It’s not just whether to buy more weapons or deliver healthcare to every American. The $610 million deal between medical device companies and the FDA over the user fees paid for product reviews could also fall victim to Congress’ bickering over the federal budget, as Medical Design Technology reported this week.
What’s at stake is the federal watchdog agency's budget, and if it goes down, there go the product reviews for devices and drugs, resulting in a potentially endless wait for approval, according to Bloomberg BusinessWeek, as posted at mdtmag.com.
The U.S. Senate last year passed a bill that will reauthorize the FDA's medical device user fee program, allowing the agency to collect an additional $308 million over five years to fund its regulatory activities and to take steps to modernize its review and approval processes.
The General Accounting Office criticized the way the FDA approves medical devices in 2011 and as a result, the Institute of Medicine called for an overhaul of the whole process.
The FDA has been under attack for some time. Ninety percent of the medical devices cleared by the FDA are currently reviewed under a process where medical devices that are “substantially equivalent” to previous devices are exempt from the lengthy safety reviews required of new medical devices, regardless of the potential for harm or injury to those who use it.
According to a story published in the Archives of Internal Medicine, a disproportionate number of the medical devices that have caused health problems and patient deaths — like malfunctioning defibrillators and faulty insulin infusion pumps — have been approved through this process.
Legislation introduced in February, H.R. 3847, asks that lawmakers finally stop pushing through medical devices for approval by requiring that even revisions of failed products must go through the process again, according to a story by Eric Wicklund.
But back to the budget. The FDA can't “spend a dime of the user fee money until it receives trigger funding from Congress,” mdtmag.com said an FDA spokeswoman told Bloomberg BusinessWeek.
With Democrats and Republicans at loggerheads over a proposed $1.2 trillion in budget cuts over the next decade, the logjam “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.
Edited by
Rachel Ramsey
