A bill that would give terminally ill patients the right to try experimental drugs and treatments currently not approved by the Food and Drug Administration is working its way through the state legislature.
Currently, five states have "right to try" laws on the books, and 24 states, including Connecticut, are considering similar legislation.
A new investigational drug must go through a rigorous three phase process before the FDA approves it to be sold in the U.S. This process usually takes more than a decade.
Connecticut's "right to try" bill would allow a terminally ill patient access to new drugs that have passed the first phase of the FDA process upon request. Patients would have to prove that they have exhausted all FDA approved treatment options, and obtain a written recommendation from their treating physician.
Insurance companies would not have to pay for the cost of the drug, and would be able to deny coverage for the patient while they are undergoing the experimental treatment.
Proponents of the bill say terminally ill patients should have unfettered access to the FDA pipeline.
"We are in a time of great medical change and breakthrough," said Richard Bunting, who testified in February in front of the legislature's Public Health committee. His wife suffers from Multiple Sclerosis. "We hear about it constantly in the news," he said. "It is a topic that will become more and more important because of the rate of breakthrough."
Critics of "right to try" legislation note that the FDA already grants terminally ill patients access to experimental drugs through their expanded access program. "Right to try" advocates say the process is too lengthy, cumbersome, and time-consuming for a patient with only months or weeks to live.
Critics also point out that "right to try" legislation doesn't force pharmaceutical companies to distribute experimental drugs to terminally ill patients. In a recent op-ed in The Hartford Courant, NYU medical ethicists Lisa Kearns, MS, MA, and Arthur L. Caplan, Ph.D wrote:
For all the talk about the right to try, these laws do not obligate drug manufacturers to actually do anything. They give patients a right they already have — a right to beg but nothing more.
Drug makers may be unwilling to either circumvent the oversight of the FDA, or potentially undermine and corrupt their clinical research, and ruin their chance for full FDA approval.
