The US Food and Drug Administration plans to shut down its regional offices and some additional field facilities, a move that
reflects an ever-tightening squeeze on agency funding and staff. FDA also seeks to make more efficient use of its limited
resources by establishing risk-based approaches for selecting those drug-manufacturing sites most in need of frequent oversight,
while reducing inspections for less risky facilities. More highly trained inspectors will be able to assess modern manufacturing
systems with greater efficiency, and field staff will collaborate better with reviewers in FDA Centers to understand company
quality-control systems better.
These changes in FDA inspection operations fit the agency's Pharmaceutical Quality in the 21st Century initiative, which encourages
broader industry adoption of quality-control and risk-management methods that can better ensure quality drug production and
distribution with less direct oversight by the agency. Instead of frequent, in-depth plant inspections, the goal is for FDA
to initially verify a manufacturer's process control and quality system and follow up periodically with more efficient audits,
commented FDA deputy commissioner Janet Woodcock at a March workshop on pharmaceutical quality initiatives cosponsored by
FDA, the American Association of Pharmaceutical Scientists, and the International Society for Pharmaceutical Engineering.
Under the "desired state" of pharmaceutical manufacturing, regulators will use risk-based approaches to make regulatory decisions
and further streamline the inspection process, she explained.
The reorganization of FDA's Office of Regulatory Affairs (ORA) has been in the works for several months and now is nearing
implementation. Margaret Glavin, FDA associate commissioner for regulatory affairs, described efforts to "dramatically change"
ORA in a February message to staff. Gary Dykstra, director of FDA's Southeast regional office, unveiled some of the specifics
at an industry conference in March. In addition to eliminating regional offices, ORA plans to streamline the reporting structure
of its 20 district offices to create a more efficient operation. ORA also plans to close 7 of its 13 field laboratories, a
move that has generated controversy since first announced in December 2006 (see sidebar, "Losing laboratories").
This downsizing of ORA reflects cuts in the agency's budget and staff. FDA's field force has dropped from a peak of about
4000 in 2003 to some 3400 today. Glavin emphasizes that the planned reorganization is not designed to accommodate further
personnel cuts, but unions representing agency personnel are leery of likely staff relocations and changes in responsibilities
A recent ORA report on inspections and enforcement actions in fiscal year 2006 documents the downward trend in domestic and
foreign inspections of biologic and drug-manufacturing facilities. ORA inspected 2411 drug facilities in the United States
and abroad last year, compared with more than 2600 in the three previous years. Similarly, the agency inspected 1826 facilities
producing biologics last year, down from about 2000 in previous years.
In Washington This Month
FDA's budget proposal for 2008 allots much of ORA's budget increase to food oversight, relying on prescription-drug user fees
to maintain the current level of drug-manufacturing oversight. Any additional funding for ORA is needed to handle new and
expanding assignments. ORA is charged with responding quickly to public-health emergencies such as Hurricane Katrina and the
rising number of food contamination crises. The agency also monitors a fast-rising volume of imported food and medical products
and is responsible for FDA involvement in detecting and preventing bioterrorism events. ORA's Office of Criminal Investigations
is expanding efforts to prosecute Web sites that illegally market counterfeit drugs. And, ORA is working with the Department
of Defense to build the Shelf Life Extension Program, a cooperative effort to test drugs in strategic stockpiles to determine
if product expiration dates can be extended to reduce unnecessary drug replacement. The program focuses on pharmaceuticals
important to the military that are purchased in very large quantities such as antibiotics and antivirals.