Legislation introduced in Tennessee could give patients speedy access to drugs that have been proven safe and show promise in treating their medical conditions but have yet to clear all the hurdles of the federal drug approval process. Similar measures, called “Right to Try,” have passed in Arizona, Colorado, Louisiana, Michigan, and Missouri.
Right to Try legislation would have benefited patients such as Diego Morris, diagnosed at age 13 with osteosarcoma, a type of cancer. Diego’s family was told the treatments Diego needed were not available in the United States.
The drug Diego needed, Mifamurtide, had already been approved and made available in other countries. The Morris family moved to London, where Diego was able to receive Mifamurtide. Today, Diego is healthy, and he and his family have returned to the United States.
Explaining why he introduced Right to Try in Tennessee, Rep. Jon Lundberg (R–Bristol) said “Phil Timp was a dear friend,… when he was diagnosed with ALS. Until that diagnosis, I never realized that we, as a state, deny people the right to try to save their own lives.”
Arduous Process for Access
The unusually elaborate U.S. government drug approval process means some medicines, such as Mifamurtide, shown to be effective in other countries and available abroad are forbidden here.
There is a narrow exception, however, through the FDA’s “compassionate use” program, permitting patients with a terminal diagnosis to access drugs that have not yet been approved in the United States.
Patients seeking an exception under the compassionate use program, however, undergo a lengthy process requiring approximately 100 hours of a doctor’s time, according to the FDA. On average, it takes nine to fifteen months to obtain approval, by which time many patients are either dead or their diseases have progressed to the point where the treatment would no longer be beneficial.
‘About Saving Lives’
The Tennessee legislation would expand the FDA’s compassionate use clause so doctors and patients can identify potentially lifesaving drugs that have been deemed safe to administer and request these medications directly from the manufacturer. This would eliminate much of the bureaucratic delay patients face in the FDA process.
Right to Try would not mandate a pharmaceutical company provide the drug, nor an insurance company cover the costs, and would require a waiver signed by the patient protecting the attending physicians from liability.
“This is about saving lives,” said Darcy Olsen, president and CEO of the Goldwater Institute, which designed the Right to Try Act. “We will work nationwide until all Americans have the right to try to save their lives.”
Lindsay Boyd ([email protected]) is policy director at the Beacon Center of Tennessee.
