It sounds like an easy solution to a devastating issue: allowing a person or their family to bypass the Food and Drug Administration’s rigorous approval process to gain access to medications and devices still in the experimental stage in the hopes that it may significantly slow or stop the progression of a debilitating or fatal disease or illness. However, anything that requires government access or approval is hardly easy and often has greater repercussions that initially realized.
House Bill 1065, authored by Rep. Wes Culver, R-Goshen, is a “Right-to-Try” bill. In its current form, it would allow a manufacturer to release a drug, product or device not yet approved by the FDA to a patient that meets certain requirements. The patient must be terminal and have exhausted all other approved options without success.
- Rep. Wes Culver, R-Goshen
After lengthy discussion in the Public Health committee, the bill was amended to put all liability on the patient and essentially absolving of any wrongdoing any physician, hospital, pharmacist, manufacturer and any other entity involved in the treatment’s administration and distribution in the process should the treatment fail to work as intended. The responsibility of treatment lies solely on the afflicted.
When HB 1065 came up for discussion in the Public Health committee, Culver stated he was interested in filing the legislation after the recent Ebola scare. Currently, there are no FDA-approved vaccines for Ebola and no antiviral drugs available for treatment. The Centers for Disease Control and Prevention reports there are some in development but they have not been tested for safety and effectiveness. Culver wanted to make those drugs available if the Ebola scare ever spread to the Hoosier state.
Many other terminal illnesses and conditions with treatments in development were added to the conversation after the committee hearing including Duchenne Muscular Dystrophy. Duchenne is a particular form of MD that affects males and has an average life expectancy rate of 25 years. The progressive deterioration of the disease leads to paralysis, pain and eventual death.
One Indiana family who testified during an amendment hearing for the bill described the process in store for their 5-year-old son. Because of his age and circumstances, the child doesn’t qualify for any of the trials currently underway for the Serapta therapeutic treatment that may slow the degenerative properties of the disease. HB 1065 could pave the way for the child to access the treatment.