Does the FDA Need New PM's??

I came across a segment on ABC called "The Fight to Make Food Safer". The segment, noted below, indicated that "each year, nearly 5,000 Americans die from food poisoning, and that 1 in 4 become ill from eating contaminated foods." The segment went on to discuss what was being done to help solve these problems but the one thing that stuck out, was the reason for why there was an increase in these issues.

They said that the FDA "doesn't have the staff or resources to keep up".

Wait a minute... did I hear that correctly!?!?!! Who's managing this ship?

Based off of that statement can I conclude that the reason spinach was contaminated with E. Coli or that the reason why jalapenos or peanuts were contaminated with salmonella, is because there just weren't enough resources at the FDA? The segment indicated that the FDA is in charge of 80% of the food supply. When you're in control of such a large chunk of the pie, I sure would hate resource constraints to be the reason why Americans are being impacted.

I realize that there's more to this then just resource issues but as a PM, I can't help but think of all the other aspects of project management that just don't seem to be applied in this situation. Things like...

• Resource plans
• Regulation and Compliance
• SLAs
• Risk Mitigation
• Testing, Testing, Testing
• Reviews, Sign offs
• Ownership & Accountability

It would be extremely juvenile for me to think that the FDA doesn't already have the items listed above and even more in place to run their daily operations. I went down the path of applying this very scenario to the technical projects that I run. If I had a resource constraint, I think the first question I'd have to answer was, "what did I originally plan for?" And if it wasn't in my original plan then I'd have to figure out a way to get more bodies. I'd have to re-evaluate the budget and determine if I wanted to compromise quality over quantity or vice versa. I'd have to see what items in my budget and scope were small enough to move to another phase or even cut out. I'd have to negotiate with stakeholders. In the end, I'd have to figure out ways to mitigate the risk of not having enough people to carry out the project. And if the end result was something as severe enough as impacting people's lives, I'd hope that some type of compliance or regulatory factor would intervene before it was too late.

Well, for the FDA, the American people are the stakeholders and we have to ask ourselves, is a little E.Coli in our spinach acceptable, simply because the FDA doesn't have enough resources? OR are the new salmonella flavored peanuts something we're willing to make peanut butter out of? I'd bet that most of us would say, "heck no!"

The FDA is not a fly by night organization; in fact, I did a little research of my own and found these interesting numbers. "The FDA's federal budget request for fiscal year (FY) 2008 (October 2007 through September 2008) totaled $2.1 billion, a $105.8 million increase from what it received for fiscal year 2007.[5] In February 2008, the FDA announced that the Bush Administration's FY 2009 budget request for the agency was just under $2.4 billion: $1.77 billion in budget authority (federal funding) and $628 million in user fees. The requested budget authority was an increase of $50.7 million more than the FY 2008 funding - about a three percent increase. In June 2008, Congress gave the agency an emergency appropriation of $150 million for FY 2008 and another $150 million for FY 2009.[4]" (http://en.wikipedia.org/wiki/FDA).

This sure seems like a lot of money, especially to later publicly announce that the reason for E.Coli and salmonella contamination is resource constraints. I'd like to understand how these budgets are managed or more importantly who's managing these budgets? What is the process for planning the budget requests? Who's putting together the resource plans and risk mitigation? What is the plan for how the funds are allocated once received?

Hmmm….is it time that the FDA hire some new Project Managers?? I think so, and it seems that I'm no the only one bothered by this atrocity. :) Early this year, President Obama appointed a new “PM” for the FDA, Dr. Margaret Hamburg.

So what’s up Doc? Are we, the stakeholders of the FDA, gonna see some process improvements in the near future?

Sources:

1. ABC News Segment: http://abclocal.go.com/wls/story?section=news/health&id=6861316
2. FDA Scope and Funding: http://en.wikipedia.org/wiki/FDA
3. Article: http://en.wikinews.org/wiki/Obama_calls_food_safety_system_a_%27hazard_to_public_health%27