President Signs Medical Device User-Fee Bill
President Obama signed into law on July10 legislation that grants the U.S. Food and Drug Administration (FDA) the authority to collect $6 billion in user fees for new devices and drugs for another five years.
The Food and Drug Administration Safety and Innovation Act “increases the FDA’s ability to provide timely and expedited review and approval of applications for prescription drugs and medical devices,” said White House Press Secretary Jay Carney.
The agency can collect up to $595 million from manufacturers for new device applications. This is double the amount in the user fee deal that expires this September.
In exchange for getting more money, the FDA has said it will hire more staff and work with companies earlier in the application process, part of an overall effort to improve the premarket review program’s efficiency.
Under the new law, the fee for a 510(k) application is 2% of the fee for a premarket approval request, a bump from 1.84%.
The measure has been welcomed by manufacturers, who praised it even before Obama signed it into law.
“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,” said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), a Washington, D.C.-based device trade association. “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.”
But some patient safety groups have argued the new law falls shorts when it comes to safety. They have complained that the bill doesn’t improve postmarket device surveillance or premarket review standards, which they describe as vital to keeping unsafe devices from reaching the public.
Posted: July 11, 2012