Murphy Administration Seeking Up To Six New Dispensaries To Expand Access To Medicinal Marijuana

NEW JERSEY: The Murphy Administration today announced it is seeking up to six new applicants to operate medicinal marijuana dispensaries — two each in the northern, central and southern regions of New Jersey.

“We look forward to the opening of six new dispensaries so we can ensure that all qualifying patients who want access to medicinal marijuana can have it,’’ said Governor Phil Murphy. “Due to the steps that Commissioner Elnahal and I have taken since January, we have seen the addition of 10,000 new patients. Accordingly, we have to expand the number of businesses who are growing product and serving patients.”

Screenshot 2018-07-16 09.45.16Currently, more than 26,000 patients, 1,000 caregivers and 700 physicians are participating in the program.

“As we strive to make the program more responsive to the needs of patients, caregivers and Alternative Treatment Centers (ATCs), we recognize the need to grow the industry and create more options for patients,” said Health Commissioner Shereef Elnahal, M.D.

A Request for Applications (RFA), which was noticed in today’s New Jersey Register and published on the Department’s website, notes that applicants would have to operate a dispensary and facilities that do cultivating and manufacturing and provide evidence of site control and verification of the approval of the governing body in the municipality where they intend to locate. The business can be either nonprofit or for profit and is also required to submit a business plan including a budget detailing revenues and expenses over a five-year period. The RFA is available here.

Applicants can submit applications for more than one region of the state but must submit a separate application for each region. The fee for applying is $20,000, although $18,000 of that fee will be returned to unsuccessful applicants.

A mandatory pre-application conference is scheduled for Thursday, Aug. 9 at the Department of Health headquarters in Trenton. The purpose of the conference is to give potential applicants a chance to have questions answered about the process. The Department will electronically accept questions until 4 p.m. on Tuesday, Aug. 7 from all potential applicants via email at mmpquestions@doh.nj.gov. Applications are due Friday, Aug. 31, 2018. Applicants chosen to proceed in the permitting process will be announced Nov. 1, 2018.

The six currently operating ATCs are not eligible to participate in this application process. Existing ATCs already have the opportunity to add additional sites for cultivating, manufacturing and dispensing. Additional opportunities to apply to build cultivating, manufacturing and dispensing sites will be available in the future.

The Commissioner is also working to expand physician participation in the program. Last week, he conducted two grand rounds lectures with 300 physicians at teaching hospitals to dispel myths and reduce stigma in the medical community. Although more than 100 new doctors have signed up since the expansion began, only 700 of the 28,000 licensed physicians in New Jersey are currently registered to participate in the Department of Health’s Medicinal Marijuana program.

FDA Approves First Cannabis-Based Epilepsy Drug

MARYLAND: The U.S. Food and Drug Administration has approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of marijuana.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others.

Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.

“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”