With his signature, Gov. Bobby Jindal made Louisiana the second state in the nation to allow people with terminal diseases access to potentially life-saving experimental drugs and treatments.
The new “right to try” law, which was drafted by a conservative think tank and passed without any “no” votes in the Legislature, would allow terminally ill patients to try experimental drugs for diseases like cancer prior to the drugs’ approval by the FDA. Drug manufacturers, who are not required to participate, would have to agree, and the experimental drug would have to clear Phase 1 testing.
“It’s a compassionate thing to do for our families and friends,” Jindal said at a signing ceremony. “This is also about individual freedom and liberty. If individuals facing terrible diseases want to try something, why should the government stop them from doing that?”
The legislation is often called the “Dallas Buyers Club” bill. That refers to the Academy Award-nominated 2013 film in which Matthew McConaughey’s character was patterned on real-life Ron Woodroof, a 1980s AIDS patient who smuggled unapproved pharmaceuticals available in other countries into Texas to help others suffering from the fatal disease.
The Goldwater Institute is pushing the legislation across the country.
Supporters say the right to fight for your own life is basic and that many people are willing to take a chance on unproven drugs.
But as proponents talk of potential access to cures and individual freedom, some question whether the laws are holding out false hopes.
The Pharmaceutical Research and Manufacturers of America trade group has warned that public safety is not best served by circumventing Food and Drug Administration oversight. The FDA has said the movement bypasses its legal authority, and some have suggested the laws could be challenged in court as unconstitutional.
Colorado became the first state to enact the “right to try” law earlier this month. The Missouri Legislature has sent similar legislation to its governor for signing into law. A statewide voter referendum is set for later this year in Arizona on the proposition.
Colorado called it the “Dallas Buyers Club” bill, instead of “right to try.” A Colorado melanoma patient who died seeking access to an experimental drug helped propel the law there. He had lobbied two drug companies trying to get drugs outside of clinical trials.
In Louisiana, House Bill 891 was sponsored by Republican state Rep. Julie Stokes, of Metairie. She said clinical trials are going on all over the country but people in Louisiana don’t have access to them.
“Now they will be able to access the care they need and save their lives, which is real freedom,” Stokes said.
HB891 authorizes manufacturers of investigational drugs, biological products and devices to make them available to patients who have been certified by at least two physicians to have a terminal illness and for whom all other available avenues of treatment have been tried. Physicians who prescribe the investigational drug would be protected from liability for any adverse outcomes.
The new law would make available potentially life-saving drugs that have passed early-stage FDA safety trials. That does not mean the drugs have been proven effective nor any associated risks determined, only that they are safe for humans to take.
“It’s government getting out of the way and people’s ability to make choices in this country,” said House Health and Welfare Committee Chairman Scott Simon, R-Abita Springs. “It’s a very compassionate bill for those looking for answers.”
Currently, the FDA has a program called “compassionate use” under which patients can get special permission to use experimental drugs or therapies outside of clinical trials. “But (terminally ill) patients run out of time” waiting for approvals, Stokes said.
In legislative testimony, Goldwater Institute senior attorney Kurt Altman said some 400,000 people a year die just from breast cancer in the U.S. He said many people are dying when there are medicines going through the FDA approval process that could help them.
Based in Phoenix, the Goldwater Institute is funded by individuals and foundations to conduct policy analysis, research and litigation on state-level policy issues. The institute reported appearing 26 times before state legislative bodies and was quoted more than 1,000 times on television and in newspaper articles.
“Many of these medicines are approved in other parts of the world. People of means can travel to Europe and Japan, where medicines developed here but not approved yet are being used sometimes effectively,” Altman said.
“It will give access to these medicines when they need it most, when they are terminal,” he said.