For the past year, Margaret O'K. Glavin has been preparing for major changes at the US Food and Drug Administration's Office
of Regulatory Affairs (ORA). Glavin became ORA director in May 2005, replacing John Taylor at a time when FDA's regional and
district offices faced more responsibilities and shrinking funds. Meeting these demands will require "fundamental changes
in the way we perform our work over the next 10 years," she said in a March 2006 memo. Glavin recognizes that ORA can't inspect
all the facilities and operations under its purview and must decide which ones are most important to monitor more closely
and more frequently. This prioritization involves reorganizing ORA staff, revising policies, and adopting risk-based approaches
for modernizing the field inspection process.
At the annual meeting of the Food and Drug Law Institute (FDLI) in April, Glavin acknowledged that ORA has "always had to
contend with rising responsibilities and declining resources." In the 1970s, the field force made up half of FDA's staff.
Now it accounts for about 35%, a change that reflects a drop in real numbers since 2002.
And during this period, ORA's job has grown considerably. More drug manufacturers are building plants overseas, and almost
all bulk ingredients now are imported, Glavin explained in an interview with Pharmaceutical Technology. FDA must monitor a vast expansion of food imports and has added responsibility for combating counterfeit drugs and the spread
of bovine spongiform encephalopathy. National emergencies such as Hurricane Katrina and the specter of avian flu also have
created new demands for strengthening the front lines of FDA's inspection system. Another new challenge is to develop a compliance
program for cellular and tissue products, which involves oversight of some 1900 registered locations with no additional resources.
Many of these activities can benefit from Glavin's counterterrorism expertise. She came to FDA in 2003 to head its counterterrorism
activities, a role that exposed her to the complexities of product-safety concerns and the challenges of developing biodefense
Glavin is preparing a 10-year plan to modernize ORA through organizational changes and new approaches that target resources
to its most critical activities. This plan involves reducing ORA's inspection burden by using third-party inspection programs,
promoting global harmonization, improving information sources, and offering incentives for manufacturers to adopt internal
quality assurance programs. The aim is to shift from a periodic, reactive inspection system to more proactive approaches.
An ORA Transformation Leadership Team composed of staffers from across the organization is developing a strategic plan to
address these challenges. In September, the panel is scheduled to unveil specific goals for the next year and list the resources
needed to accomplish them. One immediate challenge is to correct staff imbalances among regions and districts that have developed
in recent years. Changes in ORA's structure "certainly are a possibility," Glavin says, noting that ORA's central region probably
is the "least well-staffed," and the Pacific region may be overpopulated. She hopes to make necessary adjustments through
voluntary reassignment, but more drastic personnel shifts may be required, a prospect that already is generating concerns
among ORA's rank and file.
Changes at the top
One of Glavin's first moves was to reorganize her administrative staff. Last year, she appointed three deputy associate commissioners
to help her handle the "enormous job" of ensuring consistent policies and procedures throughout this far-flung operation.
Management of ORA's five regional offices, 20 district offices, and 13 field laboratories now is handled by Deputy for Field
Operations Diana Kolaitis, a long-time and highly respected field leader.