Shutdown Impact: Who Will Work, Who Won’t at Health Agencies

January 2, 2019

The looming partial government shutdown means the Food and Drug Administration (FDA) will stop routine drug plant inspections and most policy and regulatory work, and other federal health employees will be sidelined as well.

A fight over funding for President Donald Trump’s proposed border wall between the U.S. and Mexico has created a stalemate in Congress. Although it looked for a moment that a shutdown could be averted, Trump and lawmakers are struggling to agree in time on stop-gap legislation that would extend funding until Feb. 8 for the remainder of the federal government.

Here’s a quick rundown of who will be off the clock if parts of the government are temporarily out of commission: 

  • The Food and Drug Administration will likely furlough its regulatory and policy-focused staff. Routine facility inspections will also take a backseat to emergency inspections and user-fee based work.
  • Although the National Institutes of Health is largely insulated from a government shutdown this time around, its hazardous waste research program is on pause. Appropriations for the Superfund toxic chemical research program under the National Institute of Environmental Health Sciences, part of the NIH, comes under the Interior Department, which was funded only through Dec. 21.

But there’s a good deal of activity that will not stop because of the shutdown:

  • The Department of Health and Human Services is mostly good to go for another year. Thanks to a funding bill signed in September 2018, the department is funded into the new year until Sept. 30, 2019. That includes roughly $866 billion in mandatory funding for Medicare, Medicaid, and Social Security.
  • The agency has about $90.5 billion in discretionary funding, which will be spread out among the National Institutes of Health, the Centers for Disease Control and Prevention, and the Substance Abuse and Mental Health Services Administration.
  • Work at FDA funded by user fees, which drug and device companies pay the agency to help speed up drug and device approvals, is generally expected to continue, according to Steven Grossman of the Alliance for a Stronger FDA, a pro-agency group that supports better FDA funding. Its members include various drug companies, including AbbVie and Merck, along with the leading lobbying groups for drug and biotech companies.
  • New drug applications that have already been paid for by companies via FDA user fees will likely be a higher priority than other duties, Grossman said. Routine facility inspections will not continue and almost half of FDA’s staff is expected to be furloughed, including most regulatory or policy-focused staff.
  • The National Aeronautics and Space Administration is not stopping its research on aging in space. The research is being conducted through a partnership between the National Institutes of Health and NASA. NASA and NIH officials said the research is likely to continue despite the shutdown.

Selected information in the "Pharmaceutical Science Update" is compiled from summaries and articles from Bloomberg BNA.

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