U.S. Food & Drug Administration officials will have to trek up to Capitol Hill once again to explain the way the agency clears medical devices for the U.S. market.
The House Energy & Commerce Committee’s oversight subcommittee will hold a hearing entitled “Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs” on July 20th at 10:30 a.m.
While the witness list has not been officially announced, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health is expected to appear before the GOP-lead panel.
The subcommittee, which is led by Rep. Cliff Stearns (R-Fla.), is responsible for oversight of agencies, departments and programs within the jurisdiction of the House Energy & Commerce Committee, including the FDA and the Centers for Medicare & Medicaid Services.
In his most recent trip to Capitol Hill back in early June, Shuren batted back several attempts by Republican lawmakers to frame the debate on medical device regulations as a question of the European system’s superiority over the FDA.
Shuren, who was the star witness at a June 2nd hearing by the House Oversight & Government Reform Subcommittee on Health Care’s “Pathway to FDA Medical Device Approval: Is there a Better Way?” said his agency was not the sole contributor pushing companies to launch products in Europe before the U.S.
“Over the past decade, most indicators of the medical device industry’s success have gone upward,” Shuren said. “However, the recession has changed the business model to be more risk-adverse and more sensitive to changes at the FDA.”
Shuren told the committee that he was “astonished that some in medical device space are calling for us to lower our standards to those of Europe. It’s not in our best interest.”