21st Century Cures Act

Floor Speech

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Mr. Chairman, I would like to start by commending Chairman Upton, Ranking Member Pallone, Ms. DeGette, Mr. Green, and so many others. I am proud to join as a cosponsor for the 21st Century Cures Act, which is really a first step to updating our approval process to help countless Americans gain access to lifesaving drugs and devices.

This bill will save lives. I am proud to support it and send a strong message that we need to move forward with reform.

But at the same time we are passing this bill, we should start thinking about what the next step is. Passage of this bill should not foreclose additional opportunities in the future to improve access to lifesaving medical device products and lifesaving drugs.

Most importantly, this body can move forward with the next generation and start the process to help people get access to medical technology that can help keep people healthy, independent, save lives, and save money.

It is in that spirit that I put forward my amendment, which would look at a two-tiered approval process for medical devices, that would allow devices to come to market once they have demonstrated safety while the FDA is still reviewing them for efficacy.

This solves a real problem in the world. In the U.S., the cost of bringing a medical device to market through the approval process is $30 million to $100 million. Those are costs that are then added to consumers of the medical device. That makes it even more difficult for niche medical devices that may help rare and unusual conditions because they are priced prohibitively.

In addition, there is the aspect of the timeline. In the European market, for instance, if somebody creates a new device to prevent blood clots, it reaches the market in 7 to 11 months. In the U.S. market, they are looking at a timeline of 2 1/2 to 4 years. Think of how many sufferers might die or have additional health problems simply because our own government is keeping that lifesaving product off the market, even though it has been demonstrated as safe.

An additional result is that some medical technology companies are bypassing the U.S. market altogether when they develop new devices, which can result in years-long delays for access to U.S. patients and, in some cases, companies who view the U.S. approval system as too expensive market their devices exclusively in other nations.

I think it is important to talk about what comes next. I think that with both devices and drugs, we need to look at the potential for a two-tiered process that allows a provisional approval and access to the U.S. market. That doesn't mean that insurance will cover it. That doesn't mean, clearly, that they can make any health claims with regard to the efficacy of their product. That is in existing law. But with regard to the safety being demonstrated, the provisional marketing of the product in America can save lives and will save lives.

I reserve the balance of my time.

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Mr. Chairman, I thank both the chair and the ranking member.

This is a very important discussion to have, both with regard to devices and also with regard to drugs.

We know that there are treatments that are available overseas. I represent a district with, by the way, one of the largest veterinary hospitals in our country, Colorado State University Veterinary Teaching Hospital, and I can tell you that there are actually treatments, advance treatments available today for animals with cancer, like horses, that are not yet approved for humans and are lifesaving.

If we can provide access in a shortened timeframe--I understand that while medical devices might cost $30 million to $100 million to bring to market, drugs often cost over $1 billion to bring to market.

There are additional opportunities, by the way, in making sure that, as part of this provisional process, at least with regard to drugs, the data can be gathered, too. So it can serve a dual function and might, at the same time complying with some of the needs or an updating of the needs of some of the phases of FDA efficacy trials, it can actually be available through a market-oriented plan where people, consumers who are fully informed and, of course, to whom no health claims have been made, can choose to purchase the product, just as they can today, by the way, but they have to buy it overseas and import it for their own personal use. I have constituents who do that. But I think we can facilitate that process.

I deeply appreciate working with the chair and the ranking member of the committee and the subcommittee with regard to helping to bring access to lifesaving medical devices and pharmaceutical products to our shore.

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