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April 20, 2014

The Government Shutdown’s Impact on Food & Drug Administration (FDA) Matters

Today, October 1, 2013 marks the beginning of a government’s shutdown for an indefinite period of time. The Food & Drug Administration (FDA) will furlough forty-five percent of its employees on Tuesday, October 2, 2013 as it enacts its contingency plan for the government shutdown. In a document released last week, the Department of Health and Human Services (HHS) broadly outlined its methodology determining which FDA employees and services will be retained or furloughed during the shutdown.

What we know:

  • The FDA will retain employees who perform duties that are not affected by the lapse in funding, all presidential appointees, and those positions that are “related to the safety of human life.” Although the agency has not disclosed specific details, HHS has stated that the FDA will continue “limited” programs that are funded by industry fees.

  • The agency will retain 587 staff to inspect products and review imports, and an additional staff of 120 to handle emergencies and high-risk recalls. These programs will continue in some capacity because they are “related to the safety of human life.”

  • The majority of the FDA’s food safety, nutrition, and cosmetics activities will be suspended.

  • The drug review process is likely to slow as the majority of laboratory research will be halted.

  • There will also be far fewer routine establishment inspections, enforcement activities, and notification programs.

While the exact impacts of the government shutdown on FDA programs remains unclear, the food and drug industry should expect significant delays and confusion as the agency implements its shutdown contingency plan.

© MICHAEL BEST & FRIEDRICH LLP

About the Author

Member

Seth Mailhot leads the FDA Regulatory practice, and is a member of the firm’s Transactional Practice Group in the Washington, D.C. office. Mr. Mailhot has worked on FDA-related matters for over 20 years, starting in various technical and enforcement positions at the U.S. Food and Drug Administration. Since entering private practice, Mr. Mailhot counsels clients on all aspects of regulation by FDA, as well as related matters regulated by USDA and Department of Health and Human Services (such as the requirements of the National Organic Program, and compliance with the Health...

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About the Author

Leah Hurtgen Ziemba Associate Michael Best and Friedrich
Associate

Leah Hurtgen Ziemba is an associate in the Madison office of Michael Best and a member of the Energy and Sustainability Industry Group and Agribusiness, Food Processing and Distribution Group.

608-283-4420
Cameron F. Field, transactional practice attorney, Michael Best, law firm
Attorney

Cameron Field is an attorney in the Madison office and a member of the firm’s Transactional Practice Group.

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