PATIENTS FORCED TO SEEK INNOVATIVE CARE IN CANADA AND EUROPE

Washington, Jul 19 - "The United States has led the global medical device industry for decades, and the industry directly employs 400,000 Americans and indirectly supports two million total jobs," said Rep. Cliff Stearns (R-FL), Chairman of the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations. "Numerous reports, case studies, and firsthand accounts indicate that a lack of consistency, predictability, and transparency in the Food and Drug Administration (FDA) review process is undermining patient care and our leadership position in medical devices."

Continuing his focus on promoting economic growth and job creation, Stearns is holding hearings on the impact of federal regulations and policies on the economy. In this hearing entitled "Regulatory Reform Series #5 - FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs," the subcommittee will examine the state of the medical device industry and the impact regulations and policies at the Center for Devices and Radiological Health have on patient access, innovation, and job creation. The hearing is scheduled for Wednesday, July 20th at 10:00 AM in Room 2322 RHOB.

Witnesses:

• Jeffrey E. Shuren, MD, JD, Director Center for Devices and Radiological Health, FDA
• Marti Conger, Benicia, CA
• Carol Murphy, Fairborn, OH
• Robert Fischell, Dayton, MD
• Pam Sagan, Los Altos, CA
• Michael Mandel, Progressive Policy Institute, Washington, DC
• Sean Ianchulev, MD, MPH, Chief Medical Officer Transcend Medical, Inc. Menlo Park, CA
• Gregory Curfman, MD, Executive Editor, New England Journal of Medicine