Shutdown Will “Severely” Limit FDA Inspections

Apr 08, 2011   

A U.S. Food and Drug Administration (FDA) official told CNN on Thursday that a shutdown of the federal government will severely restrict FDA inspections. The FDA has announced that it will furlough 86% of its staff and that 1,962 of its approximately 13,000 staff members will continue working. All drug and device reviews and all public meets will be canceled in the event of a shutdown. Food importation inspections will continue without interruption.

The FDAs Office of Regulatory Affairs (ORA) is responsible for food inspections and will not be operating with its full staff should the shutdown occur. The ORA will have some inspectors on staff next week in the event that a resolution regarding the budget is not reached. FDA inspections of drug manufacturing facilities and food processing plants will be conducted in order of the level of risk involved. Inspections of plants and facilities that are deemed “high risk” by the agency will be inspected in lieu of routine plant inspections. Facilities that are classified as “high risk” typically have a history of violations or significant safety concerns.

When a drug or medical device manufacturer files a new product or registration with the FDA, the FDA conducts an initial inspection. These initial inspections will not be conducted in the event of a shutdown and pending applications with the FDAs Center for Biologic Evaluation, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Center for Veterinary Medicine will be subject to delayed review. All of these centers will be operating at reduced staffing levels.

Should an emergency situation, such as a food borne illness outbreak, occur during a government shutdown, the FDA will recall the furloughed staff into action. The anonymous FDA official told CNN that the agencys monitoring of food products coming from Japan for possible radiation contamination will not be affected in the event of a shutdown.

Interestingly, of the agencys nine centers, only the Center for Tobacco Products will remain fully staffed should the shutdown occur. The Center for Tobacco Products is funded by the tobacco industry and will not be affected.