House Passes Device User Fee Bill
The U.S. House of Representatives overwhelmingly passed a bill to reauthorize the U.S. Food and Drug Administration’s (FDA) device user fee program on June 20.
The voice vote by the House means the Medical Device User Fee Act now goes before the Senate, which could take it up some time next week, according to an article on Politico.
The bill, which is a reconciled version of legislation that already passed both chambers of Congress, would allow the FDA to collect $595 million in user fees for new device applications over the next five years. The amount is double what Congress approved in 2007, the last time the act was reauthorized.
In exchange for more funds, FDA officials said during a public meeting in March that the agency agreed to improve the review program’s efficiency. It will hire more staff, and engage companies earlier in the review process.
Patient safety advocates have complained about the deal, with some saying there should be additional post-market user fees.
“If a device clears the FDA, then the company should pay another user fee for postmarket surveillance,” said Paul Brown, government relations manager for the National Research Center for Women & Families, a Washington, D.C.-based research and advocacy group, at the March meeting. “If it is recalled, the company should pay a user fee for the FDA to manage the recall.”
One device trade group praised the House vote and the agreement itself.
“The user fee agreement reached between FDA and industry and implemented by this legislation is a potential game changer that could help accelerate the development and approval of safe and effective treatments and diagnostics,” said Stephen J. Ubl, president and CEO of the Washington, D.C.-based Advanced Medical Technology Association (AdvaMed), in a statement. “Through a combination of groundbreaking accountability and transparency measures and enhanced FDA resources, the user fee agreement has the potential to increase the predictability, consistency and efficiency of FDA’s decision-making, while maintaining the agency’s stringent product approval standards.”
Posted: June 21, 2012