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Congressman Frank Pallone Hosts Roundtable Discussion with FDA and Medical Industry Leaders

November 21, 2011
Press Release

Rep. Pallone works with medical device industry leaders to encourage innovation, create jobs and kick start the economy

New Brunswick, NJ—Today, Monday, November 21, 2011, Congressman Frank Pallone (NJ-06), joined by leaders from the medical device industry and the U.S. Food and Drug Administration (FDA), hosted a roundtable discussion to encourage a dialogue between the corporations and FDA officials at Rutgers University.  The forum offered an opportunity for medical device companies and FDA representatives to work together and develop ideas that would grow the medical device industry, create jobs, spur innovation and improve New Jersey’s economy. 

As a national hub of the medical device development industry, corporations operating in New Jersey were encouraged to take part in the panel.  Meeting participants included representatives from Becton, Dickinson and Company, Cardinal Health, Colgate-Palmolive Co., C.R. Bard, Inc., Healthcare Institute of New Jersey, Johnson & Johnson, Novo Nordisk, Philips, Roche Diagnostics, Siemens, Stryker Corporation and Zimmer Holdings, Inc.

The following are excerpts from Congressman Pallone’s comments at the roundtable:

“In the planning staging of this meeting, Rutgers seemed like the perfect backdrop to these issues.  I am so proud to represent Rutgers and I am so proud of the work that is being done here, often with support from industry leaders and companies that are here today.  I am also very excited about the proposed integration into Rutgers of the Robert Wood Johnson Medical School, the School of Public Health, and the Cancer Institute of New Jersey.  Strengthening these relations will go a long way toward creating the vibrant environment for medical research that attracts federal funding, promotes university-industry collaboration, and propels economic growth.

“I’ve convened today’s discussion because I believe we are at an important crossroads in this country and it is critical that we all work together and not against one another moving forward.   As we continue to work our way out of the recession towards a thriving economy that offers economic opportunities to all Americans, we must out-innovate the rest of the world.  America’s competitiveness depends on our ability to innovate and keep America number one – and we all have a role to play in making that happen.

“That said the government must help facilitate an environment where Americans can continue to innovate.   That is the key to creating new thriving industries that will produce millions of good jobs here at home and a better future for the next generation.  If government abandons its role, we run the real risk of squandering too many opportunities that lead to innovative discoveries and great economic benefits.

“This is an industry that has become increasingly important as dramatic improvements over the last decade have revolutionized healthcare and improved the quality of life for millions of Americans. Today, the United States accounts for 40 percent of the global medical technology market and the industry indirectly creates two million American jobs. Maintaining American leadership in this field is essential for jobs and for patients. Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system.

“In New Jersey, the numbers are just as staggering.  There are 20,500 device jobs in New Jersey, a 14 percent increase over a couple of years ago -- which is so promising because that means the industry is growing, even in tough economic times.  In addition, for each of those 20,500 device jobs another 3.1 jobs are created.  This is an industry that has become increasingly important as dramatic improvements over the last decade have revolutionized healthcare and improved the quality of life for millions of Americans.

“Now, I’ve been interested in today’s topic of FDA regulation for a long time.  That includes examining where the current system works well and where shortfalls might be.  I’ve heard from patients, from physicians, and from companies about problems with the 510(k) process.  Physicians and patients are concerned that products aren’t fully evaluated before they’re allowed on the market. And of course, I hear from companies who are frustrated at the lack of predictability and transparency in the process, as well as increased review times, inconsistent expectations, and poor communication from the FDA.

“But I did not convene this discussion today to gripe.  What I hope to accomplish today is an open dialogue, a 3-way street, if you will, between industry, the FDA and me.  It is my hope that we can lay the foundation for a long-standing, stronger working relationship.

“Together we will all find some common ground to move forward in achieving the best outcome for the future of the medical device industry and of course, medical innovation in this country.  I also believe that we can work together to change the rhetoric we’ve heard in the past to be more constructive, and from what I’ve seen as of late, that is already taking shape.”