21st Century Cures Act -- Extension of Remarks

Floor Speech

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The House in Committee of the Whole House on the state of the Union had under consideration the bill (H.R. 6) to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes:

Mr. BILIRAKIS. Mr. Chair, on a personal level, I have family members who have suffered with Parkinson's--I witness this debilitating disease through them. It is hard to see. Few things in America are truly ubiquitous--diseases, sadly, are one of those things.

In addition to the struggle chronic and rare disease patients face, physicians, researchers, clinicians, and medical device companies (among others) deal with an outdated and overly burdensome regulatory structure. These regulations stifle the development of new cures and treatments, whether they are drugs, biologics, or devices.

Given the reality, we have to ask: how can we get cures and treatments to the people who desperately need them?

That is the question the 21st Century Cures Initiative was created to answer. The 21st Century Cures Initiative is a bipartisan undertaking by members of the Energy and Commerce Committee to help our healthcare innovation infrastructure thrive and deliver more hope for all patients. This is a tremendous undertaking, and is much easier said than done.

It is about finding new ways to drive innovation. In addition to adequate funding and resources, we need to think critically about structural changes to streamline and modernize our health care system. We need to rethink what we have been doing and how we are doing it for the 21st Century.

This is what 21st Century Cures Initiative is giving us: an opportunity to address some of the structural barriers to new cures and promote new ways to incentivize developments. The 21st Century Cures Initiative has examined and seeks to accelerate the complete cycle of cures--from discovery to development to delivery and back again to discovery. This has resulted in the 21st Century Cures Act--a culmination of over a year's worth of engaging with patients, researchers, physicians, government, and private entities.

This year included numerous hearings and roundtables in Washington D.C. As legislators, we worked tirelessly to engage all stakeholders from across the spectrum. The only way we can answer the question--how do we get better cures and treatments?--is to work with everyone involved in the American health care system.

I am proud that I was able to have several provisions that were included in the final version of the Cures Act. These provisions will help to change the lives of patients in small to larger ways. I want to take a moment and highlight some of the provisions and some of the people that helped shape the policy.

Rare diseases are not a rare problem. Nearly 30 million Americans--1 in every 10 people--are living with a rare disease.

That is why I introduced the OPEN Act--the Orphan Product Extensions Now Act. It was included as a provision of the 21st Century Cures Act.

My bipartisan bill has the potential to help millions of people by incentivizing the testing of mainstream drugs--or repurposing them--to treat rare diseases and pediatric cancers, and it was included as a major provision in the 21st Century Cures Act.

The OPEN Act would unlock a new world of potential treatments--it would put FDA-approved, safe, and effective treatments ``on-label.''

Through the 21st Century Cures Act, Congress has a chance to come together to make a real difference in the lives of the 160 million Americans who suffer from a rare or chronic condition, as well as the family members and friends of all those afflicted.

The OPEN Act is one provision in the 21st Century Cures Act, but it is one I am proud to have authored, and one I believe will make a substantial difference in the lives of a lot of people.

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