While mission-critical activities related to imminent safety concerns will remain largely untouched during the latest partial government shutdown, activities involving the payment of fees are now in a state of suspended animation.
The Food and Drug Administration (FDA) will continue to support activities funded by carryover user fee balances, which allows it to continue to bring new therapeutic options to patients. However, during the lapse period, the FDA will not have legal authority to accept user fees assessed for FY 2019 until an FY 2019 appropriation or Continuing Resolution for the FDA is enacted. This will mean that the FDA will not be able to accept any regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse period.
While some reviews should continue, there is a risk that agency time frames may slip, warns the Alliance for a Stronger FDA (ASF).
“It is possible that a product review could require some activity or input unavailable in the absence of appropriated resources,” ASF said. “Based on past shutdown planning, products on which user fees have already been paid (e.g., NDAs) are more likely to be staffed than earlier stage activities. However, we do not know where the precise lines are being drawn and cannot provide assurance than any given activity will be fully continued (or partly continued or not continued) during a shutdown,” it added.
Despite the partial funding freeze, the FDA will continue specific activities within the scope of its user fee funded programs, including those for prescription drugs, generic drugs, biosimilars, medical devices, animal drugs, and tobacco products. User fee work supports the approval of new medical products, the ability to review requests to conduct important clinical research, issue guidance, and other necessary activities to help patients have access to new therapies and important generic and biosimilar treatment options, FDA said in a notice posted late last week.
The FDA will also continue vital activities to respond to emergencies, manage high-risk recalls, pursue criminal enforcement work and civil investigations related to imminent threats to human health or life, review import entries to determine potential risks to health, and respond to other critical public health issues, as appropriate. The FDA will also continue to address existing critical public health challenges, including drug shortages.
Author: Michael Causey