Florida Medical Marijuana Services



09 29 18“THE BIG PICTURE”TIMELINEAll Things Medical & CannabisTHE FLORIDA MEDICAL CANNABIS ALTERNATIVE TREATMENT (FMCAT) PROGRAMNEWS & TRENDS______________________________________________________________________________________________________________________March 201903/05/19Florida2019 Legislative Session The 60-day session begins and is expected to end on May 3, 2019.February____________________________________________________________________________________________________________January 2019____________________________________________________________________________________________________________December 2018____________________________________________________________________________________________________________November 201811/16/18FLORIDAFDOH – FBOM/FBOOM Joint Committee on Medical Marijuana (JCMM) MeetingRe: To Review the (final proposed) report in Orlando, FL11/06/18National/FloridaU.S. General Elections - Florida US Senate/Gubernatorial/Commissioner of Agriculture____________________________________________________________________________________________________________October 2018Begin-NovEnd-OctFLA US SENATE DEBATE #3Bill Nelson (D) v Rick Scott (R) Date TBA#3 of 3 Agreed-Upon Debates10/24/18FLORIDA GUBERNATORIAL DEBATEAndrew Gillum (D) v Ron DeSantis (R)7pmMid-OctFLA US SENATE DEBATE #2Bill Nelson (D) v Rick Scott (R) Date TBA#2 of 3 Agreed-Upon Debates10/16/18FLORIDA FDOH – FBOM/FBOOM Joint Committee on Medical Marijuana (JCMM) Meeting1. Presentation of draft report for the 2018 Annual Physician Certification Pattern Review Panel Report to the Florida Governor, President of the Senate, and Speaker of the House. 2. Discussion related to report data. 3. Discussion of recommendations from the Panel to be included in the report. 10/06/18Empowering Wellness 1st political event – St. Petersburg, FL - Hilton Carillon Park Hotel 950 Lake Carillon Drive, St. Petersburg, FL 33716 1pm registration; EVENT 1:30pm - 5:00pmNewly formed medical marijuana advocacy group Empowering Wellness hosts a bi-partisan conference in St. Petersburg featuring cannabis (marijuana) friendly elected officials and industry representatives who support expanding patient access to cannabis, including co-founder Ben Pollara and co-sponsors U.S. Reps. Charlie Crist, D-St. Petersburg, Darren Soto, D-Orlando and state Sen. Jeff Brandes, R-St. Petersburg.10/03/18Florigrown v FDOH 37 2017 CA 002549HEARING – Case Management Conference10/03/18FLORIDA 1 Year Post-DEADLINE = for the FULL IMPLEMENTATION of AMENDMENT 2 (2016)One (1) year ago today was the DEADLINE for the Florida Department of Health (FDOH) to have issued ‘reasonable regulations necessary for the implementation and enforcement of’ [AMENDMENT 2 (2016)]. One (1) year later the FDOH is STILL writing the necessary regulations and holding development workshops. Floridians had expected great changes and greatly expanded access to the the availability and safe medical use of cannabis (marijuana) by qualifying patients. The FDOH has failed the 71.3% of Floridians who voted in favor of AMENDMENT 2 (2016) and the FDOH continues to fail Florida residents …There are 83,000+ PHYSICIANS licensed to practice medicine in Florida. Until every Florida physician has unrestricted legal access to the FMCAT program in accordance with AMENDMENT 2 (2016), greatly expanded access to the program will never be achieved. Florida needs to encourage its physician population to engage medical cannabis and the FMCAT program. But most physicians are not interested in or willing to participate in the current FMCAT program. UNLESS Florida amends its governmentally-enacted laws and regulations that unconstitutionally limit physician access and place them at greater risk of legal liability, harm and scrutiny,Florida voters will be left holding the stick… Florida patients should be allowed to go to ANY of their own attending and treating physicians to be issued a physician certification to qualify for FMCAT program participation.10/02/18FLA US SENATE DEBATE #1Bill Nelson (D) v Rick Scott (R) 7pm - Telemundo TVTuesday#1 of 3 Agreed-Upon Debates________________________________________________________________________________________________________________________________________________________________________________________________________________________September 201809/30/18FEDERAL – DEADLINEU.S. FARM BILL (2014) = EXPIRES= Deadline for Congress to pass FARM BILL 2018 = FARM BILL 2018 = could contain HEMP FARMING and HEMP status under the CSA Rescheduling provision09/28/18FLORIDAFDOH-OMMU UPDATETOTALS: Patients 169,632Physicians 1743 Patients-to-Physicians RATIO = 97:109/27/18FEDERAL – CONGRESSU.S. FARM BILL (2014) = DELAYED = to miss the 09/30/18 deadlineSenate Agriculture Chairman?Pat Roberts announced that 2018 Farm Bill negotiations had reached a temporary impasse, and that the self-imposed September 30, 2018 deadline would be missed, and that committee differences likely would not be resolved until the “lame duck” session, or the period of time between the November 6, 2018 election and the end of year 2018.?09/27/18FEDERAL – DEAThe Drug Enforcement Administration (DEA) rescheduled Epidiolex to Schedule 5 under the federal Controlled Substance Act, but stopped short of reclassifying hemp and/or any other cannabidiol (CBD) derivative products.09 /25/18FEDERAL - DEADLINE FDA = APPROVED EPIDIOLEX @ 90 Days agoA formal response is due from the DOJ-DEA any day now… ?On June 25, 2018, at the federal level and for the first time in U.S. history, the U.S. Food & Drug Administration (FDA) approved a cannabis plant-based medicine called Epidiolex. Epidiolex, made by British medical cannabis drug company G.W. Pharmaceuticals, is an oromucosal spray made from cannabidiol (or CBD), one of the main chemical cannabinoid compounds found in the cannabis plant, as a treatment for two rare forms of epilepsy. The FDA has already sent a ‘Letter of Recommendation’ to the DEA to agree to approve the medication, but that would entail the rescheduling of CBD (a cannabis derivative) from its current Schedule I classification to a lower schedule or even the removal of CBD (and essentially “HEMP”) from the CSA schedule in its entirety and regulate CBD/Hemp like tobacco or alcohol. The DEA had ninety (90) days (deadline @ September 25, 2018) to decide whether to either object to the drug’s approval or to agree with the FDA with its approval. If the DEA approves Epidiolex, at the very minimum, the DEA will have to recommend the rescheduling of CBD from its current Schedule I ‘cannabis’ status to a lower controlled substance scheduling. Regardless, the FDA’s approval of this cannabis plant-based medicine now places CBD, a constituent of cannabis, in direct contradiction with its current cannabis-based scheduling under the CSA (1970) as a Schedule I drug.09/21/18FLORIDAFDOH-OMMU UPDATETOTALS: Patients 166,286Physicians 1727 Patients-to-Physicians RATIO = 96:109/13/18FEDERALHouse Judiciary Committee= To vote on a medical cannabis reform/research expansion bill sponsored by US Representative Matt Gaetz (R-FL) to greatly expand access to medical cannabis by requiring that the US government issue more growing licenses to cultivators to improve access to quantity and quality cannabis for future research purposes.On September 7, 2018, the FDOH-OMMU now reported there were 159,746 patients and 1694 physicians in the OMMU registry, and the ratio of patients-to-physicians continues to climb, now at 94:1.09/07/18 (8/7/18sic)FDOH Reported completed-cme (‘50’, since no cme number assigned) _ 1707 _ up 11 ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________August 201808 31 18FEDERALRepublican Congressmen send LETTER to AG JEFF SESSIONSRe – 2 years post-DEA statement being made that new cannabis grower cultivation registrations would be accepted for research and requested the current status of the 26 medical cannabis manufacturing applications and an estimated date as to when the review process will be completed08/28/18Florida Primary Elections 08/28/18PUMM v FDOHCase Management Hearing/Evidentiary Hearing- Motion to Tax Costs (Gievers)08/20/18FDOH v Redner 1D-18-1505 (1DCA)DEADLINE – For Appellant (FDOH) to file initial brief08/03/18Florigrown v FDOH 37 2017 CA 002549HEARING – (Cancelled)Case Management Conference08/02/18Florigrown v FDOH 37 2017 CA 002549ORDER – Denying Plaintiff’s Motion for Temporary Injunctive Relief, Without Prejudice= Second (2nd) Circuit Judge Charles W. Dodson found that the plaintiff failed to show that it would suffer ‘irreparable harm’ if injunctive relief was not granted and that granting temporary injunctive relief would be in the ‘public interest’, but madeSIGNIFICANT FINDINGS = IN FAVOR OF THE PLAINTIFF and finding that the law is unconstitutional because the Florida Constitution or Amendment 2 does not allow/require:1. Vertical Integration2. Arbitrary Caps that limit the # of dispensaries allowed to register3. Impermissible Special Laws that give special rights and preferences to certain private entities that violate Art. III, Section 11(a)(12) of the Florida ConstitutionOrdered = Case Management Conference for 10/03/18 at 2pm____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________July 201807/2718FDOH-OMMU***OMMU DIRECTOR CHRISTIAN BAX RESIGNS (effective on or before 08/10/18)On July 27, 2018, the FDOH-OMMU now reported there were 141,618 patients (up 3060) and 1596 physicians (up 24) in the OMMU registry, and the ratio of patients-to-physicians continues to climb, now hovering at 89:1.07 24 18FEDERALHR 1227Marijuana Data Collection Act Hawaii Rep TulsiGabbard & Fla Rep Curbelo introduced the bipartisan Marijuana Data Collection Act to learn what works in states across the nation that will help to make better federal cannabis policyOn July 20, 2018, the FDOH-OMMU now reported there were 138,558 patients (up 2857) and 1572 physicians (up 19) in the OMMU registry, and the ratio of patients-to-physicians continues to climb, now at 88:1.07/20/18FDOH Reported completed-cme (45a - no cme number assigned) _ 1583 _ up 11 07/19/18Legislative Budget Committee The committee reprimanded the FDOH for the delays in the implementation of the FMCAT program, but approved the department’s request anyway for another $13.3 million dollars to meet their budget 07/16/18= FDOH issues new MMTC Rule - MMTC Applications and laid out the framework for the new application process= FDOH announces it will issue another 4 more MMTC licenses since under the MUMA (2017) and since the OMMU registry patient count now exceeds 100,000 patients (with issued OMMU ID Cards)07/13/181 FDOH = ISSUES NEW MMTC LICENSE to Nature’s Way Nursery (Miami) =after ALJ John Laningham issued a blistering order last month recommending that the FDOH award the nursery a MMTC license for using a flawed system to decide which former MMTC applicants should be granted licensesand2FDOH = Laid out the procedure and the new rule for MMTC applicants to apply for a license, Rule 64-4.002 (published 07/16/18)and3FDOH asks Legislative Budget Committee for $13+million more dollars to meet their budget due to an expected 400 MMTC applications and ongoing litigation costs, etc07/13/18FDOH-OMMU Registry CountsOn July 13, 2018, the FDOH-OMMU now reported there were 135,701 patients (up 3445) and 1553 physicians (up 14) in the OMMU registry, and the ratio of patients-to-physicians continues to climb, now at 87:1.07/06/18FDOH v Redner 1D18-1505 (1DCA) Appellant’s motion for extension of time filed June 18, 2018, is granted. Appellant shall file the initial brief on or before August 20, 2018.On July 6, 2018, the FDOH-OMMU now reported there were 132,256 patients and 1539 physicians in the OMMU registry, increasing the patient-to-physician ratio to 86:1.On July 6, 2018, the FDOH-OMMU reported that there were actually 1553 physicians in the OMMU registry, so the actual patient-to-physician ratio at this time was 85:1.07/03/18FDOH v PUMM(Morgan Right to Smoke)ORDER - 1DCA – PCA – Circuit Ct Order to Vacate Stay = Quashed‘Accordingly, upon consideration of the State's motion for review, we hold that it was an abuse of discretion for the circuit court to vacate the automatic stay. The circuit court's order vacating the automatic stay is quashed and the automatic stay provided by rule 9.310(b)(2) is reinstated and shall remain in effect pending the outcome of the appeal.’______________________________________________________________________________________________________________________June 201806/27/18Federal – FDAFDA Deadline = to approve Epidiolex = to be the 1st cannabis plant medicine = approved by the FDAIf that happens, Epidiolex will become the very first cannabis plant-based (not synthetically made) cannabis medicine to be approved by the FDA, opening up the door for more cannabis plant-based medicines to the market and a potential rescheduling for Epidiolex could occur during the following months, Schultz said. If all goes smoothly, Epidiolex could be on the market soon hereafter … and analysts have estimated that Epidiolex could be a $1 billion drug for GW Pharmaceuticals. SOON THEREAFTER …*** INSURANCE COVERAGE will ripen and roll in under cutting-edge, customer-patient driven health insurance plans and packages offered by big employers, both self-insured and insurance-covered firms, but it will be up to the physician and the patient to determine what are the best covered therapeutic options are in a deal between the patient, physician and the ultimate payor.06 /25/18*** FDA = APPROVES EPIDIOLEX ***See Letter to GW Research, Ltd. dated June 25, 2018- NDA dated 10/27/17 is hereby approved- The DEA MUST SIGN OFF – Letter of Recommendation has been sent- Rescheduling of CBD = expected within 90 days06/19/18Nature’s Way v FDOH-OMMURecommended ORDER (ALJ John Van Laningham)= Judge Laningham scalded the FDOH-OMMU for using a flawed system to decide which dispensary applicants were granted the coveted licenses.06/19/18OMMU CME REPORT(3 wks late)completed-cme (3) _ (new cme#) _[should be cme (44)] _ 1506_ UP 16706/18/18PUMM v FDOH- 1DCA ORDER - Smoking ‘stay’ will remain in place until the 1DCA issues a final ruling on the merits of the case on appeal06/11/18Federal-FDA-COLORADOColorado’s governor signed a bill into law allowing physicians to “prescribe” CBD medicines that are FDA-approved drugs. A ruling by the FDA on a cannabis-derived medication is expected in a matter of weeks.06/08/18FLORIDAPatients 120,351up 2829Physicians 1339up -0-06/01/18FLORIDAPatients 117,522up 2644Physicians 1339DOWN 65______________________________________________________________________________________________________________________May 2018May 2018InternationalWHO-ECDDThe ECDD concluded in November 2017 that current information did not justify the scheduling of cannabidiol (CBD) and postponed a fuller review of cannabidiol preparations to May 2018, when the committee was supposed to have undertaken a comprehensive review of cannabis and cannabis related substances; but ECDD did not meet in May 201805/25/18FLORIDAPatients 114,878up 2908Physicians 1404up 0 05/25/18FloridaPUMM v FDOH Judge Karen Gievers’ ORDER = finds the TTs have a constitutional right to SMOKE medical cannabis, that smoking is a route of administration allowable under Amendment 2FloridaRedner v FDOHFlorida Supreme Court refuses to take on 'home grow' case - Florida Politics05/24/18FederalSenate AppropriationsCommittee approves a $145.1 billion agricultural appropriations bill(linked to this year’s FARM BILL) AND continues to allow states to carry out industrial hemp research program without federal interference AND approved $500k in funds to restore the HEMP SEED Genomic Data Bank to help develop the American Hemp IndustrySenators Approve Funds For Feds To Restore Cannabis GeneticsFloridaFDOH-OMMU-BAXThe Florida Department of Health (FDOH) regulates the Florida medical cannabis alternative treatment (FMCAT) program through its Office of Medical Marijuana Use (OMMU).OMMU director,?Christian Bax,?spoke with reporters after a rulemaking hearing in Tallahassee to respond to the JAPC’s letter of inquiry dated 05/08/18. Here is a report of what BAX had to say to the JAPC …Medical marijuana regulator: We'll change our rules or not - Florida Politics FloridaFDOH-OMMU-BAXA hearing held today re the proposed FDOH rule on issuing new MMTC licenses Businesses warned the FDOH of numerous flaws in a proposed rule that now 7 months past its Oct. 3, 2017 deadline. Pot Rule Could Lead to More Challenges, Delays | Sunshine State News FPN05/18/18FloridaOMMU REPORTcompleted-cme(42) _ 1404 _up 26= ALL-TIME RECORD HIGH # of Physicians in the OMMU Registry05/18/18FLORIDAPatients 111,970up 2644Physicians 1378up 1005/11/18FloridaOMMU REPORTcompleted-cme(41) _ 1378 _ 1005/11/18FLORIDAPatients 108,981up 2633Physicians 1368up 3905/08/18FloridaLegislature-ExecutiveJoint Administrative Procedures Committee (JAPC) Letter to FDOH (05/08/18) re: Committee (standing) Objections to FDOH Rules05/07/18 FloridaFMCAT – HCPsEditorial: Florida needs to get medical marijuana right05/04/18 FloridaFMCAT - HCPs Florida’s medical marijuana program is attracting troubled doctors: ‘It’s like the Wild Wild West’ | Tampa Bay Times05/04/18FLORIDAPatients 103,348up 2888Physicians 1327up - 0 -______________________________________________________________________________________________________________________April 201804/27/18FLORIDAPatients 103,460up 2884Physicians 1327up - 13 -04/24/18NationalCNN physician correspondent, Dr. Sanjay Gupta’s letter to AG Jeff Sessions:“Medical cannabis could save many addicted to OPIOIDS”04/20/18FLORIDAPatients 100,576up 2531Approved ID cards 75,208Physicians 1314up - 0 -04/19/18Federal-FDAA panel of government health advisers gave a unanimous recommendation Thursday to the U.S. Food and Drug Administration (FDA) to approve Epidiolex, a CBD medicine for rare epilepsy conditions that don’t respond to other drugs. British drugmaker GW Pharmaceuticals is seeking FDA approval to sell the drug in the United States.FDA approval of Epidiolex likely would trigger a change in how cannabis is classified in the Controlled Substances Act (CSA). A final decision on rescheduling would be made by the U.S. Drug Enforcement Administration (DEA) and the FDA’s parent agency, the U.S. Department of Health and Human Services (DHHS).The advisory panel’s 13-0 recommendation doesn’t bind the agency to approving Epidiolex, but its recommendations carry serious weight. The FDA has said it will issue a decision by late June.04/13/18FLORIDAPatients 98,045up 2585Physicians 1314up - 45 -04/06/18FLORIDAPatients 95,460up 2458Physicians 1269up - 0 -______________________________________________________________________________________________________________________March 201803/30/18FLORIDAPatients 93,002up 2884Physicians 1269up - 23 -03/23/18FLORIDAPatients 90,464up 2310Physicians 1246up - 21 -03/21/18FLORIDANON-JURY TRIALRedner v. DOH, et. al., 13th Judicial Circuit Case No. 17-CA-5677= Joe Redners ‘Right to Grow’ Lawsuit = goes to trial 9:00am = Before 2nd Circuit Court Judge Karen Gievers03/20/18 FLORIDAFDOH PUBLIC WORKSHOPFDOH and the Florida Department of Agriculture and Consumer Services = 64-4.016 Testing Lab Certification and Testing Standards= Public workshop to discuss the proposed rule regarding lab testing.03/16/18FLORIDAPatients 88,154up 2169Physicians 1225up - 0 -03/13/18 –03/12/18 FLORIDAFDOH PUBLIC WORKSHOPFDOH and the Florida Department of Agriculture and Consumer Services = 64-4.014 Standards for Production of Edibles= 64-4.015 Dosing for Low-THC Cannabis and Medical Marijuana= Public workshop to discuss the proposed rules on edibles and dosing03/09/18FLORIDAPatients 85,985up 2482Physicians 1225up - 39 -03/09/18FLORIDA2018 FLA LEGISLATIVE SESSION = ENDS03/07/18FLORIDAHEARINGPeople United for Medical Marijuana, Inc. vs FDOH (Florida Dept of Health)2017-CA-001394= Case Management (Pre-trial) Hearing03/07/18FLORIDAFDOH = JAPC RESPONSE DEADLINE= Deadline to Respond to the Legislature’s JAPC objections to their promulgated rules and to respond to the JAPC’s 15 unanswered letters sent to FDOH – (FBOM/FBOOM) Joint Committee on Medical Marijuana03/02/18FLORIDAPatients 83,503up 2384Physicians 1186up - 0 -______________________________________________________________________________________________________________________February 201802 28 18FLORIDAJoint Status Report DueEdward Miller & Son, Inc vs FDOH2016-CA-7002nd Circuit Court Judge Karen Gievers = ordered the parties to estimate= the time required to complete discovery and time for trial02 24 18FLORIDAOMMU Qualified Physician Countcompleted-cme(35) _ 1186 _ up 4002/24/18FLORIDAPatients 81,119up 2190Physicians 1186up - 40 -02/23/18FLORIDAFDOH PUBLIC WORKSHOPFDOH and the Florida Department of Agriculture and Consumer Services = 64-4.013 Pesticide Use on Marijuana= Public workshop to discuss the proposed rule regarding pesticide use.02/22/18FLORIDAFDOH – PCP Review Panel Meeting = FBOM/FBOOM’s Physician Certification Pattern Review Panel= *Meeting CANCELLED* = NO FUTURE MEETINGs set02 16 18FLORIDAOMMU Biweekly Update180216-bi-weekly-update _ pt 78929_2411_ hcp 1146_up 11102 16 18FLORIDAOMMU Qualified Physician Countcompleted-cme (34b) _ 1169 _ up 2302/15/18FLORIDA= Board of The COALITION 1st REPORT DUE= to Gov Scott, House Speaker, Senate President, State Surgeon General= on research projects, community outreach initiatives, and Coalition future plans02 09 18FLORIDAOMMU Biweekly Update180209-bi-weekly-update _ pt 76518_2385_ hcp 1035_ 0 02 09 18FLORIDAOMMU Qualified Physician Countcompleted-cme(34) _ 1146 _ up 3802/05/18FLORIDAFLA LEGISLATURE - JAPC = Joint Administrative Procedures Committee Meeting= The JAPC = publicly scolded the FDOH and Director Christian Bax for failing to respond to 15 letters the JAPC sent to the FDOH voicing concerns, issues and inquiries regarding many of the FDOH Rules created to implement SB 8A and Fla Constitutional Amendment 2= Result = The JAPC made formal OBJECTION to 17 specific areas where the JAPC held that the FDOH either created rules that did not conform with the state laws or that amounted to an over-reaching of their delegated powers and duties= Next = The FDOH has 30 days to formally respond to the JAPC’s rulings and objections02 02 18FLORIDAOMMU Biweekly Update 180202-bi-weekly-update _ pt 74133_2413_ hcp 1035 _ 0 02 02 18FLORIDAOMMU Qualified Physician Countcompleted-cme(33)_ 1108 _up 4202/01/18FLORIDAFDOH – JCMM Meeting 2018 (#1) = FBOM/FBOOM’s Physician Certification Pattern Review Panel= Meeting to discuss approval of miscellaneous new FMCAT Regulations= NO FUTURE MEETINGs = SET______________________________________________________________________________________________________________________January 201801/31/18FLORIDAHouse Appropriations Committee Meeting = Rep Jason Brodeur (R-Sanford) tagged an amendment to the proposed health care spending bill to effectively FREEZE $ 2.1 million in FDOH-OMMU salaries and expenses until the FDOH properly responds to the Legislature/JAPC’s concerns and inquiries regarding certain FDOH-created Regulations01 26 18FLORIDAOMMU Biweekly Update 180126-bi-weekly-update _ pt 71720_4335_ hcp 1035_up 36_netloss 29601 26 18FLORIDAOMMU Qualified Physician Countcompleted-cme(32)_ 1066_ up 3101/25/18FLORIDA HEARING People United For Medical Marijuana, Inc v. State of Florida, FDOH et al2017-CA-001394= Motion to Dismiss DENIED = at Hearing in John Morgan’s ‘Right to Smoke’ Lawsuit01/25/18FEDERALFDAEpidiolex, a cannabis-based anti-seizure drug developed by GW Pharmaceutical could be approved by the FDA very soon after strong Phase 3 clinical trial results were published.Epidiolex would be the very first full-plant derived cannabis medicine to be approved by the FDA ever in U.S. HISTORY … and opening the FDA and the pharmaceutical market up to more phytocannabinoid-based medicine NDAs and cannabis plant-based medicines on the market.01/24/18FLORIDA HEARINGRedner v. FDOH, et. al., 13th Judicial Circuit Case No. 17-CA-5677= Defendant FDOH’s Motion to Dismiss = DENIED per 2nd Circuit Court Judge Karen Gievers = in Joe Redner’s ‘Right to Grow’ Lawsuit01 19 18FLORIDA Physicians 1035 up 4601 18 18Patients 69579Physicians 989 01/15/18FLORIDA FDOH= 1st PATIENT ‘DATA SETS’ are DUE to be reported to the Board for the COALITION - The Coalition for Medical Marijuana Research and Education = Established w/in the H. Lee Moffitt Cancer Center and Research Institute, Inc01 12 18FLORIDAPatients 67385up 2075Physicians 916up 3301 12 18FLORIDAPhysician Count989 up 7301/09/18FLORIDA2018 FLA LEGISLATIVE SESSION = BEGINS01 05 18FLORIDAPatients 653106312Physicians 883DOWN 389WHY? _____________01 05 18FLORIDAPhysician Count916up 33cme(29) ***01/01/18FLORIDAPCPRP Physician Certification Pattern Review Panel = 1st REPORT = due to Gov Scott, House/Senate 01/01/18CALIFORNIACalifornia opens its massive recreational marijuana market expected to bring in another $5 billion.______________________________________________________________________________________________________________________2018YEAR BEGINsCannabis Industry = expected to hit $11 billion this year______________________________________________________________________________________________________________________2017YEAR ENDCannabis Industry = now a $9 billion market in the United States despite still being illegal$9 billion 12/29/17FLORIDAPhysician Count883Up 0 cme(28) 12/26/17 Physicians 789 DOWN 542/ 2wks = Down 42% ALL-TIME RECORD LOW = # of Physicians in the OMMU Registry = Lowest # of physicians registered since MAY 201712/26/17FLORIDAPhysician Count883Up 94 cme(28) 12 22 1763,054PatientsUp 8803/4 wks 1,293 Physicians DOWN 38/ 2wks???12 15 171,331 Physicians Up 60/ 2wkscompleted-cme(26) _ hcp 1331 HIGH _ Up 60_ 12 15 17171208-bi-weekly-update _ pt 58998_ hcp 1272 _ 12 08 1712/13/17INTERNATIONALWHO-ECDDThe WHO endorsed the recommendation from the ECDD (11/10/17)The ECDD concluded in November 2017 that current information did not justify the scheduling of cannabidiol (CBD) and postponed a fuller review of cannabidiol preparations to May 2018, when the committee would undertake a comprehensive review of cannabis and cannabis related substances.12 01 171,271 Physicians Up 37/ 2wkscompleted-cme(25) _ hcp 1271_ up 205 _ 12 01 17______________________________________________________________________________________________________________________11/30/17FLORIDAFDOH – PCP Review Panel Meeting = FBOM/FBOOM’s Physician Certification Pattern Review Panel= Meeting #111/30/17FLORIDA FBOM/FBOOM (JCMM) MEETING #6 - Joint Committee on Medical Marijuana= Emergency Rules, M2 Consent Form, FS 381.986(4) Form= JAPC Letter of Inquiry - Voluntary Consent Form ISSUESNov 21 201754,251PatientsUp 3476/2 wks 1,233 Physicians Up 167/ 2wks???Nov 08 201750,775PatientsUp 3823/2 wks 1,066 Physicians Up 0/ 2wks11/06/17 – INTERNATIONALUnited Nation Agency WHO – ECDD 39th Meeting of the ECDD11/10/17– The Expert Committee on Drug Dependence(ECDD) of the World Health Organization (WHO) met in Geneva and performed a Pre-Review Report on the cannabinoid, Cannabidiol (CBD). The ECDD convenes yearly and met in November of 2017 to perform an initial review several psychoactive substances including New Psychoactive Substances (NPS) and to recommend whether or not they should be placed under international control. The organization’s Expert Committee on Drug Dependence (ECDD) declared CBD to be non-addictive and nontoxic after finding no evidence of public health related problems associated with the use of pure CBD.According to several clinical trials, CBD could be used to treat epilepsy and a number of other medical conditions.The ECDD concluded in November 2017 that current information does not justify the scheduling of cannabidiol (CBD) and postponed a fuller review of cannabidiol preparations to May 2018, when the committee will undertake a comprehensive review of cannabis and cannabis related substances.______________________________________________________________________________________________________________________10/30/17FEDERALFDAGW Pharmaceuticals/ Greenwich Biosciences filed a NDA - New Drug Application for Epidiolex,a cannabidiol (CBD), cannabis-based compound formulation for the treatment of seizures associated with two (2) specific types of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.Steve Schultz, a GW spokesman said that the submission was a significant event… and that GW’s goal is to provide an additional treatment option to epileptic patients,” he said.Epidiolex’s fate is in the hands of the U.S. Food and Drug Administration. The FDA must respond to the 10/30/17 NDA filing within 60 days. Founded in 1998, London-based GW Pharmaceuticals plc (operating in the United States as Greenwich Biosciences) is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas.10/27/17Physicians 1066 0/ 2wks?10/27/17Physician Count 1066up 109cme(24) 10/26/17Patients46,952Up 3586/2 wks 1,066 Physicians Up 0/ 2 wks10 20 171066 Physicians Up -/ 2wks10/12/17FBOM/FBOOM (JCMM) MEETING #5 - Joint Committee on Medical Marijuana= FBOM/FBOOM’s Physician Certification Pattern Review Panel (PCPRP) = created per vote Oct 11 201743,366PatientsUp _/_ wks 1,066 Physicians Up 23/ 3 wksThu 10/05/17FBOM - Division of MQA- 2017 Medical Marijuana Law Update WEBINARTue 10/03/17Amendment 2 DEADLINE** AMENDMENT 2 IMPLEMENTATION ** = FDOH missed the deadline to have all the reasonable regulations implementedMUMA (2017) DEADLINE**= FDOH missed the deadline to issue 10 new MMTC licenses under the MUMA______________________________________________________________________________________________________________________Fri 09/29/17FBOM/FBOOM (JCMM) MEETING #4 - Joint Committee on Medical Marijuana- Emergency Rules, M2 Consent Form, FS 381.986(4) FormThu 09/28/17**FMA/FOMA CME Course (finally) RELEASED**= 2-Hr Florida Physician Medical Marijuana (CME) Course = 1st Published/OfferedSep 20 201737,830PatientsUp 1389/2 wks 1,043 Physicians Up 36/ 2 wksSep 06 201736,441PatientsUp 2980/2 wks 1,007 Physicians Up 2/ 2 wks__________________________________________________________________________________________________________________________________________________________________________________________________________________________________08/25/17FBOM/FBOOM (JCMM) MEETING #3 - Joint Committee on Medical Marijuana- Emergency Rules, Informed Consent Form, FS 381.986(4) Form08 23 1733,461Patients Up 6493/ 4wks1005 Physicians Up 57/ 4wkscompleted-cme(22) _ hcp 957 _ up 132 _ 08 04 1708/03/17FBOM/FBOOM (JCMM) MEETING #2 - Joint Committee on Medical Marijuana- Emergency Rules, Informed Consent Form, FS 381.986(4) Form______________________________________________________________________________________________________________________07 27 1726,968Patients Up 3618/ 2wks948 Physicians Up 4/ 2wks07/23/18New Bank Coming to Florida to Serve the Florida Medical Cannabis Industry (FMCI)= Seattle-based?GRN Funds?says his firm has come to Florida to offer banking services to the state’s medical marijuana providers. Bank executives met with state financial regulators as a courtesy.07/20/17Florida Legislature - Joint Legislative Budget Committee Meeting= Less than a month after the FDOH-OMMU’s 2018 budget (less than $1 million) went into effect, the FDOH-OMMU made a request to the JLBC for a $13.3 million increase to cover the costs of several operations, including tracking medical marijuana plants “from seed to sale” through a computer system, securing a vendor for patient identification card processing and paying for legal fees.07/14/17FBOM/FBOOM (JCMM) MEETING #1 - Joint Committee on Medical Marijuana- Emergency Rule 64B8ER17-1, M2 Consent Form, FS 381.986(4) Form07 12 1723,350Patients Up 3856/ 3wks944 Physicians Up 70/ 3wks07 06 172017 CA 001394: PEOPLE UNITED FOR MEDICAL MARIJUANA INC vs FLORIDA DEPARTMENT OF HEALTHPeople United for Medical Marijuana, Inc. seeks a declaratory judgment against the defendants to determine the constitutionality of amendments to Section 381.986, Florida Statutes, passed by the Florida Legislature during the 2017 Special Session A, which excludes the use of marijuana in a form for smoking from the statute's definition of "medical use".07 03 17FDOH DEADLINE for Amendment 2 - Final Rule-Making & Promulgation______________________________________________________________________________________________________________________06/23/17EFFECTIVE DATE SB 8A AMENDMENT 2 IMPLEMENTATION BEGINSJun 22 201719,494PatientsUp 2734/ 2wks 874 PhysiciansUp 53/ 2wks Up 544/ 6 months06 07 17 1066 Physicians Up 247/ 2wks???Jun 06 201716,760Patients Up @ 3,000 / month 819 PhysiciansUp @ 100 / month 5Dispensaries06/08/17Florida Legislature SPECIAL SESSIONPASSES SB 8-ATO IMPLEMENT AMENDMENT 2 06/04/17-06/06/17InternationalThe Cann10 International Medical Cannabis Conference, Tel Aviv, Israel. Noted Speaker: Professor Raphael Mechoulam, “The Godfather of Cannabis Research”The man who first discovered THC, CBD and the endocannabinoid system (ECS)______________________________________________________________________________________________________________________05/12/17FDOH - OCUcompleted-cme(21) _ hcp no count _ approx 825 _ 05 12 1705 05 17FLA LEGISLATURE2017 LEGISLATIVE SESSION = ENDSSB 460 FAILS TO PASS03 07 17FLA LEGISLATURE2017 LEGISLATIVE SESSION = BEGINS (60days)02 09 17FDOHFMCAT Program Rule Development Workshop#54pmTallahassee, FL02 08 17FDOHFMCAT Program Rule Development Workshop#46pmOrlando, FL02 08 17FDOHFMCAT Program Rule Development Workshop#39amTampa, FL02 08 17HOUSEHealth Quality Subcommittee Meeting 3 9-11am02 07 17FDOHFMCAT Program Rule Development Workshop#210amFt. Lauderdale, FL02 07 17SENATEHealth Policy Committee Meeting 310-12pm02 06 17FDOHFMCAT Program Rule Development Workshop#12pmJacksonville, FL02 01 17SENATESen. JEFF BRANDES = files SB 614 to overhaul and repeal current FMCAT laws and replace them with an entirely new FMCAT system______________________________________________________________________________________________________________________January 201701 25 17HOUSEHealth Quality Subcommittee Meeting 2 Speakers: Andy Freedman, Former Colorado Drug Czar/Cannabis Program Director01 24 17PCBCC Pinellas County Board of County Commissioner Meeting #2- FMCI MORATORIUM (6 months) = VOTE = PASSED01 24 17SENATEHealth Policy Committee Meeting 2FEDERAL01 20 17 US PRESIDENTDonald Trump = sworn in as the 45th President of the USA01 19 17SENATESenator Rob Bradley (R-Fleming Island) = files SB 406 = the 1st MC bill to be filed - 2017 Session01 17 17 FDOHFlorida Department of Health FAC Rule 64-4.012Re:= RELEASE = 1st proposed A2 Implementation RuleResult: = A lot of post-release protests and comments= FDOH = wants to CONTROL the Non-listed QMCs = to approve themselves01 11 17 HOUSEHealth Quality Subcommittee Meeting 1Speakers: Christian Bax, OCU Director; Dr Sue Sisley01 10 17PCBCC Pinellas County Board of County Commissioner Meeting #1- FMCI MORATORIUM (x6 months) - Public HearingJan 05 2017@ 1,500Patients@ 340Physicians01 03 17 Amendment 2EFFECTIVE DATE** Florida MC Legalization Constitutional Amendment 2FDOH = given 6 months to promulgate implementation rules and = given 9 months to begin issuing state medical marijuana user Identification (ID) cardsJan 03 2017EFFECTIVE DATEAMENDMENT 2 IMPLEMENTATION CLOCK BEGINS2017______________________________________________________________________________________________________________________201612 13 16 SENATEHealth Policy Committee Meeting 1Re: Meeting #1 - AMENDMENT 2 (A2) – IMPLEMENTATION12/14/16FEDERAL-DOJ-DEADEA = established a new drug code for “marihuana extract” per 21 CFR Part 1308New Drug Code (7350) for Marijuana ExtractNote regarding this rule – In light of questions that the Drug Enforcement Administration has received from members of the public following the publication of the Final Rule establishing a new Controlled Substance Code Number (drug code) for marijuana extract, DEA makes the following clarification:The new drug code (7350) established in the Final Rule does not include materials or products that are excluded from the definition of marijuana set forth in the Controlled Substances Act (CSA).1The new drug code includes only those extracts that fall within the CSA definition of marijuana.If a product consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360).Even though it’s the non-psychoactive ingredient in marijuana, the Drug Enforcement Administration emphasized in 2016 that it is?still illegal and still a Schedule I substance, along with drugs like heroin and LSD. The DEA does not recognize a distinction between CBD and any other kinds of marijuana.12 07 16US Senate 21st Century Cures Act $6.3 billion Passed 94-5 The $6.3 billion Cures Act is good news for patient care and builds on efforts to improve mental health parity with specific provisions that will expand research, treatment and care for mental illnesses and disorders and to foster more innovation in health care and medical science.The Cures Act would inject the views of patients into the drug approval process and accelerate the regulatory process to bring treatments and cures to the market more quickly. Modernizing clinical trials, boosting funding for mental health care, expanding opioid painkiller abuse, prevention and treatment programs and encouraging the use of EHR - electronic health records systems will strengthen and improve patient health in America in the 21st century.?______________________________________________________________________________________________________________________November 201611 08 16FEDERAL US PRESIDENTIAL – GENERAL ELECTIONS DAYFLORIDAAMENDMENT 2 = PASSES OVERWHELMINGLY AT THE POLLS (72.3%)______________________________________________________________________________________________________________________03 04 16FLORIDAFDOH-OCUQualified MC HCP List #1 _ 03 04 16 _ completed-cme(1)________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________2014THE FARM ACT OF 2014Agricultural Act of 2014Section 7606 of the Agricultural Act of 2014 authorizes institutions of higher education (e.g., universities) and state Departments of Agriculture to grow and cultivate ‘industrial hemp’ (defined under the Act as marijuana with a THC content of 0.3 percent or less) for agricultural research purposes where permitted under state law.?? However, the Agricultural Act of 2014 does not permit such entities, or anyone else, to produce non-FDA-approved drug products made from cannabis. Thus, the CSA and FDCA restrictions mentioned above remain in effect with respect to the production of ‘Charlotte’s Web’/CBD oil for human consumption.” ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download