US Senate Passes ‘Right to Try’ Bill to Help Terminally Ill Patients get Experimental Treatments such as Stem Cell TherapySeptember 25, 2017
Recently, the U.S. Senate passed by unanimous consent a measure designed to make it easier for terminally ill patients to get access to experimental treatments without oversight from the Food and Drug Administration.
According to the Washington Post, the “right to try” legislation has been championed by the libertarian Goldwater Institute, which has worked to pass similar legislation in 37 states. The Federal version would bar the government from blocking patients from getting access to experimental treatments and medications that have undergone preliminary testing in humans. Patients first would have to try all other available treatments and be unable to participate in clinical trials.
“Patients with terminal diseases ought to have a right to access treatments that have demonstrated a level of safety and could potentially save their lives,” Sen. Ron Johnson (R-Wis.), who wrote the bill, said in a statement after the vote.
He added, “These are real people facing their mortality with no hope. This ‘right to try’ piece of legislation will give those individuals and their family hope.”
The reauthorization bill was approved 94 to 1. Cleared by the House, it now goes to President Trump for his signature. It authorizes the collection of billions of dollars in user fees from the drug and device industries to help pay for reviews for their products over the next five years.
Rita Alexander, Chief Administrative Officer at StemGenex Stem Cell Research Centre in La Jolla, CA, applauded Texas for this landmark. She noted that over the past three years, “Right to Try” advocates in 34 states have helped enact legislation to eliminate obstacles for terminally ill patients seeking treatments that may not be approved by the Food and Drug Administration (FDA).
“Having this legislation move forward at the Federal level is an amazing advancement for the Right to Try advocates who have worked collectively on behalf of individuals seeking hope for terminally ill patients seeking non-FDA approved treatments,” said Alexander.
“At StemGenex, we are committed to helping people achieve optimum health and better quality of life through the healing benefits of their own stem cells. Specifically, we use adipose-derived adult stem cell therapy for patients battling conditions such as Multiple Sclerosis, Parkinson’s Disease, COPD, Rheumatoid Arthritis and Osteoarthritis.”
“I have stated previously, and herein reiterate that I have personally witnessed many patients who had exhausted conventional medical treatments but wanted to try alternative therapies. I was one of them, suffering from severe Rheumatoid Arthritis. I had only three options; I could seek a clinical trial, travel to outside of the U.S. to try alternative therapies such as stem cell treatment or petition the FDA for access to drugs under the agency’s “expanded access,” or “compassionate use” program. Now, with Federal law awaiting only President Trump’s signature, doctors and patients will be able to make their own informed decisions on alternative treatments not yet approved by the FDA.”
Last year, in a move that was seen by some as a response to “Right to Try” laws, the 21st Century Cures Act, a landmark piece of legislation focused on medical innovation and medical research, was signed into law by President Obama. This Act provides the FDA with the flexibility to accelerate how it evaluates regenerative medicine treatments, such as stem cell therapies, while maintaining its high standards of safety and efficacy.
“Major change is now a reality for terminally ill patients,” said Alexander. “Today, new treatment options, such as stem cell therapy are giving new hope to people affected by a wide range of autoimmune and degenerative illnesses. StemGenex Stem Cell Research Centre is proud to offer the highest quality of care and to potentially help those with unmet clinical needs improve their quality of life.”