FDA will be 'severely' limited by shutdown

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney) -- A government shutdown will severely restrict food and drug inspections, an official with the Food and Drug Administration warned Thursday.

"We will be pretty severely limited. We're hopeful that a resolution is reached before it comes to that," the official said.

The FDA, which is an agency within the Department of Health and Human Services, consists of nine centers and offices and employs 13,000 workers.

The official did not say how many of those employees will be furloughed by a shutdown.

In the event of a shutdown, the agency's Office of Regulatory Affairs, which oversees food inspections, won't operate at full capacity but will have some inspectors on staff.

As a result, all FDA inspections of food processing facilities and drug manufacturing plants will be prioritized by risk. That means that inspections of high-risk plants which have a history of serious safety concerns will be prioritized ahead of routine plant inspections.

In the event of an emergency situation, such as a food borne illness outbreak, the FDA will able to call furloughed staff into work.

The FDA's current effort to monitor for radiation in food products coming from Japan - and for higher radiation levels in existing food products already in the market - will not be affected by staffing changes.

However, the FDA will not be able to conduct specific inspections of drug or medical device manufacturing facilities that are required when a manufacturer files for a new product application with the agency.

The FDA's other centers, including the Center for Biologic Evaluation, Center for Veterinary Medicine, Center for Medical Devices and Radiological Health will also operate at reduced capacity.

Of the agency's nine centers, only the Center for Tobacco Products, which employs 275 workers, will remain fully staffed in the event of a shutdown. That's because it is funded by the tobacco industry. To top of page

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