Regulatory Focus™ > News Articles > Report Claims Staffing Problems Continue to Plague FDA

Report Claims Staffing Problems Continue to Plague FDA

Posted 20 November 2012 | By Alexander Gaffney, RAC

The reputation of a federal agency often precedes it. For the US Food and Drug Administration (FDA), the public's perception of its reputation is proving to be a significant impediment to its attempts to recruit the best regulatory staff it can get, says a new report from the Partnership for Public Service (PPS).

The group acts as a sort of advocacy group for those working in, or hoping to work in, the government. PPS said it had recently been approached by the Pew Charitable Trusts to follow up on a landmark report published by FDA's Science Board that found the agency's scientific and technical capabilities to be insufficient to meet its growing needs.

FDA Science and Mission at Risk, published in 2007, found three main deficiencies at FDA: Its scientific base was weak and eroding; FDA had insufficient regulatory capacity or capability to accomplish its mission; and the agency's information technology infrastructure was inadequate to accomplish its mission.

That same report said that FDA regulators were in something of a firefighting posture-unable to keep up with scientific advancements happening all around them, they were stuck being reactive to innovations and scrambling to stretch meager resources to meet ever-increasing needs.

FDA announced in August that it, too, is preparing to revisit the report by establishing a new subcommittee of its Science Board specifically tailored to investigate its progress. The Board is currently seeking new members.

But even as FDA prepares to undertake the new task, PPS's report, "The State of the FDA Workforce," raised troubling new questions regarding how far FDA has managed to come since 2007.

"From our review, we discovered that the FDA has made progress since the Science Board issued its findings, including taking steps to expand its workforce," PPS explained in its report. "But we also found that the FDA continues to have significant workforce and management challenges in the scientific and medical arenas that need to be addressed for the agency to fulfill its public health obligations to the American public and its responsibilities to the industries it regulates."

The good news, for FDA, is that its efforts to recruit new staff have borne fruit. Hiring of permanent and temporary staff is up nearly three-fold relative to 2007 (817 total hires in 2007 to 2,221 in 2010)-a trend likely to increase now that FDA has received new resources under the FDA Safety and Innovation Act (FDASIA), PPS noted. The total expansion in staff totaled 3,552-a rise of 31.5%, PPS notes.

"The hiring surge gave FDA a needed infusion of manpower," PPS noted. Unfortunately, it also created new human resource and leadership issues which were made more problematic by the substantial new authorities thrust onto the agency by legislators, most notably increased inspections of global manufacturing facilities and the regulation of tobacco products.

In short: More staff, but considerably more responsibilities as well.

PPS explained that FDA is working to balance those responsibilities with intellectual growth, and has taken steps to bring in experts to brief staff on new technologies, started a new fellows program and training program, and instituted a peer-review program to identify promising staff and new planning measures aimed at strengthening its management of staff.

But the agency's progress has been tempered by-of all things-its reputation. The agency has been faced with a number of high-profile and embarrassing scandals over the last decade, including some initiated by staff who said their concerns were disregarded to the detriment of public safety.

Human resource problems, too, feature prominently in PPS' assessment of FDA.

"FDA officials said their effort to recruit and hire top talent had been impeded by the poor quality of the human resources services provided by a centralized HR staff at FDA's parent agency, the Department of Health and Human Services (DHHS)," PPS explained. Though such authority has since been returned to FDA (as of February 2012), the agency still has a long way to go if it is to rebuild its human resource capabilities, PPS said.

The report goes on to make five main recommendations to FDA:

  • "FDA needs to develop targeted recruitment programs and talent pipelines for high-priority scientific and medical disciplines, speed up the hiring process, recruit executives from outside the FDA to bring fresh perspectives to the organization, and ensure that subject matter experts, not just HR staff, are meaningfully involved in the assessment of job applicants for critical STEMM leadership and project management positions."
  • FDA needs to make sure each of its centers has its own workforce plan which it "owns" and is held accountable to.
  • FDA's human resource managers must assist in identifying competency gaps and work to close them.
  • Employees must be given better-defined career paths to allow them to understand how they can move up within the agency and what professional growth opportunities are available to them.
  • FDA must develop strategies on replacing employees to ensure that no gaps occur when or if a mission-critical staff member departs. The agency must also address high rates of attrition, particularly among pharmacists and consumer safety officers.


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