Rep. McNamara legislation would allow chronically ill patients to use experimental drugs
STATE HOUSE — Rep. Joseph M. McNamara (D-Dist. 19, Warwick, Cranston) has introduced legislation that would allow chronically ill patients to obtain experimental drugs that have not yet been federally approved but which may be in the final stages of FDA testing.
The legislation (2020-H 7266) would create the Rhode Island Terminally Ill Patients Right to Try Act of 2020, which would establish the conditions for the use of experimental treatments. Under the legislation, a clinical trial patient would have the right to continue the experimental treatment in a hospital setting, provided the patient or guardian signs a waiver of liability in favor of the hospital and its staff.
“When a drug trial is canceled, it can be devastating for individuals who saw a result from that trial,” said Representative McNamara, who chairs the Committee on Health, Education and Welfare. “That’s a situation that many Rhode Islanders are in today. The relevance of this bill has become more pronounced in today’s world of clinical trials. I want Rhode Island to do all it can to give these people hope. I want Rhode Island to give terminally ill patients the ‘right to try’ anything that might help them.”
As an example, Representative McNamara points to a clinical trial that took place right here in the Ocean State. Sixty volunteers at Butler Hospital participated in the clinical trial of an investigative Alzheimer’s drug called Aducanumab. While the drug was found to keep the disease from further degenerating the condition of the patients, the trial was abruptly canceled by the drug company last March. The company later reconsidered its decision, and the drug is on an FDA fast track to becoming the first new drug approved in 16 years that actually targets the disease.
“Right to Try” laws have been approved in 40 states. In 2018, Congress caught up and passed a similar federal bill. The Goldwater Institute, a public policy research and litigation organization, reports that, “The results show that the impact of Right to Try isn’t merely theoretical. Since the Texas Right to Try law went into effect in June 2015, at least 78 patients in the Lone Star State have received an experimental cancer treatment not allowed by the FDA. While the FDA would have allowed these patients to die, Houston-based oncologist Dr. Ebrahim Delpassand continued their treatment through the Texas law.”
The bill is named after the late Neil Fachon of East Greenwich, who had been accepted into a newly opened clinical trial. Because of governmental red tape, Neil was denied the drug for a period of time and the Fachons had to hire a lawyer. Neil passed away on Feb. 19, 2017.
Chronically ill patients who have exhausted their conventional treatment options have few, if any places, to turn. They can attempt to enroll in a clinical trial, but many of the sickest individuals do not qualify. The only other option for them is to obtain potentially life-saving drugs by requesting that the U.S. Food and Drug Administration grant them expanded access. But only a few hundred patients are granted such access each year because of the complicated, time-consuming and expensive process currently required by the FDA.
Under the McNamara bill, a terminally ill patient may make a request for an experimental drug and a manufacturer of an experimental drug, biological produce or device may make it available, but is not required to do so. The legislation provides protections for all parties (patients and medical professionals) and insurance companies are also protected because there is no requirement for them to cover the cost of any investigational drugs.
The legislation has garnered bipartisan support, and is cosponsored by Rep. Justine A. Caldwell (D-Dist. 30, East Greenwich, West Greenwich), House Majority Leader K. Joseph Shekarchi (D-Dist. 23, Warwick ), House Minority Leader Blake A. Filippi (R-Dist. 36, New Shoreham, Charlestown, South Kingstown, Westerly) and House Minority Whip Michael W. Chippendale (R-Dist. 40, Foster, Glocester, Coventry).
For more information, contact:
Daniel Trafford, Publicist
State House Room 20
Providence, RI 02903