State Rep. Jon Lundberg and Sen. Joey Hensley are sponsoring HB0143, the "Tennessee Right To Try Act," which allows terminally-ill patients to ask pharmaceutical companies for experimental drugs or medical devices that the FDA hasn't approved.
Such drugs and devices are already available to patients with life-threatening illnesses, but obtaining them requires the patient and his or her doctor to file a request through the FDA's compassionate use program. That program can be inefficient, according to Lindsay Boyd, director of the Nashville-based Beacon Center think-tank. Patients sometimes die while waiting for the FDA to consider their requests. The Beacon Center is advocating for a quicker pathway.
"We want to broaden compassionate use eligibility," says Boyd, "or at least the process for receiving access."
If passed, Right To Try would allow patients and their physicians to avoid FDA bureaucracy by going straight to the drug companies and asking for help.
Colorado, Louisiana, Michigan, and Missouri and Arizona have already passed similar Right To Try legislation (often by a unanimous vote) so it seems likely a similar law could pass in Tennessee.
However, Right To Try laws do have critics.
Dr. Arthur Caplan, director of the Division of Medical Ethics in New York University’s Langone Medical Center, calls these laws "Right To Buy" instead of Right To Try. That's because insurance is unlikely to help patients pay for experimental medications, and Tennessee's proposed law does not require insurers to cover the cost.
"You have the right to beg a company to give you something," Dr. Caplan says, "and then if you can afford it... you have the right to buy it."
Also, such drugs and treatments could be unavailable because companies may have only small supplies meant for clinical trials.
"I think these laws are a little bit too feel-good," Dr. Caplan says. They're compassionate ideas, and it's hard to imagine most legislators voting against them, but the laws could amount to little practical benefit.
The FDA has a three-stage process of reviewing new drugs. The proposed Tennessee law specifically grants access to drugs that have passed the first review stage, meaning they've been tested for safety, but not efficacy. There is no guarantee the drugs will help. Critics of the laws say they give dying patients false hope. But the Beacon Center's Lindsay Boyd says it's the patients' right to hope.
"If they want to take a risk by taking an experimental medication," says Boyd, "because they have no other opportunities available to them, that should be their choice. And it’s an informed choice. It’s a choice that’s being made with a physician."
Read the bill here.