Arizona voters overwhelmingly approved a measure to allow terminally ill patients to obtain experimental drugs that haven’t been approved by the Food and Drug Administration.
So-called “right to try” laws, which have passed in several state legislatures this year, got their start with the Goldwater Institute, a conservative think tank. But Arizona was the first to put the issue directly to voters, and they passed Proposition 303 with nearly 80 percent of the vote.
Colorado was the first to approve such a law earlier this year, doing so with overwhelming legislative support. Missouri. Louisiana and Michigan soon followed.
The laws allow for access to unapproved drugs, but with some caveats. The drug must have passed initial toxicity and dosage testing under the FDA’s clinical trial process. Doctors also can’t prescribe an unapproved drug unless the patient has exhausted other options. Manufacturers are under no obligation to provide the drugs and insurers aren’t required to pay for them.
While the laws have received bipartisan support in state legislatures, they’re not without detractors. Critics in academia and medicine argue they’re premised on false hope, because less than 10 percent of drugs actually make it through clinical trials and few manufacturers will risk defying the FDA by giving out unapproved drugs. Also, critics say, the laws could undermine clinical trials by discouraging participation, in which some participants receive placebos instead of the drug under examination.
The issue is likely to appear again in state legislatures next year. Goldwater spent this year finding sympathetic lawmakers to shepherd experimental drug bills through legislatures with a high success rate, and next year the group plans to launch efforts in about 10 new states, including Texas and Florida.