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.
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.
Many in the industry who would be affected by the bill have taken a position of neutrality on the legislation. Representatives with Indiana-based pharmaceutical company Eli Lilly said the company isn’t taking a position on the bill, but is watching its progress very closely. Representatives from the Indiana State Medical Association and the Indiana Hospital Association also testified at the committee hearing for the bill, but neither organization took a position in support or in opposition. Still, there are some questions as to whether or not this legislation is in the best interest of the state and its citizens.
“Right-to-Try” legislation isn’t a new concept. The Goldwater Institute is a policy, research and litigation organization that champions many national causes and issues. “Right-to-Try” is one of many on their list. On their website, the Goldwater Institute says, “States should enact ‘Right to Try’ measures to protect the fundamental right of people to try to save their own lives.” The Goldwater Institute has championed the effort and provided guidelines for legislation that has passed in Colorado, Missouri, Michigan and Louisiana. The statute recently passed in Arizona through a voter referendum. Rep. Culver indicated he was unaware of the institute when he authored the bill, but sources say the institute contacted him after the bill began its journey though the Indiana Statehouse.
And while these states have successfully enacted “right-to-try” in their states, what has some Hoosiers on edge about the legislation is an amendment a few of these states have added to clarify how its use would affect those who are receiving hospice or end-of-life care.
In essence, the clarification states that a patient must be withdrawn from hospice eligibility when they begin taking the experimental treatment. The patient may be eligible for hospice at another time, but only if the experimental treatment doesn’t work. Those who work in the hospice industry are concerned a similar provision will be added to HB 1065, thereby eliminating affordable care for those in need.
Hospice treatments (and other types of long term care) for those battling a chronic or terminal illness have certain rights and uniform standards of care guaranteed in state and federal laws regardless of the patient’s ability to pay for services.
However, those rights and standards are often nullified if the patient chooses a “right-to-try” path.
Kristen Jones, CEO of the Indiana Health Industry Forum also brought forth questions of fair distribution, patient burden, false senses of hope and other issues that “Right-to-Try” legislation can create.
The FDA does have a process in place called “compassionate use” that people can apply for to gain access to experimental treatments not yet approved. Jones told the committee that Indiana’s legislation would attempt to undermine that process. Congress is looking at the FDA’s process for approving drugs while the FDA is considering ways to streamline compassionate use cases. But patients and families say the process is difficult and time-consuming and time is the one thing they don’t have.
HB 1065 is currently making its way through the Indiana House and if passed, Sen. Ed Charbonneau plans to carry the legislation through the Senate.