FDA Seeks Streamlined, More Effective GMP Inspections

Fewer field offices and inspectors will increase reliance on manufacturers to ensure product and process quality.
May 02, 2007
Volume 31, Issue 5

Jill Wechsler
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.

Streamlining ORA

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 and authority.

In Washington This Month
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.

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.

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