Senate Approves Device User-Fee Bill
By an overwhelming 92-4 margin, the U.S. Senate voted Tuesday to renew the Food and Drug Administration’s (FDA) authority to collect user fees on new devices and drugs.
The Food and Drug Administration Safety and Innovation Act was approved by the U.S. House of Representatives last week and now heads to President Obama for his signature.
Once signed into law, the act will renew the agency’s user fee program for another five years starting in 2013, and allow the FDA to collect $6 billion from pharmaceutical and device companies, according to an article in The Washington Post.
A small portion of that figure, $595 million, will come from fees for new device applications. That is double what the industry paid in the current user fee deal, which expires this September.
In the new agreement, when a manufacturer submits a 510(k) application the company would pay 2% of the fee for a premarket approval request, an increase from 1.84%.
In accepting the fee hike, industry representatives successfully pressed the FDA to improve its premarket review program by hiring more staff and engaging with companies earlier in the process.
One device trade group praised the bill’s passage.
“This legislation will help improve an already robust review process by giving FDA the additional tools and resources it needs to improve its timeliness and consistency,” Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed) in Washington, D.C., said in a statement. “That means more American patients will have access to safe and effective treatments and diagnostics sooner, which is the shared goal of both FDA and industry.”
Not everyone is pleased with the bill. Patient safety groups have complained it doesn’t improve postmarket device surveillance or create stricter premarket review standards.
Posted: June 27, 2012