California to allow experimental drug treatments for the terminally ill

Terminally ill patients in California will have access to experimental drugs that have not yet been approved by the Food and Drug Administration (FDA) under legislation signed Tuesday by Gov. Jerry Brown (D).

{mosads}California becomes the 32nd state to pass a “right to try” law allowing drug manufacturers to offer new treatment options to patients who have already tried other FDA-approved options. Proponents say the law will give new options to patients who cannot wait for the FDA’s approval process to unfold.

“Terminally ill patients in our state will finally have access to potentially life-saving treatments,” California Assemblyman Ian Calderon (D) said in a statement. Calderon, the assembly majority leader, authored the bill.

Brown vetoed a similar measure offered by Calderon last year, with the hope, he said at the time, that the FDA would shorten its approval process.

In 2015, the FDA did streamline the process by which patients can apply for expanded access or compassionate use in order to obtain experimental drugs. But the new California law — and others like it around the country — goes even further, allowing patients to circumvent the FDA altogether.

Opponents of right to try legislation, including oncologists and medical ethicists, say access to experimental drugs offers false hope to those with life-threatening illnesses. Experimental drugs have only a limited chance of actually working, they say, and pharmaceutical companies have no obligation to actually offer drugs that are still working their way through trials.

In a 2015 report for The Hastings Center, a medical ethics institute in New York, Washington University Law School bioethicist Rebecca Dresser said pharmaceutical companies do not have the capacity to treat all terminally ill patients seeking new treatments.

Right to try measures have passed in red and blue states alike, from liberal Oregon and Connecticut to conservative Wyoming and Louisiana. Hawaii Gov. David Ige (D) vetoed right to try legislation in May.

Similar measures have been introduced in 17 other states. New Mexico is the only state that has not seen a right to try bill introduced.

The Goldwater Institute, a conservative think tank based in Phoenix, Ariz., is the main driver of right to try laws around the nation. The institute offers model legislation that serves as the basis for laws passed in most states. 

But on Wednesday, an effort to advance right to try legislation at the federal level fell short. Senate Minority Leader Harry Reid (D-Nev.) objected to a unanimous consent request from Sen. Ron Johnson (R-Wis.), lead sponsor of the Trickett Wendler Right to Try Act.

In an email, Adam Jentleson, a Reid spokesman, called Johnson’s request for unanimous consent a “cheap stunt.”

“If Sen. Johnson wants to bring his bill to the floor, he should follow regular order and go through the committee process,” Jentleson said. “Sen. Johnson’s actions today show that he’d rather phone it in than put in the hard work necessary to get things done.”

Johnson, in a statement, called Reid’s objections “beyond disappointing.”

“Patients with terminal diseases … ought to have a right to access treatments that have been proven safe and could potentially save their lives. They should have the right to hope,” Johnson said.

Johnson’s bill is named after a woman from Waukesha, Wis., who died of Amyotrophic Lateral Sclerosis, or ALS, in 2015. ALS activists have been among the prime drivers backing right to try legislation in several states.

Calderon testified on behalf of the federal law before the Senate Homeland Security and Governmental Affairs Committee, which Johnson chairs, last week.

–This report was updated at 3:41 p.m.