Colorado, Louisiana and Missouri may become the first states to pass “Right to Try” laws that would allow terminally ill patients to take experimental drugs, bypassing approval from the Food and Drug Administration.
All three states passed Right to Try legislation unanimously in the last month. Colorado Gov. John Hickenlooper (D) is expected to sign its bill into law Saturday, the Washington Post reported.
The laws allow terminally ill patients to bypass a lengthy bureaucratic process of filing with the FDA for approval of early access to experimental drugs and the cumbersome issue of getting pharmaceutical companies of providing them.
“For people who are facing death and have one last hope, they should have a choice to try every possible drug,” Colorado Democrat Rep. Joann Ginal, the bill’s co-sponsor.
Opponents say the laws are dangerous and do more harm than good. Supporters say patients feel they have nothing left to lose.
“The notion is based on the ‘Dallas Buyers Club’ — the idea that you have to get around the indifferent and cruel government to get access to drugs,” said Arthur Caplan, director of the bioethics division at New York University Langone Medical Center.
Caplan told The Associated Press that the FDA almost always approves “compassionate use” exemptions and the new laws won’t even compel drugmakers to comply.
Frank Burroughs, the founder of the Virginia-based Abigail Alliance for Better Access to Experimental Drugs, says patients aren’t after every unapproved drug they can get their hands on.
“We’re talking about ‘promising’ drugs,” Burroughs said. “Patients are much smarter and savvy than they get credit for.”
He says patients are out of options and the FDA won’t work quickly enough.
“The risk-benefit is much different than someone who’s waiting for a new allergy medication or a new toe fungus cream,” he said.
As the bills pass with flying colors, they raise another important question about insurance and the availability of drugs already approved by the FDA. Right to Try may cut through the red tape when it comes to federal regulations, but what about health insurance bureaucracy?