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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.

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About this Author

Seth Mailhot, Michael Best Friedrich, FDA regulatory attorney, transactional administration lawyer, national organic program legal counsel, human services law
Partner

Seth Mailhot leads the FDA Regulatory practice and is a member of the firm’s Transactional Practice Group.

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 has counseled 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...

202-747-9566
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

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

Cameron Field is an attorney in the Transactional Group. He focuses his practice on advocating for clients navigating the state and federal regulatory process. He assists clients with water, waste, and air permitting matters, and provides support for clients facing hazardous waste reporting and liability questions. Mr. Field is a graduate of Vermont Law School, where he received a Masters of Environmental Law and Policy as well as a Juris Doctorate.

608-283-2259