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Focus on Regulation

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019.  Unfortunately, FDA is one of the agencies with at least some functions shut down, as was announced yesterday.  Among other things, FDA has furloughed 42% of its employees, according to a tweet from Commissioner Scott Gottlieb, M.D.  Nonetheless, Dr. Gottlieb said the agency would be “continuing vital activities, to the extent permitted by the law, that are critical to ensuring public health and safety in the United States,” including:

  • Maintaining core functions to handle and respond to emergencies,
  • Supporting high-risk food and medical product recalls,
  • Pursuing civil and criminal investigations when the public health may be imminently at risk,
  • Screening imported food and medical products,
  • Addressing other critical public health issues that involve imminent threats to the safety of human life, and
  • “Mission critical” surveillance for significant safety concerns with medical devices and other medical products.

On the other hand, until legislation making FY 2019 appropriations for FDA is enacted, the agency will not be able to:

  • Accept user fees assessed for FY 2019, or
  • Accept any regulatory submissions for FY 2019 that require a user fee payment and that are submitted during the lapse period.

According to an HHS contingency staffing plan, FDA will “be unable to support some routine regulatory and compliance activities,” including “some medical product, animal drug, and most food related activities.”  The plan says FDA “will also pause routine establishment inspections, cosmetics and nutrition work, and many ongoing research activities.”

Possible Implications for CDER-Regulated Products

The impact on CDER will be similar to the other product Centers that rely on user fees. The biggest impediment will be that FDA will not accept new applications or supplements that require a fee because fees cannot be processed during the lapse period.  Otherwise, the user fee-supported activities will generally continue.  For PDUFA, that includes the broadly defined “process for the review of human drug applications,” under Sec. 735(6) of the Act, which includes the “activities necessary for the review of human drug applications and supplements.” But based on past experience with FDA shutdowns, the absence of a significant portion of the FDA staff, over time, places a strain on CDER drug review activities, which can cause delays that indirectly affect drug review.

Implications for CDRH-Regulated Products

For medical device applications subject to user fees, FDA has communicated that:

  • It will not accept any applications subject to user fees if the user fee has not been paid and fully processed prior to the lapse in funding.
  • It will accept such filings for review if the user fee was paid and fully processed prior to the funding lapse.
  • If the user fee has been paid but not fully processed prior to the funding lapse, the application will be placed on user fee hold until the government reopens and the payment can be fully processed.

Additionally, Hogan Lovells has learned through direct agency discussions that processing of Investigational Device Exemptions is expected to continue.

Some agency correspondence is likely to be delayed, particularly for informal inquiries or those not subject to user fees.  For example, the Office of Combination Products has communicated that it is not able to read or respond to messages until either a FY 2019 appropriation or continuing resolution for FDA has been enacted. Similar communication delays are anticipated among other FDA offices.

In sum, while FDA’s review of pending applications subject to user fees is expected to continue during this partial shutdown, new applications subject to user fees will not be reviewed until such time as a FY 2019 appropriation or continuing resolution for the FDA is enacted and the fee processing office reopens.  Depending on the length of the shutdown, medical product centers may well be looking at a sizable backlog of applications to triage when the agency is fully operational again, not to mention other industry correspondence.  Thus, if the current shutdown persists, industry should anticipate that certain agency delays will likely continue for some time.

With respect to domestic and foreign inspections, it is unclear to what extent the furlough period will impact scheduling of these inspections into 2019.

In a Thursday letter to FDA employees, Dr. Gottlieb expressed sympathy for the challenges that the shutdown would impose on agency staff.  We will continue to monitor and report on how the government shutdown is affecting regulatory work in the U.S.