Washington, D.C. – Today, U.S. Representative John D. Dingell (D-MI15) issued the following opening statement at the House Energy and Commerce Subcommittee on Oversight and Investigations hearing entitled “Regulatory Reform Series #5 - FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs”:
“Thank you Mr. Chairman for holding today’s hearing.
“Like most Americans I support creating jobs, promoting innovation amongst our medical suppliers, and ensuring safe and effective devices for those in need. But unlike my colleagues on the other side of the aisle, I do not believe that we can achieve these goals by gutting the funding we have tasked to do so.
“I understand the industry having their concerns about FDA’s medical device approval process. The approval process is critical to providing access to life-saving medical devices to patients who need them to live a full, healthy and balanced life. I have heard complaints about the increase in total review time, delays and inconsistencies in the review process, lack of clarity in data requirements, among other things.
“Now I don’t believe that throwing money at a problem will fix it, but I do believe that Congress and FDA cannot address these problems under the proposed budget offered by my Republican colleagues which makes draconian and reckless cuts to the Food and Drug Administration. FDA has long been a chronically underfunded agency, and just as Congress makes successful in reversing this disturbing trend, my Republican friends propose cutting their fiscal year 2012 budget by $285 million.
“A cut of this magnitude to FDA’s budget will only result in a cut in the number of personnel dedicated to reviewing device applications, a likely delay in review times, further exasperating the valid concerns of industry and patients.
“Further, as Members of this Committee we have a responsibility to improve the medical device approval process not tear it down. Rushing devices to the market may help to pad the pockets of industry, but it does not keep the promise to the American public that medical devices approved by FDA will be both safe and effective.
“I hope to continue to work with my colleagues to strengthen the medical device approval process and provide FDA the capacity to do so. I look forward to hearing from today’s panels.”
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