Fitzpatrick Testifies Before House Committee Regarding ‘Right to Try’
WASHINGTON, D.C. – Congressmen Brian Fitzpatrick (PA-08) and Andy Biggs (AZ-05) testified in front of the Committee on Energy and Commerce Subcommittee on Health Tuesday as part of a hearing on their ‘Right to Try’ legislation.
“Each year more Americans receive the devastating news of a terminal diagnosis. Even with the amazing work done in American medical research and development, for too many families, access to these potentially lifesaving treatments will come too late, or not at all. For those patients caught between the traditional drug approval delays, a clinical trial process for which they do not qualify, and limited time, Right to Try simply establishes the freedom for patients and their doctors to try therapies where the benefits far outweigh the risks. It gives them the option of trying to save their life,” said Fitzpatrick in his testimony. “Whether it’s a father courageously battling ALS or a brave child living with Duchene Muscular Dystrophy, they deserve the right to try.”
Fitzpatrick and Biggs are co-authors of legislation which would ensure that terminally ill patients, together with their physicians, and pharmaceutical manufacturers are allowed to administer investigational treatments where no alternative exists. The bill is a companion to Senate legislation (S. 204) introduced by Sen. Ron Johnson (R-WI) which unanimously passed the Senate in August.
“This bill is needed to protect the pharmaceutical industry from litigation and allow them to respect the individual 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,” said US Navy LCDR (Ret.) Matthew Bellina, a Bucks Co. resident who also testified at the hearing. “I know that it is probably too late for me and I have made my peace with that. I need to know before I die that if my children find themselves in this unenviable position, that this nation that I proudly served will respect their liberties and their right to make their own decisions about their medical treatments.”
The Right to Try Act of 2017 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 prevents “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.
From ALS to Duchene Muscular Dystrophy, over one million Americans die from a terminal disease each year and thousands more are diagnosed. However, current ‘compassionate-use exceptions’ are only granted to about 1,000 patients annually. Many patients simply run out of time before they can qualify or before the FDA’s approval process completes. The Right to Try Act would allow for potentially life-saving access to care. Currently, 37 states have signed into law their own Right to Try legislation; Pennsylvania does not. Fitzpatrick’s bill ensures that the federal government - and the FDA, specifically - does not interfere with state laws.
Fitzpatrick is a member of the Congressional Rare Disease Caucus.