Rye, Brook, NY (May 23, 2018) – The House of Representatives yesterday voted 250-169 in favor of the Right to Try Act, which the Senate passed in August 2017. The bill will now be sent to President Trump, who is expected to sign it.
The Right to Try Act fails to meet all of The Leukemia & Lymphoma Society’s (LLS) principles regarding access to investigational therapies, which are outlined below.
The Leukemia & Lymphoma Society (LLS) Principles:
Patient Access to Investigational Treatments
The mission of The Leukemia & Lymphoma Society (LLS) is to find cures for leukemia, lymphoma, Hodgkin’s disease, and myeloma, and to ensure that blood cancer patients have access to quality, affordable, and stable healthcare. We believe that the ideal way to ensure access to safe and effective experimental treatments for the largest number of patients is through the clinical trials process. However, LLS recognizes that there are circumstances in which patients with serious or life-threatening conditions are not eligible for a clinical trial or have exhausted all available treatments and may seek access to investigational therapies outside of a clinical trial setting. Fortunately, the U.S. Food & Drug Administration (FDA) has a long history of facilitating access to investigational treatments for patients who lack therapeutic alternatives.
Wherever possible, LLS believes the use of an investigational treatment by a patient as part of a clinical trial is preferable to seeking experiment therapies through other means. However, when a clinical trial is not an option, LLS supports policies that promote patient access to investigational treatments, when provided in accordance with the following principles:
- The patient and the patient’s healthcare provider must agree that the investigational therapy provides the best course of treatment for the patient.
- The FDA must determine that there is sufficient evidence of the safety and effectiveness of the investigational treatment to support its use in the particular circumstance.
- Each patient must be made aware of and accept the physical risks of the investigational treatment.
- Patients must be protected from financial hardship resulting from use of these therapies, given that those patients seeking access to investigational treatments are an extremely vulnerable population. No entity should be allowed to profit off the provision of an experimental therapy to such vulnerable patients.
- Patients seeking access to investigational treatments outside of clinical trials must be afforded the same ethical protections as patients taking part in clinical trials.
- All outcomes data related to the use of the investigational treatment must be made available to both the manufacturer of the therapy and the FDA.
- Providing the investigational treatment must not interfere with current or planned clinical development due to drug supply constraints, patient enrollment, or diversion of personnel or financial resources.