Food and Drug Administration Safety and Innovation Act

Floor Speech

Mr. WAXMAN. Mr. Speaker, I yield myself 3 minutes.

Today, the House considers a bill that represents a significant bipartisan and bicameral achievement.

On May 30 of this year, the House passed its user fee legislation by a dramatic vote of 387 5. That bill was a strong one, but through our collaborative process with the Senate, we have made it even better.

It has been a pleasure to work not only with Mr. Upton, Mr. Pitts, Mr. Pallone, and Mr. Dingell, among many involved House colleagues, but also with our Senate colleagues, Senators HARKIN and ENZI.

When we began this process, there were divergent views on the various issues contained in this bill. But we worked together and found ways to bridge our differences in a fashion that protects patients and fosters innovation.

This legislation contains many provisions that are critical to the functioning of major parts of the FDA. We reauthorize the FDA's drug and medical device user fee programs which will provide resources to enable the efficient review of applications and give patients rapid access to new therapies. We're also reauthorizing two pediatric programs which foster the development and safe use of prescription drugs in children.

This year, we're establishing two new programs to help the FDA speed up their review of new generics and biosimilars. These provisions illustrate our bipartisan commitment to ensuring a vibrant generic marketplace. All
of us will see the benefits when more low-cost generics are on the market.
One of the most important improvements to the House-passed bill is in the area of antibiotics. We accepted the Senate language that directs incentives for the development of antibiotics toward serious and life-threatening infections.

This bill also includes provisions to modernize FDA's authorities with respect to the drug supply chain. Today, 80 percent of active ingredients and bulk chemicals used in U.S. drugs come from abroad and 40 percent of finished drugs are manufactured abroad. FDA has been trying to keep pace with this increasingly globalized drug supply change using an outdated statute. This legislation will give the FDA critical new tools to police this dramatically different marketplace.

We have also worked to address the area of drug shortages, which is a complex and multifaceted problem, but this legislation takes some sensible first steps.

I want to thank my colleagues on both sides of the aisle and their staffs for the hard work they've put into making this a strong bipartisan bill. I particularly want to thank Mr. Pallone and Mr. Dingell's staff members, Tiffany Guarascio and Kim Trzeciak, as well as Mr. Upton and Mr. PITT'S staff, Ryan Long and Clay Alspach.

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Mr. WAXMAN. I yield myself an additional 30 seconds.

Warren Burke and Megan Renfrew have done tremendous work on this bill. I'd like to express my appreciation for their efforts. I want to thank my own staff: Karen Nelson, Rachel Sher, Eric Flamm, and Arun Patel.

The American public will benefit from the provisions of this bill. The FDA will have the resources to remain the gold standard for the future. This is an important bill, a good one. I urge its support.

I reserve the balance of my time.

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