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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

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About this Author

Seth Mailhot, Michael Best Law Firm, Life Sciences and Agribusiness Attorney
Partner

Seth brings more than 20 years of experience in a full spectrum of U.S. Food and Drug Administration-related matters to his leadership of the firm’s FDA Regulatory practice group. Incorporating his training as a chemical engineer and experience gained while serving the FDA with a practical business approach, Seth offers clients a valuable perspective on highly technical areas of the FDA’s regulatory authority.

Prior to joining the firm, Seth worked for the U.S. Food and Drug Administration in various capacities and in key roles at several...

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Leah Hurgten Ziemba, Michael Best Law Firm, Agribusiness and Energy Attorney
Partner, Industry Group Chair

Leah takes a big-picture approach in advising clients as they face challenges on environmental, food safety, and regulatory compliance issues. She draws on experience gained in cases involving the EPA, FDA, and other public agencies.

Leah’s success as a counselor, litigator and negotiator reflects her combination of subject matter expertise, industry knowledge, and creativity. Her work includes:

  • Investigating, assessing, and remediating vapor intrusion issues at sites with historic solvent contamination

  • Providing environmental liability assessments and risk management during transactional due diligence

  • Implementing the Food Safety Modernization Act and advising on food labeling matters (e.g., “natural” claims, standards of identity)

  • Navigating local, county, and state environmental regulations to permit and build or expand manufacturing facilities and commercial dairy operations

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Cameron F. Field, transactional practice attorney, Michael Best, law firm
Associate

Cameron brings a broad focus to his work advocating for clients in the agribusiness, food and beverage, and energy industries. He assists clients in navigating the state and federal regulatory process and evaluating strategic business decisions. Clients rely on Cameron for well-informed counsel on water and air permitting matters, as well as on hazardous waste reporting and liability questions. 

For example, Cameron advises on risk factors involved in the purchase, sale, and cleanup of contaminated properties. Relying on his...

608-283-2259