House Overwhelmingly Passes PDUFA Package
By Mari Serebrov
The reconciled PDUFA package sailed through the House Wednesday with unanimous support and is now headed for its final vote in the Senate.
Democrats and Republicans alike hailed S. 3187 as a good bill that will create jobs and provide quicker access to affordable, life-saving drugs. However, prior to the vote, many lawmakers pointed out holes that need to be filled in the months to come.
Rep. John Dingell (D-Mich.), for instance, expressed disappointment that the final user fee package doesn’t include a track-and-trace measure that’s needed given the increasingly global drug supply chain. He charged Congress with tackling track-and-trace next. (See BioWorld Today, June 20, 2012.)
Other lawmakers voiced concerns about the level of FDA funding dependent on user fees, the lack of protection for FDA whistleblowers, some Senate “contributions” that cross the line into the practice of medicine and failure to close a loophole that allows medical devices to get market clearance based on defective devices that have been withdrawn.
The Senate is expected to vote on the bill by next week, well ahead of a self-imposed July 4 deadline.
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