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.
"Even without sequestration, FDA’s workload and statutory responsibilities have grown far faster than its budget," the spokeswoman told BusinessWeek.
In March, the White House OK’d the latest iteration of the Medical Device User Fee & Modernization Act, more than doubling the fees medical device companies pay to have their products reviewed, from $295 million to an estimated $609 million over 5 years. That amounts to about 35% of the entire budget for the FDA’s Center for Devices & Radiological Health, according to the news service.
Industry stakeholders and FDA representatives brokered the deal, which also calls for the FDA to meet a slate of performance goals.