Patrick B. McGuigan
OKLAHOMA CITY – Governor Mary Fallin held a formal signing ceremony for House Bill 1074, deemed the “Right to Try Act.”
The event in the Blue Room came as one of several ceremonies held at the state Capitol this week.
The measure, co-sponsored by state Rep. Richard Morrissette, D-Oklahoma City, and Sen. Rob Standridge, R-Norman, reforms state law in an effort to make potentially life-saving medications more quickly available to terminally ill Oklahomans.
Rep. Morrissette said in a statement sent to CapitolBeatOK, “This is a day of hope. But sadly, since we began investigating the clinical trial process in preparation for bringing this legislation, hundreds have lost their chance for hope.
“Only about 3 percent of patients today are even enrolled in clinical trials. Those that aren’t must have their doctors complete a ‘compassionate use’ application that can take 100 hours of preparation time. Then, the manufacturer of a promising drug must also submit lengthy reports. Only about 1,000 people make it through the process.”
According to a summary Morrissette circulated, the Goldwater Institute, an Arizona-based organization working to bring “right-to-try” provisions to all 50 states, contends “that if one’s physician understands that the disease a patient has will ultimately kill them, but the investigational drug will not, it’s time to remove barriers that limit doctors from providing the care they are trained to give.”
Although ultimately enjoying overwhelming support in the Legislature, getting the measure through the process required diligent work from the two sponsors.
In brief summary, the measure allows patients to try “investigational medicines” that have passed through early phases of approval by the U.S. Food and Drug Administration (FDA) but which may be years away from actually getting onto pharmacy shelves.
Oklahoma now joins the cluster of states which have enacted the right-to-try concept, including Arizona, Colorado, Louisiana, Michigan, and Missouri.
Although FDA provisions allow for a “compassionate use” process, that takes hundreds of hours to maneuver, Morrissette has noted.
Scores have died while awaiting federal approval, he said -- and in any given year only about 1,000 people successfully make through the federal application process.
Previously, President Darcy Olsen of the Goldwater Institute had commented, “Americans shouldn’t have to ask the government for permission to try to save their own lives. They should be able to work with their doctors directly to decide what potentially life-saving treatments they are willing to try. This is exactly what Right To Try does.”
When the proposal cleared final hurdles in early May and headed to Fallin’s desk, Morrissette observed, “No one can guarantee that a particular treatment will be effective, but these laws return choice and control over treatment options to where it is most effective: with patients and their doctors.”
According to a summary of the measure provided by Morrissette's office, under Right to Try, a terminal patient is able to access an investigational medicine if:
* The patient has a terminal disease and has exhausted all conventional treatment options;
* The patient’s doctor has advised the use of an investigational medication is the best medical option to extend or save the patient’s life;
* The medication has successfully completed basic safety testing and is part of the FDA’s on‐going approval process;
* The patient has provided “informed consent” acknowledging the potential risk of the drug; and
* The company developing the medication is willing to make it available to the patient.
In debate, Sen. Standridge described the proposal as “a right to life issue that must be addressed.” The new law, he said, “[will] make promising medications available to those who are simply out of options.”
The Tufts Center for the Study of Drug Development estimates it takes 5.5 to 10.5 years for a drug to receive FDA approval.
The sponsors, Standridge and Morrissette, said repeatedly during the process that is time that terminally-ill patients obviously don't have.
As reported here in May, “Under the new law, manufacturers would not be required to make experimental treatments available to eligible patients. Health insurance companies wouldn't be required to provide coverage for such products either.
“A licensing board could not take action against a provider based solely on their recommendations to an eligible patient regarding access to, or treatment with, such products.
“Additionally, the measure would not create a private cause of action against a manufacturer or against any other person or entity involved in the care of an eligible patient using such products.”
Right to Try laws have been assailed in some professional journals as leading to “false hope” for some patients. However, defenders of the reform include influential policy analysts, including Benjamin Domenech of the Heartland Institute, an organization based in Chicago.
In a May 29 analysis for Heartland, he wrote, “State legislatures cannot overrule federal policies. But they can set up political contrasts and legal clashes that lead in time to policy changes. Suggesting Right to Try laws are false advertising would suggest any state policy that puts pressure on the federal government is being advocated under false pretenses.
“This point of view would render many state legislative advances moot and would restrict the actions of states to those things they know they can control within their borders as opposed to teeing up conflicts that can demonstrate state interests in a tangible way and force the feds and the administrative state to reconsider their policy stances.”