Sen. Johnson Introduces Right to Try for Individualized Treatments Act
WASHINGTON – Today, U.S. Sen. Ron Johnson (R-Wis.) introduced the Right to Try for Individualized Treatments Act (Right to Try 2.0) to provide access to individualized, one-patient therapies that are not eligible for approval under the Food and Drug Administration’s (FDA) regulatory regime. Right to Try 2.0 builds on the Right to Try Act of 2017 to create a pathway for patients with life-threatening or severely debilitating conditions to receive unique, patient-specific therapies that cannot undergo Phase I trials and may lack any commercial regulatory path.
Right to Try 2.0 is voluntary for all involved parties. To partake in such treatments, patients must have considered all approved treatment options, in addition to obtaining a physician recommendation. Manufacturers are not obligated to provide treatments and physicians are not required to recommend such treatments. Manufacturers will receive coverage for direct costs but cannot profit from the unapproved treatment.
“I championed Right to Try to provide hope and freedom to those with terminal illnesses by giving them access to experimental treatments without waiting for full FDA approval. The original Right to Try Act was about giving terminal patients a fighting chance by cutting through red tape. Right to Try 2.0 builds on that success and would provide access to individualized, rare disease and one-patient therapies that the current regulatory environment has yet to accommodate. This is about medical freedom and putting doctors and patients at the top of the treatment pyramid,” Sen. Johnson said.
“When someone is fighting for their life, the last thing they need is the government standing in their way. We are entering a new era of medicine where breakthroughs in genomics and precision therapies can create treatments designed specifically for an individual patient, but our regulatory system was built for a different time and simply hasn’t kept up. This legislation makes sure patients have a clear, durable path to pursue individualized treatments when all other options have failed,” Rep. Harshbarger said.
U.S. Rep. Harshbarger (R-Tenn.) and U.S. Rep. Andy Biggs (R-Ariz.) introduced companion legislation in the U.S. House of Representatives.
Read more about Sen. Johnson’s work on Right to Try here.
Full text of the legislation can be found here.
NOTE: This press release was submitted to Urban Milwaukee and was not written by an Urban Milwaukee writer. While it is believed to be reliable, Urban Milwaukee does not guarantee its accuracy or completeness.
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