On June 16, 2015, Governor Abbott signed into law H.B. 21, known as the “Right to Try Act” and the law became immediately effective, thereby allowing patients with terminal illnesses the right to use potentially life-saving investigational drugs, biological products, and devices. With the passage of this new law, Texas joins 21 other states that have passed similar “right-to-try” legislation. Although the new law is intended to give terminally ill patients access to experimental and potentially life-saving treatments, the Right to Try Act conflicts with federal FDA laws and questions remain regarding the actual impact of the new law.
Under current federal regulations, patients seeking to use experimental drugs before FDA approval must apply for expanded access to the investigational drug. In order to be eligible for the expanded access (also called compassionate use), the patient must (a) have a serious or immediately life-threatening disease or condition, (b) have no comparable or satisfactory alternative therapy to treat the disease or condition; and (c) be unable to otherwise obtain the investigational drug or to participate in a clinical trial. In addition, the patient’s physician must determine that the probable risk to the patient from the investigational drug is not greater than the probable risk from the disease or condition and the patient must be willing to accept the possible risks and unknown effectiveness associated with the investigational medical product. A licensed physician who makes the individual patient expanded access submission must manage the use of the investigational drug and the patient’s medical care, including obtaining Institutional Review Board (IRB) approval, reporting adverse events and outcomes, and submitting the necessary paperwork to FDA. Generally the FDA will approve the expanded access upon the patient meeting the participation standards and the FDA’s determination that there is sufficient evidence of the safety and effectiveness of the investigational product to support its use in the particular circumstance; and that providing the investigational product will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval. While the FDA has a procedure in place for expanded access, many terminally ill patients are unable to participate in the program because of the technical application requirements or the delays in the application process. As a result, many states, including Texas, have passed laws permitting terminally ill patients legal access to experimental drugs that are not yet approved by the FDA.
Under Texas’ Right to Try Act a patient is eligible to access and use an investigational drug, biological product, or device that has successfully completed phase one of a clinical trial (the “investigational drug”) if: (1) the patient has a terminal illness, attested to by the patient’s treating physician; and (2) the patient's physician (a) in consultation with the patient, has considered all other treatment options currently approved by the FDA and determined that those treatment options are unavailable or unlikely to prolong the patient’s life; and (b) has recommended or prescribed in writing that the patient use a specific class of investigational drug. Before receiving an investigational drug, the patient, or the patient’s parent or legal guardian, must sign an informed consent. The manufacturer of the investigational drug may, but is not required to, make its product available to the terminally ill patient who provides an executed informed consent. A manufacturer who provides the investigational drug to the patient must do so at no cost.
While the Right to Try Act provides terminally ill patients access to investigational drugs, it also protects manufacturers, physicians and other care givers from legal liability associated with a patient’s use of the investigational drug. Accordingly, the law provides that there is no private or state cause of action against a manufacturer of an investigational drug or against any other person or entity involved in the care of the patient using the investigational drug, for any harm done to the patient resulting from the investigational drug. Moreover, the Texas Medical Board may not revoke, fail to renew, suspend, or take any action against a physician's license based solely on the physician’s recommendations to a patient regarding access to or treatment with an investigational drug.
Texas’ Right to Try Act facially appears to give terminally ill patients access to investigational drugs, however, numerous questions remain regarding whether the law will achieve its desired result, including: (1) will the FDA’s exclusive jurisdiction over the regulation of drugs preempt the state law, (2) will the FDA take action against a manufacturer of an investigational drug who distributes the drug to patients outside the clinical trial process, (3) will there be an adverse impact on clinical trials because patients may be reluctant to consent to a study when they know that if they participate, there is a chance the patient will receive a placebo rather than the investigational drug, and (4) will the data regarding the safety and effectiveness of an investigational drug be compromised because some of the data may not be captured outside of a clinical trial process? While the Right to Try Act is now effective, we will have to wait for the answers to these and other questions. Stay tuned…
