State laws on ‘right-to-try’ experimental drugs backed by new Senate proposal

The 28 states who have passed laws guaranteeing terminally ill patients the “right to try” experimental treatments without enrolling in a clinical trial wouldn’t have to worry about the FOod and Drug Administration (FDA) getting involved under a new bill introduced by Sen. Ron Johnson, R-Wis.

Current FDA guidelines allow for experimental drugs to be prescribed to patients outside of trials under its Expanded Access program, but Johnson argued the process is too slow and the amount of paperwork may deter patients and physician from submitting a request.

“In an era of unprecedented medical innovation, we have to do more to ensure that patients facing terminal illnesses have access to potentially life-saving treatments,” Johnson said in a statement. “These patients don’t have the time to wait–often years and years–for the FDA to grant final approval.” 

The legislation would prevent the FDA from restricting or prohibiting access to experimental drugs for a terminal patient in a state with a right-to-try law. It would also free the manufacturer or prescriber of the treatment from any liability and wouldn’t allow the results of any use under a right-to-try statute from being used by a federal agency to deny or delay approval of a drug.

The concept of right-to-try laws isn’t universally supported. In Johnson’s own state, Wisconsin Medical Society CMO Donn Dexter, MD, is opposed to it on grounds that treatments without the FDA’s approval may be unsafe.

“While everybody understands the anguish of a terminal diagnosis, just because a person is desperate doesn’t mean that they don't deserve protection,” Dexter said to Milwaukee Public Radio, adding he also fears experimental treatments may give patients false hope.

Johnson’s proposal wouldn’t establish a federal version of state right-to-try laws. A separate bill introduced by Rep. Matt Salmon, R-Ariz., would, but it hasn’t been moved out of committee since being introduced in July 2015.