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Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

By:
Date:
Location: Washington, DC

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Mr. PITTS. Mr. Speaker, I stand to strongly support this legislation.

This bipartisan agreement represents over 18 months of work from the Energy and Commerce Health Subcommittee, and I'm especially proud and appreciative of the hard work of Ryan Long and Clay Alspach for their diligent and tireless efforts in helping to make this bill possible.

The FDA Safety and Innovation Act is critical to saving lives, improving regulatory operations, and sustaining a vital and dynamic American industry.

American companies are the leading developers of new medical devices and drugs to save and sustain life. To ensure that products are both safe and effective, we've tasked the Food and Drug Administration with reviewing products before they make their way into the market, and this is a critical responsibility.

The device and drug industries are dynamic and innovative. Companies spend hundreds of millions of dollars and years of research and work to develop products. The review stage is a critical time for any company. Inconsistent reviews mean that the true cost of developing new products is hidden, making it difficult to properly prepare.

When our Health Subcommittee began considering this legislation last year, we heard from a number of individuals about the increasing difficulty of working through the review process. American patients were waiting almost 4 years longer for new devices that had already been approved in Europe. And despite the slower U.S. review process, the safety outcomes were comparable.

The FDA Safety and Innovation Act contains important reforms to the Medical Device User Fee Act and will hold the FDA accountable and keep reviews on schedule. There are many reforms in this bill.

Finally, we include language to help patients and doctors and hospitals deal with drug shortages. Mr. Speaker, I'm proud of the work we've done. I'm proud that we have such a bipartisan effort.

I'd like to especially thank Ranking Member Frank Pallone and his staff for patiently working with us, for Mr. Dingell, Mr. Waxman. We've accomplished much with this legislation, and it will help save lives, create jobs--two goals that we can all agree on. Thanks to our chairman, Mr. Upton.

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