Last week, Congress passed and the president signed into law the “Right to Try Act,” legislation President Trump had touted in his previous State of the Union address. Here is what you should know about the new law.
What is “Right to Try”?
Right To Try is the concept that terminally ill Americans should be able to try medicines that have passed Phase 1 of the FDA approval process and remain in clinical trials but are not yet on pharmacy shelves.
What is the Right to Try Act?
The Right to Try Act of 2017 authorizes the “use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.”
Which patients are eligible under the Act?
Eligible patients are those who, as certified by a physician, have been diagnosed with a life-threatening disease or condition, have exhausted approved treatment options, and are unable to participate in a clinical trial involving the eligible investigational drug.
What drugs are eligible under the Act?
Medicines that have passed Phase 1 of the FDA approval process and remain in clinical trials but are not yet on pharmacy shelves. The term ‘phase 1 trial’ means a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, Code of Federal Regulations, which includes the initial introduction of an investigational new drug into humans.
Can a patient sue a drug maker that provided the investigational drug?
Yes. The law doesn’t affect the right of any person to bring a private action under any State or Federal product liability, tort, consumer protection, or warranty law.
Are drug makers and doctors required to provide the investigational drug?
No. According to the law, no liability shall lie against a sponsor manufacturer, prescriber, dispenser or other individual entity for its determination not to provide access to an eligible investigational drug.
Are insurance companies required to pay for the investigational drugs?
No. The Act merely “expands the scope of individual liberty and agency among patients, in limited circumstances” and does not require any third-party to pay for the treatment.
Are there also State-level Right to Try laws?
Yes, there are Right-to-try laws in 40 states: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. Eleven additional states have introduced the law, though the federal law allows it in any state.
What are the claimed drawbacks of the Right to Try law?
Skeptics of the law say it may harm more people than it helps, and that it could lead to the exploitation of the sick and vulnerable. As Wesley Smith says, “Fraudsters could pretend to have the drugs — as has happened in the stem-cell field. Or, desperate people may be only able to get drugs at high cost. These drugs will not be cheap at the experimental stage.”
What are the claimed benefits of the Right to Try law?
Supporters say the law was needed because most terminal patients are too sick to be selected to participate in clinical trials and that they may die before promising treatments are approved by the FDA. At a minimum, some contend, the law removes unnecessary governmental interference between patients, their doctors, and pharmaceutical companies.