PATIENTS TESTIFY THAT FDA REGULATIONS DENY THEM THE MEDICAL DEVICES THEY NEED

Washington, Jul 20 -

"The medical device industry has brought hundreds of thousands of high-paying jobs to our country and life-saving, life-improving devices to our nation's patients in a safe and efficient manner," said Rep. Cliff Stearns (R-FL), Chairman of the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations. "Unfortunately, it appears that regulatory inconsistency and inefficiency at the Food and Drug Administration (FDA) is causing innovative medical device companies to move offshore and launch their products abroad, oftentimes years before they enter the U.S. market, if at all. These systemic problems at the Center for Devices and Radiological Health (CDRH) must be resolved."

Carol Murphy suffers from migraines and has been successfully treated with a transcranial magnetic stimulator, but the device is not FDA approved. Murphy testified, "I want my machine back!! I want to look forward to a quality of life free of pain. We, as Americans, should not have to go to England to get medical equipment to help live a normal life. This is a product made in America, by Americans, but not for use by Americans."

Dr. Robert Fischell has invented several medical devices and testified that the regulatory policies at FDA are getting more severe, "Unfortunately, the environment that exists at FDA's CDRH over the past few years is the worst I have experienced in my 42 year career innovating medical technologies."

Dr. Sean Ianchulev pointed out that the regulatory policies undermine patient care and force them to seek help overseas. He stated, "As a physician who not only delivers the standard of care, but also innovates in the ophthalmic field, I have failed on a number of times to treat patients with what I would have thought is the best therapeutic approach. On several occasions, I have had to refer patients to other countries (Europe and Canada) to receive the necessary treatment because the medical devices were not available in the US and were years away from being commercialized."

Michael Mandel, Ph.D., Chief Economic Strategist at the Progressive Policy Institute, testified, "With fairly modest changes, FDA standards can be adjusted to encourage cost-saving innovation without compromising safety. That's essential for growth and jobs going forward."