This report was prepared by the Global Education Group, A Division of Ultimate Medical Academy. To download and read the full PDF, click here.
Cannabidiol (CBD)-based therapies achieved several important regulatory, clinical, and legislative milestones in 2018 removing many barriers to new CBD-based drug approvals in the near future. In June 2018, the FDA approved Epidiolex (CBD) for the treatment of 2 rare childhood epileptic disorders, Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), heralding a new wave of investment and clinical research into the therapeutic potential of cannabis. Over 200 clinical trials are currently investigating CBD for use in more than 40 clinical applications.
The 2018 Farm Bill, passed in December 2018, removed hemp (cannabis containing less than 0.3% -9-tetrahydrocannabinol [THC]) from the definition of marijuana under the Controlled Substances Abuse (CSA) Act, therefore permitting cultivation, processing, marketing, and sale of hemp and its derived products (eg, CBD). At the same time, the FDA reiterated its regulatory oversight of CBD and CBD-containing products making clear that the Agency views CBD as a drug and not as a dietary supplement. To paraphrase the FDA’s stance: Because CBD is marketed as a drug with therapeutic benefits, CBD will be regulated like a drug with therapeutic benefits.
Despite the uncertain legal status of CBD products, economic interest in CBD has ballooned. The recreational marijuana industry is projected to generate $40 billion in total economic output by 2021.4 Consumer sales of CBD in particular are anticipated to reach $1.8 billion by 2022.5 CBD can be found in a variety of consumer products, from edibles like cookies and gummies to topical ointments for pain and niche items like mascara and skin care products. This report will detail the chemical nature of CBD, describe the current conflict between the 2018 Farm Bill and an FDA statutory provision known as the investigational new drug (IND) preclusion, and provide an overview of what to expect based on regulatory trends.
Take free mandatory CME, including Florida’s newly required human trafficking course, live at the Hilton Orlando or via livestream on Saturday, Jan. 18, 2020. Click here
Proposed price transparency rule: We want your feedback On Nov. 15, the Trump Administration announced two rules aimed at increasing price transparency in the healthcare system: the 2020
Final Table Talk! Dr. Brown and Dr. Chiu are hosting MUV Wednesday December 4, 2019 at the AMRX office. It’s an exclusive time for our
Pinellas County Medical Associations mission is to inform, serve and advocate for patients and physicians in our county. We are tasked to further county physician’s ability to provide high quality medical care for patients. And, promote and monitor the ethical and competent practice of medicine in our county. In addition, the Association provides consumer advocacy through a referral service, physician participation in community events, services and programs, and the general dissemination of information about physicians and health services available.
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** The PCMA refers patients to members, however this DOES NOT apply to pain management. PCMA is working on this high priority in coming up with a pain management protocol. Our recommendation is to call the Department of Health closest to you.
** Due to the high amount of call volume, the PCMA phones are turned over to take a message and checked daily. Calls are returned in order of most serious, physicians and physician practices Email Executive Director.
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