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Public Statements

Food and Drug Administration Reform Act

Floor Speech

Location: Washington, DC


Mr. BILBRAY. Mr. Speaker, I want to indicate my strong support of H.R. 5651, the Food and Drug Administration Reform Act of 2012, which we are addressing on the House floor today. This bipartisan legislation is not only good for the health of the American public; it is also a key component to restoring the health of our economy.

Nowhere will the impacts of this legislation be felt more than in Southern California and the San Diego region. According to BIOCOM, Southern California's life sciences cluster employs just over 97,000 in five sectors: biopharmaceuticals, industrial biotechnology and biofuels, life sciences trade, medical devices and diagnostics, and research and lab services. Medical devices and diagnostics is the region's largest life sciences sector, employing 33,871, followed by research and lab services with 31,878 jobs. These two sectors account for 68 percent of the total employment in the cluster, with over 65,000 jobs in the region. These innovative companies are on the forefront for discoveries from everything from Cancer therapies to the latest medical device that will prolong life.

The Food and Drug Administration Reform Act of 2012 will provide timely and necessary improvements to the user fee programs for drugs, medical devices, generics and biologics. Through this legislation, FDA will now be committed to meeting their performance goals for the review of life saving drugs--thus expediting these products to patients who need them, create an independent review entity to hold FDA accountable for the approval and clearance process for devices, as well as the creation of a new user fee program for generic drug and biologics approval all the while ensuring the safety of U.S. patients.

H.R. 5651 contains many provisions that will improve the lives of American patients and promote the competitiveness of the U.S. life science enterprise. However, there are two provisions in this legislation that I am most proud of including. Included in the final House draft were two pieces of bipartisan legislation that I sponsored and worked with my colleagues on both sides of the aisle to get included. They are:
H.R. 3203, the Novel Device Regulatory Relief Act, coauthored with Representative LOIS CAPPS (D-Santa Barbara) improves the FDA's third party review and inspection of medical devices by making the process more efficient, transparent, and beneficial to the life science industry seeking approval.

H.R. 5334, the Breakthroughs Therapy Act, coauthored with Representative DIANA DEGETTE (D Denver) expedites the review of breakthrough drugs for patients with serious or life-threatening disease or a condition where preliminary clinical evidence shows an improvement over existing therapies.

As we move forward in reconciling our legislation with the Senate it is my hope that we can address another national crisis that was not included in the House bill--the need for a reliable track and trace system for pharmaceutical products. For years, Congress has attempted to craft legislation that would secure the distribution chain for pharmaceuticals. Either due to lack of consensus from industry and patient participants or poor timing, this was never accomplished. This lack of action has resulted in a patchwork of State laws which create opportunities for bad actors to shop for States with the lowest safety requirements in order to introduce unsafe products into the legitimate supply chain. This patchwork also creates regulatory uncertainty in the supply chain, which adds increased costs and burden to the health care system.

But this year is different. For the first time, we have seen industry stakeholders put aside differences and come to a consensus on a language that is supported by me and my friend Mr. MATHESON that will create a national pedigree system which will replace a patchwork of State laws that are currently in place. While not a perfect solution, this legislation is a first step in creating a secure supply chain system that will protect the U.S. public from counterfeit drugs while preventing unwanted regulatory burden on American businesses. It is my goal to work with my colleagues to include track and trace language in the final legislation which will secure the drug supply chain and address the concerns of the large pharmaceutical distributors, secondary pharmaceutical distributors, local pharmacists, third party logistical providers and the large scale pharmacies.

In closing, I wish to thank Full Committee Chairman FRED UPTON and Health Subcommittee Chairman JOE PITTS for their commitment to this issue. Without their guidance and hard work, this legislation would never have seen the light of day. I look forward to casting my vote in support of H.R. 5651 and urge my colleagues to do the same.


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