CDRH head Jeffrey Shuren will finally appear before the a U.S. House Oversight & Government Reform subcommittee to discuss the FDA and its medical device approval process. The panel had been slated to hold the hearing in April, but it was abruptly cancelled at the last minute.
The other witnesses are Rep. Erik Paulsen (R-MN), Jack Lasersohn, general partner at The Vertical Group, David Gollaher, president and CEO of the California Healthcare Institute and Rita Redberg, director of Women's Cardiovascular Services in the Division of Cardiology University of California, San Francisco. The hearing will "study the FDA's inconsistent application of reasonable standards for safety and effectiveness in approving medical devices, and the impact it has on American job creators."
Paulsen has taken the lead in pushing against the $20 billion tax on medical devices and calling on the FDA to modernize. When Shuren was in Minneapolis recently for a town hall meeting to hear from industry insiders, he contacted Paulsen, as MinnPost.com notes. "Dr. Shuren got wind I might be proposing changes at the FDA, so last week he actually contacted my office. At some point, I expect we're actually going to get together," he said. Paulsen is on record for calling the FDA product approval process "inconsistent, inefficient and unpredictable."
The House subcommittee hearing comes a week after the release of survey results that showed roughly two-thirds of small medical device and diagnostic companies are obtaining clearance for new products in Europe first because of uncertainty over the FDA's 510(k) process. Because these firms go to Europe first, the availability of those products in the U.S. is delayed, according to a study from Northwestern University reviewing the FDA's 510(k) process.