Dr. Jeffrey Shuren, head of the Food & Drug Administration’s medical device arm, defended his agency’s performance before a U.S. House subcommittee today, rebutting a spate of recent criticism directed at the Center for Devices & Radiological Health.
Appearing before the House Energy & Commerce Committee’s health panel, Shuren said comparisons between the U.S. regulatory system and the European Union’s are specious.
“Some would say that, despite the record of growth and prosperity in the U.S. device industry, the European regulatory system is better for industry and patients,” Shuren told the subcommittee, chaired by Rep. Joe Pitts (R-Pa.). “It is difficult to make direct comparisons between the U.S. and European systems given their fundamental differences, including, at the most basic level, differing approval standards — the EU lacks the requirement in U.S. law that a device be shown to be effective.”
Shuren was responding to criticism from the med-tech industry founded on a trio of recent studies by PricewaterhouseCoopers, Stanford University and the Boston Consulting Group which conclude that medical innovation in the U.S. is sagging from over-regulation. Shuren said one of those studies overestimated review times because it counted the “substantial pre-submission assistance” the federal watchdog agency offers applicants, according to The Hill.
Review times could grow even more sharply if the budget cuts House Republicans are promoting take effect, Shuren warned. The GOP wants to shave $220 million from the FDA budget, according to the website.
