Top FDA Officials Address Medical Technology Industry

WASHINGTON, DC – More than 200 companies, associations, investors and others attended the 16th Annual Meeting of the Medical Device Manufacturers Association (MDMA) to discuss the critical need for more transparency and predictability at the Food and Drug Administration (FDA).  Industry leaders, lawmakers and government officials gathered over three days in Washington, DC this week, covering various pressing issues affecting one of America’s fastest growing sectors.

“The United States’ medical device industry is the global leader in developing innovative products that improve patient care and reduce the long term costs of health care,” said Eamonn Hobbs, President and CEO of Delcath Systems Inc. and newly elected Chairman of MDMA.  “This year’s MDMA Annual Meeting showcased just how integral the industry is to patient care and the economy, and how potential misguided policies could threaten our leadership position in world.  It is essential that government officials support policies that promote innovation and entrepreneurship so that we may continue to develop the next generation of technologies and therapies that will allow patients to live longer, more productive lives.”

Highlights of the event included a keynote address by FDA Principal Deputy Commissioner Dr. Joshua Sharfstein, as well as an in depth question and answer session with FDA Director of the Center for Devices and Radiological Health Dr. Jeffrey Shuren.  In addition, panelists discussed the consequences of the new medical device tax, including reductions to research and development, moving jobs outside the Unites States and laying off employees to offset the tax.

Congressman Erik Paulsen (MN-03) received the 2010 Chairman’s Award to recognize “his strong leadership on issues that promote patient care and innovation in the medical device industry, ensuring the U.S. as a leader in producing cutting-edge medical advancements.”

“Coming off of the heels of the recently enacted health care legislation and the current concerns with FDA, it is clear that our members recognize the importance of engaging policy makers,” said Mark Leahey, President and CEO of MDMA.  “If the United States is to maintain its leadership position in medical technology innovation, we must have a reasonable and predictable regulatory pathway and not impose taxes on the very companies that are developing the cures of tomorrow.  We will continue to work with Congressional and agency leaders to ensure that patients have timely access to safe and effective products and that innovation continues to flourish.”