We rang in 2019 with a federal government shut-down. The thirty-five day shut-down commenced at midnight on December 22, 2018. On January 25, 2019, President Trump declared the government reopened and funded until February 15, 2019. In the wake of our country’s longest federal government shut-down to date, which might not even be finished, we are forced to examine the very real consequences for citizens during such times.
The effects of a long-term federal government shut-down are insurmountable. The recent shut-down impacted the Food and Drug Administration (FDA) in many ways. The FDA is a crucial player when it comes to medical products, drugs, and food safety. The recent shut down certainly effected the FDA’s ability to operate wholly, and subsequently put our country’s health at risk.
Thousands of FDA employees considered non-essential were furloughed and the FDA had to pause routine regulatory and compliance activities. For instance, during the shut-down, the FDA was unable to accept new medical product applications that required payment or to review drug applications that were not user-funded. Applications typically take several months to review. The FDA’s Center for Drug Evaluation and Research was forced to put all non-emergency over-the-counter monograph drug activities on hold because they were determined not to address immediate threats to human life and safety. More than ten drug makers were expecting FDA decisions in March, weeks after the agency was expected to run out of money. During the shutdown, the FDA used carryover “user fee” subsidies to resume review of certain applications that required a user fee, such as New Drug Applications, Biologics License Applications, and Premarket Approval applications for medical devices if the fee had already been paid. Still, the FDA was unable to accept new user fees during the shutdown. If fee payment was required, sponsors had to postpone review until the government reopened. Some companies and industry segments, such as allergenic products, discussed excepting user fees and chose to rely on budget authority. Thus, when budget authority lapsed, assessment for those products ceased, unless review was warranted because there was an emergency involving the safety of human life.
FDA foreign food inspections continued, almost normally, because they were considered essential. But the FDA basically had to stop inspecting domestic food production facilities during the shut-down. This means threats to the public, like bacteria outbreaks, were potentially going undetected. Much of FDA’s funding appropriated by Congress was put on hold. Therefore, decisions had to be made based on an analysis of importance and imminence. The most urgent inspections would be at facilities with prior safety issues, such as factories with listeria, salmonella contamination, or other hygienic problems. Next came foods that were more prone to contamination. For example, cheese might be a high-risk food, and a facility that manufactures crackers would be low risk, according to Scott Gottlieb, commissioner of the FDA.
Besides the logistical issues of ranking tasks by importance, he went on to explain how difficult the circumstances were for the employees. “We are trying to build accommodation in for people who have unusually difficult circumstances,” Gottlieb said.
As we approach mid-February, time will tell how President Trump’s three-week plan went, and what is in store for the FDA and our health moving forward.