House Passes McNamara Legislation That Would Allow Chronically Ill Patients to Use Experimental Drugs
STATE HOUSE — The House of Representatives today passed legislation introduced by Rep. Joseph M. McNamara (D-Dist. 19, Warwick, Cranston) 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 (2021-H 5077) would create the Neil Fachon Terminally Ill Patients Right to Try Act of 2021, 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 in March 2019. The company later reconsidered its decision, and the drug is currently being considered by the FDA to become 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. Major research organizations report that, 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.
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. Although he prevailed in court, he passed away on Feb. 19, 2017.
Terminal 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 product 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 measure now moves to the Senate for consideration.
President Trump is announcing sweeping cost cuts on obesity drugs. The White House says that Eli Lilly, which makes Zepbound, and Novo Nordisk, which manufactures Wegovy, will lower the price of those injectable weight loss drugs to as little as 350-dollars a month for starter doses. The list prices now exceed one-thousand-dollars. 
