negotiated rule" workshop last month.
The top lawyer for the Joint Administrative Procedures Committee, which plays a key role in overseeing state agency regulations, raised concerns about a variety of issues, including a scoring system proposal to decide which nurseries will get the licenses. The committee's chief attorney Marjorie Holladay suggested that the proposed scoring system is too vague.
But, in a two-page response released to the public late Friday, Nelson wrote that the department intentionally made it incumbent upon the applicants to describe their ability to create the product instead of establishing specific requirements in the proposed rule.
"Our single statutory duty is to pick the best applicants such that the product is available and accessible to the people that need it. Our statutory duty is NOT to tell any applicant how to structure its organization and operation," Nelson wrote. "Once you have comprehended the entirety of the regulatory structure, the department is confident that your many questions about what certain words or phrases mean will become abundantly clear."
Nelson also provided another answer to dozens of Holladay's questions: "Plain and ordinary meaning."
On Monday, nursery owners sought clarification about the latest proposal, including about the decision to allow dispensing organizations to grow the marijuana in one place, process it in another and distribute it at one or more separate locations.
The nurseries also wanted more information about the ownership of the organizations. Nelson insisted Administrative Law Judge W. David Watkins' November order and the language in the law left little wiggle-room: The applicant must be a nursery that has been in business for 30 years and is registered with the state to produce at least 400,000 plants.
"The fact that the nursery is the applicant and is the dispensing organization isn't going to change. I don't know what else to do about that. There is nothing else the department can do about that other than brainstorm with folks about what businesses you could create. I can't help," Nelson said.
Parents frustrated by delays chastised unnamed entities for dragging out the process, accusing them of putting financial interests before patients' needs.
An emotional Holley Moseley, who was instrumental in pushing the bill through the Legislature last year and served on the committee that hashed out the details of the latest rule during a marathon two-day session last month, said her daughter, RayAnn, "fights for her life every minute of every day."
Moseley and her husband, Peyton, have joined forces with Colorado marijuana grower Joel Stanley, who with his brothers developed the "Charlotte's Web" low-THC, high-CBD cannabis that prompted Florida's law.
"Every morning when I wake up I have no idea if this will be the day I discover my child did not survive the night," Holley Moseley told Nelson.
Moseley called the uncertainty unbearable, saying that children in other states have died since the bill was signed into law last summer.
"It's been approved by the Legislature. It's been signed by the governor. And yet we can't get access to it. I had no way of knowing that a year later, RayAnn would still not receive her first dose," she said. "I was unaware of how selfish and greedy some people could be. Will my little girl be the martyr for this cause? I cannot stand by and let this happen."
But lobbyist Jeff Sharkey, who created the Medical Marijuana Business Association of Florida, said nurseries and investors are seeking more information to make sure they get quality products on the market.
"I don't think there's anybody here trying to hold this up for reasons that are other than trying to make sure it works correctly," he said.
It will be at least six weeks before the department can start selecting applicants. Those wanting to file another challenge must do so within 10 days of Monday's hearing. Health officials must wait two weeks from Monday's hearing to publish the rule again, and another 20 days before the application process can begin, if no challenges are filed. Applicants would then have 21 days to file their applications.
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