Margaret O'K. Glavin became the director of FDA's Office of Regulatory Affairs (ORA) in May 2005 and now faces a serious challenge:
finding ways to manage expanding oversight responsibilities in the US and abroad for ORA's regional and district inspection
teams despite shrinking resources. Glavin recognizes that ORA cannot inspect all the facilities and operations under its purview
and has to determine which ones are most vital to monitor more closely with increased frequency. This determination involves
reorganizing the ORA staff, revising policies, and adopting risk-based approaches for "transforming" the field inspection
Since the 1970s, FDA's field force has shrunk from half of the agency's staff to about 35 percent today. And also during this
period, ORA's job has grown considerably. Pharmaceutical and biotech manufacturers are adopting more complex production processes
and building more plants overseas, Glavin explained in an interview with BioPharm International. ORA has to monitor a vast expansion of food imports and has the added responsibility of combating counterfeit drugs and
the spread of bovine spongiform encephalopathy (BSE). One new assignment is to develop a compliance program for cellular and
tissue products, which involves oversight of some 1,900 registered locations with no additional resources. And national emergencies
such as Hurricane Katrina and the specter of avian flu have created new demands for strengthening FDA front line defenses.
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 involves utilizing third-party inspection programs, promoting global harmonization,
improving information sources, and offering incentives for manufacturers to adopt internal quality assurance programs. The
plan's goal is to shift from a periodic, reactive inspection system to more proactive approaches.
An ORA Transformation Leadership Team composed of staffers within the organization plans to unveil a strategic plan in September
2006 to address these challenges. An immediate task 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," while the Pacific region may be over-populated. The prospect of personnel shifts is already generating
concerns among ORA's rank and file.
One of Glavin's initial moves has been to reorganize her top administrators. Last year, she appointed three deputy associate
commissioners to help ensure 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.
Steven Niedelman, deputy for regulatory operations and chief operating officer, oversees regulatory policy implementation
at the national level. ORA's Office of Enforcement, Office of Criminal Investigations, and Office of Regional Operations report
to him. Regional Operations, under Deborah Ralston, coordinates field inspections in the US and overseas with FDA centers
and manages Team Biologics, the specially trained cadre of national investigators established in 1997 to conduct routine inspections
of biological manufacturers. Ralston also handles FDA interaction with state inspection programs, with US Customs officials,
with foreign regulatory authorities, and with emergency preparedness organizations.
New to ORA is David Horowitz, deputy for compliance policy, who is spearheading efforts to implement risk-based approaches
for ORA activities. Horowitz led similar efforts as the former head of the Office of Compliance in the Center for Drug Evaluation
and Research (CDER), and now is extending these initiatives to medical devices, veterinary drugs, and other regulated products.
CDER compliance officials have set the pace by devising a risk model for selecting sites for GMP inspections based on a range
of risk factors: plant size and compliance history; product characteristics (sterile parenterals vs. dentifrices); complexity
and contamination potential of manufacturing process; and time lapsed since last inspection. This approach is also being
applied to FDA oversight of manufacturer adverse-event-reporting programs and to drug product sample analysis.