BREAKING: ‘Right to Try’ Signed into Law
WASHINGTON, D.C. – Bipartisan legislation granting patients with terminal illness access to potentially lifesaving treatments was signed into law by the President Wednesday at the White House. The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act [S.204], a Senate companion bill to Congressman Brian Fitzpatrick’s Right to Try legislation, creates a new pathway for terminally ill patients caught between the traditional drug approval delays, a clinical trial process for which they do not qualify, and limited time to access experimental treatments.
Congressman Fitzpatrick joined ‘Right to Try’ advocates at the bill signing, including the bill’s namesake Matt Bellina and Frank Mongiello from Bucks County.
“Today, we witnessed American history when the President signed our Right to Try bill into law. After years of debate and relentless work by Right to Try advocates around the nation, American patients and families facing an unimaginable terminal illness now have the opportunity to fight for their lives and the lives of their loved ones,” said Fitzpatrick. “They deserve the chance to try whatever option is available to fight for their life. For patients who might not qualify for certain clinical trials, or who have exhausted all their options, Right to Try opens the door to potentially lifesaving treatments.”
Although the FDA has a program that allows terminal patients to apply for early access to a promising treatment, Right to Try is needed because the FDA compassionate-use process isn’t far reaching enough. While 99-percent of Expanded Access applications are approved, the application process is complicated, time-consuming, and expensive. Only about 1,200 people a year make it through the application process.
Right to Try does not undo the FDA approval process, but provides a potential lifeline for those with a terminal diagnosis who cannot 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.
Advancing this policy has been a longtime priority for Fitzpatrick and Vice President Pence, who signed Indiana’s Right to Try law while serving as governor. It has also been a priority for President Trump, who called for the bill’s passage in his State of the Union Address earlier this year.