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Lifesaving Results

November 22, 2016

Lifesaving Results

Before Right To Try was introduced, the FDA hadn’t changed its compassionate use process in nearly three decades; and the only federal reforms that had been introduced were those that gave the FDA more latitude in granting early access to investigational drugs. Even though the FDA was given this authority, it is rarely used. 

As of today, Right to Try is law in 32 states and counting: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maine, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, North Carolina, North Dakota, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia and Wyoming. Nineteen additional states have considered the law.  

We have evidence that the pressure is working in Washington. In June 2014, inspired by the Right To Try movement, senators Tom Coburn, Richard Burr, and Lamar Alexander called for an investigation of the FDA’s compassionate use process.

Then in February 2015, the Obama administration announced that the Food and Drug Administration would streamline its compassionate use program to improve access to medicines in the clinical trial pipeline. Before Right To Try, the FDA refused to even acknowledge how cumbersome the process was. Now it is acknowledging at least part of the problem and moving to address it.

In July 2015, a handful of lawmakers introduced H.B. 3012, a federal law to protect states, drug companies, doctors and patients who are lawfully implementing or using a state Right To Try law. There are now more than 50 co-sponsors on that piece of legislation.

In November 2015, Harper Collins released The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need. This book, written by Goldwater Institute president Darcy Olsen, was well-reviewed by book critics, political pundits, healthcare industry leaders, and fellow free-market advocates.

In February 2016, the U.S. Senate held a hearing on ways to increase patient access to promising drugs. Darcy Olsen, Goldwater Institute president, was among the witnesses. Three others who strongly supported Right To Try—two families whose sons needed access to drugs in clinical trials and a medical doctor who runs clinical trials, joined her.

In April 2016, the FDA announced it was considering creating a “compassionate use navigator” position within the agency to help more people get through the life-or-death application process. Regulatory Affairs explained the need for the new position: “The need for such a navigator comes as more than 20 states since 2014 have introduced ‘Right to Try’ bills that aim to help terminally ill patients or those with no treatment options gain access to potential drugs that are still undergoing clinical trials.”
 

In May, 2016, the a bill was introduced in the U.S. Senate to protect the state-passed Right To Try laws from federal interference.

In July 2016, on the first day of business at the 2016 Republican National Convention, party delegates adopted a new official party platform that includes language supporting laws that give terminally ill Americans the right to access drugs that are being safely used in clinical trials but are not yet on pharmacy shelves.

In September 2016, California became a 32nd state to adopt Right to Try law for terminally ill. The California Right To Try Act, Assembly Bill 1668, was sponsored by Assembly Majority Leader Ian Calderon, and it passed the state House and Senate with nearly unanimous bipartisan support.

Also in September 2016, Dr. Ebrahim Delpassand in Houston, Texas, provided video testimony to a U.S. Senate hearing explaining that he has used his state’s Right To Try law to successfully treat nearly 80 terminal pancreatic cancer patients. 

 

 

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