Correction June 26, 2012, at 11:15 am: This article mistakenly stated that the Senate approved the bill. The Senate had voted only to close debate on the measure, the final vote will occur this evening.
MASSDEVICE ON CALL — The U.S. Senate voted 89-3 to close debate on the latest iteration of the FDA’s user fee bill, which doubles the previous amount that medical device makers pay for agency review for new products.
The Medical Device User Fee & Modernization Act is on its 2nd round in the Senate, with the House of Representatives having put its stamp of approval on the bill with a ⅔ majority vote last week.
The MDUFMA bill, which is wrapped in a larger FDA user fee measure and doubles medical device user fees from $295 million over 5 years to $595 million.
The user fee measure has sailed through both houses with bipartisan support as Congress works against an Oct. 1 deadline on what many call a "must-pass" piece of legislation.
Nonetheless, not all members of Congress have thrown their support behind the bill. Sen. Bernie Sanders (I-Vt.) was the only down vote in the bill’s 1st round in the Senate last month, but he was joined by Sens. Richard Burr (R-N.C.) and Rand Paul (R-Ky.) in voting against closing debate last night.
Watchdog groups such as Consumers Union, the policy advocacy arm of Consumer Reports magazine, have also weighed in with criticism for the bill, calling on legislators to use this bill to force companies to prove that new devices are free from flaws that led to recalls or safety issues in prior products that are serving as a foundation for review.
"This bill gives the FDA some new tools so it can better monitor medical devices once they are on the market, which could make it easier to notify patients when things go wrong and require more timely testing when safety problems are uncovered," Consumers Union’s Safe Patient Project director Lisa McGiffers said in prepared remarks. "But it does not give the FDA the stronger authority it needs to more thoroughly assess the safety of devices before they are allowed on the market."
The bill will now head to a vote in the Senate, expected to occur tonight, after which it will head to the White House to receive a final signature before becoming law.
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