NEWS

Government Shutdown: The Impact on the Agencies that Regulate Labs

As we go to press, the longest U.S. government shutdown in history drags on with no end in sight. And while it may not affect your lab directly, the shutdown will have an indirect impact to the extent it affects the regulatory agencies that oversee your business and healthcare operations. Here’s the rundown of the impact on some of those key agencies

The FDA

Excerpt from Current Shutdown Notice on the FDA Website

“[During the shutdown], the agency will be continuing vital activities, to the extent permitted by the law, that are critical to ensuring public health and safety in the United States.”

These “vital activities” that will continue during the shutdown include:

  • Maintaining core functions to handle and respond to emergencies, such as monitoring for and quickly responding to outbreaks related to foodborne illness and the flu;
  • Supporting high-risk food and medical product recalls when products endanger consumers and patients;
  • Pursuing civil investigations and criminal investigations when public health is imminently at risk;
  • Screening the food and medical products that are imported to the U.S. to protect consumers and patients from harmful products;
  • Addressing other critical public health issues that involve imminent threats to the safety of human life; and
  • Addressing significant safety concerns related to medical devices and other medical products.

The FDA points out that it will continue to support activities funded by carryover user fee balances, to continue to bring new therapeutic options to the patients that need them. Nevertheless, during the shutdown, the FDA won’t have legal authority to accept user fees assessed for FY 2019 until an FY 2019 appropriation or Continuing Resolution for the FDA is enacted. Result: the FDA can’t accept any regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse.

This is key, because fees paid for new drug applications before the shutdown have allowed the FDA to continue reviewing new drugs. But this funding will reportedly carry the FDA until around Feb. 1. Thereafter, new drug and pending applications will have to be put on ice since the agency can’t collect new fees during a shutdown.

In addition, it is important to note that already the FDA is not currently supporting many routine regulatory and compliance activities. This includes some medical product, animal drug, and food related activities. The FDA has also ceased routine establishment inspections, cosmetics and nutrition work, and many ongoing research activities.

CMS
The Medicare program is continuing largely without disruption during the shutdown. Other non-discretionary activities, including Health Care Fraud and Abuse Control, have also been unaffected, at least so far.

CDC
The CDC continues to focus on urgent disease outbreaks, including seasonal influenza. This includes all activity related to such outbreaks. However, if not directly related to protection of life and limiting disease progression, limits on CDC staff resources under the lapse result in more time to review, analyze, and report out public health information. The CDC is currently unable to support most non-communicable disease prevention programs, continuous updating of disease treatment and prevention recommendations, and technical assistance, analysis, and other support to state and local partners.

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