Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018

Floor Speech

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Mr. FITZPATRICK. Mr. Speaker, I want to thank Chairman Walden, Mr. Burgess, Mr. Griffith, and my friends Andy Biggs and Senator Johnson for their unflinching commitment to see right to try debated, passed, and signed into law.

Moreover, I thank the overwhelming bipartisan majority of the House, who, just last week, supported the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, and proved emphatically that right to try is about more than politics. It is about hope.

Each year, thousands of Americans receive a life-altering diagnosis of a terminal illness. 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.

As their Representatives, we should each endeavor to support these individuals in their time of need, as well as support new pathways to potentially lifesaving treatment. That is what right to try is all about.

For those patients caught between 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.

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 doesn't help enough people. Moreover, the application process is complicated, time consuming, and expensive. Only about 1,200 people each year can make it through the application process.

In 2014, more than 12,000 people in France were using investigational treatments through that government's equivalent program. If a country with one-fifth the population of the United States can help 900 percent more people then the FDA's plan, clearly, is not working.

In Australia, doctors are allowed to work directly with drug and device manufacturers to provide investigational treatments to terminal patients without the government's approval. They simply must report to the government at some point that the patient received the drug. No permission slip is required.

This bill requires robust informed consent between the patient, doctor, and manufacturer, while requiring notification be given to the FDA after an unapproved drug becomes available to an eligible patient and requires doctors and manufacturers to report adverse events to the FDA.

Mr. Speaker, when a life hangs in the balance, the Federal Government should not stand in the way of access to these potential treatments. I have traveled our district in all corners and have met so many different people--L.J. Kidon and Claire Concilio, most recently. Mr. Speaker, these people are an inspiration for this bill. They want to see this bill passed. Let's get this done for them.

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