By: Dustin Robinson & Steven Avalon
The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act (“Federal Right to Try Act”), was signed into federal law May 30, 2018 as a direct result of similar laws in 41 states, including Florida. Florida’s Right to Try Act (Senate Bill 1052: Experimental Treatments for Terminal Conditions) was signed into law in July 2015 and allowed Florida terminally ill patients to undergo non-FDA approved treatments for their illnesses, while also absolving manufacturers of the drugs, products, and devices used for said treatment of any liability.
The Federal Right to Try Act, which is a reflection of the state laws which preceded it, allows terminally ill patients to seek investigational treatments for their diseases. To qualify as an eligible patient under the Federal Right to Try Act, an individual must:
1. Be diagnosed with a life-threatening disease or condition;
2. Have exhausted approved treatment options;
3. Be unable to participate in a clinical trial involving the eligible investigational drug, as certified by a doctor, who is in good standing with her licensing organization and will not be compensated directly by the manufacturer for so certifying; and
4. Give written informed consent regarding the risks associated with taking the investigational treatment.
However, only certain drugs and treatments qualify. Specifically, a drug or treatment must:
1. Have completed an FDA-approved Phase 1 clinical trial;
2. Be in an active clinical trial intended to form the basis of an application for approval or be the subject of an application for approval that has been filed with the FDA; and
3. Be in ongoing active development or production and not discontinued by the manufacturer or placed on clinical hold.
With the recent legalization efforts surrounding psilocybin and other entheogenic plants, many of our clients have asked about psilocybin as related to the Federal Right to Try Act. Psilocybin has completed an FDA-approved Phase 1 clinical trial (Compass Pathways and Usona both currently have Phase-2 trials ongoing) and has been granted “breakthrough therapy” status by the FDA (see our blog here for a brief discussion of what a breakthrough therapy designation is). Therefore, psilocybin qualifies as a drug that fits squarely within the language of the Federal Right to Try Act, which mirrors Florida’s Right to Try Act.
An eligible patient does not need to apply to the FDA. Instead, the eligible patient and their treating physician must follow the requirements of the Right to Try Act. For an eligible patient to lawfully use psilocybin under the Right to Try Act, an eligible patient or their legal representative must first provide “written informed consent” to their treating physician about using psilocybin. Under the federal Act, there is not a definition or outline specific requirements for “written informed consent.” Therefore, it is unclear what specific consent an eligible patient must provide their physician looking only at the Federal Right to Try Act. To understand what is required of “written informed consent,” we must look to state law. Each of the 41 states with a state Right to Try Act has its own requirements. Under s. 499.0295 (2)(d) Fla. Stat., Florida defines “written informed consent” as:
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; and
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.
Once an eligible patient or their legal representative provides the treating physician written informed consent, the physician and patient must contact a manufacturer of the desired substance. To acquire a psilocybin product in the United States, an eligible patient must look towards the companies currently undergoing clinical trials of psilocybin products. Therefore, an eligible patient and their treating physician would be allowed to contact Usona or Compass Pathways to acquire psilocybin products under Right to Try. If a psilocybin manufacturer agrees to provide the eligible patient psilocybin products, there are no further requirements.1 In other words, neither the eligible patient nor the treating physician are required to contact the FDA or any other federal agency about the eligible patient’s use of the psilocybin product.
Psilocybin’s “breakthrough therapy” status and other milestones show that the US is beginning to accept the medical benefits of psilocybin. Furthermore, Right to Try under federal and state law allows patients to enjoy these benefits of investigatory substances prior to widespread FDA approval. Therefore, terminally-ill individuals would be permitted to use psilocybin to treat their illnesses under the Federal Right to Try Act and the Florida Right to Try Act. The biggest challenge right now is getting Usona or Compass Pathways on board with supplying such medicine.
1. Byrne, Jennifer. “Right to Try: A ‘Well-Intentioned’ but ‘Misguided’ Law.” Healio, 10 Mar. 2020, www.healio.com/news/hematology-oncology/20200303/right-to-try-a-wellintentioned-but-misguided-law.