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.

 

Police in Georgia are confirming that three officers were injured as shots were fired during a vehicle chase early this morning. It happened in Carroll County near Bremen after the Georgia State Patrol started a pursuit of a vehicle in another county. A spokeswoman with the sheriff's office said two deputies were injured by gunfire, but the extent of their injuries is currently unknown.       Health experts are worried Michigan's surge in COVID-19 cases among younger people could be a sign of things to come across the U.S. One epidemiologist has said that Michigan is "the bellwether for what it looks like when the B.1.1.7 variant spreads in the United States." Health experts say the B.1.1.7 variant is now the dominant strain in the U.S.       People in a Minneapolis suburb are coming off an overnight curfew after police used flash-bang grenades to clear out protesters over the fatal shooting of a Black man. The crowd began forming Sunday afternoon in Brooklyn Center, near where an officer shot and killed a man during a traffic stop.       The murder trial of the former Minneapolis Police officer accused of killing George Floyd enters its third week today. Former officer Derek Chauvin [[ SHO-vin ]] is accused of killing Floyd by kneeling on the handcuffed Black man's neck for more than nine minutes last May.       President Biden meets with a bipartisan group of lawmakers today on his two-trillion-dollar infrastructure plan. The proposal aims to fix roads and bridges, support electric vehicles and clean energy, and boost pay to caregivers. Biden and Democrats in Congress hope to get it approved by summer.       Disneyland fans will be a lot happier on April 30th when the Happiest Place on Earth opens for the first time in more than a year. People with unused tickets can book a reservation today while ticket sales for everyone else begin Thursday.