“Right To Try” Act Expands To Include Marijuana
As set forth in previous articles (see here), Florida marijuana laws have now expanded to allow terminally-ill patients in Florida to legally buy and use medical marijuana in Florida. Although this change has already been signed by Governor Scott and become law, implementation of the law cannot begin until the previously-licensed Florida dispensaries begin growing and selling medical marijuana:
499.0295 Experimental treatments for terminal conditions
(2) As used in this section, the term:
(a) “Eligible patient” means a person who:
1. Has a terminal condition that is attested to by the patient’s physician and confirmed by a second independent evaluation by a board-certified physician in an appropriate specialty for that condition;
2. Has considered all other treatment options for the terminal condition currently approved by the United States Food and Drug Administration;
3. Has given written informed consent for the use of an investigational drug, biological product, or device; and
4. Has documentation from his or her treating physician that the patient meets the requirements of this paragraph.
(b) “Investigational drug, biological product, or device” means
A drug, biological product, or device that has successfully completed phase 1 of a clinical trial but has not been approved for general use by the United States Food and Drug Administration and remains under investigation in a clinical trial approved by the United States Food and Drug Administration
(c) “Terminal condition” means a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered by a treating physician to be reversible even with the administration of available treatment options currently approved by the United States Food and Drug Administration, and, without the administration of life-sustaining procedures, will result in death within 1 year after diagnosis if the condition runs its normal course.
(d) “Written informed consent” means a document that is signed by a patient, a parent of a minor patient, a court-appointed guardian for a patient, or a health care surrogate designated by a patient and includes:
1. An explanation of the currently approved products and treatments for the patient’s terminal condition.
2. An attestation that the patient concurs with his or her physician in believing that all currently approved products and treatments are unlikely to prolong the patient’s life.
3. Identification of the specific investigational drug, biological product, or device that the patient is seeking to use.
4. A realistic description of the most likely outcomes of using the investigational drug, biological product, or device. The description shall include the possibility that new, unanticipated, different, or worse symptoms might result and death could be hastened by the proposed treatment. The description shall be based on the physician’s knowledge of the proposed treatment for the patient’s terminal condition.
5. A statement that the patient’s health plan or third-party administrator and physician are not obligated to pay for care or treatment consequent to the use of the investigational drug, biological product, or device unless required to do so by law or contract.
6. A statement that the patient’s eligibility for hospice care may be withdrawn if the patient begins treatment with the investigational drug, biological product, or device and that hospice care may be reinstated if the treatment ends and the patient meets hospice eligibility requirements.
7. A statement that the patient understands he or she is liable for all expenses consequent to the use of the investigational drug, biological product, or device and that liability extends to the patient’s estate, unless a contract between the patient and the manufacturer of the investigational drug, biological product, or device states otherwise.
(3) Upon the request of an eligible patient, a manufacturer may:
(a) Make its investigational drug, biological product, or device available under this section.
(b) Provide an investigational drug, biological product,
or device to an eligible patient without receiving compensation.
(c) Require an eligible patient to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product,
Section 3. (1) Notwithstanding s. 381.986(5)(b), Florida Statutes, a dispensing organization that receives notice from the Department of Health that it is approved as a region’s dispensing organization, posts a $5 million performance bond in compliance with rule 64–4.002(5)(e), Florida Administrative Code, meets the requirements of and requests cultivation authorization pursuant to rule 64–4.005(2), Florida Administrative Code, and expends at least $100,000 to fulfill its legal obligations as a dispensing organization; or any applicant that received the highest aggregate score through the department’s evaluation process, notwithstanding any prior determination by the department that the applicant failed to meet the requirements of s. 381.986, Florida Statutes, must be granted cultivation authorization by the department and is approved to operate as a dispensing organization for the full term of its original approval and all subsequent renewals pursuant to s. 381.986, Florida Statutes. Any applicant that qualifies under this subsection which has not previously been approved as a dispensing organization by the department must be given approval as a dispensing organization by the department within 10 days after the effective date of this act, and within 10 days after receiving such approval must comply with the bond requirement in rule 64–4.002(5)(e), Florida Administrative Code, and must comply with all other applicable requirements of chapter 64–4, Florida Administrative Code.
(2) If an organization that does not meet the criteria of subsection (1) receives a final determination from the Division of Administrative Hearings, the Department of Health, or a court of competent jurisdiction that it was entitled to be a dispensing organization under s. 381.986, Florida Statutes, and applicable rules, such organization and an organization that meets the criteria of subsection (1) shall both be dispensing organizations in the same region. During the operations of any dispensing organization that meets the criteria in this section, the Department of Health may enforce rule 64–4.005, Florida Administrative Code, as filed on June 17, 2015.
(3) This section does not apply to s. 381.986 (5)(c), Florida Statutes.
Section 4. Any college or university in the state that has a college of agriculture may conduct cannabis research consistent with state and federal law.
Section 5. This act shall take effect upon becoming a law.
Approved by the Governor March 25, 2016.
Filed in Office Secretary of State March 25, 2016.