The California Senate unanimously passed The Right to Try Act, which effectively nullifies certain Food and Drug Administration (FDA) rules preventing terminally ill patients from accessing experimental treatments.
State Sens. Jeff Stone (R-Palm Desert) and Joel Anderson (R-Alpine) introduced Senate Bill 149 in January. The bill gives terminally ill patients access to medicines that have not been given final approval for use by FDA.
California’s Right to Try (RTT) bill follows the lead of 18 other states that have already enacted similar legislation. Twenty-one other states are also now considering such laws.
Under the Federal Food, Drug, and Cosmetic Act, general access to experimental drugs is prohibited, but under the expanded access provision of the act, patients with serious or immediately life-threatening diseases may access experimental drugs once they receive express FDA approval.
California’s Right to Try Act bypasses FDA’s expanded access program, allowing patients to obtain experimental drugs from manufacturers without first obtaining FDA approval.
Stone, who is also a pharmacist, says he was motivated to introduce his bill because he had seen firsthand the frustration of people and families who are battling not only horrible, life-threatening illnesses but also the government bureaucracy that prevents needed treatments.
“At this point in the illness, the patient has exhausted any other treatment options and simply does not have the time to wait for the FDA’s approval for the drugs and treatments, which can prolong for months or years,” Stone said.
FDA does have a process, known as “compassionate use,” allowing individuals to request permission to use unapproved drugs, but it takes countless hours and paperwork to be of use for the patient in the short amount of time they have left, Stone says.
Providing Legal Protection
Right to try laws protect doctors and drug makers who administer the experimental drugs from lawsuits filed when the treatment harms the individual. Under right to try, patients agreeing to experimental treatments sign a legal form of consent, acknowledging the risks involved and his or her understanding the treatment has no guarantee of success.
The Goldwater Institute, a pro-liberty think tank, has been a major advocate of right to try legislation in states across the country. Kurt Altman, a national policy advisor for Goldwater, says his organization developed the model legislation for RTT after conducting significant research into the FDA drug approval process.
“Once the data was collected, Goldwater identified … the lack of access terminal patients had to investigational new drugs [as a significant problem that, if resolved,] could potentially help them,” Altman said.
“We believe right to try will enable more terminally ill patients to access investigational medications that could potentially benefit them,” Altman said.
Concerns, But Also Hope
Those skeptical of right to try say it could produce false hope for patients or even worsen their condition. Altman acknowledges those concerns but remains hopeful.
“We have no illusions that this will save millions or even thousands, but we are certain it will help many,” Altman said.
“Right to try gives control over medical decisions back to the patient and doctor, where it rightly belongs,” Altman said. “So far, the bill in California has received bipartisan support. This commonsense bill has gained positive momentum, and we believe that momentum will continue.”
FDA has not commented on the right to try issue. Altman and other proponents hope the movement behind this legislation will prompt the FDA to change some of its requirements right to try supporters believe to be outdated.
Katie Clancy ([email protected]) is a government relations intern for The Heartland Institute.
