FDA User Fee Bill Could Pass This Summer

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The long and winding road for the FDA’s user fee bill may finally be reaching its destination on Capitol Hill. In a rare display of bipartisanship, the smart money is on the bill being sent to the full House of Representatives next month after more than a year of twists and turns.

The good new for medical device firms: It appears an amendment that would let the FDA nix applications based on similarity to recalled, defective medical devices won’t be in the final bill. That’s a disappointment to some consumer groups, and the amendment’s sponsor, Rep. Ed Markey, Democrat from Massachusetts.

Looming over the bill and healthcare-land in general is an expected June Supreme Court ruling on President Obama’s national healthcare program.  However that ruling goes, it could re-politicize the healthcare debate and knock the FDA user fee bill off the tracks unless it gets passed before the ruling.

The bill as currently written would let the FDA collect user fees from medical device, pharmaceutical, and biologics manufacturers to help fund the agency’s approval and monitoring work.

The Senate is expected to take up its own, similar, version of the bill next week.

Based on the relatively smooth mark-up, or review, of the bill, most insiders expect it to emerge in pretty much its current form and become the law of the land quite soon.

Watch this space in the coming weeks and months. We’ve had a bit of a respite from partisanship, but it’s election season in D.C. and anyone who expects this relative harmony to continue is as naive as a Washington Redskins fan expecting the team to win a Super Bowl anytime soon.

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FDA User Fee Bill Could Pass This Summer
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FDA User Fee Bill Could Pass This Summer
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The long and winding road for the FDA’s user fee bill may finally be reaching its destination on Capitol Hill. In a rare display of bipartisanship, the smart money is on the bill being sent to the full House of Representatives next month after more than a year of twists and turns.
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