I have done my share as have most bloggers about what has happened at the FDA, but long and short of it, is we had a little bit of a lack of keeping up with technology. Last year they were blasted by Congress for not even asking for more money over the past 2 years, so again it’s a bit of the old mind set here with not wanting or maybe accepting “change” all the way around. In the post below, I somewhat made some observations in my travels all over healthcare.
When I found out through reading on the web last year that many clinical studies were still being written on paper, I asked this:
And then I read this…
“Some of our members don’t even use computers,” Olcott said. “They have some discomfort talking about technology.” ...so if this happens at the top levels...I do ask myself...where does this leave me? They have staff that writes the legislation...so who's really in control here...do we need to lobby the staff instead? What impact does this have on electronic medical records? What does this do for HIPAA? ...some questions kicking around in my head..who is in charge?
So we had the FDA still writing studies in longhand on paper and members of Congress that felt uncomfortable about talking about technology! So that pretty much explains how we go to where we are today.
I still think that bank of servers for the FDA in Washington would be helpful to have manufacturers of drugs and food products report in before packaging and shipping products, would help the FDA better allow their employees time too as if they try to do enforcement and inspections without some business intelligence and who to see and where to go, it will be a mess. BD
Government Accuses Georgia Plant of Knowingly Shipping Bad Peanut Butter – How about some FDA electronic audit trails on consumables?
Under Obama’s proposed budget, the FDA would receive an additional $1 billion to “increase and improve inspections, domestic surveillance, laboratory capacity and domestic response to prevent and control food-borne illness.” The increased funding is directed to the precise areas of the FDA that have been roundly criticized in the recent outbreaks.
In additional to increasing funding for FDA food inspection efforts, Obama also proposes hiking the funding for FDA reviews of new drugs, treatments, and head-to-head trials of drugs. Under the proposed budget, the FDA would get $1.1 billion to pay for the increased review of proposed drugs. There has been a call by many consumers to increase the use of cheaper, generic drugs, which have been shown to work just as well, if not better, than costlier brand-name and patented drugs.