News for Life Science Professionals:

FDA Crisis: An Attrition of Brain Power
by Marci Crane



If people are an organization's greatest asset, the FDA's current "people status" is one of serious attrition.

Life science industries on the other hand are being credited with a significant need for new people, new brain power and the money to buy it. What will the impact of these changes be? Probably significant. After all, the FDA wields a power that affects the health, well being--and let's face it--the mortality of millions of Americans, and so do the life science industries.

While one organization stands to lose will the others gain?

"FDA's leadership is scrambling to recruit a new generation of food and drug regulators, as the average age of FDA's 10,100-person work force reaches 54. Thirty percent of the agency's regular staff is already eligible to retire and FDA expects to hire 600 staffers by October to replace those leaving."

Why the Attrition?
Like most queries this question requires multiple answers. One of these answers lies somewhere in the hands of baby boomers. Baby boomers have and will continue to have the power to shake up the economy in more ways than one but who would have thought they'd have such an impact on the FDA?

According to www.usatoday.com however baby boomers do have their affect on the governmental agency. The USA Today online news piece states the following:

"FDA's leadership is scrambling to recruit a new generation of food and drug regulators, as the average age of FDA's 10,100-person work force reaches 54. Thirty percent of the agency's regular staff is already eligible to retire and FDA expects to hire 600 staffers by October to replace those leaving."1

In addition to the FDA's baby-boomer evolution there are other attrition factors which may present additional difficulties. FDA timelines for example are currently mandated by the PDUFA (Prescription Drug User Fee Act) and MDUFMA (Medical Device User Fee and Modernization Act) and result in additional data requirements and less review time leaving many FDA employees overworked and underpaid.

FDA staffing issues also contribute to the attrition:

Perone states: "FDA's staffing pains - exacerbated by the departure of baby boomers and increasing competition for science graduates - has caught the attention of lawmakers and consumers, who blame declining inspections for a string of problems with tainted food and drugs." (emphasis added)

Reasons for attrition do not end at staffing pains however. The increased demand for science graduates also contributes toward attrition by creating a sellers market for new and experienced scientists. Many times, industry will intentionally court FDA scientists knowing that the high work load, lower pay and "politics" of the agency will work in their favor. Current FDA employees are also tempted to scope out new employment options and significant pay increase by considering industry opportunities.

With all these tendencies toward attrition how hard will it be for the FDA to hire dedicated and long-term employees who will be satisfied with their newly proffered positions? Only time will tell.

What's Left?
There are other contributors to the rate of FDA employee attrition and some of them must to be chalked up as internal issues. The Perrone article, for instance, poses the FDA culture as a major deterrent to employee commitment and states the following:

"Staffers who disagree with management are reportedly discouraged from speaking up, according to [the] Institutes of Medicine report on FDA's drug safety system."

In regard to the drug companies, it would seem they are doing a famous job of attracting brilliant candidates who were once a part of the FDA circle. This subtraction and addition game may greatly influence the faster development of pipelined compounds, although the timely approval of the same remains questionable as FDA says au revoir to some of their most experienced employees.

A Silver Lining
Though this story seems dim there is a silver lining. In an article published by The RPMReport.com Kate Rawson states the following:

"Indeed, OND [Office of New Drugs] is on a virtual hiring frenzy to bulk up long-understaffed review divisions...the Center for Drugs Evaluation & Research will hire 663 employees [A good portion of these positions have actually already been filled but many remain]-helped in large part by new money into FDA, as well as CDER director Janet Woodcock's successful efforts to gain direct-hiring procedures from HHS.

"...at 108 employees, new hires into the Office of New Drugs have far outstripped any other CDER office...Plus, most of the hiring is within the divisions themselves, with few, if any, additions at the immediate office level. That means more division-level medical reviewers, and more time spent on new drug applications."

So even though FDA attrition has loomed like a rampant disease (heaven forbid) the "gain of brains" in the pharmaceutical sector and the "new money" and "more time spent on new drug applications" in the FDA should leave drug companies and the FDA with the option of looking on the bright side.

References
1 Drug companies drain scientific brains from FDA http://www.usatoday.com/tech/science/2008-06-03-drug-companies-fda_N.htm
2 CDER Hiring Frenzy: More Reviewers Means Faster Reviews http://therpmreport.com/Free/firsttake.aspx

Marci Crane is a marketing communication specialist at MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies (www.mastercontrol.com).


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