If a doctor said you were terminally ill with little time left, would you experiment with a drug yet to be approved by the U.S. Food and Drug Administration?
Dying patients in North Carolina will have that option after their lawmakers passed a “right to try” act on Tuesday, sending House Bill 652 to Gov. Pat McCrory to sign into law.
Rep. Hugh Blackwell, a Burke County Republican and primary bill sponsor, said the bill is similar to legislation that has passed in 21 other states in recent years, and he is pleased that the North Carolina legislature passed it unanimously.
The bill passed the House in April 118-0. It cleared the Senate Tuesday in a 47-0 vote.
The bill authorizes access to experimental treatments for terminally ill patients who have considered all other FDA approved options with their physician, who must also give a recommendation for the treatment.
Eligible patients would have access to treatments that have passed the first of three FDA trial phases, meaning it has been proven non-toxic. It is a long, expensive process for a drug or treatment to receive FDA certification, and many with terminal illnesses don’t have time to wait for a drug that could improve their condition.
The average drug certification process takes eight to 15 years and costs as much as $1 billion, according to Craig Handzlik, deputy national policy adviser for the Goldwater Institute, the Arizona-based think tank that backs the legislation.
Handzlik said “right to try” options give patients hope.
“That decision should be in the hands of the patient, not the the federal government,” he said.
The FDA has a process by which terminally ill patients can apply to receive trial treatments called “expanded access” or “compassionate use.”
However, Handzlik said it’s a long application process by which the FDA requires paperwork for each patient that can take physicians many hours to prepare. The manufacturer must also complete paperwork, and then the FDA has a 30-day approval window to approve or send it back with questions. Finally, an independent state review board must grant approval.
“It’s a time intensive, bureaucratic process,” Handzlik said.
The other option for patients has been to participate in the clinical trial of a drug, but Handzlik said 90 percent are not accepted and that 3 percent of those who are receive a placebo.
Rep. Mike Hager, a Rutherford County Republican and bill sponsor, said in a statement that one of his constituents with a terminal illness expressed her concern for others.
“She is living today, three years past her terminal diagnoses, because of her participation in multiple clinical trials. She raised the point to me, however, that many people don’t have the overall physical health, family support, or financial means to travel to distant research facilities and meet the strict FDA guidelines,” Hager said. “This bill was drafted to give my constituent, and the many others with similar stories, a chance at life.”