The FDA has been under fire ever since I started writing this blog about 3 years ago, and 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 tank, the Center for Health Transformation, as an adviser.  It was only 2 years ago I was posting articles like this, from Jacob Olcott of the House Homeland Security Subcommittee on Emerging Threats, Cyber Security, and Science and Technology. (Thursday, April 10, 2008)

Congress to industry: 'We need your help' 

which was followed by this:

FDA Head: We're Boosting I.T.

Study Calling For Medical Device Information To Better Serve Patients And Doctors from the FDA

“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 grow, those in responsible positions could certainly benefit with some technology updates, at 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 someday, depending 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 do, I might guess that when it comes to medical device software there might need to be some beefing up in that department as well, perhaps some programmers who can do more than just test, but dig in and get a better physicist’s opinion as that’s who’s taking care of the MRIs, CT 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 either, they 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 stuff, called 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 quarter, to $4.03 billion, to renovate its medical device, food safety and tobacco use prevention programs, the agency announced this week. 
As set out in President Obama's 2011 budget proposal, the new plan calls for a 23 percent increase of the agency's current budget of $3.28 billion.
The request, which covers the 2011 federal fiscal year beginning October 1st, 2010, will help pay the salaries of more than 1,000 new workers, raising the number of employees at the agency to 13,586.

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

DOTmed.com - FDA Wants $4 Billion to Overhaul Medical Device, Food Safety Monitoring

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