By Mike Maharrey
A bill prefiled in the Texas House would expand the state’s “Right to Try” law, setting the foundation to nullify in practice additional Food and Drug Administration (FDA) rules that deny access to experimental treatments by patients with severe chronic diseases.
On Nov. 14, Rep. Steve Toth (R) filed House Bill 638 (HB638) for introduction in the 2023 legislative session. The legislation would enable patients suffering from chronic diseases to access medications and treatments not yet given final approval for use by the FDA.
The bill defines “severe chronic disease” as “a condition, injury, or illness that requires medical attention and entails significant functional impairment or severe pain that limits a person’s activities of daily life.” Under the proposed law, the executive commissioner of the Health and Human Services Commission would designate specific medical conditions as “severe chronic disease.”
HB638 is based on the Texas Right to Try law that went into effect in June 2015. The law enables terminally ill patients to access medications and treatments that do not have final FDA approval.
The Federal Food, Drug, and Cosmetic Act generally prohibits access to experimental drugs. However, under the expanded access provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb, patients with serious or immediately life-threatening diseases may access experimental drugs after receiving express FDA approval. Right to Try allows terminally ill patients to bypass the expanded access provision and obtain experimental drugs from manufacturers without first obtaining FDA permission.
Since the Texas Right to Try law went into effect, at least 78 patients in Texas have received an experimental cancer treatment not allowed by the FDA. If passed, HB638 would expand Right to Try to patients suffering from chronic illnesses.
Language in the findings section of HB638 references the success of Right to Try in the Lone Star State.
“The Right To Try Act, as added by Chapter 502 (H.B.21), Acts of the 84th Legislature, Regular Session, 2015, has had tremendous success in saving the lives of many patients with a terminal illness. … patients who are battling a severe chronic disease that is debilitating or causes severe pain, do not have the luxury of waiting until an investigational drug, biological product, or device receives final approval from the United States Food and Drug Administration.”
HB638 includes provisions similar to those in the current Texas Right to Try law. Specifically, the legislation prohibits state officials from any actions that would prevent the lawful administering of experimental procedures to eligible patients. It reads, in part:
“An official, employee, or agent of this state may not block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device under this chapter.”
This is important since local law enforcement often works closely with federal agencies to take aggressive actions to stop state programs that aren’t in line with federal law. Including this provision ensures that the “boots on the ground” for law enforcement – the locals, won’t be taking any action to stop sick people from trying new treatments. The feds will have to handle it, and they don’t have the manpower or resources to get the job done.
Healthcare providers are also protected under the bill, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. Manufacturers of medications and treatments are shielded from legal recourse as well.
Congress passed a federal Right to Try law in 2018 after 40 states enacted laws allowing terminally ill patients to effectively bypass the FDA and try experimental treatments without federal permission.
HB638 expands on the foundation established by Right to Try for terminally ill patients. This demonstrates an important strategic point. Passing bills that take a step forward sets the stage, even if they are limited in scope. Opening the door clears the way for additional steps. You can’t take the second step before you take the first.
HB638 will be officially introduced when the 2023 session of the Texas legislature kicks off on Jan. 10. At that time, it will receive a committee assignment. It will need to receive a hearing and pass the committee by a majority vote before moving forward in the legislative process.