‘Right to Try’ Bill Faces First Test

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January 13, 2015 —

INDIANAPOLIS – Terminally-ill patients would gain access to experimental medication under a proposal heard by the House Public Health Committee on Monday.

The measure, authored by state Rep. Wes Culver, R-Goshen, would allow terminally-ill individuals to use drugs which have not yet reached the final stage of approval by the Food and Drug Administration.

A number of states, including Colorado and Michigan, have already passed “Right-to-Try” legislation, and many other states are hearing similar bills this year.

Under the legislation, the doctor, hospital, and manufacturer must approve the use of the drug before allowing the patient to use it. The bill also provides that a drug would not be permitted for approval if the patient’s probable risk of death is less than the percentage of likely harm the drug could cause to an individual.

Because the patient would volunteer to use the drug and assumes the risk, insurance won’t cover any medicine or devices the patient is permitted to obtain. Payment for the patient’s treatment is under the discretion of the various pharmaceutical companies that offer the experimental drugs.

Kristin Jones, president and CEO of the Indiana Health Industry Forum, said that these experimental drugs may not have been fully developed and all side effects may not be known until it is given approval by the FDA.

“There are serious challenges associated with providing access to experimental medicines that they overlook (in) this unfamiliar drug development process.” Jones said as she spoke at the committee hearing. “Safety must be carefully considered not only by the patient, caregiver and physician, but also by the manufacturer.”

The patients who will qualify to receive drugs that have not yet been approved by the FDA are those who are terminally ill and have few other options.

“Let’s give them hope,” Culver said.

Because the drugs would not be covered by insurance, many questions were raised during the committee meeting about the accessibility of treatment for those who face poverty.

The proposed legislation was held by the House Public Health Committee in order to address those concerns.


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