Fitzpatrick Testifies On ‘Right to Try’
WASHINGTON, D.C. – Congressman Brian Fitzpatrick (PA-08) testified in front of the Committee on Energy and Commerce Subcommittee on Health Tuesday as part of a hearing on his ‘Right to Try’ legislation.
Fitzpatrick’s full testimony as prepared for delivery is below:
“I want to start by thanking Chairman Burgess, Ranking Member Green, Vice-Chairman Guthrie and other members of the Energy and Commerce Subcommittee on Health for holding this hearing on Right to Try. Thank you to my colleague and friend, Rep. Biggs, for your partnership on this issue.
Fellow colleagues, each year thousands of 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.
Thousands of terminally ill patients suffer needlessly while awaiting final approval for drugs, therapies, and other medical technologies. While the Food and Drug Administration carries out its three-phase approval process – which can take years and cost billions of dollars – many patients simply want the chance to try treatments that are already demonstrated to be safe.
Mr. Chairman, it is my hope to come together with federal regulators and industry leaders to clear the path forward to care for those who are fighting just for a shot at living. A bill that was unanimously passed by the Senate will offer them a chance to extend their lives.
The Right to Try Act would ensure that terminally ill patients - together with their physicians, and pharmaceutical manufacturers - can administer investigational treatments where no alternative exists. In fact, this bipartisan idea is already law in 37 states in our nation. A federal Right to Try law would prevent the government from blocking access to potentially lifesaving medications. It would require patients to first try all other available treatments and be unable to participate in clinical trials.
Mr. Chairman, I want to note that these provisions only apply to terminally-ill patients. It does not undo the FDA approval process, but provides a potential lifeline for those who cannot wait. It requires physician certification that other options to be exhausted or unavailable. This maintains the incentive for patients to seek out and join clinical trials. This bill requires that a product meet a demonstrated level of safety by attaining FDA Phase I approval. We’ve worked with drug companies to ensure adverse outcomes are not used against the ongoing application for approval. Additionally, patients, doctors, and manufacturers do not assume any additional liability under this act.
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 and their doctors to try therapies where the benefits far outweigh the risks. It gives them the option of trying to save their life.
Whether it’s a father courageously battling ALS or a brave child living with Duchene Muscular Dystrophy, they deserve the right to try.
Thank you all for your time and consideration. As your colleague. I ask that you work with us to get this done on behalf of all terminally ill patients across America. All that we ask is that this bill be put on the floor of the House and allow each one of us to cast our vote and go home and answer for that vote.
Mr. Chairman, I yield back.”
Watch the Fitzpatrick's testimony HERE