A U.S. Food and Drug Administration program that provides access to investigational drugs for patients that don’t qualify for clinical trials or unapproved therapies was the subject of a hearing convened on Tuesday by U.S. Rep. Michael Burgess (R-TX).
Burgess, the chairman of the House Energy and Commerce Subcommittee on Health, also led discussions on legislation introduced by U.S. Reps. Brian Fitzpatrick (R-PA) and Andy Biggs (R-AZ) to expand access to unapproved therapies for terminally ill patients.
“Since 2014, 37 states, including my state of Texas, have passed a version of Right to Try laws, through a strong grassroots movement,” Burgess said. “With that in mind, it is my hope this hearing will start a constructive discussion on this important issue.”
While the nation has experienced unprecedented innovation and scientific breakthroughs over the last decade, Burgess said he routinely hears from patients with serious, life-threatening illnesses that face regulatory barriers preventing them from experimenting with new therapies.
In response, Fitzpatrick and Biggs introduced the Right to Try Act of 2017 to enable terminally ill patients to work with physicians and pharmaceutical manufacturers to undertake investigational treatments when other alternatives aren’t available.
“Each day, families across the country receive the devastating news of a terminal diagnosis,” Fitzpatrick testified. “Even with the amazing work done in American medical research and development, for too many, access to these potentially lifesaving treatments will come too late, or not at all.”
More than 1 million people die every year from a terminal illness, and many more are diagnosed, Fitzpatrick said, adding currently Pennsylvania is one state that does not have its own Right To Try legislation.
“The Right to Try Act opens the opportunity to trial-stage care and establishes the freedom for patients and their doctors to try therapies where the benefits far outweigh the risks,” he said.
Americans should have every opportunity to fight for their life or the life of a loved one when they’re battling conditions like ALS and Duchenne muscular dystrophy, said Fitzpatrick, who serves as a member of the Congressional Rare Disease Caucus.
Retired U.S. Navy Lieutenant Commander Matthew Bellina, a resident of Bucks County, Pennsylvania, testified at the hearing, stating that the bill is needed to protect the pharmaceutical industry from lawsuits and to respect state laws.
“Once this bill is passed we should see more widespread use of the 37 state laws. I have no illusion that this will solve the entire problem but it is absolutely a step in the right direction and a step we need to take now,” Bellina said.
Biggs said in 2014 that Arizonans passed a state version of Right to Try with nearly 80 percent of the vote, “which demonstrates that giving patients access to a potentially life-saving drugs has strong bipartisan support.”
“Right to Try now needs to be enacted at the federal level,” Biggs added. “Americans facing a terminal illness should be allowed to try all options that could save their lives, and our bill will give power to those patients.”