A Letter on the Importance of Reauthorizng MDUFA and PDUFA

The following letter was delivered to leaders in Washington DC thanking them for their efforts on behalf our our industry working in partnership with the FDA and the value to our state and our country on reauthorising the MDUFA and PDUFA user fee agreements.



April 23, 2012

Senator Tom Harkin                     Representative Fred Upton
Chairman                                         Chairman
Senate HELP Committee             House Energy & Commerce Committee
Senator Mike Enzi                          Representative Henry Waxman
Ranking Member                           Ranking Member
Senate HELP Committee              House Energy & Commerce Committee

Dear Chairman Harkin, Chairman Upton, Senator Enzi, and Representative Waxman:

On behalf of the over 600 companies that make up Arizona’s Bioscience Industry, I am writing to thank you for your leadership and for your legislative proposals to reauthorize the medical device user fee program and the prescription drug user fee program.

Here in Arizona, we are celebrating both our centennial as a state and year 10 of Arizona’s Bioscience Roadmap which brought together over 100 leaders committed to building an ecosystem where new discoveries are developed and our companies deliver products and services that sustain and improve health and also lower the escalating financial burden of healthcare costs. The result of these efforts, with industry and government working together hand in hand, has resulted in significant job growth.  (Arizona’s Bioscience industry jobs have grown 41% for the period of 2002-2012 compared to the US gain of 11%.) The economic impact of these companies in Arizona alone is $28.8 Billion and represents $1.1 Billion in taxes paid at the state level.

Together, we are moving forward faster, not just economically but with innovations that will greatly benefit the people of the United States.  Here are just two examples of the many innovations that are being developed in Arizona:

  • The SynCardia Total Artificial Heart has been implanted in over 1,000 patients creating a bridge to transplant for patients.  Just last month this amazing medical device received HUD designation for Destination Therapy from the FDA.  (www.syncardia.com)
  • VisionGate is dedicated to saving lives through early cancer detection and prevention, utilizing its revolutionary automated 3D cell imaging platform, the Cell-CT™, that is capable of generating high-resolution 3D biosignatures from intact cells.  In the future, this noninvasive test will allow us to catch cancer early and save thousands of lives while dramatically lowering healthcare costs. (www.visiongate3d.com)

As you know, without Congressional reauthorization, the Food and Drug Administration’s (FDA) authority to collect user fees under these programs and, by reference, FDA’s obligation to meet specified performance goals, will expire on September 30, 2012.

At the national level, Industry and the FDA have negotiated a new user fee agreement, which is reflected in your legislation. These new user fee agreements are another example of industry and government working together.  The “user fee agreement package” is beneficial for patients, industry and FDA.  What is being proposed is a substantial improvement over the current user fee agreements and lays the groundwork for significantly improved agency performance through increased accountability, more meaningful goals, important process improvements, better metrics and additional resources.

FDA is a critical partner in our companies’ efforts to bring safe and effective medical devices, drugs and diagnostics to patients. Without a strong, effective, and efficient FDA, we cannot have a strong and competitive industry.   As you may know, the medical technology and bioscience industry employs over 96,000 people in Arizona and play an important role in our state’s economy.  It is important that Congress move expeditiously to pass this agreement, which will provide certainty to both the agency and industry.

We commend you for your bipartisan efforts, and are greatly encouraged by the legislation you have put forward. In addition to the underlying user fee agreements, the legislation includes a number of proposals that have been introduced with the goal of improving the FDA’s operations. We are appreciative of efforts by all Members who seek to give the FDA the tools and structure it needs to succeed, and are supportive of many of the legislative reforms put forward by the committees.

It is essential that the legislative process advances quickly, and we are committed to working with you to achieve reauthorization of the medical device user fee program on a timely basis.

I will be in Washington, D.C. along with representatives of the bioscience industry from across the United States on Tuesday, April 24th and Wednesday, April 25th.  If you or members of your team would like more information, I would be happy to share more details  in person.


Joan Koerber-Walker

President and CEO
AZBio (The Arizona Bioindustry Association)
107 S. Southgate Drive
Chandler, Arizona 85226



CC:  Arizona House and Senate Delegations

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