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Public Statements

Food and Drug Administration Reform Act of 2012

Floor Speech

Location: Washington, DC


Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.

Today marks a very exceptional day in this body, one that deserves great praise. The bill before us, H.R. 5651, the FDA Reform Act of 2012, is the product of bipartisanship, collaboration, and compromise that I'm very proud of. The bill is a result of more than a year of negotiations between industry, FDA, and Congress.

In the Energy and Commerce Committee, we held a number of hearings on the critical issues within the bill, and earlier this month it passed unanimously in both subcommittee and full committee. The bill is slightly modified from the bill reported by committee, as it now includes a bipartisan provision which results in the bill reducing the deficit by $370 million over the next 10 years.

The FDA Reform Act will ensure that Americans have access to safe and effective new medicines and medical devices by reauthorizing the user-fee programs for prescription drugs and medical devices. It will reduce drug costs for consumers by speeding the approval of lower-cost generic drugs with the establishment of new user-fee programs for generic drugs and for lower-cost versions of biotech drugs.

The bill will also reform and revitalize many FDA programs to improve its regulatory scheme to facilitate a more efficient and predictable review process.

Mr. Speaker, the bill also makes permanent two complementary programs, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, which both help to foster the development and safe use of prescription drugs for children.

In addition, a significant improvement was made to the FDA's ability to police an ever-growing global drug supply chain to improve patient safety, and these provisions will give the FDA critical tools it needs to keep our medicine safer.

It also includes important provisions to help prevent and mitigate drug shortages by requiring that drugmakers notify the FDA in advance of any expected disruption in the supply of certain critical drugs, and for the FDA to inform health care providers of the potential drug shortage.

I want to thank Chairman Upton and Chairman Pitts, Ranking Member Waxman, Mr. Dingell, and my other colleagues on the committee for their leadership and dedication to this important piece of legislation, a special thanks to the staffs, in particular my staff person, Tiffany Guarascio, who's to my right. But on both sides of the aisle, the staff worked hard, and they should be very proud of what we've accomplished.

Reauthorizing and revitalizing the FDA user-fee system is a critical investment to our Nation's public health.

Mr. Speaker, I urge all Members of the House to vote ``aye.''

I reserve the balance of my time.


Mr. PALLONE. Mr. Speaker, I just want to say in closing that I think it's a great example with this bill of what we can do, not only in the Energy and Commerce Committee but in general in this House, on a bipartisan basis when everyone works together for a common goal.

This is actually a very important piece of legislation. It's important for the pharmaceutical industry. It's important in terms of job creation. It's important in terms of innovation and also bringing low-cost drugs to the American people. Without the type of bipartisan cooperation we had, we would not have been able to get here with this time schedule, which is truly amazing. So I want to thank everyone. I would like to say that I hope that we can do similar good work in the remainder of this Congress, and I would urge my colleagues to vote ``aye.''

I yield back the balance of my time.


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