What the Shutdown Means for Food and Drug Oversight

Contact: Josh Wenderoff, jwenderoff@pewtrusts.org, 202.540.6542

Washington , DC - 10/09/2013 - With Congress unable to reach agreement on funding the day-to-day operations of the federal government by Oct. 1, more than 800,000 federal workers have been furloughed and many government activities have ceased.

The following Q&A—prepared by the food and medical products programs at The Pew Charitable Trusts–helps explain how the shutdown is affecting the U.S. Food and Drug Administration and other agencies and departments with responsibility to protect the public’s health.

Q. How many employees are staying on at the Food and Drug Administration during the shutdown?

A. As of Oct. 1, the Department of Health and Human Services says that FDA has retained about 55 percent of its staff—8,180 of its 14,779 employees. By comparison, the department as a whole is retaining 48 percent of its staff, and the Centers for Disease Control and Prevention, or CDC, is retaining 32 percent of its staff.

Q. How will the shutdown affect food safety?

A.FDA regulates about 80 percent of the food we eat—produced domestically and abroad—including fresh produce, seafood, and processed foods such as peanut butter and pasta. FDA food safety inspectors visit food plants infrequently under normal circumstances, but, as a result of the shutdown, the percentage of even those routine inspections is zero.

According to Department of Health and Human Services’ contingency plan, the agency will continue to inspect facilities as part of any investigation into the outbreak of foodborne illnesses, yet the CDC has furloughed workers who help FDA identify and respond to outbreaks of illness. Furthermore, the CDC has stopped providing support to state and local health agencies that also help monitor infectious diseases, including those spread by contaminated food. On October 8, the CDC announced that more than two dozen employees would return to work to help investigate an outbreak of salmonella infections associated with chicken.

Q.How will the shutdown affect drug safety and innovation?

A. FDA also conducts routine proactive inspections of drug and medical device manufacturers—including pharmacy compounders, which prepare customized medicines for individual patients—as well as for-cause inspections to address identified safety problems when they arise. Under the shutdown, FDA will conduct only the latter in response to adverse events and product recalls. Capacity to identify such incidents is further limited by furloughs at the CDC.

To support drug and medical device innovation during the shutdown, FDA is relying on industry user fees collected in the previous calendar year to fund review of new product applications that had been submitted to the agency before the shutdown.  These activities will cease when existing funds are spent. FDA cannot collect new user fees during the shutdown, meaning it also cannot accept the great majority of new drug or device applications from industry.

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