Right to Try improves access to experimental treatments for patients with terminal diseases
The Times
Right to Try legislation introduced by U.S. Rep. Brian Fitzpatrick (R-8th dist.) passed the House last week by a vote of 267–149.
The bill — the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018 [H.R. 5247] — follows months of negotiating and legislative efforts and improves access to experimental treatments for patients with terminal diseases or conditions.
“After years of debate, discussion and negotiation, today, the House of Representatives showed tonight 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, co-chairman of the ALS Caucus. “With the House’s vote, both chambers have now showed that Right to Try can pass with bipartisan support. I stand with my colleagues at the forefront of this issue, Rep. (Andy) Biggs and Sen. (Ron) Johnson, in demanding that Right to Try — in any form — make it to the president’s desk to be signed into law.”
From ALS to Duchene Muscular Dystrophy, more than 1 million Americans die from a terminal disease each year and thousands more are diagnosed. While compassionate-use exceptions exist, they are granted to only about 1,000 patients annually. Many patients simply run out of time before they can qualify or before the Food and Drug Administration’s approval process completes.
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. Moreover, the legislation addresses concerns that 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.
Advancing this policy has been a longtime priority for Fitzpatrick and Vice President Mike Pence, who signed Indiana’s Right to Try law while serving as governor. It has also been a priority for President Donald Trump, who called for the bill’s passage in his State of the Union Address earlier this year.
The bill was supported by 232 Republicans and 35 Democrats. In opposition were 147 Democrats and two Republicans.
Bellina is a former Navy pilot who lives in Holland with his family. Mongiello lives in Yardley with his wife and children. ••
