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Patrick Stone

FDA Compliance

Is the FDA Better Off Than It Was Five Years Ago?

Many needed improvements are too logical for government comprehension

Published: Thursday, September 6, 2012 - 12:59

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

Is the Food and Drug administration (FDA) better off than it was four or five years ago?

Another full year has passed with the FDA’s continuing resolutions, however, there’s no clear budget, which makes it four or five years in a row. The FDA did get a budget boost for fiscal year 2011, but that will change with this year’s planned lower amount.

How has the FDA done this year with respect to inspections in all program areas? Does it really deserve lower funds for conducting fewer inspections? The 2011 FDA metrics show the number of inspection going down annually 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 the FDA will always be top heavy; that seems to be inevitable in any government agency. We will have to wait until January 2013 or so to get the final count of inspections completed by the 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 the journeyman grade of GS-12, so they can’t 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 realistic output we’ll see from the FDA will be lower inspection numbers and more staff turnover. Many new hires have come to me after leaving the 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 the FDA would be much better. Supervisors are doing many other tasks, including their bosses’ work, which takes them away from their core duties. The FDA is also using way too many funds for building new offices overseas. These new offices are for managers and administrators, but not inspection staff. 

There is also a need to update and streamline computer software and hardware at the FDA that is way behind the technology widely used in the very 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.

The FDA can do a better job with the right internal focus, but its current shotgun approach to reacting after a problem occurs is giving us more of what we are already getting: inefficient enforcement lacking a strong overarching strategy.

The FDA needs certainty from policymakers and a fiscal balance that hasn’t been seen in more than five years.

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

This article first appeared in the Sept. 4, 2012, edition of the AssurX blog.

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About The Author

Patrick Stone’s picture

Patrick Stone

Patrick Stone works toward a future where disease cures and prevention are the main goal of all new test articles. Stone is president and lead consultant at TradeStone QA LLC, which serves the global public by protecting the supply and quality of healthcare products before entering the market place. Stone specializes in Institutional Review Board (IRB) compliance and quality assurance audits; computer system validation and 21 CFR Part 11 compliance; LIMS/data management system compliance; and 21 CFR, GCP, cGMP, and ICH compliance. Stone is the author of Bubble Gum Badge—An FDA His-Story (Xlibris Corp., 2011). You can follow Stone on Twitter.