Subcommittee Investigates Delays at FDA

July 20, 2011

WASHINGTON, DC - The House Energy and Commerce Subcommittee on Oversight and Investigations, chaired by Rep. Cliff Stearns (R-FL), today held a hearing on the Food and Drug Administration's medical device regulations and the impact on American patients, innovation, and job creation. Patients and innovators adversely affected by regulatory inconsistencies and inefficiencies at the FDA shared their personal testimonies and Dr. Jeffrey Shuren, Director of the Center for Device and Radiolical Health at the Food and Drug Administration, provided an update on the FDA's approval process.

Stearns said, "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. Unfortunately, it appears that regulatory inconsistency and inefficiency at FDA is causing innovation medical device companies to move offshore and launch their products abroad, oftentimes years before they enter the U.S. market, if at all."

Carol Murphy, a migraine sufferer from Fairborn, Ohio, provided first-hand testimony that FDA's overly burdensome approval process has prevented American patients from accessing critical medical treatment

.

Murphy said, "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. Sean Ianchulev, Chief Medical Officer at Transcend Medical, Inc., explained, "On several occasions, I have had to refer patients to other countries to receive the necessary treatment because the medical devices were not available in the US and were years away from being commercialized."

In addition to patient concerns, FDA's increasingly burdensome regulations are stifling innovation and job creation. Award-winning inventor Dr. Robert Fischell testified, "Unfortunately, the environment that exists at the FDA's Center for Devices and Radiological Health over the past few years is the worst I have experienced in my 42 year career, innovating medical technologies. I am here today because of the millions of patients and physicians who are searching for therapies to improve the human condition. Unfortunately it is not technology, science, ingenuity or the economy that is standing in the way of success in developing new medical technologies. It is the FDA. As a strong supporter of President Obama, this is not easy for me to say, but it is the truth."

Rep. Leonard Lance (R-NJ) asked Dr. Fischell how these barriers weaken the United States' leadership position in medical technology and innovation. Dr. Fischell explained, "From twenty to about five years ago, venture capitalists would come to me and say, "˜Dr. Fischell, I'd like to support your latest invention tell me what it is.' Now I've recently gone to venture capitalists and say, "˜We have this great new cure for migraines and I need another $2 million to finish it.' And they say, "˜Because of the FDA, we can't give it to you. It's too risky.'"

When Rep. Michael C. Burgess, M.D. (R-TX) questioned whether the FDA is causing the US to lose its competitive edge, Dr. Shuren admitted, "The FDA needs to do a better job to ensure we keep our edge as the world's leader in medical device innovation."

Stearns said, "Hopefully, Dr. Shuren will gain insight from these patients' experiences and better understand the fact that patient safety and public health are not only jeopardized by approving devices that are unsafe, but also by failing to approve devices that are safe. We need to find solutions soon. Patients are waiting."

###