Is the FDA better off than it was 5 years ago?

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Patrick Stone, President, TradeStone QA

Ronald Reagan famously asked Americans if they were better off four years ago during a debate with then-President Jimmy Carter. It worked for Reagan, so we’re going to try a variation of it here.

Is the FDA better off than it was four or five years ago?

Another full year of continuing resolutions with no clear budget has passed FDA by and that makes like 4 or 5 in a row. The FDA did get a budget boost for fiscal year 2011 but that will change with this year’s lower planned amount.

How has FDA done this year with respect to inspections in all program areas? Does FDA really deserve lower funds for conducting fewer inspections? The 2011 FDA metrics show the number of inspection going down per year across the board. This lower trend is continuing to drop even as the FDA has more worker bees on staff.

Well, the management side of FDA will always be top heavy, that seems to be inevitable in any government agency. We will have to wait until January or so to get the final count of inspections completed by FDA this year. But until then, it is already clear that many of the new hires from 2008-2009 are feeling the pay freeze crunch and are stuck below journeyman grade of GS-12 so they can not conduct international inspections when they should be.

They are not performing up to standard according to their supervisors and handlers. Working conditions like these breed low morale and sap production.  Despite what some might think, FDA employees are humans and they are like the rest of us: They are motivated by duty, honor, and a stable household income. I should know, I’ve worked with many at the FDA.

But in my humble opinion these newbies need to be given their step increases and trained less on the job and more in the training room. Don’t throw them out in the field without enough preparation.

All the ingredients for failure are in the mix with little success to sprinkle in. The only output from FDA will be lower inspection numbers and more staff turn over. Many new hires have come to me after leaving FDA asking for help starting a small business and I have answered their call.

If FDA supervisors could focus on facilitating inspection reports and employee retention, life at FDA would be much better. Supervisors are doing many other tasks that take away from their core duties as in doing their bosses work. FDA is also using way too many funds on building new offices overseas with little to no space in those offices for inspectors.

These new offices are for managers and administrators, but not inspection staff. The FY13 budget from FDA was paired down to cut out more funds for this type of allocation.

There is also a need to update and streamline computer software and hardware at FDA that is way behind the technology widely used in the industries the FDA regulates. The focus should be on getting investigators the tools necessary for the tasks assigned, but that may be too logical for government comprehension.

FDA can do a better job with the right internal focus but the shotgun approach to reacting after a problem is simply going to give us more of what we are already getting: Inefficient enforcement lacking a strong overarching strategy.

The FDA needs certainty from policy makers and fiscal balance that has not been seen in more than five years.

I hope we don’t ask this same question five years later only to find the situation has continued to deteriorate. The public health deserves better.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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Is the FDA better off than it was 5 years ago?
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Is the FDA better off than it was 5 years ago?
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Ronald Reagan famously asked Americans if they were better off four years ago during a debate with then-President Jimmy Carter. It worked for Reagan, so we’re going to try a variation of it here.
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