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BioWorld - Saturday, February 27, 2021
Home » Blogs » BioWorld MedTech Perspectives » Congress enjoys a rare moment of harmony with passage of FDA user fee act

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Congress enjoys a rare moment of harmony with passage of FDA user fee act

June 7, 2012
By Holland Johnson
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With all the acrimony between Democrats and Republicans in Congress these days, it was truly edifying to see lawmakers on both sides of the aisle agreeing on a piece of legislation - and in the healthcare sector no less - the FDA user fee reauthorization act.

Last week, the U.S. House of Representatives reaffirmed passage of the FDA user fee reauthorization act in a 387-5 roll call vote taken after an earlier voice vote.

The House affirmation followed close on the heels of the earlier congenial vote on the act by the Senate, a nearly unanimous 96-1 approval.

The groundwork for this quick approval came about back in February when industry stakeholders and FDA representatives came to terms on a tentative version of the agreement. At that time the parties agreed in principal to the new five-year user fee agreement for medical devices, and the $595 million agreed to was more than double the amount collected under the prior user fee agreement, which netted the agency less than $290 million. As a sweetener for all the extra money from industry, FDA agreed to measure device reviews by total elapsed time rather than just the number of days an application is on the agency's clock, a much more rigid standard.

Don’t expect the two chambers to partake in a spontaneous rendition of the spiritual song Kumbaya just because they accomplished the passage of some legislation though. As a matter of fact, shortly after this effort, the partisan rancor erupted again; this time over the House’s planned passage of a repeal of the 2.3% device tax.

Republicans on the U.S. House of Representatives' Ways & Means Committee voted to repeal the excise tax included in the Affordable Care Act on May 31. The full House is expected to take up the bill June 7 or 8. The tax is expected to raise $29 billion starting in 2013 to help pay for insurance for the uninsured.

And while the device tax repeal bill is expected to pass the full House, it faces certain defeat in the Senate, where parallel legislation introduced by Republican Senators Orrin Hatch and Scott Brown lacks bipartisan authors.

Well so much for peace, love and understanding.

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