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FDA Asking for $4 Billion to Overhaul Medical Device and Food Safety Monitoring – Give It To Them

Posted Feb 05 2010 8:58pm

The FDA has been under fire ever since I started writing this blog about 3 years agoand when under our former administration there was not a lot they could do as the form head of the FDA Andrew von Eschenbach was  not in line with technology and the pace it is moving at today  Actually he was grilled by Congress at one point as to why he “didn’t” ask for more funds.  Now Mr. von Eschenbach has joined Newt Gingrich’s health think tankthe Center for Health Transformationas an adviser.  It was only 2 years ago I was posting articles like thisfrom Jacob Olcott of the House Homeland Security Subcommittee on Emerging ThreatsCyber Securityand Science and Technology. (ThursdayApril 102008)

“On a prior post it was noted that the FDA needs some new technology...as the article states that key employees were still writing these things out in longhand...on paper...as technology continues to growthose in responsible positions could certainly benefit with some technology updatesat least with hardware for a start...”

“Hello Intel...anybody listening...maybe Craig Barrett...could we get some Classmates over there to help out?  BD”

So in a couple of years they have had to really pick up the pace quickly and I’m sure all key employees have computers today as that is hardly an option any where you work.   The old familiar dividing lines of which agency will cover what is also changing and collaboration between various government departments is needed too.  Your cell phone somedaydepending on what medical information it collects and delivers may need to be approved by the FDA.  I still think they are overlooking some areas in technology where they could advance rapidly too.

Being software is the king pen today with algorithmic formulas running some part of everything we doI might guess that when it comes to medical device software there might need to be some beefing up in that department as wellperhaps some programmers who can do more than just testbut dig in and get a better physicist’s opinion as that’s who’s taking care of the MRIsCT scanners and so on.  As software gets more complex we may need physicist opinions in more than this area too.  Granted too there is travel and you can’t bring every MRI to Washington for approval eitherthey don’t a lot of moving around for one. 

Bottom line is that software applications and how they work with devices to include new biometric type drug delivery systems is a new big area of focus that you can’t over look as people die from some of this stuffcalled recalls for one example.  They are pressured and lobbied a bit too with VC funded companies with a short string of financing too so that is another area to deal with too.  They also have the overseas offices to administrate too and that has basically just begun.  BD 

The U.S. Food and Drug Administration sought to increase its operating budget by nearly a quarterto $4.03 billionto renovate its medical devicefood safety and tobacco use prevention programsthe agency announced this week. 
As set out in President Obama's 2011 budget proposalthe new plan calls for a 23 percent increase of the agency's current budget of $3.28 billion.
The requestwhich covers the 2011 federal fiscal year beginning October 1st2010will help pay the salaries of more than 1,000 new workersraising the number of employees at the agency to 13,586.

Currentlythe FDA swells its budget with nearly a billion dollars in fees it levies from drug and tobacco companies.
But under proposed lawsthe FDA would also get close to $289 million dollars from fees collected from food companies and firms making specialized generic biotech products.

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