The House of Representatives voted to advance “Right To Try” legislation that has Bucks County ties.
The House voted 267-149 Wednesday night to move the HR 5427, also known as the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018. The bill will now advance to the Senate.
The proposed law would allow terminally ill patients, physicians, and pharmaceutical manufacturers to administer investigational treatments where no alternative exists.
The office of Republican Congressman Brian Fitzpatrick, who has supported the bill, said there were months of negotiating and legislative efforts to get the bill moved forward. A vote last week failed.
“After years of debate, discussion and negotiation, today, the House of Representatives showed what has always been clear to me and those I represent: that the Right to Try is a common sense, bipartisan measure that gives American patients and families facing an unimaginable situation the opportunity to fight for their lives or the lives of their loved one. For those patients caught between the traditional drug approval delays, a clinical trial process for which they do not qualify, and limited time, this Right to Try simply establishes the freedom for patients to try therapies in situations where the benefits far outweigh the risks,” said Fitzpatrick, a co-chair of the congressional ALS Caucus.
The Right To Try legislation, according to Fitzpatrick’s office, does not undo the Food and Drug Administration (FDA) approval process but extends an avenue for those with terminal illnesses who can not wait.
“Physicians must certify that other options are exhausted or not available and all products must have completed FDA Phase I (safety) testing to prevent ‘snake oil salesmen’ and other bad actors. Moreover, the legislation addresses concerns which could prevent its successful utilization by ensuring patients, doctors, and manufacturers do not assume any additional liability under this act. Nearly 40 states, including Pennsylvania, have signed into law their own Right to Try legislation. The federal legislation ensures that the federal government – and the FDA, specifically – does not interfere with state laws,” Fitzpatrick’s office said in a statement.
While there are already “compassionate-use exceptions” for experimental treatments granted to patients with terminal diseases, only about 1,000 waivers are approved by the FDA each year.
Some 38 states, including Pennsylvania, have similar policy and it has received backing from the Libertarian-leaning Goldwater Institute. The majority of those who voted against the Right To Try legislation Wednesday were Democrats.
“By allowing patients access to investigational treatments that have only completed a phase 1 clinical trial, patients will be exposed to treatments with no or relatively little data that they are actually effective,” Democratic New Jersey Congressman Frank Pallone Jr. said during the House debate, according to The Hill.
President Donald Trump’s administration has pushed for the legislation, but there have been ethical questions raised about whether the Right To Try would actually help most patients.
“Even if right to try does simplify federal regulation, patients must still convince a reticent pharmaceutical industry to provide drugs outside of trials, and patients must still bear the costs for these experimental treatments, which is out of reach for almost all Americans,” academic lecturer Morten Wendelbo and Texas A&M Assistant Professor
Fitzpatrick has been a supporter of the Right To Try effort during his first term. Northampton husband, father, and Navy veteran Matt Bellina, who has ALS, and Newtown Athletic Club owner Jim Worthington have worked with the congressman to move forward Right To Try legislation. Earlier this year, Bellina was Fitzpatrick’s guest at the State of the Union.