The Government Shutdown’s Impact on FDA Matters

Expert Guest Blog Entry by Seth A. MailhotLeah H. Ziemba and Cameron F. Field. Article originally posted on 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.
Reprinted with permission from Michael Best & Friedrich LLP. © 2013 Michael Best & Friedrich LLP