FDA Faces Challenges in U.S. Government Shutdown

As FDA heads into 2019, it faces ongoing challenges from the partial government shutdown that now is in its second week — and no relief in sight for the impasse over a southern border wall. President Trump told the press during a 1/2 cabinet meeting that he will not budge on his request for border wall funding, indicating that the shutdown will last as long as it takes to secure it.

During the impasse, FDA operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds, according to the Alliance for a Stronger FDA. Under the current plan, about 60% (10,000 employees) of the agency’s workforce continue to work without pay. Those not working are largely involved in developing regulations or administrative or policy work, the Alliance notes.

FDA says that “mission-critical, public health activities that will continue include, among other things: 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 when we believe public health is imminently at risk and pursuing criminal investigations, screening the food and medical products that are imported to the U.S. to protect consumers and patients from harmful products, and addressing other critical public health issues that involve imminent threats to the safety of human life. Mission-critical surveillance for significant safety concerns with medical devices and other medical products will also continue.”

Additionally, FDA will continue its activities funded by carryover user fee balances. However, during the shutdown, the agency says it 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.”

“The FDA regulates products that make up 20% of consumer spending,” said Alliance vice president Wayne Pines. “Forty percent of FDA’s workforce has been shut down because of an unrelated issue in an appropriations bill that doesn’t involve FDA. The Alliance will now redouble our efforts to make sure that policymakers and the public understand that FDA provides public health services that are core functions of government. When FDA is unable to perform them, the public is at unnecessary risk.”