For years, the U.S. Food and Drug Administration has had a “compassionate use” application process meant to provide patients expanded access to investigational medical products not yet approved by the FDA. However, for the terminally ill this process is impractical and has denied them access to potentially life-saving treatments and devices. I know this from personal experience.
Nearly three years ago when my father’s leukemia came back, rather than go through the harrowing chemotherapy he endured less than one year earlier, he asked his oncologist about accessing an experimental medication which was reported to have success with leukemia patients. My father was hopeful this drug would help him. More importantly, my father, who had lived a long and full life, wanted to add at least anecdotal evidence the drug company could use to help others in his situation.
His oncologist informed him that the compassionate use application process was too much work. The work the oncologist wanted to avoid was the 100+ hours of paperwork the FDA requires of doctors. Thwarted by the FDA bureaucracy, my father opted for conventional non-chemotherapy treatments that had little effect. A few months later he passed away in late 2013.
Since then, 22 states have passed Right to Try laws which provide terminally ill patients an alternate and much easier route to access investigational medical products not yet fully approved by the FDA – without the burdensome paperwork required by the FDA’s compassionate use application process. For this reason, I was actively involved in enacting Utah’s Right to Try law.
Right to Try laws give terminal patients who have explored conventional treatment options and consulted with their doctor access to drugs that have successfully completed Phase I of FDA testing. A drug passes Phase I when the FDA has determined it to be reasonably safe for human trials. Utah’s law also shields healthcare providers, insurers and manufacturers from liability which might arise from use of the investigational medical products.
There is no question the FDA plays an important role in keeping harmful or ineffective drugs off the market. But, the process is so slow and cumbersome that it often keeps new drugs from terminally ill patients desperate to extend and preserve their lives. On average, it takes 10-15 years and hundreds of millions of dollars for drugs to get through the FDA’s multi-phase approval process and finally become available to the public. Thousands of potentially lifesaving drugs and treatments are bogged down in the red tape of the seemingly never-ending FDA approval process.
Right to Try laws allow insurers to deny coverage for the investigational medical products, but do not prohibit insurers from covering such costs and require insurers to continue to cover preexisting conditions and current, palliative and hospice care.
In Utah we have formed the Right to Try Foundation, which raises money to assist those in our state who can’t afford the cost of the investigational medical products. This is a funding model other states should consider.
Patients, especially terminally ill patients, armed with their doctor’s recommendations should be allowed to make their own medical decisions – without the current hurdles imposed by Washington’s bureaucracy. As more states consider changing health care laws, they should consider the “Right to Try” solution. Making our own decisions That’s the American way.
