FL Stat § 499.0295 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067)|499.0295 - Experimental treatments for terminal conditions.

499.0295 Experimental treatments for terminal conditions.—(1) This section may be cited as the “Right to Try Act.”1(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; and4. Has documentation from his or her treating physician that the patient meets the requirements of this paragraph.1(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.1(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, or device.(4) A health plan, third-party administrator, or governmental agency may provide coverage for the cost of, or the cost of services related to the use of, an investigational drug, biological product, or device.(5) A hospital or health care facility licensed under chapter 395 is not required to provide new or additional services unless those services are approved by the hospital or health care facility.(6) If an eligible patient dies while using an investigational drug, biological product, or device pursuant to this section, the patient’s heirs are not liable for any outstanding debt related to the patient’s use of the investigational drug, biological product, or device.(7) A licensing board may not revoke, fail to renew, suspend, or take any action against a physician’s license issued under chapter 458 or chapter 459 based solely on the physician’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device. A state entity responsible for Medicare certification may not take action against a physician’s Medicare certification based solely on the physician’s recommendation that an eligible patient have access to an investigational drug, biological product, or device.(8) This section does not create a private cause of action against the manufacturer of an investigational drug, biological product, or device; against a person or entity involved in the care of an eligible patient who is using the investigational drug, biological product, or device; or for any harm to the eligible patient that is a result of the use of the investigational drug, biological product, or device if the manufacturer or other person or entity complies in good faith with the terms of this section and exercises reasonable care.(9) This section does not expand the coverage an insurer must provide under the Florida Insurance Code and does not affect mandatory health coverage for participation in clinical trials.History.—s. 1, ch. 2015-107; s. 2, ch. 2016-123; ss. 1, 9, ch. 2017-232.1Note.—Section 1, ch. 2017-232, provides that “[i]t is the intent of the Legislature to implement s. 29, Article X of the State Constitution by creating a unified regulatory structure. If s. 29, Article X of the State Constitution is amended or a constitutional amendment related to cannabis or marijuana is adopted, this act shall expire 6 months after the effective date of such amendment.” Section 9, ch. 2017-232, deleted paragraph (2)(a); redesignated paragraphs (2)(b)-(e) as paragraphs (2)(a)-(d); and amended former paragraph (2)(c), now paragraph (2)(b), and subsection (3). If such amendment or adoption takes place, paragraph (2)(a), paragraph (2)(b), renumbered as paragraph (2)(c), and subsection (3), as amended by s. 1, ch. 2017-232, will read:(a) “Dispensing organization” means an organization approved by the Department of Health under s. 381.986(5) to cultivate, process, transport, and dispense low-THC cannabis, medical cannabis, and cannabis delivery devices.* * * * * (c) “Investigational drug, biological product, or device” means:1. 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; or2. Medical cannabis that is manufactured and sold by a dispensing organization.* * * * * (3) Upon the request of an eligible patient, a manufacturer may, or upon a physician’s order pursuant to s. 381.986, a dispensing organization may:(a) Make its investigational drug, biological product, or device available under this section.(b) Provide an investigational drug, biological product, device, or cannabis delivery device as defined in s. 381.986 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, device, or cannabis delivery device as defined in s. 381.986.