Medical devices: FDA's user fee deal is on the rocks

Mon, 09/10/2012 - 11:41am
Mass Device

The $610 million deal between medical device companies and the FDA over the user fees paid for product reviews could be in danger as Congress bickers over the federal budget.


The $610 million deal between the FDA and the medical device industry is in jeopardy as Congress dithers over the federal watchdog agency's budget, meaning that product reviews for devices and drugs could slow or even grind to a halt, according to Bloomberg BusinessWeek.

That's because the FDA can't spend a dime of the user fee money until it receives trigger funding from Congress, an FDA spokeswoman told the news service. With Democrats and Republicans perpetually at odds on Capitol Hill, this time over a proposed $1.2 trillion in budget cuts over the next decade, that all-too-familiar Beltway stasis "could result in the loss of whole user fee programs, programs that have become essential to public health and medical product innovation," the spokeswoman wrote in an e-mail.

If Congress fails to act, a series of automatic budget cuts will go into effect across the federal government, resulting in $1.2 trillion in cuts through 2021. Economists say that the so-called "sequestration" represents a "fiscal cliff" that could halt the economic recovery and push the U.S back into recession.


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