CNSNews.com is reporting that Utah and Indiana have become the eighth and ninth state in the U.S. to pass “right to try” laws that give patients access to experimental drugs that have only passed through the first phase of the FDA’s years-long approval process. These laws allow physicians to prescribe “ investigational” medication to terminally ill patients who have exhausted all other options.
This potentially life-saving trend toward saving lives rather than ending them is beginning to gain traction in the U.S. The National Conference of State Legislatures is reporting that similar bills have been filed in 32 states and the District of Columbia so far this year.
Just this month, Governor Asa Hutchinson of Arkansas signed the Right to Try Act into law which states that “patients who have a terminal disease do not have the luxury of waiting until an investigational drug, biological product, or device receives final approval” from the FDA. The law grants immunity to pharmaceutical companies, doctors and hospitals who administer experimental drugs except in cases of “gross negligence or willful misconduct.”
Governor Matt Mead of Wyoming also signed a similar bill into law this month which goes into effect on July 1 and allows the terminally ill who have considered all other options to be treated with investigational drugs or devices that have cleared the first phase of clinical trials. Insurance companies are permitted, but not required, to cover these treatments.
“When someone is on their deathbed, the fact that FDA regulations would let them die rather than try has got to be one of the most inhumane policies of the federal government. Every state should nullify the FDA like this,” said Mike Maharrey, communications director of the Tenth Amendment Center, which supports “right to try” laws, to CNS.
Critics say laws that allow untested drugs to be used could backfire on a patient and do more harm than good.
“Having passed phase 1 does not mean a drug is safe…If there’s one thing worse than dying of a terminal illness, it’s suffering unnecessary complications from a drug that is incredibly unlikely to save or significantly prolong your life and bankrupting yourself and family in the process,” Dr. David Gorski blogged late last year.
Others say the FDA already has a “compassionate use” program in effect, but the application is so time-consuming and cumbersome that many sick people and their doctors are discouraged from using it. In many cases, patients who do apply die before their paperwork is approved.
As a result of this criticism, the FDA created a working group last December to “develop policies that would improve access to investigational therapies” by streamlining the process.
In the meantime, lawmakers are stepping in to help those who are fighting for their lives.
Darcy Olsen, president of the Arizona-based Goldwater Institute, which developed model “right to try” legislation, said the FDA’s current process is “an inhumane system that prevents the vast majority of Americans with terminal illnesses from accessing promising investigational treatments.”
She added, “Compassionate use should be the rule for everyone, not the exception.”
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