Pilon pushing experimental drug bill
Originally written by Lloyd Dunkelberger in HT Politics
TALLAHASSEE — Rep. Ray Pilon says Floridians who are dying from cancer and other fatal illnesses should not have to travel to foreign countries and acquire questionable drugs in a bid to sustain their lives.
Pilon, a Sarasota Republican, wants the Legislature to pass his “Right to Try Act” (HB 269) that would add Florida to a growing list of states that allow seriously ill residents who have exhausted available drugs and treatments to use experimental medications.
Patients would have access to “investigational” drugs under review by the federal Food and Drug Administration but not yet approved — a process that often takes more than a decade.
“This bill is a bill about giving people choices in their lives,” Pilon said.
“In this world rather than having people go to Mexico or go to some dark corner and buy snake oil, which may work for them, but with no guarantee, we have an obligation,” he said. “We owe it to our citizens to preserve life and it will be their choice if they want to continue that life.”
The House Insurance and Banking Subcommittee on Wednesday unanimously backed Pilon’s bill that would allow Florida to join 10 states that have already approved the use of experimental drugs, with governors in Utah and Indiana approving similar legislation this week. Florida is one of more than two dozen states with experimental drug legislation pending.
The “Right to Try Act” will set up a procedure where drug manufacturers may bypass the FDA’s already existing emergency access program and provide terminally ill patients with experimental drugs that have passed at least the first of three phases of FDA testing for safety and effectiveness.
Under the bill, the patient would have to have a “terminal” condition, which would be certified by a physician and confirmed by a second opinion. The patient will have to have considered all other treatment options already approved by the FDA.
The manufacturer could charge, or not charge, the patient for the experimental drug. Insurance companies would not be required to cover the drug or treatment cost, although they would have that option. Hospitals and other medical facilities would not be obligated to participate.
The bill provides immunity for liability for the manufacturers, physicians and medical facilities that participate in the program.
“Patients who are dying may need it now and it just opens up the door and gives them that availability,” said Rep. Ronald “Doc” Renuart, R-Ponte Vedra Beach, an osteopathic physician who voted for the bill as a member of the House Health Innovation Subcommittee.
Proponents, who include the AARP and some physician groups, say state laws are needed because the existing FDA emergency drug access program is not widely used. Over a one-year period, ending last Oct. 1, the FDA approved only 1,066 requests for emergency access to experimental drugs, according to legislative analysts.
The movement by the states to bypass the FDA in cases of terminal patients was prompted in part by a campaign by the libertarian Goldwater Institute.
And the state action comes as the FDA announced last month a simplified procedure for allowing patients and doctors to access experimental drugs for “compassionate use.” The new form is expected to take 45 minutes to complete, according to the FDA.
Pilon’s bill has now cleared two House committees, with one more committee stop before it can reach the floor. A similar bill (SB 1052), sponsored by Sen. Jeff Brandes, R-St. Petersburg, has been approved by one Senate committee, with two more committees yet to review the legislation.