US Government Partial Shutdown And It's Repercussions Regarding FDA - FDA 2019 Lapse in Funding Information

We rely a lot on FDA to to keep all us healthy and protected. From food medicine and medical device control to food and Medicine recalls. Following is an statement released by FDA regarding the current situation.

In the absence of either an FY 2019 appropriation or a Continuing Resolution for FDA, beginning on December 22, 2018 and continuing until the date of enactment of an FY 2019 appropriation or Continuing Resolution ("lapse period"), agency 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.

The FDA plays a critical public health role. Our work protects the food that families feed their children and pets and ensures the effectiveness of the medicine they need, all of which contribute to improving the health and welfare of Americans. All our work is important, but only some of our work is permitted to continue during a lapse in funding.

During the lapse period, 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. The 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.

In addition, the FDA will continue to support activities funded by carryover user fee balances, which allows us to continue to bring new therapeutic options to the patients that need them. 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.